[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hospital for Special Surgery, New York\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":628},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,36,0,25,[9,59,74,96,115,149,176,199,219,248,269,289,314,339,369,395,417,439,473,495,516,538,564,587,605],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100610370","phase-3-suzetrigine-in-total-hip-arthroplasty-100610370",false,"NCT07226700","Suzetrigine in Total Hip Arthroplasty","A Randomized, Placebo-controlled, Double-blind Trial of Suzetrigine in Total Hip Arthroplasty","Inclusion Criteria:\n\n* Patients undergoing primary THA (posterior approach) with participating surgeons\n* Age 18 to 80 years old\n* Planned discharge to home\n* Planned use of neuraxial anesthesia\n* American Society of Anesthesiologists (ASA) Physical Status 1 - 3\n\nExclusion Criteria:\n\n* ASA greater than 3\n* Chronic opioid use (daily MME of greater than 30 mg for at least 3 months and within 1 month of surgery)\n* History of chronic pain syndromes or uncontrolled pain (i.e. complex regional pain syndrome, fibromyalgia, implanted spinal cord stimulator)\n* History of QT prolongation\n* Presence of automated implantable cardioverter defibrillator, pacemaker or cardiac resynchronization device\n* Evidence of misuse, aberrant use, or addiction to alcohol or an illicitly used drug of abuse, or had a positive test for drugs of abuse\n* Inability to comply with any component of the study protocol\n* Younger than 18 or greater than 80 years old at the time of enrollment\n* Patient already on Suzetrigine\n* Allergy or contraindication to Suzetrigine or excipients (eg moderate to severe liver disease\u002FChild Pugh B or C, use of strong CYP3 inhibitors or inducers)\n* Contraindications to neuraxial anesthesia or any other part of the study protocol\n* Participation in another investigational drug or device study\n* Pregnancy",true,"ALL","18 Years","80 Years",{"count":22,"type":23},210,"ESTIMATED","INTERVENTIONAL",[26],"PHASE3","Total hip and knee joint replacements are among the most common and painful orthopedic procedures performed worldwide, often requiring intensive analgesia to support early ambulation and recovery. Despite widespread use of multimodal regimens, many patients still rely on opioids, which can cause sedation, nausea, constipation, and long-term dependency. Evaluating Suzetrigine in this high-need population may improve recovery trajectories, reduce opioid consumption, and support enhanced recovery protocols. Given the growing surgical volume and the emphasis on opioid-sparing strategies, rigorous investigation of Suzetrigine's efficacy in joint replacement is of high clinical value. In this study, patients undergoing primary total hip replacement will be randomized to receive either Suzetrigine or placebo for seven days, with the loading dose administered prior to surgery. The primary outcome is cumulative 48-hour opioid consumption in oral morphine equivalents starting from entry into the post-anesthesia care unit (PACU).",[29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45],"Total Hip Arthroplasty (THA)","Total Hip Arthroplasty \\(THA\\)","Total Hip Replacement","Total Hip Replacement Surgery","Total Hip Replacements","Total Hip Replacement Arthroplasty","Suzetrigine","Pain Management","Pain","Nav 1.8","JOURNAVX","Opioid Cessation","Opioid Consumption, Postoperative","Multimodal Analgesia","Randomized Controlled Trial","Randomized Controlled Study","Randomized Controlled Trials","RECRUITING","2026-06-02",{"date":49,"type":50},"2026-06-03","ACTUAL",{"date":52,"type":50},"2025-11-03",{"date":54,"type":23},"2028-11-01",{"name":56,"class":57},"Hospital for Special Surgery, New York","OTHER",1,{"id":60,"slug":61,"hasResults":12,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":4,"eligibilityCriteria":64,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":65,"phases":4,"briefSummary":66,"conditions":67,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":73,"locationsCount":58},"100227924","humanitarian-use-of-avanta-orthopaedics-proximal-interphalangeal-joint-100227924","NCT02244788","Humanitarian Use of AVANTA Orthopaedics Proximal Interphalangeal Joint","Inclusion Criteria:\n\n* patient is in need of a revision of failed PIP prosthesis(es)\n* patient expects to place his\u002Fher hands under loading situations which preclude the use of an alternative implant in the painful osteo-arthritic and post traumatic arthritic PIP joint\n\nExclusion Criteria:\n\n* patient is not in need of a revision of a failed PIP prothesis(es)\n* patient is eligible to use an alternative implant","EXPANDED_ACCESS","The purpose of this study is to allow patients to undergo surgery with the SR™ PIP (Proximal Interphalangeal) Implants for finger arthritis. This is NOT a research study, but rather, a requirement by the FDA for humanitarian use of device",[68],"Arthroplasty of the PIP Joint","AVAILABLE","2026-05-12",{"date":72,"type":50},"2026-05-14",{"name":56,"class":57},{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":58},"100590757","cervical-radiculopathy-imaging-using-mrn-with-electrodiagnostic-correlation-100590757","NCT06971575","Cervical Radiculopathy Imaging Using MRN With Electrodiagnostic Correlation","Cervical Radiculopathy Imaging Using MR Neurography With Electrodiagnostic Correlation","Inclusion Criteria:\n\n* Patients presenting with symptoms compatible with acute or subacute unilateral (one-sided) cervical radiculopathy and signs of clinical weakness\n* 18-60 years old at the time of evaluation\n* Symptom onset of 2 to 12 weeks leading up to baseline visit\n* Diagnosis of unilateral cervical radiculopathy, with or without spinal cord compression, based on signs and symptoms, physical exam and supported by MRI findings of radiculopathy (as evidenced by foraminal stenosis\u002Fnarrowing) based on standard-of-care cervical spine MRI\n* Patients who have undergone or have planned electrodiagnostic testing at HSS prior to surgery\n\nExclusion Criteria:\n\n* Prior cervical surgery or instrumentation\n* Those who have had a prior episode of cervical radiculopathy\n* History of peripheral neuropathy or another acute or chronic neurodegenerative condition\n* History of stroke, cerebellar disease, or central nervous system disease\n* Contraindications to undergoing a standard MRI examination (e.g., pregnancy)\n* Patients presenting with bilateral cervical radiculopathy","60 Years",{"count":83,"type":23},20,"OBSERVATIONAL","This project will study patients with cervical radiculopathy. We will evaluate the combined diagnostic and prognostic value of magnetic resonance neurography (MRN), electrodiagnostic (EDX) studies, and historical and physical clinical elements. Specifically, this project will explore whether these data individually or in combination correlate with response to procedural and non-procedural treatment.",[87],"Cervical Radiculopathy","2026-04-23",{"date":90,"type":50},"2026-04-27",{"date":92,"type":50},"2023-10-24",{"date":94,"type":23},"2026-10",{"name":56,"class":57},{"id":97,"slug":98,"hasResults":12,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":109,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":4},"100588765","dei-education-in-anesthesiology-100588765","NCT06945653","DEI Education in Anesthesiology","An Assessment of Diversity, Equity and Inclusion Education in Anesthesiology: A Survey of the American Society of Anesthesiologists (ASA) Members","Inclusion Criteria:\n\n* American Society of Anesthesiologist Member\n\nExclusion Criteria:\n\n* Not a member of the American Society of Anesthesiologists",{"count":104,"type":23},3000,"To date, there has not been an assessment of ASA members to determine satisfaction with DEI and cultural humility\u002Fstructural competency education within institutions and programs. We developed a 24-question survey that will be distributed via email to current members of the American Society of Anesthesiologists. Members include learners at all levels - medical students, residents and fellows - as well as attending anesthesiologists, CRNAs, research staff etc. The survey questions are aimed to assess the current state of diversity training in anesthesiology education. This survey serves as a needs assessment and will help gather information on the current state of DEI education within the specialty. The results of the survey will serve as an impetus for improvement in this domain by developing novel educational modules and workshops on these topics, at the institutional level and nationwide.",[107],"Diversity","NOT_YET_RECRUITING",{"date":90,"type":50},{"date":111,"type":23},"2026-05",{"date":113,"type":23},"2026-07",{"name":56,"class":57},{"id":116,"slug":117,"hasResults":12,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":123,"enrollmentInfo":124,"targetDuration":4,"studyType":24,"phases":126,"briefSummary":128,"conditions":129,"keywords":134,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":143,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":58},"100584741","impact-of-bone-marrow-aspirate-injections-in-knee-arthroscopy-100584741","NCT06893302","Impact of Bone-Marrow Aspirate Injections in Knee Arthroscopy","Bone Marrow Aspirate Injections in Knee Arthroscopy: A Randomized, Single-Blind, Controlled Trial","BMA","Inclusion Criteria:\n\n1. Require a primary knee arthroscopy for a meniscal injury or focal chondral defect (knee debridement or meniscectomy)\n2. Have Kellgren-Lawrence grade 0 arthritis\n3. Have Outerbridge cartilage grade 2 or lower\n4. Ages 18-64\n\nExclusion Criteria:\n\n1. Have previously undergone ipsilateral knee surgery\n2. Have Kellegren-Lawrence grade 3 or greater\n3. Have received other OrthoBiologics within 3 mo of surgery\n4. Have ligament deficiencies\n5. Need meniscal repair\n6. Need a concomitant osteotomy or other realignment surgery\n7. Have used DMARDs within the last three months\n8. Have a hx of anemia, bleeding disorders, or inflammatory joint disease (rheumatoid arthritis, infectious arthritis, hemophilic arthropathy, Charcot's knee)\n9. Have a hx of metabolic bone disease (osteoporosis, osteomalacia, rickets, osteitis fibrosa cystica, Paget's disease of bone)\n10. Patients who are currently pregnant","64 Years",{"count":125,"type":23},50,[127],"NA","This study will examine whether using bone marrow aspirate (BMA) during knee arthroscopy surgery can improve patient outcomes. The investigators will enroll 50 patients who need knee arthroscopy surgery for meniscus injuries or cartilage damage. Like flipping a coin, patients will be randomly assigned to one of two groups of 25 patients each. One group will receive standard arthroscopic surgery plus an injection of bone marrow aspirate, while the other group will receive standard surgery plus a saline (salt water) injection. During surgery, for patients in the treatment group, approximately 4mL (less than one teaspoon) of bone marrow will be taken from their hip bone using a special needle system. A small amount (1mL) will be sent to the laboratory for testing. Patients will be followed for 12 months after surgery and will complete questionnaires about their pain levels and knee function at several time points: before surgery, 2 weeks, 6 weeks, 3 months, 6 months, and 12 months after surgery. These questionnaires will ask about pain, daily activities, and overall improvement.",[130,131,132,133],"Chondral Lesion of the Knee","Meniscal Injuries","Cartilage Defects of the Knee","Osteoarthritis (OA) of the Knee",[135,136,137,138,139,140,141,142,121],"knee arthroscopy","meniscal injury","knee debridement","meniscectomy","osteoarthritis","cartilage defect","chondral lesion","bone marrow aspirate",{"date":90,"type":50},{"date":145,"type":23},"2026-06",{"date":147,"type":23},"2029-04",{"name":56,"class":57},{"id":150,"slug":151,"hasResults":12,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":12,"sex":18,"minAge":156,"maxAge":20,"enrollmentInfo":157,"targetDuration":4,"studyType":24,"phases":159,"briefSummary":160,"conditions":161,"keywords":165,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":173,"leadSponsor":175,"locationsCount":58},"100584967","fiber-smoothie-supplement-100584967","NCT06896240","Fiber Smoothie Supplement","The Impact of a Daily Whole Food Plant-based Smoothie Utilization 2 Weeks Prior to Revision Total Knee Replacement Surgery on Inflammation and Post-operative Pain.","Inclusion:\n\n* Scheduled for revision TKA at HSS with participating surgeons; not as a result of infection or trauma and all components (tibial and femoral) needing replacement\n* Age between 40 and 80\n* Diagnosed with osteoarthritis\n* Diagnosed with 2+ modifiable chronic lifestyle diseases: Type 2 DM, CVD (such as CAD, heart disease, stroke, HTN), stress, anxiety, depression, ADHD, metabolic syndrome, certain types of cancer (such as breast, colorectal, lung, prostate), Alzheimer's disease, vascular cognitive impairment, CKD, RA, asthma, chronic pain conditions (such as chronic back pain and osteoarthritis), fibromyalgia, migraines, COPD (Steiber 2011, Grant 2014)\n* ASA Class 1 ('normal' healthy patient) or 2 (patient with mild systemic disease and no functional limitations; the diseases the patient has are well controlled)\n* Ability to understand written and spoken English\n* Willing to complete entire pre-operative and post-operative work up in NYC, main campus site\n* Willing to follow a 2-week smoothie supplement, including willingness to purchase ingredients and have access to a blender for preparation\n\nExclusion:\n\n* Age \\>80 years or \\\u003C40 years\n* Revision due to infection or trauma\n* ASA class 3 (patient with severe systemic disease that results in functional limitations) or 4 (patient with severe systemic disease that is a constant threat to life)\n* Not interested or unable to provide informed consent\n* Unstable weight (\\>5kg weight change in the past 3 months, documented in Epic) or currently on weight loss drugs such as GLP-1 agonists (Prasad et al., Cardiovasc Diabetol 2022; empagliflozin CRP studies.)\n* Active infection, flare-up of seasonal allergies, or physical trauma (all can alter CRP)\n* Medication changes the month leading up to surgery\n* Specifically medications altering inflammation: Statins (Ridker 2008), steroids (Boumpas et al., Ann Intern Med 1993; glucocorticoid cytokine modulation research.), DMARDS\u002Fbiologics\u002Fimmunosuppressants (Clinical rheumatology guidelines, biologic RCTs (e.g., TNF inhibitors, IL-6 inhibitors), Colchicine (Tardif et al., N Engl J Med 2019; colchicine cardiovascular inflammation studies.), hormone replacement therapies (Ridker et al., JAMA 1999; OCs and CRP meta-analyses.), new psychiatric medications (Miller \\& Raison, Nat Rev Immunol 2016; psychotropic-inflammation associations.)\n* BMI \\>40 kg\u002Fm2\n* Food intolerance\u002Fallergy\u002Fsensitivity to ingredients suggested for smoothies\n* History of IBD (and IBD medication)\n* History of bariatric surgery\n* History of cancer\n* History of thyroid disease\n* History of or current drug abuse\n* Pregnancy\n* Current smoker\n* Any patient with an electronic cardiac implant","40 Years",{"count":158,"type":23},24,[127],"This study aims to assess the feasibility of a 2-week dietary whole-food smoothie intervention and compare outcomes between two groups: patients that integrated a daily whole food plant-based smoothie into their diet for two weeks prior to surgery, and a control group of revision TKA patients that made no nutritional changes to their diet prior to surgery. The main research questions are:\n\n1. Among patients planned for elective TKA revision surgery, what is the feasibility of a 2-week dietary intervention implemented 2 weeks prior to surgery? \\[Outcomes will be compliance, noted barriers and\u002For facilitators, satisfaction with diet\\]\n2. Determine if the implementation of a daily whole food plant- based smoothie dietary supplement 2 weeks prior to TKA revision surgery will reduce inflammation -measured in plasma levels of IL-6 and CRP- at POD0, POD1, POD2, POD3, and 6 Weeks Post-operative as compared to 1) baseline (prior to dietary intervention initiation) and 2) control patients who did not make changes in their diet prior to surgery.\n3. Determine if the implementation of a daily whole food plant-based smoothie dietary supplement 2 weeks prior to TKA revision surgery will result in quantifiable changes in the gut microbiome composition -measured via fecal samples- as compared to control patients who did not make changes in their diet prior to surgery.\n4. Determine if the implementation of a daily whole food plant- based smoothie dietary supplement 2 weeks prior to TKA revision surgery will result in improved immediate postoperative pain -measured through numeric rating scale (NRS) pain scores- and opioid use -measured in morphine milligram equivalents (MME)- as compared to control patients.\n5. Compare patient satisfaction and adoption of nutritional behavioral changes in patients implementing a whole food plant-based smoothie 2 weeks prior to TKA revision surgery to patients undergoing the same surgery but did not me pre-surgery dietary changes.\n\nThe researcher's primary outcome is measuring feasibility and patient compliance with smoothie consumption. Secondarily, the investigators are interested in measuring if the preoperative smoothie can alter the gut microbiome and decrease systemic inflammation, leading to lowered post-operative pain and opioid use.",[162,163,164],"Total Knee Arthroplasty Revision","Inflammatory Markers","Gut Microbiota",[166,167,168,169],"TKA Revision","Inflammation","Diet","Gut Microbiome",{"date":171,"type":50},"2026-04-28",{"date":111,"type":23},{"date":174,"type":23},"2028-01-01",{"name":56,"class":57},{"id":177,"slug":178,"hasResults":12,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":183,"enrollmentInfo":184,"targetDuration":4,"studyType":24,"phases":186,"briefSummary":187,"conditions":188,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":193,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":58},"100443736","phase-3-lumbar-steroid-use-in-patients-undergoing-posterior-lumbar-decompression-100443736","NCT05058287","Lumbar Steroid Use in Patients Undergoing Posterior Lumbar Decompression","Topical Epidural Steroid Usage in Patients Undergoing Posterior Lumbar Decompression: A Randomized Control Trial","Inclusion Criteria:\n\n* Patients scheduled to undergo 1 to 2 level laminectomy\n* Between the ages of 18-85\n\nExclusion Criteria:\n\n* Minimally invasive surgery\n* Prior daily opioid usage within 6 months.\n* Use of concomitant procedures such as spinal fusion, revision procedure at the same level.\n* History of a chronic pain syndrome, uncontrolled diabetes defined as A1C \\> 6.5, immunocompromised condition such as active cancer treatment, history of transplant, benign prostatic hyperplasia or history of urinary retention, and other conditions which require chronic steroid therapy or immunosuppressants.\n* Non-English speakers\n* Patients allergic to Depo-Medrol and\u002For glucocorticoids, or other steroids","85 Years",{"count":185,"type":23},150,[26],"This study seeks to evaluate the impact of intra-operative topical epidural steroid usage in patients undergoing 1-2 level lumbar laminectomy. The study will examine post-operative opioid usage, length of stay, return to work, and patient reported outcomes following these procedures.",[189,190,191,192],"Opioid Use","Lumbar Spinal Stenosis","Pain, Postoperative","Pain, Back",{"date":171,"type":50},{"date":195,"type":50},"2021-11-05",{"date":197,"type":23},"2026-12-31",{"name":56,"class":57},{"id":200,"slug":201,"hasResults":12,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":81,"enrollmentInfo":206,"targetDuration":4,"studyType":24,"phases":208,"briefSummary":209,"conditions":210,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":213,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":58},"100417833","categorized-pt-for-non-arthritic-hip-and-groin-pain-100417833","NCT04720846","Categorized PT for Non-arthritic Hip and Groin Pain","Assessment of a Categorized Physical Therapy Protocol for Non-arthritic Hip and Groin Pain: a Randomized Controlled Study","Inclusion Criteria:\n\n* New patient presenting with non-arthritic hip impingement, hip pain, and groin pain (Tonnis 0-1)\n* 18-60 years old\n\nExclusion Criteria:\n\n* Arthritic hip pain (Tonnis 2+)\n* \\\u003C18 and \\>60 years old\n* History of spinal fusion surgery\n* History of low back pain with radicular pain\n* History of hip arthroscopy\n* History of inflammatory conditions, and other concurrent problems interfering with hip therapy (i.e., concurrent back\u002Fknee\u002Ffoot\u002Fankle\u002Fshoulder issues)\n* Patients currently taking TNF-alpha inhibitors for inflammatory conditions\n* History of prior knee osteotomy\n* Non-English speakers",{"count":207,"type":23},70,[127],"There is currently limited literature on a categorized physical therapy protocol for management of hip pain. Only a handful of studies have looked at the treatment of osteoarthritis of the hip with a standardized physical therapy treatment, primarily looking at manual therapy versus exercise therapy protocols. However, there are no studies observing the effect of a standardized physical therapy program on patients presenting with non-arthritic hip and groin pain. Based on the gap in the literature, this study will aim to assess the effect of matrix-based standard of care therapy in patients presenting with non-arthritic hip and groin pain.",[211,212],"Hip Pain","Groin Pain",{"date":171,"type":50},{"date":215,"type":50},"2020-12-02",{"date":217,"type":23},"2027-02",{"name":56,"class":57},{"id":220,"slug":221,"hasResults":12,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":4,"eligibilityCriteria":225,"healthyVolunteers":17,"sex":18,"minAge":226,"maxAge":227,"enrollmentInfo":228,"targetDuration":4,"studyType":24,"phases":230,"briefSummary":232,"conditions":233,"keywords":235,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":242,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":58},"100374214","phase-4-effects-of-bisphosphonates-on-oi-related-hearing-loss-100374214","NCT04152551","Effects of Bisphosphonates on OI-Related Hearing Loss","Effects of Bisphosphonates on OI-Related Hearing Loss: A Pilot Study","Inclusion Criteria (Adult Treatment Arm):\n\n* Diagnosis of OI type I\n* Diagnosis of at least mild hearing loss (\\>20dB pure tone average) by audiogram testing\n* 18+\n* Vitamin D level \\> 30\n\nInclusion Criteria (Adult Control Arm):\n\n* Diagnosis of OI type I\n\nInclusion Criteria (Child Observational Bisphosphonate Arm)\n\n* Diagnosis of OI\n* Age 6-17 years\n* Currently receiving bisphosphonate treatment as standard of care\n\nInclusion Criteria (Child Observational No Treatment Arm)\n\n* Diagnosis of OI\n* Age 6-17 years\n* NOT receiving bisphosphonate treatment and will not receive bisphosphonate treatment for the duration of the study\n\nExclusion Criteria (ALL ARMS):\n\n* Family history of hearing-loss (not related to OI or occupational hearing loss)\n* Pregnancy","6 Years","100 Years",{"count":229,"type":23},100,[231],"PHASE4","Osteogenesis Imperfecta-related hearing loss usually occurs in individuals with mild (type I) OI and is much earlier in onset than age-related hearing loss, with the majority of individuals experiencing some minor hearing loss in their 20s. Bisphosphonates have been successfully used to treat otosclerosis, a common cause of hearing loss similar to OI-related hearing loss. As many individuals with OI-related hearing loss also present with otosclerosis and because of their mechanistic similarities, the investigators propose studying the effects of bisphosphonate treatment on individuals diagnosed with both OI type I and hearing loss, thereby determining its effectiveness as a potential treatment for hearing loss.\n\nThe investigators will enroll 50 individuals diagnosed with type I OI and age 18-100. 25 adults will be enrolled into the treatment arm and receive bisphosphonate treatment (must have at least mild hearing loss), while 25 adults will be enrolled into the control arm. The investigators will enroll 25 children (6-17 years of age) diagnosed with OI who are currently receiving bisphosphonate treatment as part of their care for orthopedic symptoms. The investigators will also observe 25 children (6-17 years of age) diagnosed with OI who are NOT currently receiving bisphosphonate treatment. The study duration is 63 months (approximately 5 years). Enrollment is anticipated to begin in November 2019.",[234],"Osteogenesis Imperfecta",[236,237,238,239,240,241],"hearing loss","bisphosphonate","skeletal dysplasia","brittle bone disorder","osteogenesis imperfecta","OI",{"date":171,"type":50},{"date":244,"type":50},"2019-11-02",{"date":246,"type":23},"2027-01",{"name":56,"class":57},{"id":249,"slug":250,"hasResults":12,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":254,"eligibilityCriteria":255,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":256,"enrollmentInfo":257,"targetDuration":4,"studyType":24,"phases":259,"briefSummary":260,"conditions":261,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":263,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":58},"100343092","enhanced-recovery-after-surgery-eras-total-knee-replacement-tkr-with-a-transitional-pain-service-100343092","NCT03747146","Enhanced Recovery After Surgery (ERAS) Total Knee Replacement (TKR) With a Transitional Pain Service","Expanding the Peri-operative Surgical Home Model: ERAS TKR With a Transitional Pain Service (TeleTPS)- Continuous Adductor Canal Catheter Versus Adductor Canal Block for Total Knee Arthroplasty, a Randomized Double-blind Controlled Trial","EKAT-TeleTPS","Inclusion Criteria:\n\n* Patients with osteoarthritis scheduled for a primary total knee arthroplasty with a participating surgeon\n* Planned use of regional anesthesia\n* Ability to follow study protocol\n* English speaking (secondary outcomes include questionnaires validated in English only)\n* Lives within one hour of the hospital\n* Has a smart phone\n\nExclusion Criteria:\n\n* Hepatic or renal insufficiency\n* Younger than 18 years old or older than 65 years ol\n* Patients undergoing general anesthesia\n* Allergy or intolerance to one of the study medications\n* BMI \\>40\n* Diabetes\n* American Society of Anesthesiologists (ASA) status III or IV\n* Chronic gabapentin\u002Fpregabalin use (regular use for longer than 3 months)\n* Patients with chronic pain (from a referral to chronic pain service) or a pain catastrophizing scale (PCS \\>30)\n* Patients with severe valgus deformity or flexion contracture\n* Patients unable to follow home catheter instructions and unwilling to go home with an infusing catheter\n* Patients who have no home caregivers in the event that a catheter is to be sent home with the patient\n* Patients with planned stay at rehab facility (to avoid medical device being tampered with at the rehab facility)\n* Non-English speakers (secondary outcomes include questionnaires validated in English only)","65 Years",{"count":258,"type":23},94,[127],"A comparison of two anesthetic techniques for total knee replacements: (1) Peri-Articular Injection (PAI), local infiltration between the popliteal artery and capsule of the knee block (IPACK) and single-shot adductor canal block (ACB) vs. (2) PAI, IPACK and continuous adductor canal block catheter (ACC).",[262],"Anesthesia",{"date":171,"type":50},{"date":265,"type":50},"2018-11-16",{"date":267,"type":23},"2026-12",{"name":56,"class":57},{"id":270,"slug":271,"hasResults":12,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":4,"eligibilityCriteria":275,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":276,"targetDuration":4,"studyType":24,"phases":277,"briefSummary":278,"conditions":279,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":283,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":58},"100328210","phase-3-tranexamic-acid-in-adult-spinal-deformity-surgery-100328210","NCT03553186","Tranexamic Acid in Adult Spinal Deformity Surgery","Topical Tranexamic Acid as a Adjunct to Intravenous Tranexamic Acid in Adult Spinal Deformity Surgery","Inclusion Criteria:\n\n* Age 18-80\n* Scheduled to undergo posterior long segment ( ≥ 5 levels) posterior spinal fusion for adult scoliosis or degenerative joint diseae\n* \\+ fusion to pelvis\n\nExclusion Criteria:\n\n* Surgical factors:\n\n  * Anterior Approach\n  * Presence or history of dural tear without repair as evidenced by pseudomeningocele on MRI imaging or by intraoperative exploration\n  * Patients donating autologous blood preoperatively\n\nPatient factors:\n\n* Diagnosis of renal (Cr\\>1.5 or CrCl \\\u003C30ml\u002Fmin) or hepatic insufficiency (AST, ALT 2x upper limit of normal)\n* Diagnosis of seizure disorder or prior seizure\n* History of thromboembolic events (CVA, TIA, DVT, PE) if within 1 year of surgery\n* Hypercoagulability (e.g. antiphospholipid syndrome)\n* History of coronary artery disease (stent, MI, +stress test) within 1 year of surgery\n* Atrial fibrillation\n* Concurrent anticoagulation therapy that cannot be discontinued within 3 days before surgery (Coumadin, plavix, LVX)\n* Concurrent anticoagulation with ASA 325 that cannot be discontinued 10 days before surgery\n* Bleeding disorder or abnormal preoperative coagulation profile (as identified by a preoperative platelet count of \\\u003C100,000\u002Fmm3, an international normalized ratio of \\>1.4, or a prolonged partial thromboplastin time \\>1.4 times normal)\n* Preexisting anemia \\\u003C10 g\u002FdL\n* Color blindness or disturbance of color vision\n* Leukemia or active cancer\n* Religious restrictions on blood transfusion\n* Pregnancy or women who are lactating\u002Fbreastfeeding",{"count":229,"type":23},[26],"Posterior spinal surgery for adult deformity is associated with high incidence of blood loss and need for blood transfusion and intraoperative blood salvage, with associated increased cost and risk for perioperative complications. Tranexamic acid (TXA) is relatively inexpensive anti-fibrinolytic agent that has been proven effective for decreasing intraoperative blood loss in various surgical specialties. Intravenous TXA (ivTXA) is routinely used at our institution for adult spinal deformity cases. Meanwhile, topical TXA (tTXA) is an attractive alternative\u002Fadjunct to ivTXA used with good results in orthopedic arthroplasty and cardiac surgery. To the investigators' knowledge, no data exists in the literature on the use of tTXA in either adult or pediatric spinal deformity surgery. The goal of this study is to determine the role tTXA has an adjunct to ivTXA in decreasing perioperative blood loss, drainage, transfusion requirements and length of stay following adult deformity spine surgery.",[280,281,282],"Spinal Deformity","Degenerative Lumbar Spinal Stenosis","Blood Loss, Surgical",{"date":171,"type":50},{"date":285,"type":50},"2018-07-11",{"date":287,"type":23},"2027-03",{"name":56,"class":57},{"id":290,"slug":291,"hasResults":12,"nctId":292,"briefTitle":293,"officialTitle":293,"acronym":294,"eligibilityCriteria":295,"healthyVolunteers":17,"sex":296,"minAge":19,"maxAge":297,"enrollmentInfo":298,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":300,"conditions":301,"keywords":304,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":308,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":312,"locationsCount":313},"100072565","predictors-of-pregnancy-outcome-in-systemic-lupus-erythematosus-sle-and-antiphospholipid-syndrome-aps-100072565","NCT00198068","Predictors of Pregnancy Outcome in Systemic Lupus Erythematosus (SLE) and Antiphospholipid Syndrome (APS)","PROMISSE","Inclusion Criteria:\n\n* Patient pregnant with live intrauterine pregnancy, as defined by positive test for elevated β-HCG, but ≤ 12 weeks by gestation (for subjects without aPL antibodies) and ≤18 weeks (for subjects with aPL antibodies)\n* Patient between the ages of 18-45 and able to give informed consent, or age \\\u003C 18 years with parental consent\n* Hematocrit \\> 26%\n* For APL positive:\n\n  * aCL: IgG \\>= 40 GPL units; IgM \\>= 40 MPL units\n  * Positive LAC (RVVT, Kaolin, dilute TTI or PTT LA)\n  * Anti-β2GPI: IgG \\>= 40 GPL units; IgM \\>= 40 MPL units\n* For control subjects:\n\n  * At least one successful pregnancy\n  * No history of fetal death (death of conceptus ≥ 10 weeks' gestation)\n  * No more than 1 miscarriage \\\u003C 10 weeks' gestation\n  * No history of positive aPL in local lab or positive aPL in core labs at screening\n  * Not currently a smoker\n  * No medical problems requiring chronic treatment\n\nExclusion Criteria:\n\n* Diabetes mellitus (Type I and Type II) antedating pregnancy\n* Known or suspected hereditary complement deficiency (defined by CH50 = 0)","FEMALE","45 Years",{"count":299,"type":23},700,"The PROMISSE Study is an observational study of 700 pregnant patients, enrolled at nine major clinical centers. The purpose of the study is 1) to determine whether certain proteins (called complement split products) that can injure healthy organs can be used to predict poor pregnancy outcome in patients with systemic lupus erythematosus (SLE) and anti-phospholipid syndrome (APS), and\u002For 2) to determine whether elevated levels of circulating antiangiogenic factors predict pregnancy complications in patients with aPL antibodies and\u002For SLE.",[302,303],"Systemic Lupus Erythematosus","Antiphospholipid Syndrome",[305,306,307],"Pregnancy outcomes","Systemic lupus erythematosus","Antiphospholipid syndrome",{"date":171,"type":50},{"date":310,"type":4},"2003-09",{"date":287,"type":23},{"name":56,"class":57},10,{"id":315,"slug":316,"hasResults":12,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":4,"eligibilityCriteria":320,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":321,"targetDuration":4,"studyType":24,"phases":323,"briefSummary":324,"conditions":325,"keywords":328,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":58},"100635417","does-joint-immobilization-following-revision-total-knee-arthroplasty-improve-range-of-motion-following-surgery-100635417","NCT07552415","Does Joint Immobilization Following Revision Total Knee Arthroplasty Improve Range of Motion Following Surgery?","Does Joint Immobilization Following Revision Total Knee Arthroplasty (rTKA) Improve Range of Motion Following Surgery?","Inclusion Criteria:\n\n* Patients undergoing revision TKA for aseptic indications including aseptic loosening, polyethylene wear, instability, malalignment, periprosthetic fracture.\n* Patients undergoing revision TKA of one or both components.\n\nExclusion Criteria:\n\n* Patients who are undergoing revision TKA for stiffness.\n* Patients with occult infection not recognized prior to revision.\n* Patients with hinged TKA component reconstructions.\n* Patients undergoing revision for liner exchange.\n* History of VTE\u002FPE.\n* Patients on pre-operative anticoagulation.\n* BMI ≥ 40.\n* Patients with preoperative opioid use equal to or exceeding 150 Morphine Milligram Equivalents (MMEs)\u002Fday within 90 days of revision TKA.",{"count":322,"type":23},170,[127],"The goal of this study is to evaluate if knee immobilization for 10 days following revision total knee arthroplasty (rTKA) improves knee joint range of motion at 3 months postoperatively compared to standard of care postoperative protocol.\n\nParticipants will be assigned to one of two groups.\n\nOne group will wear a knee brace that keeps the knee straight for 10 days after surgery and will not perform knee range of motion exercises during that time. The other group will not wear a brace and will follow the standard physical therapy program, including knee range of motion exercises, starting after surgery.",[326,327],"Aseptic Revision Knee Arthroplasty","Stiffness Following Revision Knee Arthroplasty",[329,330,331],"revision arthroplasty","stiffness","knee swelling","2026-04-20",{"date":90,"type":50},{"date":335,"type":23},"2026-04",{"date":337,"type":23},"2028-04",{"name":56,"class":57},{"id":340,"slug":341,"hasResults":12,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":4,"eligibilityCriteria":345,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":346,"enrollmentInfo":347,"targetDuration":4,"studyType":24,"phases":349,"briefSummary":350,"conditions":351,"keywords":354,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":363,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":368,"locationsCount":58},"100479254","preoperative-oral-hydration-in-the-ambulatory-arthroplasty-population-100479254","NCT05520593","Preoperative Oral Hydration in the Ambulatory Arthroplasty Population","Preoperative Oral Hydration in the Ambulatory Arthroplasty Population :A Single-Blinded Randomized Control Trial","Inclusion Criteria:\n\n* Candidates for ambulatory total knee arthroplasty\n* Candidates for ambulatory total hip arthroplasty\n* Candidates for ambulatory revision knee arthroplasty (liner exchange only)\n* Candidates for ambulatory revision hip arthroplasty (liner exchange only)\n* Case scheduled before noon (12 pm)\n* Patient agrees to same-day discharge and has a responsible adult to spend the night on the day of discharge\n\nExclusion Criteria:\n\n* BMI less than 18.5 or greater than 37.0\n* Patients with diabetes, chronic kidney disease, clotting disorders, or neurological conditions preventing control of the affected limb.\n* Pregnant women\n* Patients scheduled as ambulatory due to insurance mandates\n* Patients with a history of active ischemia, significant valvular disease, significant arrhythmias, obstructive sleep apnea as per Hospital for Special Surgery guidelines, chronic opioid dependence (chronic daily opioid use for six or more months), and glomerular filtration rate \\\u003C 60ml\u002Fmin.","75 Years",{"count":348,"type":23},312,[127],"The purpose of this study is to investigate if the consumption of a complex carbohydrate drink preoperatively, decreases the length of stay and causes for failure to launch in patients undergoing ambulatory total joint arthroplasty.",[352,353],"Same-day Discharge","Length of Stay",[355,356,352,357,358,359,360,361],"Carbohydrate Drink","Perioperative Fluids","Total Joint Arthroplasty","Nausea","Vomiting","Same-day total hip arthroplasty","Same-day total knee arthroplasty","2026-04-08",{"date":364,"type":50},"2026-04-13",{"date":366,"type":50},"2022-11-07",{"date":246,"type":23},{"name":56,"class":57},{"id":370,"slug":371,"hasResults":12,"nctId":372,"briefTitle":373,"officialTitle":374,"acronym":4,"eligibilityCriteria":375,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":376,"targetDuration":4,"studyType":24,"phases":378,"briefSummary":379,"conditions":380,"keywords":385,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":58},"100631825","comparing-original-patient-educational-materials-vs-ai-simplified-materials-to-improve-patient-comprehension-and-health-literacy-100631825","NCT07505719","Comparing Original Patient Educational Materials vs. AI-Simplified Materials to Improve Patient Comprehension and Health Literacy","AI-Simplified Patient Educational Materials: Investigating the Potential for Improved Patient Comprehension and Health Literacy","Inclusion Criteria:\n\n* Parents or guardians of pediatric patients receiving treatment at Hospital for Special Surgery\n\nExclusion Criteria:\n\n* Non-English Speaking\n* primary occupation is in healthcare\n* participants with prior knowledge on the condition pertaining to the material (osteogenesis imperfecta)",{"count":377,"type":23},80,[127],"Poor health literacy and patient comprehension have been associated with adverse health outcomes. Patient educational materials (PEMs) are articles that are intended to assist patients in their understanding of a given medical condition. Given that the average American adult reads at the 8th grade level, the American Medical Association and the Center for Disease Control recommend PEM be written at the 6th grade level. However, literature has found the majority of PEMs to be written significantly higher than the 8th grade level. In order to improve their readability, a number of studies have displayed the effectiveness of large language models (LLMs) such as ChatGPT to simplify the text of a given PEM. Despite the improvement in readability, the effectiveness of these simplified PEMs on improving patient comprehension of the AI augmented material has yet to be investigated.\n\nThe purpose of our study is to test whether the improvement in readability found in AI-simplified PEMs corresponds to a greater understanding of the material compared to the original PEM. Understanding if AI-simplified PEM truly improves comprehension could further support this use case for AI and aid providers and healthcare organizations in improving the health literacy of their patients.\n\nThis study aims to answer the following question:\n\nDo AI simplified PEMs improve the comprehension of pediatric orthopaedic conditions?\n\nResearchers will compare AI-simplified PEMs to their original, unmodified counterparts in order to see if there is any difference in post reading comprehension of the participants.\n\nParticipation in the study will include:\n\n* A brief baseline survey (e.g. demographics and educational attainment)\n* A randomly assigned reading of either the original PEM or the AI simplified version.\n* A 10 question post-reading multiple choice quiz",[381,382,383,384],"Artificial Intelligence (AI)","Health Literacy","Patient Comprehension","Patient Educational Material",[386,382,383,384],"Artificial Intelligence","2026-04-02",{"date":389,"type":50},"2026-04-03",{"date":391,"type":50},"2026-02-13",{"date":393,"type":23},"2027-05",{"name":56,"class":57},{"id":396,"slug":397,"hasResults":12,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":401,"eligibilityCriteria":402,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":403,"targetDuration":4,"studyType":24,"phases":405,"briefSummary":406,"conditions":407,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":411,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":416,"locationsCount":58},"100517197","early-versus-delayed-bathing-of-orthopaedic-surgical-wounds-100517197","NCT06014411","Early Versus Delayed Bathing of Orthopaedic Surgical Wounds","Early Versus Delayed Bathing of Orthopaedic Surgical Wounds: a Prospective Randomized Controlled Study","EVDB","Inclusion Criteria:\n\n* Patients over 18 years of age\n* Patient who are not pregnant\n* Isolated acute fractures of the upper or lower extremities (humerus, radius, ulna, femur, tibia, or fibula)\n* Diagnosis of a fracture meeting indication for operative intervention\n* Any fracture not requiring a splint for post-operative management\n* Non-complicated wounds (non-traumatic wounds, closed injuries, fractures not requiring external fixation, and acute fracture surgery)\n\nExclusion Criteria:\n\n* Fractures associated with presumed infection\n* Patients with multiple fractures\n* Fractures in patients with underlying associated immune compromise\n* Fractures in patients with underlying peripheral vascular disease\n* Use of VAC\n* Surgery performed through previous surgical wound\n* Patient homeless\n* Fractures in patients with underlying diabetes mellitus\n* Complicated wounds (traumatic wounds, need for post-op wound care, open injuries, need for external fixation)",{"count":404,"type":23},56,[127],"This is a single center randomized control trial assessing the effect of early versus delayed bathing on orthopaedic surgical wounds in patients undergoing surgical treatment of fractures. Patients will be recruited by screening all patients undergoing surgical treatment for fractures at our institution. Patients who provide written consent will be randomized to one of two treatment arms after confirming eligibility criteria. Group A will be advised to begin early normal bathing (non-submerged showering) with uncovered surgical wounds. Group B will be advised to follow traditional delayed bathing with covered wounds.\n\nThose who do not wish to participate in the randomized trial will be invited to participate observationally (no randomization) and have the same prospective follow-up.",[408,409],"Surgical Wound","Post Operative Wound Infection","2026-03-25",{"date":412,"type":50},"2026-03-30",{"date":414,"type":50},"2024-01-29",{"date":267,"type":23},{"name":56,"class":57},{"id":418,"slug":419,"hasResults":12,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":4,"eligibilityCriteria":423,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":424,"targetDuration":4,"studyType":24,"phases":426,"briefSummary":428,"conditions":429,"keywords":431,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":432,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":58},"100350534","phase-2-belimumab-and-rituximab-combination-therapy-for-the-treatment-of-diffuse-cutaneous-systemic-sclerosis-100350534","NCT03844061","Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis","A Randomized, Double-Blind, Placebo-Controlled Study of Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis","Inclusion Criteria:\n\n1. Age greater than or equal to eighteen years and less than or equal to 80.\n2. Classification of systemic sclerosis (SSc), as defined using the 2013 American College of Rheumatology\u002FEuropean Union League Against Rheumatism classification of SSc.\n3. Diagnosis of dcSSc, as defined by LeRoy and Medsger.\n4. Disease duration of less than or equal to 3 years as defined by the date of onset of the first non-Raynaud's symptom.\n5. A modified Rodnan Skin Score (mRSS) of \\> 14\n\nExclusion Criteria:\n\n1. Inability to render informed consent in accordance with institutional guidelines.\n2. Disease duration of greater than 3 years.\n3. Patients with mixed connective tissue disease or \"overlap\" unless the dominant features of the illness are diffuse systemic sclerosis.\n4. Limited scleroderma.\n5. Systemic sclerosis-like illness associated with environmental or ingested agents such as toxic rapeseed oil, vinyl chloride, or bleomycin.\n6. The use of other anti-fibrotic agents including colchicine, D-penicillamine, or tyrosine kinase inhibitors (nilotinib, imatinib, dasatinib) in the month prior to enrollment.\n7. Use in the prior month of corticosteroids at doses exceeding the equivalent of prednisone 10 mg daily. Use of corticosteroid at \\\u003C 10 mg of prednisone can continue during the course of the study.\n8. Concurrent serious medical condition which in the opinion of the investigator makes the patient inappropriate for this study such as uncontrollable CHF, arrhythmia, severe pulmonary or systemic hypertension, severe GI involvement, hepatic impairment, serum creatinine of greater than 2.0, active infection, severe diabetes, unstable atherosclerotic cardiovascular disease, malignancy, HIV, or severe peripheral vascular disease.\n9. A positive pregnancy test at entry into this study. Men and women with reproductive potential will be required to use effective means of contraception through the course of the study, such as (1) surgical sterilization (such as a tubal ligation or hysterectomy), (2) double-barrier methods (such as a condom and occlusive cap (diaphragm or cervical\u002Fvault caps) plus spermicidal agent (foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository)(3) an intrauterine device (IUD) or intrauterine system (IUS) (4) estrogenic vaginal ring (5) percutaneous contraceptive patches, or (6) implants of levonorgestrel or etonogestrel. Approved hormonal contraceptives (such as birth control pills, patches, implants or injections) may interact with and reduce the effectiveness of MMF so women receiving MMF who are using oral contraceptives for birth control should employ an additional method (e.g. barrier method). Contraceptive measures such as Plan B (TM), sold for emergency use after unprotected sex, are not acceptable methods for routine use.\n10. Women not willing to use effective birth control for the duration of the study\n11. Breastfeeding.\n12. Participation in another clinical research study involving the evaluation of another investigational drug within ninety days of entry into this study.\n13. The presence of severe lung disease as defined by a diffusion capacity of less than 30% of predicted or requiring supplemental oxygen and forced vital capacity (FVC) of less than 45% of predicted.\n14. Grade 3 hypogammaglobulinemia\n15. Have a significant IgG deficiency (IgG level \\\u003C 400 mg\u002FdL)\n16. Have an IgA deficiency (IgA level \\\u003C 10 mg\u002FdL)\n17. Have a historically positive HIV test or test positive at screening for HIV\n18. Neutrophils \\\u003C1.5X10E9\u002FL\n19. Hepatitis status:\n\n    1. Serologic evidence of current or past Hepatitis B (HB) infection based on the results of testing for HBsAg and HBcAb as follows:\n\n1\\. Patients positive for HBsAg or HBcAb are excluded b) Positive test for Hepatitis C antibody 20. Known active bacterial, viral, fungal, mycobacterial, or other infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening, or oral antibiotics within 2 weeks prior to screening 21. Infection history:\n\n1. Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria)\n2. Hospitalization for treatment of infection within 60 days of Day 0.\n3. Use of parenteral (IV or IM) antibiotics (antibacterials, antivirals, anti-fungals, or anti-parasitic agents) within 60 days of Day 0 22. Suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes zoster and atypical mycobacteria) 23. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications 24. Prior use of Belimumab, Rituximab, or other B-Cell depleting therapies ever 25. The use of other biologics including TNF inhibitors, abatacept, or tocilizumab within the washout period below for each particular drug:\n\n   Tocilizumab - 1 month for patients on 2mg\u002Fkg or 4 mg\u002Fkg. 2 months for patients on 8mg\u002Fkg.\n\n   Cyclophosphamide (oral or IV) - 3 months. Abatacept - 2.5 months. TNF Inhibitors : Etanercept - 1 mo, Infliximab - 2 mo, Adalimumab - 2.5 mo. Any biologic investigational agent (e.g., abetimus sodium, anti CD40L antibody, BG9588\u002F IDEC 131) - 365 days prior to belimumab.\n\n   Any non-biologic investigational agent - 30 days prior to belimumab.\n\n   26\\. Have evidence of serious suicide risk including any history of suicidal behavior in the last 6 months and\u002For any suicidal ideation in the last 2 months or who in the investigator's judgment, pose a significant suicide risk.\n\n   27\\. Current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to Day 0.\n\n   28\\. History of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies 29. Live vaccines within 30 days prior to baseline 30. Have a history of malignant neoplasm within the last 5 years with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the uterine cervix treated locally and with no evidence of metastatic disease for 3 years 31. Have a history of a primary immunodeficiency 32. Have any other clinically significant abnormal laboratory value in the opinion of the investigator 33. Have any intercurrent significant medical or psychiatric illness that the investigator considers would make the candidate unsuitable for the study 34. Non English speakers",{"count":425,"type":23},30,[427],"PHASE2","This is a 52 week, single center, randomized, double-blind, placebo-controlled study.\n\nAfter patients maintain a stable dose of Mycophenolate Mofetil (MMF) for at least 1 month, they will be randomized to treatment with either Belimumab \\& Rituximab or placebo.Patients in both groups will be on background MMF for the entirety of the study. Belimumab will be administered subcutaneously and Rituximab intravenously. Placebo injections and infusions will be of normal saline. Randomization will be done in a 2:1 manner to favor the treatment group. It is hypothesized that that Rituximab and Belimumab combination therapy with Mycophenolate Mofetil background therapy will improve fibrosis in SSc skin when compared to treatment with placebo and Mycophenolate Mofetil in a group of patients with early dcSSc.",[430],"Systemic Sclerosis",[430],{"date":433,"type":50},"2026-03-27",{"date":435,"type":50},"2019-07-29",{"date":437,"type":23},"2026-06-30",{"name":56,"class":57},{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":443,"acronym":4,"eligibilityCriteria":444,"healthyVolunteers":12,"sex":18,"minAge":445,"maxAge":446,"enrollmentInfo":447,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":449,"conditions":450,"keywords":457,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":465,"lastUpdatePostDateStruct":466,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":471,"locationsCount":472},"100583981","jupiter-40---risk-factors-for-failure-of-isolated-medial-patellofemoral-ligament-reconstruction-100583981","NCT06883396","JUPITER 4.0 - Risk Factors for Failure of Isolated Medial Patellofemoral Ligament Reconstruction","Inclusion Criteria:\n\n* 10-35 years old\n* Recurrent patellar instability with at least one episode defined as either (1) a dislocated patella requiring reduction in the emergency department or (2) a convincing history for dislocation, associated with full giving way, and the following physical findings: (a) hemarthrosis or effusion, (b) tenderness along the medial retinaculum, and (c) apprehension when laterally directed force was applied to the patella or (3) MRI-documented dislocation with associated bone bruises\n\nExclusion Criteria:\n\n* Previous ipsilateral knee surgery\n* Obligatory\u002Ffixed\u002Fhabitual patella dislocation or subluxation\n* Unloadable inferior or lateral chondral damage on the patella that would require a tibial tubercle transfer for unloading purposes\n* Pathologic tibiofemoral instability","10 Years","35 Years",{"count":448,"type":23},850,"The goal of this observational study is to learn about the outcomes of medial patellofemoral ligament (MPFL) reconstruction for the treatment of recurrent patellar instability. The main questions it aims to answer are:\n\n* What are the risk factors for recurrent patellar instability after MPFL reconstruction?\n* What functional outcomes do patients report after MPFL reconstruction?\n\nParticipants undergoing MPFL reconstruction will answer survey questions about their knee and activity level 1 year and 2 years after surgery.",[451,452,453,454,455,456],"Patellar Dislocation, Recurrent","Patellar Dislocation","Patellar Instability","Patellofemoral Dislocation","Patellofemoral Joint Dislocation","Patellofemoral Disorder",[458,459,453,460,461,462,463,464],"Patella","Patella Dislocation","Recurrent Patellar Instability","MPFL","Medial Patellofemoral Ligament","Medial Patellofemoral Ligament Reconstruction","Patellofemoral Instability","2026-02-11",{"date":391,"type":50},{"date":468,"type":50},"2023-01-01",{"date":470,"type":23},"2027-12",{"name":56,"class":57},16,{"id":474,"slug":475,"hasResults":12,"nctId":476,"briefTitle":477,"officialTitle":478,"acronym":4,"eligibilityCriteria":479,"healthyVolunteers":12,"sex":18,"minAge":480,"maxAge":346,"enrollmentInfo":481,"targetDuration":4,"studyType":24,"phases":483,"briefSummary":484,"conditions":485,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":465,"lastUpdatePostDateStruct":489,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":493,"locationsCount":494},"100553818","phase-4-post-operative-thoracolumosacral-orthosis-for-pjk-100553818","NCT06491030","Post-Operative Thoracolumosacral Orthosis for PJK","The Use of a Novel Post-Operative Thoracolumosacral Orthosis for Prevention of Proximal Junctional Kyphosis After Adult Spinal Deformity Surgery","Inclusion Criteria:\n\n* 30-75-years-old\n* Undergoing primary thoracolumbosacral fusion for ASD with an upper instrumented vertebrae (UIV) between T8-L2 and lower instrumented vertebrae (LIV) of S1 or the ilium.\n\nExclusion Criteria:\n\n* Osteoporosis (defined as a T-score \\\u003C-2.5 at the time of surgery)\n* Body mass index (BMI) \\>35 kg\u002Fm2\n* Revision fusions\n* Fusions for trauma\n* Those with a neuromuscular etiology for their deformity (i.e. Parkinson's disease, cerebral palsy, post-stroke, etc.)\n* An underlying inflammatory arthropathy","30 Years",{"count":482,"type":23},84,[231],"Proximal junctional kyphosis (PJK) is a common post-operative radiographic finding after surgery for adult spinal deformity (ASD) patients. Although the clinical relevance of isolated PJK is unclear, PJK can progress to symptomatic proximal junctional failures which requires a large revision surgery. Currently, post-operative bracing with a thoracolumbosacral orthosis (TLSO) is common practice after spinal deformity surgery, however the efficacy of this in preventing PJK is unknown. This multi-center randomized control trial identified 84 patients undergoing thoracolumbosacral fusion for ASD and plans to study the efficacy of a novel post-operative TLSO in preventing the development of PJK as defined by the proximal junctional angle on 6-month post-operative X-rays.",[486,487,488],"Proximal Junctional Kyphosis","Adult Spinal Deformity Surgery","Thoracolumbosacral Orthosis",{"date":391,"type":50},{"date":491,"type":50},"2024-12-02",{"date":267,"type":23},{"name":56,"class":57},6,{"id":496,"slug":497,"hasResults":12,"nctId":498,"briefTitle":499,"officialTitle":500,"acronym":4,"eligibilityCriteria":501,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":502,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":504,"conditions":505,"keywords":507,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":465,"lastUpdatePostDateStruct":511,"startDateStruct":512,"completionDateStruct":514,"leadSponsor":515,"locationsCount":58},"100499367","analysis-of-t-and-b-cell-repertoire-changes-in-response-to-orencia-abatacept-in-rheumatoid-arthritis-100499367","NCT05782335","Analysis of T and B Cell Repertoire Changes in Response to Orencia® (Abatacept) in Rheumatoid Arthritis","Analysis of T and B Cell Repertoire Changes and CTLA4 Genetics and Gene Expression to Understand the Mechanisms of Treatment Response to Orencia ® (Abatacept) in Rheumatoid Arthritis","Inclusion Criteria: M or F \\>=18 y.o. with diagnosed RA. Disease related inclusion criteria:\n\n1\\. Patients being treated with MTX with or without csDMARDS at stable doses for at least 4 weeks, who are either: (a) about to start ABA, OR, (b) who are likely to remain on stable DMARDs and who might also be using a TNFi but in whom all therapies will have been stable for 4 or more weeks.\n\n2.) meet diagnostic criteria for RA, based on 2010 ACR Criteria or 1987 RA criteria, OR, are one point short of meeting the criteria but are being treated for RA, OR, have previously identified RA typical erosions.\n\n3\\) have never received ABA or rituximab, and, if previously used a JAKi, will have stopped this for over a month, OR, if previously used an IL-6 inhibitor, will have stopped for at least 3 months.\n\n4\\) RA subject must not be taking prednisone at doses over 10 mg daily, and will not have received injectable Depomedrol or equivalent within 4 weeks of baseline or prior to the 3 or 6 month study assessment. Healthy control patients cannot be taking prednisone. Any subject can use oral or nasal inhalers that include glucocorticoids 5) have evidence of recent or currently active disease depending on treatment arm. Subjects starting ABA (Arm 1) are expected to have at least moderate disease activity, OR if CDAI is between 2.81 and 10, there should be two or more swollen and tender joints. For subjects being included in Arm 2, the stable treatment arm, CDAI \\\u003C13 and one swollen joint observed by a rheumatologist in the prior 6 months. Subjects recruited to the healthy control arm (Arm 3) will be free of any autoimmune disease or systemic form of an inflammatory arthritis.\n\n6\\) WOCBP must be using acceptable forms of contraception to avoid pregnancy throughout the study, i.e. oral contraceptives, other hormonal contraceptives.\n\nSpecific Exclusion Criteria:\n\n1. Have severe complications of RA that might require imminent escalation of therapy, e.g. pericarditis, active vasculitis of a major organ system.\n2. Have an autoimmune disease or systemic inflammatory rheumatic disease (e.g., lupus erythematosus) that could confound T and B cell subset results\n3. Have a concurrent serious medical disease (e.g., terminal malignancy)\n4. Have a BMI indicating poor health (\\\u003C18 or \\> 40)\n5. Have received the following Prohibited Treatments and\u002For Therapies\n\n   1. treatment with rituximab\n   2. exposed to ABA or CTLA-4Ig\n   3. exposed to any investigational drug within 28 days.\n   4. received any live vaccines within 2 weeks prior to study start. Subjects cannot receive a live vaccine at any time during the study.\n6. WOCBP with a positive pregnancy test on enrollment or prior to study start, OR who are unwilling or unable to use an acceptable method to avoid pregnancy despite continuing MTX.\n7. part of a vulnerable population",{"count":503,"type":23},72,"The condition that will be studied is Rheumatoid Arthritis (RA), and in particular, RA patients with moderate to highly active disease who were prescribed Abatacept (Orencia®) (ABA) by their physician during their setting of care at Hospital for Special Surgery (HSS). This investigator-initiated, prospective, comparative, 3-arm observational study will examine changes in lymphocytes in RA patients starting abatacept compared to RA patients starting TNF inhibitors and to healthy controls. This will help investigators to learn more about the processes that cause joints to swell and hurt. This may also offer clues that might predict which patients will have a good or poor response to these treatments.",[506],"Rheumatoid Arthritis",[508,509,510],"abatacept","b cell repertoire","t cell repertoire",{"date":391,"type":50},{"date":513,"type":50},"2022-11-01",{"date":267,"type":23},{"name":56,"class":57},{"id":517,"slug":518,"hasResults":12,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":4,"eligibilityCriteria":522,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":523,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":525,"conditions":526,"keywords":530,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":465,"lastUpdatePostDateStruct":532,"startDateStruct":533,"completionDateStruct":535,"leadSponsor":536,"locationsCount":537},"100491168","return-to-golf-after-orthopaedic-surgery-100491168","NCT05675618","Return to Golf After Orthopaedic Surgery","Golfing After Orthopaedic Surgery: a Longitudinal Follow-up (GOLF) Project","Inclusion Criteria:\n\n* Age 18+ years\n* A self-reported golfer\n* Able to consent to treatment\n* Indicated for one of the following surgical procedures: total hip arthroplasty, hip resurfacing, revision hip arthroplasty, total knee arthroplasty, unicompartmental knee arthroplasty, revision knee arthroplasty, total shoulder arthroplasty, reverse shoulder arthroplasty, shoulder resurfacing arthroplasty, revision shoulder arthroplasty\n\nExclusion Criteria:\n\n* Inability to complete follow-up questionnaires\n* Declining operative management\n* No desire to return to golf postoperatively\n* Medical problem that affects the patient's ability to play golf (e.g., angina, shortness of breath, etc.)",{"count":524,"type":23},432,"The GOLF study is a multicenter, prospective study with the goal to investigate golfers' return to the sport following hip, knee or shoulder arthroplasty. The prevalence of return to golf, by level of returning to golf will be assessed at 6 weeks, 3 months, 6 months, and 12 months postoperatively. Patients who are active golfers undergoing joint replacement will be identified from outpatient clinics and pre-assessment clinics and given information about the study at least two weeks prior to surgery. Participants in this study must have a desire to return to golf after surgery. Previous studies have only been able to report the return to golf after arthroplasty retrospectively; the prospective nature of this study will allow for a greater understanding of this process.",[527,528,529],"Hip Osteoarthritis","Knee Osteoarthritis","Shoulder Osteoarthritis",[531],"return to golf, arthroplasty",{"date":391,"type":50},{"date":534,"type":50},"2023-01-09",{"date":267,"type":23},{"name":56,"class":57},2,{"id":539,"slug":540,"hasResults":12,"nctId":541,"briefTitle":542,"officialTitle":543,"acronym":4,"eligibilityCriteria":544,"healthyVolunteers":12,"sex":18,"minAge":545,"maxAge":546,"enrollmentInfo":547,"targetDuration":4,"studyType":24,"phases":548,"briefSummary":549,"conditions":550,"keywords":554,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":465,"lastUpdatePostDateStruct":559,"startDateStruct":560,"completionDateStruct":562,"leadSponsor":563,"locationsCount":58},"100470939","phase-3-prp-in-aclr-to-prevent-ptoa-100470939","NCT05412381","PRP in ACLR to Prevent PTOA","Platelet Rich Plasma (PRP) Treatment of the Anterior Cruciate Ligament Injured Knee to Decrease the Risk of Post-traumatic Osteoarthritis (PTOA): a Randomized Double-blind Controlled Trial","Inclusion Criteria:\n\n* Acute ACL injury within 6 weeks of presentation\n* Age 14-50\n* Male or female\n* Meniscus injury that can be treated with meniscectomy or repair (the lack of meniscus injury will not exclude patients)\n\nExclusion Criteria:\n\n* Prior ACL reconstruction\n* Prior cartilage repair procedure\n* Prior meniscus surgery within 12 months\n* Prior steroid, hyaluronic acid, or PRP injection within 6 months\n* Other ligament injury requiring repair\n* Any cartilage lesion requiring repair\n* Any cartilage lesion greater than grade 2 (partial thickness injury)\n* History of inflammatory arthritis or joint sepsis\n* Non English speakers","14 Years","50 Years",{"count":404,"type":23},[26],"The purpose of our study is to examine the effect of platelet-rich-plasma (PRP) injection on the short-term resolution of post-injury inflammation (biomarkers) and improvement in joint function in patients with acute ACL injury. This RCT has been powered based on the questionnaire KOOS Jr. but it is considered a 'pilot study' in terms of the lab analysis proposed.",[551,552,553],"Anterior Cruciate Ligament Injuries","Post-traumatic Osteoarthritis","PRP",[555,556,557,558],"platelet-rich plasma","regenerative medicine","anterior cruciate ligament reconstruction","post-traumatic osteoarthritis",{"date":391,"type":50},{"date":561,"type":50},"2022-06-27",{"date":197,"type":23},{"name":56,"class":57},{"id":565,"slug":566,"hasResults":12,"nctId":567,"briefTitle":568,"officialTitle":568,"acronym":569,"eligibilityCriteria":570,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":571,"targetDuration":572,"studyType":84,"phases":4,"briefSummary":573,"conditions":574,"keywords":576,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":465,"lastUpdatePostDateStruct":580,"startDateStruct":582,"completionDateStruct":584,"leadSponsor":586,"locationsCount":58},"100227128","undifferentiated-connective-tissue-disease-registry-100227128","NCT02234388","Undifferentiated Connective Tissue Disease Registry","UCTD Registry","Inclusion Criteria:\n\n* Any patient under the care of an HSS rheumatologist\n* Positive ANA or a positive anti-ds DNA, anti-Ro\u002FSS-A or other autoantibody on 2 or more occasions at least 12 weeks apart\n* One or more signs or symptoms of connective tissue disease, including but not limited to arthralgia, arthritis, myalgia, rash, sicca symptoms, pericarditis, pleuritis, pulmonary symptoms, peripheral neuropathy, photosensitivity, alopecia, oral or nasal ulcers, leucopenia, anemia, and abnormal nailfold capillaroscopy\n\nExclusion Criteria:\n\n* Patients who meet criteria for well defined CTD including SLE, rheumatoid arthritis, polymyositis or dermatomyositis, systemic sclerosis, or antiphospholipid syndrome\n* Patients who are less than 18\n* Those unable to give informed consent in English",{"count":229,"type":23},"3 Years","This registry has been established to gain a better understanding of the clinical and emotional presentations of patients with undifferentiated connective tissue disease.",[575],"Undifferentiated Connective Tissue Disease",[577,578,579],"connective tissue disease","registry","hospital for special surgery",{"date":581,"type":50},"2026-02-12",{"date":583,"type":4},"2012-03",{"date":585,"type":23},"2027-03-31",{"name":56,"class":57},{"id":588,"slug":589,"hasResults":12,"nctId":590,"briefTitle":591,"officialTitle":592,"acronym":4,"eligibilityCriteria":593,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":594,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":596,"conditions":597,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":465,"lastUpdatePostDateStruct":599,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":604,"locationsCount":537},"100097298","hospital-for-special-surgery-shoulder-arthroplasty-cohort-100097298","NCT00527839","Hospital for Special Surgery Shoulder Arthroplasty Cohort","Prospective Evaluation of the Clinical and Economic Outcomes of Total Joint Replacement: HSS Shoulder Arthroplasty Cohort","Inclusion Criteria:\n\n* 18 years or older and undergoing total shoulder arthroplasty at HSS\n\nExclusion Criteria:\n\n* No other exclusion criteria. Pregnant women are eligible for the registry as this is a non-interventional study which only involves filling out questionnaires.",{"count":595,"type":23},250,"Total joint replacements are some of the most successful medical devices developed over the last fifty years. They enable millions of people to remain ambulatory and pain free, with minimal risk. In 2002, over 200,000 total hip replacements, 350,000 total knee replacements, and 25,000 total or partial shoulder replacements were performed in the United States (HCUP data). Future use will likely be even higher: it is estimated that by the year 2020, the population 65 and over in developed countries will increase by 71%. Existing studies do not provide adequate prospective data to evaluate long-term outcomes.\n\nHSS is a world leader in total joint replacement including total shoulder arthroplasty. However, there is no systematic follow-up or evaluation of patients who have their shoulders replaced here.\n\nThe purpose of this study is to establish a prospective cohort of HSS total shoulder arthroplasty to evaluate predictors of outcome, causes of failure and to allow ongoing evaluation of the results of our patients over time.",[598],"Shoulder Arthroplasty",{"date":581,"type":50},{"date":601,"type":4},"2007-04",{"date":603,"type":23},"2027-04",{"name":56,"class":57},{"id":606,"slug":607,"hasResults":12,"nctId":608,"briefTitle":609,"officialTitle":610,"acronym":4,"eligibilityCriteria":611,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":346,"enrollmentInfo":612,"targetDuration":4,"studyType":24,"phases":614,"briefSummary":615,"conditions":616,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":620,"lastUpdatePostDateStruct":621,"startDateStruct":623,"completionDateStruct":625,"leadSponsor":627,"locationsCount":58},"100514638","enhanced-recovery-after-major-surgery-and-chronic-pain-for-total-knee-arthroplasty-100514638","NCT05981105","Enhanced Recovery After Major Surgery and Chronic Pain for Total Knee Arthroplasty","Expanding the Peri-operative Surgical Home Model: ERAS TKR With a Transitional Pain Service (TeleTPS) - Continuous Adductor Canal Catheter Versus Adductor Canal Block for Total Knee Arthroplasty, a Randomized Double-blinded Controlled Trial.","Inclusion Criteria:\n\n* Patients with osteoarthritis scheduled for a primary total knee arthroplasty with a participating surgeon\n* Age 18 to 75 years\n* Planned use of regional anesthesia\n* Ability to follow study protocol\n* English speaking (secondary outcomes include questionnaires validated in English only)\n* Patients of participating surgeons: Drs. Mayman, Jerabek, Westrich, Su, Della Valle, Alexiades\n* Lives within one hour of the hospital\n* Has a smartphone\n\nExclusion Criteria:\n\n* Hepatic or renal insufficiency\n* Younger than 18 years old and older than 65\n* Patients undergoing general anesthesia\n* Allergy or intolerance to one of the study medications\n* BMI \\> 40\n* Diabetes\n* ASA of III,IV\n* Chronic gabapentin\u002Fpregabalin use (regular use for longer than 3 months)\n* PCS \\> 30\n* Chronic opioid use (taking opioids for longer than 3 months, or daily oral morphine equivalent of \\>5mg\u002Fday for one month)\n* Patients with severe valgus deformity or flexion contracture\n* Patients unable to follow home catheter instructions and unwilling to go home with an infusing catheter\n* Patients who have no home caregivers in the event if a catheter is to be sent home with the patient\n* Patients with planned stay at rehab facility",{"count":613,"type":23},64,[127],"The goal of this interventional clinical trial is to assess opioid consumption 24-48 hrs post anesthesia block among patients undergoing total knee arthroplasty. The main question it aims to answer is:\n\n1\\. Is there a difference in opioid consumption 24-48 hours post block administration among patients that receive an adductor canal catheter (ACC) versus adductor canal block (ACB)?\n\nParticipants will be:\n\n* Randomized to receive an adductor canal catheter (ACC) or a sham adductor canal catheter.\n* Asked to use the Diagnotes application to communicate with the pain doctor while the catheter is in place.\n* Follow up for up to 6 months post-operation. Researchers will compare the interventional group (ACC) to the control group (sham ACC + ACB) to see if there is difference in opioid consumption and chronic pain at 6 months post-operation.",[617,189,618,619],"Chronic Pain","Adductor Canal Block","Total Knee Arthroplasty","2026-01-14",{"date":622,"type":50},"2026-01-15",{"date":624,"type":50},"2023-06-12",{"date":626,"type":23},"2027-01-01",{"name":56,"class":57},""]