[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"knee\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:knee":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,77,104,140,163,190,217,238,270,295],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":41,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":76},"100636568","cartiz-registry-cartilage-arthropathy-and-imaging-under-tirzepatide-in-zone-stratified-cohorts---a-four-institute-mexican-observational-registry-100636568",false,"NCT07567378","CARTIZ Registry: Cartilage, Arthropathy and Imaging Under Tirzepatide in Zone-stratified Cohorts - A Four-Institute Mexican Observational Registry","Cartilage, Arthropathy and Imaging Under Tirzepatide in Zone-stratified Cohorts (CARTIZ): A Prospective Observational Multi-Institutional Registry of the VAT-Articular-Cardiac-Aging Axis in Adults Exposed to Tirzepatide in Mexico, With Quantitative Knee Cartilage T2 Mapping, Cardiac CT Epicardial Adipose Tissue Radiomic Phenotyping, HLA Stratification, Longitudinal Multi-Frequency Bioimpedance Body Composition, and a Prespecified Surgical Tissue Acquisition Subcohort","CARTIZ","Inclusion Criteria:\n\n* 1\\. Age ≥18 years at the time of informed consent. 2. Currently receiving tirzepatide under an independent clinical indication (type 2 diabetes, insulin resistance, obesity with or without associated metabolic disease, renal protection, metabolic hypertension, or associated off-label metabolic use) prescribed by the treating physician independently of the registry.\n\n  3\\. Presence of at least one objectively documented musculoskeletal manifestation - current or historical - defined as any of: (i) inflammatory arthralgia affecting one or more joints with clinical, imaging, or serological support; (ii) CASPAR-positive psoriatic arthritis; (iii) radiographically documented knee osteoarthritis; (iv) enthesitis on physical examination or ultrasound; (v) documented inflammatory arthropathy of the spine or peripheral joints with a specialist diagnosis.\n\n  4\\. For the retrospective-prospective component: availability of clinical documentation of articular state prior to tirzepatide initiation in the patient's medical record. Documentation may include physical examination notes, imaging, laboratory values, or specialist consultation notes.\n\n  5\\. Signed informed consent for registry enrolment, longitudinal serum biobanking, HLA typing at INCMNSZ, quantitative knee MRI with T2 mapping at Ci3M UAM-Iztapalapa at Week 0 and Week 52, non-contrast cardiac CT at INCar at Week 0 and Week 52, multi-frequency bioelectrical impedance analysis at Universidad La Salle México at six timepoints, and (where applicable) medical record review. Each attestation is consented modularly within a single document.\n\n  6\\. Clinical plan to continue tirzepatide for at least 52 weeks from registry Week 0, based on the treating physician's evaluation of current clinical indication. Discontinuation during follow-up is captured as an outcome variable and does not remove the patient from the registry.\n\n  7\\. Capacity to attend scheduled follow-up visits and to undergo bilateral knee MRI at Ci3M (without severe claustrophobia requiring sedation, without absolute contraindication to MRI - see Exclusion 6) and non-contrast cardiac CT at INCar (without uncontrolled arrhythmia precluding ECG-gated imaging of diagnostic quality).\n\nFor the Surgical Tissue Subcohort (Cohort 3) only - additional criteria applied at the time of subcohort enrolment:\n\n8s. Scheduled clinically indicated cardiac surgery at the Instituto Nacional de Cardiología Ignacio Chávez (coronary artery bypass grafting, valve replacement, or combined procedures) during registry follow-up.\n\n9s. Specific additional informed consent for intraoperative collection of epicardial adipose tissue fragments.\n\nExclusion Criteria:\n\n* 1\\. Initiation or modification of a biologic disease-modifying antirheumatic drug (biologic DMARD) or JAK inhibitor within the 12 weeks prior to Week 0, or clinically anticipated initiation or modification during the first 12 weeks of follow-up. Washout may permit re-screening.\n\n  2\\. Major joint surgery within the 3 months prior to Week 0, or planned major joint surgery within the 12 months following Week 0, involving any joint scheduled for evaluation in the registry.\n\n  3\\. Intra-articular corticosteroid or hyaluronic acid injection within the 6 weeks prior to baseline biospecimen collection in any joint. Patients beyond the 6-week washout are eligible.\n\n  4\\. Active malignancy, with the exception of adequately treated non-melanoma skin carcinoma. History of malignancy in remission ≥5 years is permitted at the discretion of the treating investigator.\n\n  5\\. Current pregnancy, lactation, or planned pregnancy within the 12-month observation period.\n\n  6\\. Absolute contraindication to MRI, including non-MRI-compatible cardiac pacemaker or implanted defibrillator, ferromagnetic intracranial vascular clips, non-documented non-MRI-compatible cochlear implants, or other contraindication per the local MRI safety protocol.\n\n  7\\. Systemic rheumatologic disease other than psoriatic arthritis or osteoarthritis requiring active immunomodulation, specifically: seropositive rheumatoid arthritis on biologic therapy, active systemic lupus erythematosus on immunomodulation, active vasculitis on immunosuppression, or other systemic disease whose treatment confounds the inflammatory axis the registry is designed to characterize.\n\n  8\\. Inability to provide informed consent (cognitive impairment, language barrier not resolvable with site interpreter, or other incapacity to understand the protocol), or anticipated inability to complete the 52-week follow-up.\n\nFor the Surgical Tissue Subcohort (Cohort 3) only - additional exclusions:\n\n9s. Prior major cardiac surgery resulting in extensive pericardial adhesions that preclude safe intraoperative EAT fragment collection, as assessed by the operating cardiac surgeon.\n\n10s. Emergency cardiac surgery precluding the specific informed consent process.","ALL","18 Years",{"count":20,"type":21},30,"ESTIMATED","52 Weeks","OBSERVATIONAL","CARTIZ is a prospective observational clinical registry of adults in Mexico receiving tirzepatide (a dual GLP-1\u002FGIP receptor agonist) under an independent clinical indication - typically type 2 diabetes, insulin resistance, obesity, renal protection, metabolic hypertension, or associated off-label metabolic use. The registry is entirely observational: CARTIZ does not initiate, modify, interrupt, or supply tirzepatide, and does not dictate dose, route, or duration. All pharmacological exposure decisions are made by the treating physician independently of study participation. The registry is operationalized through a four-institute architecture integrating three Mexican National Institutes of Health and one national imaging laboratory. Core 1 (Knee Cartilage Imaging, Ci3M UAM-Iztapalapa) performs bilateral 3T MRI with quantitative T2 mapping at Week 0 and Week 52. Core 2 (Cardiac Imaging, Instituto Nacional de Cardiología Ignacio Chávez) performs non-contrast cardiac computed tomography for radiomic phenotyping of epicardial adipose tissue at Week 0 and Week 52 under cardiovascular Co-Principal Investigator Dr. Erick Alexánderson Rosas. Core 3 (HLA Typing, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Transplant Department) performs Class I and Class II HLA typing by PCR-SSO Reverse Luminex. Core 4 (Body Composition, Universidad La Salle México) performs multi-frequency bioelectrical impedance analysis (seca mBCA) at six longitudinal timepoints capturing visceral adipose tissue trajectory, phase-angle trajectory, appendicular skeletal muscle mass, and hydration ratios at zero marginal cost. The registry enrolls n=30 patients across three clinical sites with identical protocol (IMSS Clínica Río Magdalena, INCMNSZ outpatient clinic, and a private practice site in Mexico City), generating 60 evaluable knees and 30 paired cardiac CT studies. The primary co-endpoints address a mechanistic question no other tirzepatide study is positioned to answer: whether the articular response to tirzepatide in inflammatory arthropathy precedes and mechanistically precedes weight loss, through formal mediation analysis of Week-4 ACR20 response via high-sensitivity C-reactive protein, SERPINB2, and dipeptidyl peptidase-4 activity, restricted to the Mechanistic Analysis Set of patients with tirzepatide exposure ≤16 weeks at Week 0 and delta-BMI \\\u003C1.0 kg\u002Fm² through Week 4. A prespecified Surgical Tissue Subcohort is declared at initial registration to establish public scientific priority on direct human epicardial adipose tissue transcriptomic characterization under dual GIP\u002FGLP-1 receptor agonism. Subcohort participants who undergo clinically indicated cardiac surgery at INCar during follow-up (coronary artery bypass grafting, valve replacement, or combined procedures) are invited to provide specific additional informed consent for collection of epicardial adipose tissue fragments routinely excised during operative access and otherwise discarded as surgical waste. Operational launch is contingent on separate INCar tissue-specific approvals and will proceed via PRS record amendment when ready",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40],"Psoriatic Arthritis","Osteoarthitis","Knee","Diabetes (DM)","Type 2 Diabetes Mellitus (T2DM)","Obesity (Disorder)","Insulin Resistance Syndrome","Metabolic Syndrome","Heart Failure","Preserved Ejection Fraction","Coronary Artery Disease","Atrial Fibrillation (AF)","Non Alcholic Fatty Liver Disease","Sarcopenia","Pericardium",[42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63],"Tirzepatide","Dual GIP\u002FGLP-1 receptor agonist","Multi-nutrient-stimulated hormones","Psoriatic arthritis","Inflammatory arthropathy","ACR20","Cartilage T2 mapping","Quantitative knee MRI","Epicardial adipose tissue","Cardiac CT radiomics","Fat Attenuation Index","HLA typing","Visceral adipose tissue","Phase angle","seca mBCA","Bioelectrical impedance analysis","Mediation analysis","Weight-independent effect","Off-label exposure","Mexican registry","Epicardial adipose transcriptomics","Single-nucleus RNA sequencing","NOT_YET_RECRUITING","2026-05-07",{"date":67,"type":68},"2026-05-12","ACTUAL",{"date":70,"type":21},"2026-05",{"date":72,"type":21},"2029-05",{"name":74,"class":75},"JULIO GRANADOS MONTIEL","OTHER",1,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":17,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":4},"100640410","sacb-vs-cacb-in-tka-100640410","NCT07581886","sACB vs cACB in TKA","Comparison of Single-shot vs. Continuous Adductor Canal Block Analgesic Effects With Catheter Positioning Confirmation in Total Knee Arthroplasty: a Double-blinded Prospective Randomized Controlled Trial","Inclusion Criteria:\n\n* Age 40-80 yrs\n* Scheduled for unilateral total knee arthroplatsy\n* ASA I-III\n* BMI 18-35 kg\u002F㎡\n* Able to read and understand consent form\n\nExclusion Criteria:\n\n* Allergy to local anesthetics\n* Infection at the block site\n* History of neuropathy or peripheral nerve disease\n* Coagulation disorders or use of anticoagulants (if discontinuation is not possible)\n* Communication disorders or cognitive impairment\n* Chronic opioid use (≥30 MME\u002Fday, 3 months or more)\n* Severe chronic pain (NRS ≥7\u002F10, 3 months or more)\n* Renal impairment (eGFR \\\u003C30 mL\u002Fmin\u002F1.73m²)\n* Hepatic impairment (Child-Pugh C)\n* Blood coagulation disorders\n* Pregnancy",true,"40 Years","80 Years",{"count":88,"type":21},78,"INTERVENTIONAL",[91],"NA","This study compares the analgesic efficacy of single-dose adductor canal block (sACB) versus continuous-dose adductor canal block (cACB) for postoperative pain management in total knee replacement patients. To ensure a high level of clinical accuracy, the investigation specifically focuses on a cACB cohort where ultrasound confirmation ensures the catheter remains correctly positioned for a full 48 hours. Participants are assigned to groups using a 1:1 randomization protocol via computer-generated tables to eliminate selection bias. Clinical consistency is maintained by using identical pharmacological agents across both groups: 0.5% Heavy Bupivacaine for spinal anesthesia and 0.5% ropivacaine with 1:200,000 epinephrine for the nerve block itself. Furthermore, both groups adhere to a standardized multimodal analgesic schedule to control for external variables. In the cACB group, intravenous patient-controlled analgesia (IV PCA) serves as a designated rescue therapy should the catheter fail. The primary technical evaluation occurs 48 hours post-surgery, utilizing ultrasound to verify catheter placement and quantify pain levels. Beyond immediate recovery, the study evaluates long-term success through Patient-Reported Outcome Measures (PROMs) at a 12-week follow-up, focusing on functional restoration and the patient's overall quality of life. By isolating the variable of catheter stability, the research aims to provide a definitive comparison of whether the continuous delivery of local anesthetic offers a statistically significant clinical advantage over a single-dose administration in the context of modern orthopedic recovery protocols.",[94,95,28],"Arthroplasty","Replacement","2026-05-06",{"date":67,"type":68},{"date":99,"type":21},"2026-05-18",{"date":101,"type":21},"2028-01-31",{"name":103,"class":75},"Yonsei University",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":111,"minAge":112,"maxAge":113,"enrollmentInfo":114,"targetDuration":116,"studyType":23,"phases":4,"briefSummary":117,"conditions":118,"keywords":126,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":76},"100639251","the-effect-of-lipedema-on-knee-osteoarthritis-100639251","NCT07575555","The Effect of Lipedema on Knee Osteoarthritis","The Effect of Lipedema on Knee Osteoarthritis: A Cross-Sectional Analysis of Clinical Symptoms and Ultrasonographic Findings","Inclusion Criteria:\n\nAll participants (Group 1 + Group 2)\n\n* Women aged 30-65\n* With a clinical and radiological diagnosis of knee osteoarthritis\n* Who agreed to participate in the study\n\nGroup 1 (knee osteoarthritis with lipedema):\n\n* Patients who meet the Wold criteria for a clinical diagnosis of lipedema\n* An increase in subcutaneous fat thickness confirmed by ultrasound\n\nGroup 2 (knee osteoarthritis without lipedema):\n\n* No diagnosis of lipedema\n* Exclusion of lymphedema and venous diseases\n\nExclusion Criteria:\n\n* Inflammatory arthritis\n* History of knee surgery\n* Intra-articular injection within the past 6 months\n* Acute trauma\n* Systemic connective tissue disease\n* Severe venous insufficiency or lymphedema\n* History of malignancy\n* Use of gabapentinoids\u002FSNRIs\u002FSSRIs due to fibromyalgia or psychiatric illness\n* Severe cognitive impairment or communication problems that would prevent participation in the study\n* Pregnancy\n* Participants who were informed about the study and refused to participate","FEMALE","30 Years","65 Years",{"count":115,"type":21},76,"1 Day","This study will be one of the few to examine the effect of lipedema on knee osteoarthritis in a comparative manner with a control group within the same osteoarthritis context. Although the relationship between obesity and osteoarthritis has been extensively studied in the literature, the effect of specific adipose tissue pathologies, such as lipedema, on osteoarthritis has not been sufficiently investigated. This study aims to demonstrate the independent effect of lipedema on osteoarthritis, evaluate clinical and ultrasonographic parameters together, and contribute to early diagnosis and targeted rehabilitation strategies.",[119,120,121,28,122,123,124,125],"Lipedema","Knee Osteoarthritis","Knee Acute and Chronic Pain","Knee Arthritis Osteoarthritis","Knee Arthropathy","Knee Cartilage Defects","Knee Cartilage Lesions",[127,128,129,130],"lipedema","knee osteoarthritis","knee joint","knee","2026-05-03",{"date":133,"type":68},"2026-05-08",{"date":135,"type":21},"2026-07-15",{"date":137,"type":21},"2027-08-15",{"name":139,"class":75},"Izmir Democracy University",{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":89,"phases":150,"briefSummary":151,"conditions":152,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":76},"100618614","orlint--orlext-orthosis-for-knee-100618614","NCT07333911","ORLINT & ORLEXT: Orthosis for Knee","ORLINT & ORLEXT: New Orthosis for the Lateral Knee Ligaments","ORLINT&ORLEXT","Inclusion Criteria:\n\n* patients with chronic knee injuries\n* patients who have already been prescribed an orthosis\n* patients older than 18 years old\n\nExclusion Criteria:\n\n* inability to stand actively and stably\n* inability to walk unaided",{"count":149,"type":21},4,[91],"The goal of this experimental study is to test the feasibility and validity of a new orthosis in patients with lateral ligament knee lesions of both sexes and older than 18 years old. The main question it aims to answer is:\n\nIs the new orthosis a support for knee stability?? Does the new orthosis improve knee function and patients' quality of life??\n\nThe control group will be the subjects themselves when wearing their conventional knee orthosis or without it.\n\nParticipants must wear the new knee orthosis for at least one month to assess the effectiveness of the orthosis and evaluate any changes that have occurred in the knee joint and muscles.",[153,28],"Knee Brace","2026-04-27",{"date":156,"type":68},"2026-04-28",{"date":158,"type":21},"2026-07-01",{"date":160,"type":21},"2026-12-31",{"name":162,"class":75},"University of Salamanca",{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":89,"phases":173,"briefSummary":174,"conditions":175,"keywords":176,"overallStatus":179,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":149},"100427660","study-to-evaluate-the-safety-and-effectiveness-of-the-real-intelligence-cori-in-total-knee-arthroplasty-tka-procedure-100427660","NCT04848896","Study to Evaluate the Safety and Effectiveness of the REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure","A Prospective, Multi-center, Randomized Controlled Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure","CORI RCT TKA","Inclusion Criteria:\n\n1. Subject is a suitable candidate for a TKA procedure using CORI and a corresponding S+N Knee Implant System.\n2. Subject requires a cemented TKA as a primary indication that meets any of the following condition:\n\n   * Non-inflammatory degenerative joint disease, including osteoarthritis\n   * Rheumatoid arthritis\n   * Avascular necrosis\n   * Requires correction of functional deformity\n   * Requires treatment of fractures that were unmanageable using other techniques\n3. Subject is of legal age to consent and considered skeletally mature (≥ 18 years of age at the time of surgery)\n4. Subject agrees to consent to and to follow the study visit schedule (as defined in the study protocol and informed consent form), by signing the Ethical Committee (EC) or Institutional Review Board (IRB) approved informed consent form.\n5. Subject plans to be available through two (2) year postoperative follow-up.\n6. Applicable routine radiographic assessment is possible.\n\nExclusion Criteria:\n\n1. Subject requires a TKA on the index joint as a revision for a previously failed surgery, or has the need for complex implants, or any other implant than a standard TKA (e.g. stems, augments, or custom-made devices).\n2. Subject has been diagnosed with post-traumatic arthritis.\n3. Subject receives simultaneous bilateral UKA OR a unilateral UKA with contralateral TKA.\n4. Subject has one or more of the following arthroplasties that are not fully healed and well-functioning, as determined by the investigator:-Contralateral primary TKA or UKA, however, the subject can only have one knee enrolled in this study.\n5. Subject does not understand the language used in the Informed Consent Form.\n6. Subject does not meet the indication or is contraindicated for TKA according to the specific Smith+Nephew Knee System's Instructions For Use (IFU).\n7. Subject has active infection or sepsis (treated or untreated).\n8. Subject is morbidly obese with a body mass index (BMI) greater than 40.\n9. Subject is pregnant or breast feeding at the time of surgery.\n10. Subject, in the opinion of the Investigator, has advanced osteoarthritis or joint disease at the time of surgery and was better suited for an alternate procedure.\n11. Subject currently enrolled in another orthopedic clinical trial study.\n12. Subject has a condition(s) that may interfere with the TKA survival or outcome (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease, or an active, local infection).\n13. Subject in the opinion of the Investigator has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, intellectual disability, drug or alcohol abuse.\n14. Subject, in the opinion of the Investigator, has a neuromuscular disorder that prohibited control of the index joint.\n15. Subject is a prisoner or meets the definition of a Vulnerable Subject per International Organization for Standardization (ISO) 14155:2020 Section 3.55.",{"count":172,"type":21},140,[91],"Background:\n\nREAL INTELLIGENCE™ CORI™ (CORI Robotics) is a computer-assisted orthopaedic surgical navigation and burring system. CORI Robotics is designed to help surgeons in planning and executing certain types of knee surgery involving bone preparation. These types of surgery are called 'unicondylar knee arthroplasty' (UKA) and 'total knee arthroplasty' (TKA).\n\nPurpose:\n\nThis study is being carried out to demonstrate the safety and effectiveness of the CORI Robotics in TKA procedure. The data collected will be used to demonstrate the safety and effectiveness of CORI and to register CORI in China mainland. The primary objective of this study is to evaluate the use of CORI in TKA procedure in achieving post-operative leg alignment as compared to procedures using conventional manual instruments.\n\nResearch participants \u002F locations:\n\n140 research participants will be recruited from up to 8 sites in 3 countries globally (Australia, China Mainland, Hong Kong and New Zealand). There will be 70 patients having TKA using CORI and 70 patients having TKA using conventional procedure.",[94,95,28],[177,178],"Osteoarthritis","Total Knee Arthroplasty (TKA)","RECRUITING","2026-03-09",{"date":182,"type":68},"2026-03-11",{"date":184,"type":68},"2022-02-12",{"date":186,"type":21},"2028-03-31",{"name":188,"class":189},"Smith & Nephew, Inc.","INDUSTRY",{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":86,"enrollmentInfo":198,"targetDuration":4,"studyType":89,"phases":200,"briefSummary":202,"conditions":203,"keywords":204,"overallStatus":179,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":216},"100570257","phase-3-amniotic-suspension-allograft-injection-for-knee-osteoarthritis-100570257","NCT06704893","Amniotic Suspension Allograft Injection for Knee Osteoarthritis","The Efficacy of Amniotic Suspension Allograft Injection in the Treatment of Knee Osteoarthritis: a Randomized Double-blind Controlled Trial","ASAIKO","Inclusion Criteria:\n\n1. Age between 18 and 80 years.\n2. Body mass index (BMI) less than 40 kg\u002Fm².\n3. Symptomatic knee osteoarthritis with X-ray evidence graded 2 or 3 on the Kellgren-Lawrence (KL) grading scale.\n4. Numerical Rating Scale (NRS) score (scale 1 to 10) for pain greater than 4 over the past 7 days.\n5. Able to walk independently or with the aid of a cane.\n\nExclusion Criteria:\n\n1. Pregnant women or women planning pregnancy.\n2. Regular use of anticoagulants.\n3. Use of pain medications (except acetaminophen) within 15 days prior to injection.\n4. History of substance abuse.\n5. Patients who take additional knee symptom-relief medications during the study must report it to the research team; failure to comply will result in exclusion.\n6. Corticosteroid or visco-supplementation injection into the affected knee within 3 months prior to enrollment.\n7. Knee surgery on the affected side within 12 months before enrollment, or surgery on the contralateral knee within 6 months before enrollment.\n\n9\\. History of organ or hematopoietic stem cell transplant. 11. Current use of immunosuppressive agents. 12. Diagnosis of cancer within the past 5 years (except for treated basal cell carcinoma).",{"count":199,"type":21},160,[201],"PHASE3","There have been few clinical trials on ASA for the treatment of knee osteoarthritis, and there is currently no literature reporting the optimal treatment dosage. Non-surgical treatment options include braces, weight loss, lifestyle changes, oral pain relievers, and intra-articular injections. Recently, placental-derived tissues have gradually been applied in the treatment of knee osteoarthritis. These tissues were initially used primarily for burns, ulcers, and wounds that are difficult to heal, but have now begun to be utilized in the orthopedic field. They have been proven to contain various anti-inflammatory cytokines and growth factors, which can reduce inflammation associated with arthritis. Reducing inflammation not only alleviates the pain of knee osteoarthritis but also improves patients' quality of life. The purpose of this study is to compare the therapeutic effects of amniotic suspension allograft (ASA), hyaluronic acid (HA), and saline on knee osteoarthritis and to examine whether there is a dose-response relationship with ASA injections.",[28,177],[205,206,128],"double-blind randomized controlled trial","amniotic suspension allograft injection","2026-01-23",{"date":209,"type":68},"2026-01-26",{"date":211,"type":68},"2024-10-21",{"date":213,"type":21},"2027-12-31",{"name":215,"class":75},"Chang Gung Memorial Hospital",2,{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":224,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":225,"conditions":226,"keywords":227,"overallStatus":179,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":76},"100418425","origin-vs-vanguard-ps-observational-study-100418425","NCT04728542","ORIGIN® vs. VANGUARD® PS Observational Study","A Post-market Observational ORIGIN® vs. VANGUARD® PS Clinical Study: a Comparative, Prospective, Randomized Controlled Clinical and Radiological Evaluation.","Inclusion\u002Fexclusion criteria",{"count":172,"type":21},"The study objective is to assess patient satisfaction after the surgery with a patient match CE marked implant (ORIGIN®) versus off-the-shelf (VANGUARD PS) device, and to document the clinical and device performance outcomes of the ORIGIN System used in routine hospital practice in a large patient cohort treatment of total knee arthroplasty.",[94,95,28],[94,28,228],"Prosthesis","2024-10-03",{"date":231,"type":68},"2024-10-04",{"date":233,"type":68},"2021-03-25",{"date":235,"type":21},"2027-02",{"name":237,"class":189},"Symbios Orthopedie SA",{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":244,"eligibilityCriteria":245,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":246,"targetDuration":248,"studyType":23,"phases":4,"briefSummary":249,"conditions":250,"keywords":258,"overallStatus":179,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":267,"locationsCount":269},"100486389","the-fast-track-centre-for-hip-and-knee-replacement-database-100486389","NCT05613439","The Fast-track Centre for Hip and Knee Replacement Database","The Fast-track Centre for Hip and Knee Replacement Prospective Database on Preoperative Patientcharacteristics and Postoperative Complications","FCD","Inclusion Criteria:\n\n* age \\>18 years\n* non-malignant surgery\n* danish social security number\n* elective procedure\n\nExclusion Criteria:\n\n* unwilling to provide informed consent",{"count":247,"type":21},80000,"3 Months","This is a prospective study-registry on preoperative patient characteristics and postoperative complications in patients having fast-track hip and knee replacement surgery in 8 Danish dedicated arthroplasty departments from all five health regions in Denmark. The registry consists of detailed patient and physician reported preoperative characteristics and including prescribed medication and lab results. Follow-up is based on electronical medical records by dedicated nurses with physician backup and includes Clavien-Dindo and Comprehensive Complication Index scoring. All patients having day-surgery also completes a patient reported questionaire on health-care utilization and return to work by day 30. Finally, a machine-learning algorithm for identification of \"high-risk\" patients based on he preoperative data is included.",[251,28,252,253,254,255,256,257],"Hip","Fast-track Surgery","Enhanced Recovery After Surgery","Perioperative Medicine","Ambulatory Surgical Procedures","Perioperative\u002FPostoperative Complications","Patient Satisfaction",[259,260,254,253,256,255],"Hip Replacement","Knee Replacement","2024-08-06",{"date":263,"type":68},"2024-08-09",{"date":265,"type":68},"2022-09-01",{"date":213,"type":21},{"name":268,"class":75},"Rigshospitalet, Denmark",8,{"id":271,"slug":272,"hasResults":11,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":4,"eligibilityCriteria":276,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":277,"enrollmentInfo":278,"targetDuration":4,"studyType":89,"phases":280,"briefSummary":281,"conditions":282,"keywords":283,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":4},"100513912","the-effect-of-progressive-relaxation-exercises-on-postoperative-pain-100513912","NCT05971641","The Effect of Progressive Relaxation Exercises on Postoperative Pain","The Effect of Progressive Relaxation Exercises on Postoperative Pain Intensity, Sleep Quality, and Recovery in Patients Undergoing Total Knee Arthroplasty","Inclusion Criteria:\n\n* 18 years and older,\n* Without diagnosed mental disorders,\n* Without visual, hearing, and speech impairments,\n* Proficient in Turkish,\n* Diagnosed with gonarthrosis and scheduled for total knee replacement,\n* No postoperative complications following total knee replacement surgery,\n* Literate with an educational level,\n* Pain level of 4 or above on the NRS,\n* Receiving analgesic treatment according to the clinical protocol,\n* Ownership of a mobile device such as a smart phone or tablet capable of accessing internet-based video content with the latest technology from any brand,\n* Patients without diagnosed sleep problems will be included in the thesis study.\n\nExclusion Criteria:\n\n* Illiterate individuals,\n* Under the age of 18,\n* Having a condition that hinders communication,\n* Referred from another center after surgery,\n* Pain level of 4 or below on the NRS,\n* Developing complications after total knee replacement surgery,\n* Receiving analgesic treatment and methods outside of the clinical protocol,\n* Not owning a mobile device such as a smart phone or tablet capable of accessing internet-based video content with the latest technology from any brand,\n* Having diagnosed sleep problems,\n* Having diagnosed mental disorders, will be excluded from the scope of the thesis study.","90 Years",{"count":279,"type":21},96,[91],"The indicators of patient recovery in the postoperative period include sleep, physical functionality, mental health, cognitive functionality, pain, and psychosocial functionality.\n\nThis thesis aims to investigate the effects of progressive relaxation exercises on postoperative pain intensity, sleep quality, and recovery in patients undergoing total knee arthroplasty.This study, designed as a randomized controlled experimental study, will be conducted between September 1, 2023, and August 1, 2024, at ÇAYCUMA State Hospital in ZONGULDAK province, Turkey, among patients undergoing total knee arthroplasty. A total of 96 patients will be recruited based on the sample size calculated using G-power analysis. Through block randomization, 48 patients will be assigned to the intervention group and 48 patients to the control group. Data will be collected using the Numeric Rating Scale for pain, the Richard-Campbell Sleep Scale, a sleep tracker smart wristband to measure sleep quality and duration, the Postoperative Recovery Index, and a Patient Information Form.",[94,95,28],[284,285],"Total Knee Replacement","Progressive relaxation exercises","2024-07-28",{"date":288,"type":68},"2024-07-30",{"date":290,"type":21},"2024-12-09",{"date":292,"type":21},"2025-09-01",{"name":294,"class":75},"Bartın Unıversity",{"id":296,"slug":297,"hasResults":11,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":4,"eligibilityCriteria":301,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":86,"enrollmentInfo":302,"targetDuration":304,"studyType":23,"phases":4,"briefSummary":305,"conditions":306,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":76},"100556654","a-randomized-controlled-trial-of-the-sagittal-alignment-difference-between-mako-robotic-tka-and-manual-tka-100556654","NCT06527911","A Randomized Controlled Trial of the Sagittal Alignment Difference Between Mako Robotic TKA and Manual TKA","A Randomized Controlled Trial of the Sagittal Alignment Difference Between Mako Robotic Total Knee Arthroplasty and Manual Total Knee Arthroplasty","Inclusion Criteria:\n\n1. The age ranged from 18 to 80 years old;\n2. OA patients who underwent Mako robot assisted TKA and manual TKA (Stryker Triathlon prosthesis) in the Department of joint surgery of the PLA General Hospital from September 2024 to September 2026;\n3. All patients were required to take full-length anteroposterior and lateral radiographs of lower limbs, anteroposterior and lateral radiographs of both knees, and lower limb sagittal EOS before and after surgery;\n4. Physical and mental health, able to participate in and cooperate with the test;\n5. Patients are willing to participate in the study and sign written informed consent.\n\nExclusion Criteria:\n\n1. People unable to conduct EOS inspection;\n2. Combined with knee meniscus injury, anterior cruciate ligament injury and other diseases that may affect the sagittal force line of the knee joint\n3. Combined with other diseases that may affect the study\n4. Patients refused to use their imaging data and knee score for this study.",{"count":303,"type":21},100,"3 Years","As China transitions into an aging society, the proportion of the elderly population is escalating, with a corresponding rise in the number of patients with knee joint diseases. Total knee arthroplasty stands as an effective treatment for joint disorders, effectively reducing knee pain, restoring functionality, and enhancing quality of life. The objectives of total knee arthroplasty are to relieve pain, restore function, and ensure a long-lasting implant. In recent years, technological advancements have integrated robotic assistance into total knee arthroplasty (TKA), aiding surgeons in planning and executing more accurate surgical plans, significantly enhancing precision and post-operative outcomes. However, the Mako mechanical axis alignment demonstrated during the Mako robot-assisted TKA procedure does not correspond to the actual straightening of the lower limb, and discrepancies may exist in sagittal alignment between Mako-assisted and manual TKA procedures, necessitating adjustments by surgeons based on their experience. Consequently, there is an urgent need to develop a mathematical formula that quantifies these differences to guide intraoperative alignment. Additionally, the Mako-assisted TKA femoral prosthesis exhibits a head-lowering issue, and differences exist in the posterior slope angle of the tibial plateau compared to manual TKA, necessitating further comparative analysis to draw definitive conclusions. This study will be carried out at the People's Liberation Army General Hospital, with an anticipated enrollment of approximately 100 participants.",[94,95,28,177,307],"Robotic Surgical Procedures","2024-07-25",{"date":288,"type":68},{"date":311,"type":21},"2024-09-01",{"date":313,"type":21},"2026-09-01",{"name":315,"class":75},"Chinese PLA General Hospital"]