[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"arthroplasty\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:arthroplasty":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,47,79,104,129,160,181,212,241,265,286,309,334,354],{"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":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100581477","heidelberg-registry-for-hip-and-knee-joint-implants-and-revisions-100581477",false,"NCT06850818","Heidelberg Registry for Hip and Knee Joint Implants and Revisions","Endoprosthesis Registry Heidelberg (EPR-HD): Registry for the Analysis of Patients Following Primary Implantation or Revision Surgery of Artificial Joints in Hip and Knee Joint Pathologies","EPR-HD","Inclusion Criteria:\n\n* All patients undergoing hip or knee arthroplasty at our institution\n* All patients undergoing revision surgery following hip oder knee arthroplasty\n\nExclusion Criteria:\n\n* Lack of prospective consent for study participation\n* Lack of capacity to provide informed consent\n* Minor status (underage)","ALL","18 Years",{"count":20,"type":21},10000,"ESTIMATED","20 Years","OBSERVATIONAL","The Endoprosthesis Registry Heidelberg (EPR-HD) is a clinical registry designed to systematically collect and analyze data from patients undergoing primary implantation or revision surgery of artificial hip and knee joints. The main objective of the registry is to evaluate long-term outcomes, complication rates, implant survival, and functional results associated with joint replacement procedures in patients with various hip and knee joint pathologies.\n\nBy gathering comprehensive clinical data, EPR-HD aims to improve the understanding of patient outcomes after endoprosthetic procedures, identify potential factors influencing implant success, and support evidence-based improvements in surgical techniques and patient care. The registry includes adult patients treated at Heidelberg University Hospital, with data collected at multiple time points during routine clinical follow-up. This registry will contribute to the optimization of joint replacement strategies and promote high-quality patient care.",[26,27],"Osteoarthritis","Arthroplasty",[29,27,30,26,31,32,33],"Endoprostheses","Joint Replacement","Registry","Knee","Hip","RECRUITING","2026-06-10",{"date":37,"type":38},"2026-06-11","ACTUAL",{"date":40,"type":38},"2007-01-01",{"date":42,"type":21},"2035-12",{"name":44,"class":45},"University Hospital Heidelberg","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100540986","inhance-stemless-reverse-shoulder-ide-100540986","NCT06323980","INHANCE Stemless Reverse Shoulder IDE","Randomized, Prospective, Multi-Center Study of the INHANCE Stemless Total Reverse Shoulder System","Inclusion Criteria:\n\n1. Individuals requiring reverse total shoulder replacement for a severely painful, disabling, arthritic joint (i.e. osteoarthritis, post-traumatic arthritis and rotator cuff arthropathy).\n2. Individuals who are anatomically and structurally suited to receive the implants and have a functional deltoid muscle.\n3. Individuals who are able to read and comprehend the informed patient consent document and are willing and able to provide informed patient consent for participation in the study and have authorized the transfer of their information to DePuy Synthes.\n4. Individuals who are willing and able to return for follow-up as specified by the study protocol.\n5. Individuals who are a minimum age of 22 years at the time of consent.\n6. Individuals who are willing and able to complete the Patient Reported Outcome Measure questionnaires (PROMs) as specified by the study protocol.\n\nExclusion Criteria:\n\n1. BMI \\> 40 kg\u002Fm2\n2. Individuals have active, uncontrolled local infection or systemic infection.\n3. Patients who have not reached skeletal maturity, regardless of age.\n4. Either preoperatively or intraoperatively and per standard of care medical assessment, bone stock in the proximal humerus or glenoid fossa is determined to be inadequate for supporting the INHANCE humeral stemless components (NOTE: exclusion applies to both arms of the study, i.e., bone stock to be evaluated independent of randomized treatment assignment).\n5. Intraoperatively and per treating physician's assessment of bone quality, bone is determined to be too soft or porous to support the implant or that is too hard or brittle to allow for proper bone preparation and fixation, i.e. osteoporosis or sclerotic bone, or tumor(s) of the supporting bone structure, where there could be considerable migration of the prosthesis and\u002For a chance of fracture of the humerus or glenoid.\n6. Fractures of the proximal humerus that could compromise the fixation of the INHANCE reverse humeral stemless components.\n7. Patients who have undergone previous treatment on the study shoulder that may compromise fixation of the INHANCE reverse humeral stemless component.\n8. Revision of a failed hemi, total or reverse shoulder arthroplasty.\n9. Patient is receiving, or is scheduled to receive, treatment that the Investigator considers could affect bone quality, such as chemotherapy or high dose corticosteroids.\n10. Individuals who are bedridden per the Investigator's determination.\n11. Individuals that have participated in a clinical investigation with an investigational product (drug or device) in the last three months.\n12. Individuals currently involved in any personal injury litigation, medical-legal or worker's compensation claims.\n13. Individuals, in the opinion of the Investigator, who are drug or alcohol abusers or have psychological disorders that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements.\n14. Patients with a known medical condition that the Investigator believes would impact the study outcomes (including, but not limited to osteomyelitis, Paget's disease, neuropathies such as Charcot's disease, metastatic or neoplastic disorders).\n15. Patient has a medical condition with less than 2 years life expectancy.\n16. Patients who are known to be pregnant or breastfeeding.\n17. Known polyethylene and\u002For metal sensitivity or allergy.\n18. Contralateral side has been enrolled in the study or has received a total shoulder operation within the last 6 months\n19. Otherwise determined by the investigator to be medically unsuitable for participation in this study\n20. Patient is a member of a vulnerable population (i.e., incarcerated individuals - those incarcerated for at least one month and considered to be an inmate)","22 Years",{"count":56,"type":21},168,"INTERVENTIONAL",[59],"NA","2:1 Randomized, Controlled, Multi-Center, Prospective, Pre-Market Study of the INHANCE Stemless Reverse Cementless Total Shoulder.",[27,62,63],"Replacement","Shoulder",[65,66,67],"Reverse Shoulder","Stemless Shoulder","Total Shoulder","2026-06-04",{"date":70,"type":38},"2026-06-05",{"date":72,"type":38},"2025-03-04",{"date":74,"type":21},"2028-10-30",{"name":76,"class":77},"DePuy Orthopaedics","INDUSTRY",19,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":86,"sex":17,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":57,"phases":91,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"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":90,"type":21},78,[59],"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.",[27,62,32],"NOT_YET_RECRUITING","2026-05-06",{"date":97,"type":38},"2026-05-12",{"date":99,"type":21},"2026-05-18",{"date":101,"type":21},"2028-01-31",{"name":103,"class":45},"Yonsei University",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":57,"phases":114,"briefSummary":115,"conditions":116,"keywords":117,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":128},"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":113,"type":21},140,[59],"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.",[27,62,32],[26,118],"Total Knee Arthroplasty (TKA)","2026-03-09",{"date":121,"type":38},"2026-03-11",{"date":123,"type":38},"2022-02-12",{"date":125,"type":21},"2028-03-31",{"name":127,"class":77},"Smith & Nephew, Inc.",4,{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":57,"phases":139,"briefSummary":140,"conditions":141,"keywords":147,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":158,"locationsCount":46},"100625655","cryoneurolysis-prior-to-total-knee-arthroplasty-cryo-tka-trial-100625655","NCT07425457","Cryoneurolysis Prior to Total Knee Arthroplasty (CRYO-TKA Trial)","Association of Pre-operative Genicular Nerves Cryoneurolysis With Improved Pain and Function in Patients Undergoing Total Knee Arthroplasty","CRYO-TKA","Inclusion Criteria:\n\n* Adults ≥18 years undergoing primary TKA for osteoarthritis.\n* Cognitively normal and able to self-assess pain and function.\n* Provide written informed consent.\n\nExclusion Criteria:\n\n* Cancer-related knee pain.\n* Neurological, psychiatric, or medical conditions interfering with assessment.\n* Chronic opioid users.",{"count":138,"type":21},100,[59],"Approximately 20-30% of patients experience persistent pain after a Total Knee Arthroplasty (TKA). This study investigates whether percutaneous cryoneurolysis of genicular nerves can reduce pain and improve physical function when performed at least 24 hours before surgery. Participants will be randomized to receive either the cryoneurolysis procedure + TKA or TKA only. Results will be tracked for 6 months to see if the intervention improves long-term recovery and quality of life.",[27,142,143,144,145,146],"Replacement Material","Knee Arthritis Osteoarthritis","Knee Arthroplasty, Total","Genicular Nerves","Chronic Pain",[148,149,150,151],"Cryoneurolysis","Interventional Radiology","Pain Management","Post-operative recovery","2026-02-19",{"date":154,"type":38},"2026-02-20",{"date":156,"type":38},"2026-01-02",{"date":125,"type":21},{"name":159,"class":45},"Attikon Hospital",{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":57,"phases":168,"briefSummary":170,"conditions":171,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":46},"100580098","phase-4-postoperative-oral-tranexamic-acid-in-patients-undergoing-primary-total-joint-arthroplasty-100580098","NCT06832878","Postoperative Oral Tranexamic Acid in Patients Undergoing Primary Total Joint Arthroplasty","Inclusion Criteria\n\n* Adults aged \\> 18 years (All women of childbearing potential undergo pregnancy testing prior to THA as per our institutional protocol)\n* Written informed consent\n* Patients undergoing primary THA diagnosis of end-stage osteoarthritis\n* Patients receiving spinal anesthesia\n* Patients being discharged on postoperative day 1\n\nExclusion Criteria\n\n* Patients with a TXA allergy\n* Patients undergoing revision procedures\n* Patients undergoing primary THA for a diagnosis other than end-stage osteoarthritis\n* Patients receiving general anesthesia\n* Patients being discharged on the same day of surgery\n* Cancer patients\n* Patients with a history of prior VTE event\n* Patients on preoperative anticoagulants other than ASA\n* Pregnant patients (All women of child bearing potential undergo pregnancy testing prior to THA as per our institutional protocol)\n* Female patients who are on hormonal contraception\n* Patients with history of retinal vein or artery occlusion",{"count":167,"type":21},101,[169],"PHASE4","The purpose of this study is to evaluate the impact of an extended oral Tranexamic Acid regimen on patient reported outcome scores, time to independent ambulation, postoperative range of motion, swelling, change in hemoglobin levels, 90-day complications, readmission and reoperation.",[27],"2026-01-29",{"date":174,"type":38},"2026-02-02",{"date":176,"type":21},"2026-06-01",{"date":178,"type":21},"2026-06",{"name":180,"class":45},"Mayo Clinic",{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":57,"phases":191,"briefSummary":192,"conditions":193,"keywords":199,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":211},"100620637","muscle-damage-of-the-tfl-tensor-fascia-latae-during-total-hip-arthroplasty-tha-through-direct-anterior-approach-daa-100620637","NCT07360210","Muscle Damage of the TFL (Tensor Fascia Latae) During Total Hip Arthroplasty (THA) Through Direct Anterior Approach (DAA)","Muscle Damage of the TFL (Tensor Fascia Latae) During Total Hip Arthroplasty (THA) Through Direct Anterior Approach (DAA), Evaluation of the Correlation With Short Term Functional Results","TFL","Inclusion Criteria:\n\n* adult (\\>18 years old),\n* patient undergoing primary Total Hip Arthroplasty through Direct Anterior Approach for osteoarthritis\n\nExclusion Criteria:\n\n* hip dysplasia\n* leg length discrepancy greater than 2cm\n* history of homolateral hip surgery\n* neuromuscular pathology\n* patients declining the protocol",{"count":190,"type":21},150,[59],"Direct Anterior Approach (DAA) is known to cause damage to the TFL during the surgical approach, the point of this study is to evaluate the impact between the severity of the per operative TFL damage and the functional short term results.",[194,195,27,62,196,197,198],"Hip Joint","Surgery","Surgical Wound","Muscle Injury","Fascia Lata",[200,201],"TFL damage","Total Hip Arthroplasty through Direct Anterior Approach","2026-01-14",{"date":204,"type":38},"2026-01-22",{"date":206,"type":21},"2026-02",{"date":208,"type":21},"2026-10",{"name":210,"class":45},"University Hospital, Bordeaux",2,{"id":213,"slug":214,"hasResults":11,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":219,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":221,"conditions":222,"keywords":223,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":240},"100543336","arthroplasty-cements-outcomes---a-post-market-follow-up-100543336","NCT06354543","Arthroplasty Cements Outcomes - A Post-market Follow-up","Safety and Clinical Performance Assessment of Bone Cements and Cement Restrictor Used in Arthroplasty - A Post-market Clinical Follow-up","Inclusion Criteria:\n\n* Be 18 years or older.\n* Be willing to sign an informed consent approved by Institutional Review Board (IRB) or European Commission (EC) (when applicable) or not oppose to the use of their clinical data in the study\n* For prospective inclusion: be considered for an arthroplasty procedure with one of the TEKNIMED orthopaedic cement and\u002For cement restrictor comprised in this study (primary or revision surgery).\n* For retrospective inclusion: have undergone a primary or revision arthroplasty procedure with a TEKNIMED orthopaedic cement and\u002For cement restrictor between the 1st January 2016 and the date of the site initiation visit (SIV).\n* Be informed of the study and not being opposed to the use of their clinical data in the study or be willing to sign an informed consent during the first follow-up visit following the site initiation (where applicable).\n\nExclusion Criteria:\n\n* Patient under trusteeship or guardianship,\n* Women who are pregnant\n* Patient unable to follow the protocol\n* Patient whose vital prognosis is unfavorable (according to investigator's opinion)",{"count":220,"type":21},1050,"A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all Teknimed Arthroplasty range of products: CEMFIX® and GENTAFIX® bone cements families and CEMSTOP® cement restrictor, and all their private labels.\n\nTeknimed bone cements and cement restrictor are legacy products, some marketed for more than 20 years. Their performance and safety have already been demonstrated by Post-Market Surveillance and previous clinical studies. The current Post-Market Clinical Follow-Up study aims to confirm these claims by collecting data in a \"real-life\" setting.\n\nThe study is a retrospective and prospective global, single arm, non-controlled, multicentric, ambispective observational study. Patients will be followed as per local standard medical care of the site.",[27],[224,225,226,227,228,229,230],"cement","prosthesis","arthroplasty","knee","hip","shoulder","joint","2025-03-24",{"date":233,"type":38},"2025-03-25",{"date":235,"type":38},"2020-12-16",{"date":237,"type":21},"2045-12",{"name":239,"class":77},"Teknimed",10,{"id":242,"slug":243,"hasResults":11,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":4,"eligibilityCriteria":247,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":248,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":250,"conditions":251,"keywords":252,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":46},"100544664","prima-eu-retrospective--prospective-100544664","NCT06371833","PRIMA EU Retrospective & Prospective","A Multicentric Study Evaluating Clinical and Radiological Outcomes of PRIMA Humeral Stem in Total Shoulder Arthroplasty","Inclusion Criteria:\n\n1. Age ≥ 18 years old;\n2. Full skeletal maturity;\n3. Life expectancy over 24 months;\n4. Patient's joint anatomically and structurally suited to receive the selected implants and functional deltoid muscle;\n5. Patient meets at least one of the following indications:\n\n   For Anatomic configuration:\n   * non-inflammatory degenerative joint disease (i.e., osteoarthritis);\n   * inflammatory arthritis of the glenohumeral joint including rheumatoid arthritis;\n   * avascular necrosis of the humeral head;\n   * cuff tear arthropathy (CTA Heads only);\n\n   For Reverse configuration:\n   * rotator cuff tear arthropathy;\n   * osteoarthritiswith rotator cuff tear;\n   * rheumatoid arthritis with rotator cuff tear;\n   * massive irreparable rotator cuff tear;\n6. Patient is able to understand the conditions of the study, to comply with the prescribed rehabilitation as well as willing to perform all scheduled follow-up visits;\n7. Patient has signed the Informed Consent form previously approved by the Ethics Committee before study activities.\n\nExclusion Criteria:\n\n1. Patients who lack capacity to be able to provide informed consent to participate in the study.\n2. Local or systemic general infection;\n3. Septicaemia;\n4. Persistent acute or chronic local or systemic osteomyelitis;\n5. Confirmed neurologic lesion compromising shoulder joint function;\n6. Deltoid muscle insufficiency;\n7. Poor meta-epiphyseal bone stock compromising stability of the implant (severe fracture of the proximal humerus, meta-epiphyseal pseudoarthrosis, osteoporosis, osteomalacia, extended bone loss after previous prosthetic or non-prosthetic surgery);\n8. Affected by malignant cancer with life expectancy less than 2 years or where cancer treatment might affect the normal postoperative course;\n9. Serious muscular, neurological, or arterial vascular diseases compromising stability of the implant;\n10. Proximal humerus fracture sequelae with inadequate bone stock;\n11. Vascular or nerve diseases affecting the concerned limb;\n12. Metabolic disorders which may impair fixation and stability of the implant;\n13. Any concomitant disease that might affect the implanted prosthesis;\n14. Metal hypersensitivity to implant materials (CoCrMo);\n15. Patient with significant renal impairment;\n16. Lower mobility issues that may affect the study evaluation;\n17. Unwillingness or inability (due to physical or mental issues) to comply with rehabilitation and to return for follow-up visits and any psychiatric illness that would prevent comprehension of the details and nature of the study;\n18. Women of childbearing potential who are pregnant, nursing, or planning to become pregnant;\n19. Any clinically significant pathology based on the medical history that the Investigator feels may affect the study evaluation.",{"count":249,"type":21},60,"This clinical study aims at evaluating clinical, radiographic and patient-reported outcomes after total anatomic or reverse shoulder replacement using PRIMA humeral stem up to 24 months after surgery, in order to assess the short-term performance of the implant. Furthermore, the objective is also to collect short-term data on the survivorship of the implant and the incidence of complications.",[27,62,63],[253,254,255],"TSA","RSA","Shoulder replacement","2025-02-03",{"date":258,"type":38},"2025-02-05",{"date":260,"type":38},"2024-10-25",{"date":262,"type":21},"2026-12",{"name":264,"class":77},"Limacorporate S.p.a",{"id":266,"slug":267,"hasResults":11,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":272,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":273,"conditions":274,"keywords":275,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":46},"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":113,"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.",[27,62,32],[27,32,276],"Prosthesis","2024-10-03",{"date":279,"type":38},"2024-10-04",{"date":281,"type":38},"2021-03-25",{"date":283,"type":21},"2027-02",{"name":285,"class":77},"Symbios Orthopedie SA",{"id":287,"slug":288,"hasResults":11,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":292,"eligibilityCriteria":293,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":296,"conditions":297,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":46},"100558694","post-surgical-multimodal-analgesia-with-oral-strong-opioids-100558694","NCT06554457","Post Surgical Multimodal Analgesia With Oral Strong Opioids","Study on the Clinical Effectiveness of Oral Strong Opioids for Common Orthopedic Surgeries Following Multimodal Analgesia","ORORA","Inclusion Criteria:\n\n1. Aged 18 or older\n2. Must undergo one of the following treatments:\n\n(1) Fracture of upper or lower limbs or pelvis requiring internal fixation surgery (2) Spinal fusion surgery (3) Joint replacement surgery 3. Requiring multimodal analgesics for postoperative pain control, with oral strong opioids as the primary opioid analgesic, as assessed by his\u002Fher physician.\n\n4\\. Voluntarily sign the informed consent form and agree to the collection of clinical questionnaires and medical-related information for this study.\n\nExclusion Criteria:\n\n1. Patients who have not received any or have only received oral potent opioids for no more than 1 day during the postoperative hospitalization period (including those known to be intolerant or allergic to opioid medications).\n2. Patients who have received or are expected to use long-acting opioid injections within 7 days before surgery or during the postoperative hospitalization period.\n3. Patients who use patient-controlled analgesics for pain control after surgery.\n4. Patients with a history of substance abuse or who require continuous treatment with other opioid receptor agonists or antagonists (such as naloxone or methadone).\n5. Patients with a history of mental illness who continue to require medication control from 28 days before surgery and until discharge.\n6. Other cases deemed ineligible by the study investigator.",{"count":295,"type":21},200,"This is a prospective observational case study, focusing on the clinical effectiveness of oral strong opioids for pain management following common orthopedic surgeries.The study aims to evaluate the effectiveness of multimodal analgesia with oral strong opioids, reduce common opioid-related side effects, and improve patient compliance and satisfaction.",[298,27,299],"Orthopedic Procedures","Fracture Fixation","2024-08-14",{"date":302,"type":38},"2024-08-15",{"date":304,"type":21},"2024-08-12",{"date":306,"type":21},"2025-07-31",{"name":308,"class":45},"Tri-Service General Hospital",{"id":310,"slug":311,"hasResults":11,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":4,"eligibilityCriteria":315,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":316,"enrollmentInfo":317,"targetDuration":4,"studyType":57,"phases":319,"briefSummary":320,"conditions":321,"keywords":322,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":332,"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":318,"type":21},96,[59],"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.",[27,62,32],[323,324],"Total Knee Replacement","Progressive relaxation exercises","2024-07-28",{"date":327,"type":38},"2024-07-30",{"date":329,"type":21},"2024-12-09",{"date":331,"type":21},"2025-09-01",{"name":333,"class":45},"Bartın Unıversity",{"id":335,"slug":336,"hasResults":11,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":4,"eligibilityCriteria":340,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":88,"enrollmentInfo":341,"targetDuration":342,"studyType":23,"phases":4,"briefSummary":343,"conditions":344,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":46},"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":138,"type":21},"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.",[27,62,32,26,345],"Robotic Surgical Procedures","2024-07-25",{"date":327,"type":38},{"date":349,"type":21},"2024-09-01",{"date":351,"type":21},"2026-09-01",{"name":353,"class":45},"Chinese PLA General Hospital",{"id":355,"slug":356,"hasResults":11,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":4,"eligibilityCriteria":360,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":361,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":362,"conditions":363,"keywords":371,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":4},"100463414","s-11-smr-tt-hybrid-glenoid-and-cementless-finned-short-stem-100463414","NCT05314387","S-11 SMR TT Hybrid Glenoid and Cementless Finned Short Stem","A Multicentre, Prospective Clinical Study Analysing Outcomes of Shoulder Arthroplasty With SMR TT Hybrid Glenoid With or Without SMR Cementless Finned Short Stem","Inclusion Criteria:(Key)\n\n* Both genders;\n* Age ≥ 18 years old;\n* Full skeletal maturity;\n* Life expectancy over 5 years;\n* Patient is requiring primary unilateral arthroplasty based on physical examination and medical history;\n* Good bone quality evaluated by the Investigator and the intraoperative evaluation;\n* A diagnosis in the target shoulder of one or more of the S-11 SMR TT Hybrid Glenoid and Cementless Finned Short Stem Version Sep 2021 2.0 Confidential Page11 following:\n\n  1. Primary osteoarthritis;\n  2. Secondary osteoarthritis;\n  3. Post-traumatic arthritis;\n  4. Rheumatoid arthritis;\n  5. Avascular necrosis\n  6. acute fractures of the humeral head that cannot be treated with other fracture fixation methods;\n  7. cuff tear arthropathy (only in combination with CTA Heads);\n  8. Glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification.\n\nExclusion Criteria (Key):\n\n* Patient requiring revision shoulder arthroplasty;\n* Osteoporosis with a history of non-traumatic fractures;\n* Steroid injections within the previous 3 months;\n* Contralateral shoulder replacement within the previous 3 months;\n* Significant proven or suspicious infection of the target shoulder or any serious infectious disease before the study according to the Investigator;\n* Significant neurological or musculoskeletal disorders that may compromise functional recovery;\n* Not recovered axillary nerve palsy;\n* Non functioning deltoid muscle;\n* Known or suspicious hypersensitivity to the metal or other components and materials of the implant;\n* Participation in any experimental drug\u002Fdevice study within the 6 months prior to the preoperative visit;\n* Women of childbearing potential who are pregnant, nursing, or planning to become pregnant.\n\nThese are key eligibility criteria, other eligibility criteria apply.",{"count":138,"type":21},"Post-market, prospective, non randomized, open label, multicentre, clinical study analysing outcomes of shoulder arthroplasty with SMR TT Hybrid Glenoid with or without SMR Cementless Finned Short Stem",[364,365,366,26,367,27,368,369,370],"Shoulder Arthritis","Shoulder Osteoarthritis","Arthrosis","Rheumatoid Arthritis","Avascular Necrosis","Humeral Fractures","Cuff Tear Arthropathy",[372,373,374,375],"Shoulder Joint","Shoulder Replacement","Arthritis with rotator cuff tear","Post traumatic fracture sequele","2022-03-29",{"date":378,"type":38},"2022-04-06",{"date":380,"type":21},"2022-04",{"date":382,"type":21},"2029-04",{"name":264,"class":77}]