[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"arthrosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:arthrosis":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,41,68,96,124,147],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100636758","outcomes-of-surgical-treatment-using-a-custom-made-device-for-total-ankle-and-talar-replacement-in-the-management-of-severe-cases-of-bone-loss-or-bone-compromise-a-pilot-study-100636758",false,"NCT07569848","Outcomes of Surgical Treatment Using a Custom-made Device for Total Ankle and Talar Replacement in the Management of Severe Cases of Bone Loss or Bone Compromise: a Pilot Study.","\\*\\*INCLUSION CRITERIA:\\*\\*\n\n1. Male or female patients aged between 35 and 75 years.\n2. Pathology of the tibiotalar joint requiring surgical intervention with prosthetic replacement.\n3. Severe cases of bone loss or talar bone compromise.\n4. Customisation performed at the Rizzoli Orthopaedic Institute.\n5. Signed informed consent for participation in the study.\n6. Patients must be prepared and motivated to comply with preoperative and postoperative investigations, rehabilitation protocols, follow-up schedules, and study questionnaires.\n\n\\*\\*EXCLUSION CRITERIA:\\*\\*\n\n1. Patients unable to understand or provide informed consent.\n2. Pregnant women.\n3. Body mass index (BMI) \\> 40.\n4. Refusal to sign the informed consent form for study participation.\n5. Substance abuse or psychological disorders that may interfere with adherence to rehabilitation and postoperative assessment protocols.\n6. Known hypersensitivity to device materials.\n7. Active or suspected latent infection in or around the affected ankle joint.\n8. Previous orthopaedic surgery on the lower limbs within the last year, or planned orthopaedic surgery within one year (excluding ankle replacement).\n9. Presence of neuromuscular or neurosensory deficits limiting the ability to assess device safety and efficacy.\n10. Diagnosis of systemic disease (e.g., systemic lupus erythematosus) or metabolic disorder (e.g., Paget's disease of bone) leading to progressive bone deterioration.\n11. Immunosuppression or excessive steroid therapy beyond physiological requirements (e.g., \\>30 days).\n12. Pregnant and\u002For fertile women.","ALL","35 Years","75 Years",{"count":19,"type":20},26,"ESTIMATED","36 Months","OBSERVATIONAL","On February 17th, 2021, the FDA officially approved the use of the first patient-specific 3D-printed talar implant for compassionate use. This is a patient-specific talar spacer designed to completely replace the talus for the treatment of talar avascular necrosis. The implant represents an alternative to other surgical procedures that allows joint preservation.\n\nRecently, at the First Clinic of the Rizzoli Orthopaedic Institute, a prosthetic device has been developed that combines the tibial and meniscal components of a FAR-type ankle prosthesis (Adler Ortho) with a total talus replacement implant. Since the device is patient-specific and implanted using custom-made cutting guides, it reduces surgical invasiveness on surrounding bone structures as well as on ligamentous and tendinous structures, thereby preserving ankle function as much as possible.\n\nThe customization is based on a next-generation prosthetic model produced using additive manufacturing technology and featuring hypoallergenic properties, as it is made of a titanium alloy and treated with a nitriding process.\n\nThe aim of this study is therefore to evaluate the outcomes of this prosthetic device over time.",[25,26,27],"Arthrosis","Ankle Arthritis","Ankle Replacement","RECRUITING","2026-04-29",{"date":31,"type":32},"2026-05-06","ACTUAL",{"date":34,"type":32},"2022-02-11",{"date":36,"type":20},"2031-03",{"name":38,"class":39},"Istituto Ortopedico Rizzoli","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":15,"minAge":48,"maxAge":17,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":67},"100266486","the-medacta-international-sms-post-marketing-surveillance-study-100266486","NCT02748408","The Medacta International SMS Post-Marketing Surveillance Study","The Medacta SMS Femoral Stem Component. A Multi-National, Multi-Centre, Clinical Surveillance Study","Inclusion Criteria:\n\n* Individuals with a severely painful and\u002For disabling hip joint with osteoarthritis, traumatic arthritis or developmental dysplasia of the hip or avascular necrosis of the femoral head.\n* In order to take part in this study, all study participants must be between the ages of 18 and 75 years of age, at the time of surgery.\n* Scheduled for a primary total hip replacement.\n\nExclusion Criteria:\n\n* Active infection\n* Pregnancy\n* Mental illness where the known condition is likely to compromise the patient's ability to consent, affect the patient's assessment of their progress or complete the 10 year cycle of follow-up appointments and reviews\n* Grossly distorted anatomy (surgeon's discretion)\n* Osteomalacia where uncemented implant fixation is contraindicated\n* Active rheumatoid arthritis.\n* Osteoporosis\n* Metabolic disorders which may impair bone formation where uncemented implant fixation is contraindicated\n* Muscular atrophy or neuromuscular disease\n* Allergy to implant material\n* Any patient who cannot or will not provide informed consent for participation in the study\n* Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems","18 Years",{"count":50,"type":20},550,"This is a Post-Marketing Surveillance of SMS femoral stem prosthesis.",[25,53,54,55,56],"Traumatic Arthritis","Rheumatoid Polyarthritis","Congenital Hip Dysplasia","Avascular Necrosis of the Femoral Head","2025-09-23",{"date":59,"type":32},"2025-09-29",{"date":61,"type":4},"2015-07",{"date":63,"type":20},"2032-07",{"name":65,"class":66},"Medacta International SA","INDUSTRY",4,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":95},"100586581","wrist-and-carpal-arthrodeses-a-1-year-follow-up-study-100586581","NCT06917235","Wrist and Carpal Arthrodeses. A 1-year Follow-up Study.","Inclusion Criteria:\n\n* All patients undergoing wrist or carpal arthrodesis, regardless of the specific technique.\n* Advanced degenerative changes unresponsive to conservative treatment.\n\nExclusion Criteria:\n\n* Patients who do not accept participation in the study",{"count":75,"type":20},20,"This study at the Orthopedic Department, Drammen Hospital, examines the effectiveness and safety of various arthrodesis procedures in the wrist and carpus to relieve chronic pain and restore functional stability. Arthrodesis, which fuses two or more bones to eliminate joint mobility, is considered as a last resort when conservative treatments do not produce the desired results. The study includes patients with advanced degenerative changes, rheumatoid arthritis, or extensive injuries. Patients assessed preoperatively and postoperatively through measurements of range of motion, grip strength, and pain using various tools such as PRWHE, QuickDASH, EQ-5D-5L and NRS. The checks include X-rays and CT to evaluate healing. The data is analyzed to identify trends and factors that influence positively outcome. The follow-up takes place after 8 weeks, 3 months and 1 year postoperatively, with a focus on pain relief and functional improvement. The data are compared before and after surgery to assess the effectiveness of the intervention efficiency. The study has been applied for approval by REK, but rejected because it was assessed as a quality control project, and applied for the Data Protection Commissioner (PVO).\n\nThe data is anonymised and stored on secure servers, with switch keys stored separately. The patients give informed consent and are insured through Norwegian Patient Injury Compensation. The study seeks to improve patient care by increasing understanding of the long-term effects of osteoarthritis, including complications and secondary osteoarthritis. The results will contribute to better clinical decisions and treatments.",[78,25,79],"Arthrodesis","Wrist Osteoarthritis",[81,82,83,84,85],"Wrist arthrodesis","carpal arthrodesis","follow-up","surgery","fusion","2025-04-09",{"date":88,"type":32},"2025-04-13",{"date":90,"type":32},"2024-09-01",{"date":92,"type":20},"2029-08-15",{"name":94,"class":39},"Vestre Viken Hospital Trust",2,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":15,"minAge":103,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":40},"100507430","investigation-of-the-clinical-efficacy-of-low-dose-ionizing-radiation-in-the-treatment-of-osteoarthritis-100507430","NCT05887284","Investigation of the Clinical Efficacy of Low-dose Ionizing Radiation in the Treatment of Osteoarthritis","IMMO-LDRT02","Inclusion Criteria:\n\n* Diagnosed osteoarthritis according to ACR criteria (exclusion of other other arthritides and chronic rheumatoid arthritis via laboratory tests):\n\n  * Finger and wrist osteoarthritis\n  * Elbow arthrosis\n  * Shoulder arthrosis\n  * Knee arthrosis\n  * Ankle and foot joint arthrosis\n* First time application of low-dose radiotherapy (LDRT) of the affected joint.\n* Willingness to cooperate and accessibility of the patients (geographical proximity) for treatment and Follow-up care\n\nExclusion Criteria:\n\n* Patients with tumor diseases\n* People capable of childbearing or procreation who do not take consistent contraceptive measures during therapy\n* Persistent drug, medication or alcohol abuse\n* Patients for whom, in the physician's judgment, participation is not justifiable with regard to their well-being due to temporary withdrawal of standard medication.\n* Patients in whom the diagnosis of osteoarthritis of the affected joint cannot be made without doubt. To establish the diagnosis, the guidelines of the American College of Rheumatology (ACR) are followed.\n* Earlier radiation therapy for treatment of cancer","39 Years",{"count":105,"type":20},132,"INTERVENTIONAL",[108],"NA","IMMO-LDRT02 is a prospective, placebo-controlled, double-blind, randomized trial to investigate the clinical efficacy of low dose radiation therapy (LDRT) in the treatment of arthrosis. Newly diagnosed or already existing arthroses of the fingers, wrists, shoulders, knees, ankles and feet will be enclosed. Finally, the evidence of clinical benefit from LDRT (6 x 0.5 Gy) will be compared to the placebo group (6 x 0 Gy), by determination via a visual analog scale and identification of immunological changes.",[25,111],"Osteoarthritis",[113,114],"low dose radiotherapy","LDRT","2024-02-12",{"date":117,"type":32},"2024-02-13",{"date":119,"type":32},"2023-07-01",{"date":121,"type":20},"2028-12-31",{"name":123,"class":39},"University of Erlangen-Nürnberg Medical School",{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":15,"minAge":48,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":106,"phases":134,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":40},"100477805","phase-2-evaluation-of-the-efficacy-of-an-intra-articular-injection-of-autologous-microfat-combined-with-autologous-platelet-enriched-plasma-in-the-treatment-of-radiocarpal-osteoarthritis-a-randomized-controlled-non-inferiority-trial-versus-total-wrist-denervation-established-standard-treatment-100477805","NCT05501743","Evaluation of the Efficacy of an Intra-articular Injection of Autologous Microfat Combined With Autologous Platelet-enriched Plasma in the Treatment of Radiocarpal Osteoarthritis: a Randomized Controlled Non-inferiority Trial Versus Total Wrist Denervation (Established Standard Treatment).","Evaluation of the Efficacy of an Intra-articular Injection of Autologous Microfat Combined With Autologous Platelet-enriched Plasma in the Treatment of Radiocarpal Osteoarthritis: a Randomized Controlled Non-inferiority Trial Versus Total Wrist Denervation.","AMIPREP-2","Inclusion Criteria:\n\n* Men and women aged ≥ 18 years\n* Patients with wrist osteoarthritis:\n* Symptomatic: pain ≥ 40 mm on the visual analog scale (VAS 0-100 mm) more or less associated with a loss of strength objectified by the Jamar dynamometer and\u002For wrist mobility leading to discomfort in activities of daily living and impaired quality of life.\n* Objectivated on radiographs and arthroscanner: stylo-scaphoid and\u002For global radiocarpal and\u002For scapho-capital and\u002For luno-capital joint pinch, more or less associated with osteophytic and subchondral changes equivalent to a grade 3 of the Kellgren and Lawrence classification (see chapter I). Depending on the etiology of the wrist osteoarthritis, the following may be associated: an adaptive carpal defect (DISI), a rupture of the scapholunate or pisotiquetral ligaments, a pseudarthrosis of the scaphoid, a necrosis of the proximal pole of the scaphoid, a vicious callus of the radius, or an avascular necrosis of one of the carpal bones.\n* In case of failure of medical treatment for at least one year: analgesics of the appropriate level for the pain, NSAIDs, wearing of an analgesic orthosis, rehabilitation by a physiotherapist +\u002F- intra-articular injections of corticoids or hyaluronic acid.\n* Informed consent form signed by the patient\n* Women of childbearing age must have a negative pregnancy test (serum or urine) (detection threshold (sensitivity): 25 mIU hCG\u002Fml). Patients of both sexes must use reliable contraception.\n* Beneficiaries or members of a social security system\n\nExclusion Criteria:\n\n* Use of antiplatelet drugs, aspirin, anti vitamin K drugs less than 15 days prior to inclusion that may interfere with the quality or therapeutic effect of the investigational drug\n* Chronic treatment with oral corticosteroids or less than 2 weeks old\n* Intra-articular corticoid injection less than 2 months old\n* Intra-articular injection of hyaluronic acid less than 2 months old\n* NSAIDs taken less than 15 days ago\n* Recent fever or infection (bacterial or viral) less than one month old\n* Current or chronic infectious diseases (viral or bacterial) as evidenced by clinical and\u002For biological elements (inflammatory work-up: VS, CRP, Fibrinogen)\n* Autoimmune diseases attested to by questioning, or clinical and\u002For biological elements (inflammatory workup: VS, CRP, fibrinogen) and which may interfere with the quality or therapeutic effect of the investigational drug\n* Inflammatory arthritis\n* Microcrystalline arthritis\n* History of surgery for the treatment of osteoarthritis of the tested wrist: total denervation of the wrist, resection of the first row of the carpus, arthrodesis, arthroplasty\n* Congenital or acquired immune deficiency\n* Malignant tumors under treatment or history of malignant tumors less than 5 years old\n* Contraindications to MRI: metallic foreign bodies (ferromagnetic material) and metallic implants (pacemakers, heart valves, vascular clips, surgical clips or staples, cochlear implants, any implanted electronic medical material or device (e.g. insulin pump), orthopedic medical prostheses.\n* Contraindications to local anesthetics.\n* Contraindications to local anesthesia or surgery\n* Positive markers for the following active infectious diseases: HIV 1 and HIV 2 human immunodeficiency virus infection; HTLV I infection; Hepatitis B virus infection; Hepatitis C virus infection; Syphilis causative agent infection. (Order of November 4, 2014 on the screening of infectious diseases during autologous therapeutic samples provided for in Article R. 1211-22-1 of the Public Health Code and amending the order of May 14, 2010 setting the content of information allowing the use of human body elements and products for therapeutic purposes)\n* Body mass index (BMI) less than 18kg\u002Fm2 not allowing to obtain a sufficient quantity of adipose tissue for the manufacturing of the experimental MTI-PP and exposing the patient to a significant discomfort during the liposuction procedure\n* Coagulation disorders that may interfere with the quality or therapeutic effect of the investigational drug:\n* Thrombocytopenia \\\u003C 150 G\u002FL\n* Thrombocytosis \\> 450 G\u002FL\n* Known thrombopathy\n* TP \\\u003C 70% o Patient\u002Fhematopoietic ratio\n* Patient to Witness APTT ratio \\> 1.20\n* Anemia \\\u003C 10g\u002Fdl contraindicating peripheral venous blood sampling\n* Pregnant or breastfeeding women\n* Persons of legal age (under guardianship or trusteeship)\n* Persons participating simultaneously in another research project involving the human person or in a period of exclusion from a previous research project\n* Persons staying in a health or social institution\n* Persons in an emergency situation\n* Persons deprived of liberty\n* Persons who are not beneficiaries of a social security system\n* Absence or refusal to give informed consent to participate in the study",{"count":133,"type":20},36,[135],"PHASE2","This is a phase II, prospective, comparative, randomized, single-center, open-label, parallel-group therapeutic trial.\n\nIt is a non-inferiority trial to establish the efficacy of intra-articular injection of autologous microfat and PRP at the wrist in patients suffering from radiocarpal osteoarthritis in reference to wrist denervation.",[25],"2023-03-09",{"date":140,"type":32},"2023-03-10",{"date":142,"type":32},"2023-02-17",{"date":144,"type":20},"2026-06",{"name":146,"class":39},"Assistance Publique Hopitaux De Marseille",{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":15,"minAge":48,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":156,"conditions":157,"keywords":165,"overallStatus":170,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"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":155,"type":20},100,"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",[158,159,25,111,160,161,162,163,164],"Shoulder Arthritis","Shoulder Osteoarthritis","Rheumatoid Arthritis","Arthroplasty","Avascular Necrosis","Humeral Fractures","Cuff Tear Arthropathy",[166,167,168,169],"Shoulder Joint","Shoulder Replacement","Arthritis with rotator cuff tear","Post traumatic fracture sequele","NOT_YET_RECRUITING","2022-03-29",{"date":173,"type":32},"2022-04-06",{"date":175,"type":20},"2022-04",{"date":177,"type":20},"2029-04",{"name":179,"class":66},"Limacorporate S.p.a"]