[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"rhizarthrosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:rhizarthrosis":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,39,66],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":5},"100493690","phase-2-tolerance-of-intra-articular-injection-autologous-stromal-vascular-fraction-for-the-treatment-of-rhizarthrosis-100493690",false,"NCT05708430","Tolerance of Intra-articular Injection Autologous Stromal Vascular Fraction for the Treatment of Rhizarthrosis","FVS-RHIZA","Inclusion Criteria:\n\n* Rhizarthrosis DELL stage 1 to 3\n* Symptomatic medical treatment for a period of at least 6 months (analgesic, orthosis, anti-inflammatory, etc. or intra-articular infiltration of the trapezio-metacarpal joint) which has become ineffective (surgical stage)\n* EVA pain ≥ 4\n* Quick Dash or PRWHE ≥ 20\u002F100\n* Affiliation to a social security scheme\n* Person who has read and understood the information letter and signed the consent form\n\nExclusion Criteria:\n\n* History of intra-articular injection of the trapezio-metacarpal (corticoid or hyaluronic acid) in the last 6 months\n* Body Mass Index \\\u003C 18 kg\u002Fm2\n* Contraindication to general or local anesthetics including XYLOCAINE 10 mg\u002FmL ADRENALINE 0.005 mg\u002FmL, solution for injection\n* Contraindication to sedation or general anesthesia (left to the discretion of the anesthesiologist)\n* Contraindication to liposuction (eg bleeding disorder)\n* Documented severe allergy to conventional antibiotics such as β-lactams, cyclins, macrolides, quinolones, aminoglycosides, etc…\n* Known hypersensitivity to human albumin or to any of the excipients (VIALEBEX 200 g\u002FL, solution for infusion)\n* A general or local infection near the sampling or injection sites\n* Any surgery scheduled over the duration of the study of the hand (carpal tunnel type operation) or upper limb that may have an impact on the assessment of pain and\u002For functional indices\n* Persons on immunosuppressants: corticosteroid therapy \\> 10 mg\u002Fd, methotrexate \\> 25 mg\u002Fweek, mycofenolate mofetil \\> 3 grams\u002Fd, azathioprine \\> 200 mg\u002Fd and intravenous cyclophosphamide and any biotherapy in the 90 days preceding the medical visit. inclusion\n* Congenital or acquired immune deficiency\n* Prescription of a new systemic treatment that may influence the condition of the hand (vasodilator or immunosuppressant) in the 90 days preceding inclusion\n* Persons infected with HIV, HCV, HBV, HTLV and syphilis\n* Contraindication to MRI, (eg, due to presence of pacemakers or other incompatible foreign material or claustrophobia)\n* Contraindication to the injection of gadolinated contrast product (gadolinium) for performing MRI (history of hypersensitivity to gadolinated contrast products)\n* Active COVID-19 infection (PCR positive)\n* Any cardiovascular, metabolic, endocrine, psychiatric or cancerous pathology in uncontrolled evolution","ALL","18 Years",{"count":19,"type":20},12,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Rhizarthosis is a common disease in the population (15%). It has a major impact on the function of the hand since it compromises the pollicidigitales claws and all gripping functions with the thumb. However, no curative medical treatment exists to date. The treatment is initially based on a symptomatic approach: analgesics, non-steroidal anti-inflammatories, immobilization orthoses or even intra-articular injections of corticosteroids or hyaluronic acid. When it is exceeded, surgical treatment is considered. This is also not a curative treatment. Indeed, the 3 types of main interventions proposed (arthrodesis, arthroplasty or trapezectomy) each have significant consequences for the patient: stiffness for the arthrodesis, risk of dislocation or failure of the material for the prosthesis, long consequences for the trapezectomy. , or potential complications of surgery.\n\nStem cell-based therapies, in particular cells of the stromal vascular fraction derived from adipose tissue (FVS), are promising in various indications, including osteoarthritis of the knee. Autologous FVS is readily accessible by standard liposuction, with FVS isolated from adipose tissue by centrifugation. A safe and well-tolerated source of cells with angiogenic, anti-inflammatory, immunomodulatory and regenerative properties, its safety has been demonstrated in particular during phase 1 trials. Our objective is to assess the tolerance of an injection of FVS into the trapezio-metacarpal joint, when standard medical treatment has failed, and the rhizarthrosis has become painful enough to be eligible for surgery. Due to its immunomodulatory and cartilage regeneration properties, this injection would be performed to offer a less invasive and possibly curative treatment instead of surgery.",[26],"Rhizarthrosis","RECRUITING","2026-02-13",{"date":30,"type":31},"2026-02-17","ACTUAL",{"date":33,"type":31},"2024-02-15",{"date":35,"type":20},"2026-12",{"name":37,"class":38},"University Hospital, Rouen","OTHER",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":52,"conditions":53,"keywords":54,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":65},"100522099","rhizarthrosis-surgery-and-functional-recovery-arthroplasty-vs-trapezectomy-100522099","NCT06078189","Rhizarthrosis Surgery and Functional Recovery: Arthroplasty vs. Trapezectomy","Comparing Short-Term Functional Recovery After Surgery for Rhizarthrosis: Arthroplasty vs. Trapezectomy - A Prospective Randomized Evaluation","TRAPEzE","Inclusion Criteria:\n\n1. Age \\>45 years\n2. Symptomatic trapezius-metacarpal osteoarthritis after failure of medical treatment ( night orthosis 3 months + failure of 2 infiltrations\u002Fyear)\n3. Patient who has given his\u002Fher consent to participate in the study after being informed by the surgeon,\n4. Patient living in France and able to answer the survey alone.\n5. Subject affiliated to a social security system or beneficiary of such a system\n6. No participation in any other clinical study\n\nExclusion Criteria:\n\n1. Minor patient\n2. Trapezium height \\\u003C 8 mm\n3. Major subject protected by law, under curatorship or guardianship\n4. Known allergy to the materials of the medical device\n5. Local infection\n6. Local skin necrosis or unhealed wound\n7. Pregnant or nursing women","45 Years","85 Years",{"count":50,"type":20},50,"OBSERVATIONAL","Rhizarthrosis is a form of osteoarthritis that affects the trapeziometacarpal joint at the base of the thumb, which is more common in women over 50. Genetic and hormonal factors as well as the frequency of certain physical movements may contribute to its appearance. Surgical treatment is recommended if medical treatment fails, and trapezectomy is currently considered the standard method, although 3rd generation trapeziometacarpal prostheses are also available.\n\nThe aim of this study is to compare the clinical and radiographic results after surgical treatment of rhizarthrosis: prosthesis versus trapezectomy.",[26],[55],"osteoarthritis - Trapezectomy","2026-01-02",{"date":58,"type":31},"2026-01-06",{"date":60,"type":31},"2023-11-24",{"date":62,"type":20},"2027-05",{"name":64,"class":38},"Clinique Bizet",1,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":77,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":65},"100576150","evaluation-of-the-performance-and-safety-of-a-type-i-collagen-based-medical-device-md-small-joints-collagen-medical-device-i-the-treatment-of-rhizoartrosis-100576150","NCT06781554","Evaluation of the Performance and Safety of a Type I Collagen-Based Medical Device (MD-Small Joints Collagen Medical Device) i the Treatment of RHIZOARTROSIS","Evaluation of the Performance and Safety of a Type I Collagen-Based Medical Device (MD-Small Joints Collagen Medical Device) i the Treatment of RHIZOARTROSIS. \"SMAGENART PILOT STUDY\"","SMAGENART","Inclusion Criteria:\n\n* Male and female subjects aged between 18 and 75 years;\n* Subjects with clinically diagnosed symptomatic thumb carpometacarpal osteoarthritis confirmed radiographically (stages I and II according to Eaton and Littler's classification);\n* \\[N.B. in case of bilateral symptomatic thumb carpometacarpal osteoarthritis, treatment can be unilateral only, at the level of the thumb carpometacarpal joint that is more affected at the time of enrollment\\].\n* Subjects with a VAS score ≥ 5; \\[The request for pain intensity (VAS) from the patient should refer to moments of hand use, nota t rest!\\]\n* Subjects with joint pain for at least 1 month;\n* Subjects not using thumb carpometacarpal orthotic devices;\n* Subjects agreeing not to take analgesics within 24 hours before the scheduled visits;\n* Subjects capable of understanding and signing the Informed Consent.\n\nExclusion Criteria\n\n* Subjects with rheumatological conditions involving the hands;\n* Subjects who have undergone hand surgery for the affected pathology;\n* Subjects who have received HA injections in the thumb carpometacarpal joint in the last 3 months;\n* Subjects who have taken NSAIDs in the last 7 days and\u002For corticosteroids in the last 30 days;\n* Subjects undergoing physical therapy such as X-ray therapy, Tecar therapy, shock wave therapy, laser therapy, ultrasound therapy in the last 3 months;\n* Subjects with neoplastic pathology;\n* Subjects with systemic infections;\n* Subjects with uncontrolled diabetes;\n* Subjects with neurological conditions that may affect active participation in the study;\n* Subjects with coagulopathies or taking anticoagulants (vitamin K antagonists, heparin);\n* Subjects undergoing immunosuppressive treatment;\n* Subjects using drugs or abusing alcohol;\n* Subjects allergic to porcine collagen;\n* Female subjects who are pregnant or breastfeeding;\n* Subjects participating in other clinical studies during the same period;\n* Subjects unable to cooperate or for whom poor compliance is expected;\n* Any condition that, in the investigator's judgment, recommends the subject's exclusion.","75 Years",{"count":76,"type":20},42,[78],"NA","Collagen is a structural protein biopolymer consisting of three polypeptide chains wrapped around to form a right-handed triple helix. Its structure, characterized by the presence of glycine every third residue, a high content of proline and hydroxyproline, is stabilized by interchain hydrogen bonds and electrostatic interactions, giving the molecules high mechanical resistance, incompressibility, and simultaneously, extensibility, plasticity, and flexibility, making tissues abundant in collagen particularly resistant to stress and load. In humans, collagen is present especially in the skin, subcutaneous tissue, cartilage, bone, joint capsule, tendons, muscles, and ligaments.\n\nGrowing evidence supports the infiltrative use of type I collagen in the treatment of musculoskeletal pathologies. In particular, the intra-articular and peri-articular use of collagen has been proposed in the treatment of osteoarthritis in various body districts with the intention of limiting joint hypermobility, stabilizing the structure of joint and peri-articular components, reducing pain, and consequently improving function. Several clinical studies have demonstrated that its intra-articular infiltrative use could result in pain reduction and improvement of functionality in various cases of gonarthrosis and coxarthrosis. Regarding the conservative management of symptomatic thumb base osteoarthritis, some studies, albeit on limited case series, have highlighted how the use of type I collagen at the joint and peri-articular level can lead to better control of painful symptoms, improvement in functionality, and reduction of joint instability.\n\nRecently, Randelli F. et al. studied the in vitro effects on tenocytes induced by type I swine collagen (MD-Tissue Collagen Medical Device). In vitro results seem to demonstrate that this medical device can induce proliferation and migration of tenocytes and synthesis, maturation, and secretion of type I collagen, favoring tendon repair.\n\nRandelli F. et al. also demonstrated the mainly mechanical activity of MD-Tissue Collagen Medical Device, which is able to induce modifications of morpho-functional properties of tenocytes.\n\nIn this Clinical Investigation, we aim to investigate the performance and safety of an injectable medical device based on type I collagen of swine origin called MD-Small Joints Collagen Medical Device, in the treatment of symptomatic thumb base osteoarthritis.\n\nThe purpose of this research project is to understand through a multicenter Clinical Investigation, the performance and safety of an intra-articular and peri-articular treatment with a medical device (MD-Small Joints Collagen Medical Device) based on type I collagen in terms of pain reduction and joint function recovery in subjects with symptomatic thumb base osteoarthritis. The primary endpoint will consist of evaluating, through the Visual Analogue Scale (VAS), the performance of MD-Small Joints Collagen Medical Device in reducing pain associated with trapeziometacarpal osteoarthritis, at time T6 weeks (T6w) compared to T0 (day0). A reduction of at least 30% in the VAS score is considered clinically significant.\n\nSecondary endpoints will consist of evaluating the performance of MD-Small Joints Collagen Medical Device through:\n\n* VAS score assessment at T3 week and T16week \u002FFU compared to T0;\n* Disability of the Arm Shoulder and Hand score assessment at T6 week and T16 week \u002FFU compared to T0 (day0);\n* Functional Index for Hand Osteoarthritis assessment at T6 week and T16 week \u002FFU compared to T0;\n* Pinch Strength Test assessment at T6 week and T16 week\u002FFU compared to T0;\n* Evaluation of analgesic drug consumption through clinical diary in various study phases;\n* Assessment of Adverse Event incidence.",[81,26,82,83],"Trapeziometacarpal Osteoarthritis","MEDICAL DEVICE","Infiltrate","2025-01-13",{"date":86,"type":31},"2025-01-17",{"date":88,"type":31},"2024-11-18",{"date":90,"type":20},"2026-03-30",{"name":92,"class":93},"Guna S.p.a","INDUSTRY"]