[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"trapeziometacarpal-osteoarthritis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:trapeziometacarpal-osteoarthritis":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,47,81,114,140,160,191,213],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100643887","thumb-muscle-activation-during-first-dorsal-interosseous-activities-of-daily-living-in-thumb-base-osteoarthritis-100643887",false,"NCT07668986","Thumb Muscle Activation During First Dorsal Interosseous Activities of Daily Living in Thumb Base Osteoarthritis","A Between-Group Comparison of First Dorsal Interosseous and Abductor Pollicis Longus Muscle Activation During First Dorsal Interosseous Activities of Daily Living in Individuals With and Without Thumb Base Osteoarthritis","Inclusion criteria for the TMC OA group:\n\n\\- Clinical diagnosis of thumb TMC osteoarthritis.\n\nInclusion criteria for the healthy group:\n\n\\- Participants with no history of musculoskeletal or neurological disorders affecting the dominant hand were included.\n\nExclusion Criteria :\n\n* Presence of numbness, tingling, or other sensory disturbances\n* Cardiac pacemaker implantation\n* Upper limb entrapment neuropathy or cervical radiculopathy\n* History of neuromuscular disease, polyneuropathy, or plexopathy\n* Systemic diseases such as diabetes, hypothyroidism, or chronic liver or kidney disease\n* History of cancer, rheumatoid arthritis, active anticoagulation therapy, chemotherapy, or exposure to neurotoxins\n* Recent upper limb soft tissue or bone injury (trauma, fracture, or surgery of the arm or neck).",true,"ALL","18 Years",{"count":20,"type":21},50,"ESTIMATED","4 Months","OBSERVATIONAL","The aim of this study is to investigate whether there are differences in muscle activation of the First Dorsal Interosseous (FDI) and the Abductor Pollicis Longus (APL) between individuals with and without trapeziometacarpal osteoarthritis (TMC OA) of the thumb during the performance of six activities of daily living (ADLs).\n\nThe FDI has been defined as a key stabilizer of the TMC joint of the thumb. However, the literature reports limited information on FDI and APL activation during ADLs. TMC OA of the thumb can cause pain, decreased thumb strength, impaired hand function, and difficulty performing ADLs. Understanding muscle activation patterns during these activities is essential to comprehend how this condition affects hand function and to guide more specific and effective rehabilitation strategies.\n\nParticipants will perform six ADLs: turning a key to open, turning a key to close, picking up a coin, writing, squeezing a tube of toothpaste, and holding a glass of water. Muscle activity will be recorded using surface electromyography (sEMG) during all tasks.\n\nAdults aged 30 years and older, both men and women, with TMC osteoarthritis and healthy controls without osteoarthritis will be invited to participate.\n\nResearchers will measure the activation patterns of the FDI and APL muscles during the ADLs, with the aim of identifying differences between both groups and providing evidence to guide the rehabilitation of patients with thumb base osteoarthritis.",[26],"Trapeziometacarpal Osteoarthritis",[28,29,30,31,32,33],"muscle activation","Trapeziometacarpal osteoarthritis","first dorsal interosseous","abductor pollicis longus","surface electromyography","activities daily living","NOT_YET_RECRUITING","2026-06-21",{"date":37,"type":38},"2026-06-25","ACTUAL",{"date":40,"type":21},"2026-06-05",{"date":42,"type":21},"2026-08-30",{"name":44,"class":45},"University of Malaga","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":46},"100628233","icf-based-biopsychosocial-assessment-with-ai-assisted-profile-prediction-trapeziometacarpal-osteoarthritis-model-100628233","NCT07458971","ICF-Based Biopsychosocial Assessment With AI-Assisted Profile Prediction: Trapeziometacarpal Osteoarthritis Model","ICF-Based Biopsychosocial Assessment With Artificial Intelligence-Assisted Profile Prediction: Trapeziometacarpal Osteoarthritis Model","ICF","Inclusion Criteria:\n\n* Diagnosis of trapeziometacarpal osteoarthritis (TMC OA) confirmed by an orthopedic surgeon and\u002For hand surgeon\n* TMC OA-related symptoms persisting for more than 3 months\n* Aged between 25 and 74 years\n* Literate in Turkish\n* Adequate cognitive function (Mini-Mental State Examination score of 25 or above)\n* No other chronic systemic disease (e.g., rheumatoid arthritis, chronic diabetes, cardiovascular disease, chronic hepatitis)\n* Voluntary participation with signed informed consent\n\nExclusion Criteria:\n\n* Unwillingness to participate\n* Presence of a different orthopedic condition or prior surgery involving the thumb on the unilateral upper extremity\n* Uncontrolled systemic diseases (chronic obstructive pulmonary disease, congestive heart failure, endocrine system disease, history of stroke)\n* Diagnosis of any major psychopathology and currently receiving psychiatric or psychological treatment\n* Pregnancy","25 Years","74 Years",{"count":58,"type":21},93,"Trapeziometacarpal osteoarthritis (TMC OA) is a common condition affecting the base of the thumb that causes pain, weakness, and difficulty with daily hand use. Current clinical assessment often focuses on physical findings alone, without considering psychological and social factors that also influence patient outcomes.\n\nThis study has three objectives organized as interrelated work packages:\n\nOBJECTIVE 1 (Clinical Assessment): To comprehensively assess individuals with TMC OA using the International Classification of Functioning, Disability and Health (ICF) framework. This includes evaluating pain, joint mobility, grip strength, daily activity limitations, social participation, psychological factors (anxiety, depression, fear of movement, pain beliefs), and environmental factors (family support, ergonomic adaptations).\n\nOBJECTIVE 2 (AI Knowledge Evaluation): To compare the medical knowledge performance of four large language models (Claude, ChatGPT, Gemini, LLaMA) in answering clinical questions about TMC OA, using criteria such as accuracy, reproducibility, comprehensiveness, clinical relevance, and readability.\n\nOBJECTIVE 3 (AI-Based Prediction): To analyze whether the best-performing large language model can predict multidimensional ICF-based patient profiles using only a limited set of core clinical parameters.",[26,61,62,63],"Thumb Osteoarthritis","Carpometacarpal Osteoarthritis","Thumb Basal Joint Osteoarthritis",[53,65,66,67,68,69,70,71],"Biopsychosocial Assessment","Large Language Model","Artificial Intelligence","Trapeziometacarpal Joint","Prediction Model","Clinical Decision Support","Pain-Activity Patterns","2026-03-04",{"date":74,"type":38},"2026-03-09",{"date":76,"type":21},"2026-02",{"date":78,"type":21},"2027-07",{"name":80,"class":45},"Hacettepe University",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":16,"sex":17,"minAge":55,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":91,"conditions":92,"keywords":93,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":46},"100627337","thumb-proprioception-in-trapeziometacarpal-osteoarthritis-100627337","NCT07447323","Thumb Proprioception in Trapeziometacarpal Osteoarthritis","Investigation of Thumb Proprioception in Trapeziometacarpal Joint Osteoarthritis","Inclusion Criteria (TMC OA group):\n\n* Voluntary participation\n* Radiographic Eaton-Littler stage I-IV confirmed by an orthopedic specialist\n* Symptom duration ≥6 months\n* Age 25-75 years\n* Pain intensity ≥4\u002F10 on the Visual Analog Scale (VAS) during daily activities at assessment\n* Ability to actively perform ≥40° palmar abduction\n* Adequate cognitive capacity to understand and perform study procedures (for participants aged ≥65 years: Montreal Cognitive Assessment \\[MoCA\\] score ≥21)\n\nInclusion Criteria (Control group):\n\n* Voluntary participation\n* No thumb pain\n* Age 25-75 years\n* No clinical signs of TMC OA\n* Negative provocation tests\n* Adequate cognitive capacity to understand and perform study procedures (for participants aged ≥65 years: MoCA score ≥21)\n\nExclusion Criteria (TMC OA group):\n\n* Inability to abduct the thumb beyond 40° due to severe pain\u002Fdeformity (especially advanced stage III-IV)\n* Acute trauma or prior surgery of the hand\u002Fwrist\n* Conservative treatment for hand\u002Fthumb pain in the same extremity within the previous 6 months\n* Current use of anti-inflammatory medication\n* Peripheral nerve disorders affecting proprioception (e.g., carpal tunnel syndrome, dorsal radial nerve irritation, cervical radiculopathy, double crush syndrome)\n* Concomitant upper-extremity musculoskeletal disorders (e.g., trigger finger, De Quervain's disease)\n* Generalized joint hypermobility (Beighton score ≥4)\n* Neuromuscular, systemic peripheral neuropathic, autoimmune, rheumatic, or infectious diseases\n* Active malignancy\n* Neurological conditions affecting pain perception\n* Visual impairment\n* Pregnancy\n\nExclusion Criteria (Control group):\n\n-Exclusion criteria identical to the TMC OA group","75 Years",{"count":90,"type":21},100,"This study looks at people who have osteoarthritis at the base of the thumb. It examines how well the thumb can sense its position and movement.\n\nThe study has three goals:\n\n1. To compare these measurements between people with thumb base osteoarthritis and healthy people.\n2. To find out whether this ability changes from milder to more advanced levels of osteoarthritis.\n3. To explore whether this ability is related to factors such as basic personal characteristics, thumb\u002Fhand muscle strength and hand use, pain and touch sensation, and emotional factors like fear of movement, anxiety, and depression.\n\nThis is an observational study. No treatment is given. Participants complete thumb measurements and several tests\u002Fquestionnaires.",[26],[94,95,96,97,98,99,100,101,102,103,104],"Thumb proprioception","Joint position sense","Pinch aperture proprioception","Trapeziometacarpal joint","Pain","Proprioception","Carpometacarpal","Proprioception*","Thumb*","Carpometacarpal Joints*","Humans","RECRUITING","2026-02-26",{"date":108,"type":38},"2026-03-03",{"date":110,"type":38},"2025-10-23",{"date":112,"type":21},"2026-05",{"name":80,"class":45},{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":88,"enrollmentInfo":121,"targetDuration":4,"studyType":123,"phases":124,"briefSummary":126,"conditions":127,"keywords":128,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":4},"100626433","phase-2-use-of-a-treated-devitalized-and-sterile-umbilical-cord-amniotic-membrane-in-the-treatment-of-trapeziometacarpal-osteoarthritis-100626433","NCT07435571","Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of Trapeziometacarpal Osteoarthritis","Evaluation of the Treatment of Trapeziometacarpal Osteoarthritis (TMC OA) With a Treated, Devitalized and Sterile Amniotic Membrane of Umbilical Cord Placed in Joint Interposition","Inclusion Criteria:\n\n* Patient presenting with symptomatic osteoarthritis of the trapeziometacarpal joint, with wrist pain ≥ 40\u002F100 according to the PRWE pain subscale (scaled to 100).\n* Patient who has received medical treatment for functional symptoms for more than 3 months without improvement, and for whom surgical intervention is indicated.\n* Patient with radiographic stage I-II trapeziometacarpal joint osteoarthritis according to the Eaton-Glickel classification.\n* Patient able to understand, date, and sign the informed consent form.\n* Patient affiliated with a social security system or beneficiary of such a system.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding woman ; woman without effective contraception.\n* Patient with scaphotrapeziotrapezoid (STT) joint osteoarthritis requiring prosthetic surgical treatment.\n* Patient with thumb osteoarthritis secondary to a systemic inflammatory disease (e.g., rheumatoid arthritis).\n* Patient with osteoarthritis experiencing an acute inflammatory flare, characterized by a warm, painful, and swollen joint at the time of enrollment.\n* Patient with amputated hand(s).\n* Patient presenting signs of neuropathy with functional impairment such as hyperesthesia. Neuropathy may be peripheral (nerve injury) or systemic (caused by diabetes or excessive alcohol consumption).\n* Patient lacking capacity to participate in rehabilitation or to comply with study follow-up.\n* Patient with a contraindication to anesthesia (poorly controlled epilepsy, neuropathy, etc.).\n* Person deprived of liberty by a judicial or administrative decision.\n* Adult subject under legal protection or unable to provide informed consent.",{"count":122,"type":21},22,"INTERVENTIONAL",[125],"PHASE2","The objective of this clinical trial is to evaluate whether a human umbilical cord amniotic membrane allograft can serve as an interposition implant in the surgical treatment of trapeziometacarpal osteoarthritis.\n\nThe main question this study aims to address is :\n\n\\- Can interposition of a human umbilical cord amniotic membrane within the trapeziometacarpal joint reduces postoperative pain and improves thumb mobility, grip and pinch strength, and overall wrist function.\n\nParticipant will:\n\n* Undergo surgical treatment of the trapeziometacarpal osteoarthritis with the interposition in articular joint of an amniotic membrane of umbilical cord allograft on Day 0\n* Visit the center for a series of tests 1 month, 3 months, 6 months and 12 months after the surgical intervention.",[26],[129],"TMC OA","2026-02-20",{"date":132,"type":38},"2026-02-27",{"date":134,"type":21},"2026-03",{"date":136,"type":21},"2028-03",{"name":138,"class":139},"TBF Genie Tissulaire","INDUSTRY",{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":146,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":148,"conditions":149,"keywords":150,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":46},"100625319","thumb-muscle-activation-during-first-dorsal-interosseous-exercise-in-thumb-base-osteoarthritis-100625319","NCT07421089","Thumb Muscle Activation During First Dorsal Interosseous Exercise in Thumb Base Osteoarthritis","A Between-Group Comparison of First Dorsal Interosseous and Abductor Pollicis Longus Muscle Activation During First Dorsal Interosseous Exercise in Individuals With and Without Thumb Base Osteoarthritis",{"count":147,"type":21},60,"The aim of this study is to investigate whether there are differences in muscle activation of the First Dorsal Interosseous (FDI) and the Abductor Pollicis Longus (APL) between individuals with and without trapeziometacarpal osteoarthritis (TMC OA) of the thumb. The study also seeks to identify which exercises are most effective for activating these muscles, in order to inform rehabilitation strategies for patients.\n\nThe FDI has been defined as a key stabilizer of the thumb TMC joint. However, the literature reports various protocols for FDI activation and limited information on APL behavior during these exercises. OA TMC of the thumb can cause pain, decreased thumb strength, impaired hand function, and difficulty performing activities of daily living (ADLs). Appropriate rehabilitation is essential to maintain muscle function, limit joint degeneration, and improve hand performance; however, the exercises that optimally activate the FDI and APL muscles are not yet established.\n\nParticipants will perform a series of standardized exercises and functional tasks designed to activate the FDI and APL muscles. Exercises include FDI strengthening with elastic bands in different hand positions (palmar and ulnar support), as well as exercises with the thumb in greater abduction. Functional tasks simulating everyday activities (e.g., turning a key, picking up a coin, writing, squeezing a tube of toothpaste, and holding a glass of water) will also be performed. Muscle activity will be recorded using surface electromyography (sEMG) during all tasks.\n\nAdults aged 40 years and older, both men and women, with TMC osteoarthritis and healthy controls without osteoarthritis will be invited to participate.\n\nResearchers will measure the activation patterns of the FDI and APL muscles during the exercises and functional tasks. The study aims to identify exercises that optimally activate these muscles, providing evidence to guide the rehabilitation of patients with thumb base osteoarthritis.",[26],[28,151,30,31,32],"trapeziometacarpal osteoarthritis","2026-02-16",{"date":154,"type":38},"2026-02-19",{"date":156,"type":21},"2026-01-28",{"date":158,"type":21},"2026-08",{"name":44,"class":45},{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":166,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":123,"phases":170,"briefSummary":171,"conditions":172,"keywords":173,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":190},"100546926","phase-2-corticosteroid-against-saline-injections-for-thumb-osteoarthritis-casitoa-100546926","NCT06401317","Corticosteroid Against Saline Injections for Thumb Osteoarthritis (CASITOA)","Comparison of the Efficacy of Intra-Articular Corticosteroid Injections Versus Saline Solution for Thumb Osteoarthritis: Double-Blind Pragmatic Randomized Pilot Study","CASITOA","Inclusion Criteria:\n\n* aged ≥18 years;\n* diagnosis of TMO was confirmed by X-ray interpreted by a radiologist;\n* suffering from pain at the base of the thumb;\n* the attending physician deems that an intra-articular corticosteroid injection would be beneficial, rather than opting for other types of intervention such as surgery\n* can read, understand and answer in either French or English.\n\nExclusion Criteria:\n\n* having received one or more corticosteroid injections in the last 12 months or surgery on the affected thumb;\n* suffering from painful thumb caused by a trauma (e.g., fracture, sprain), rheumatoid arthritis, or De Quervain's tendonitis; and\n* being pregnant or breastfeeding; and\n* known allergies to any components of the solutions (triamcinolone acetonide, benzyl alcohol, carboxymethylcellulose sodium, hydrochloric acid, polysorbate, sodium chloride, or sodium hydroxide) or to iodinated contrast media.",{"count":169,"type":21},40,[125],"Thumb osteoarthritis or trapeziometacarpal osteoarthritis (TMO) is a common and painful form of hand arthritis that limits thumb mobility and hand function, affecting patients' quality of life. Although corticosteroids injections are a typical treatment, their effectiveness has been challenged, and side effects have been reported. Recent studies suggest that saline injections, usually considered inactive, might be a viable treatment option. The primary goal of this study is to compare the effectiveness of saline injections versus corticosteroids injections in reducing TMO-related pain and improving hand function. In this study, 40 people with TMO will be randomly assigned to receive either a corticosteroids or a saline injection, without them or the doctors performing the injection knowing which one was administered (double blind). If saline injections prove more effective, they could provide a less harmful and cheaper therapeutic alternative for TMO patients.",[26],[174,175,176,177,178,29,179,180],"Corticosteroids","Feasibility","Blinding","Randomized controlled trial","Saline","Intra-articular injection","Pragmatic trial","2026-01-20",{"date":183,"type":38},"2026-01-22",{"date":185,"type":38},"2025-11-04",{"date":187,"type":21},"2028-12-31",{"name":189,"class":45},"Université du Québec à Trois-Rivières",2,{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":123,"phases":200,"briefSummary":202,"conditions":203,"keywords":4,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":46},"100605971","treatment-of-peritrapezial-osteoarthritis-with-isolated-trapeziometacarpal-arthroplasty-in-300-patients-100605971","NCT07169474","Treatment of Peritrapezial Osteoarthritis With Isolated Trapeziometacarpal Arthroplasty in 300 Patients","Treatment of Peri-trapezial Osteoarthritis With Isolated Trapeziometacarpal Arthroplasty","Inclusion Criteria:- Patients over 18 years of age who are members or beneficiaries of french social security\n\n* Patient requiring surgical management\n* Clinical and radiographic diagnosis of peri-trapezial osteoarthritis in the 1 or 2 joints:\n\nTM osteoarthritis: glickel sign + grinding test STT osteoarthritis: pain on wrist mobilization in flexion-extension and prono-supination\n\n* TM (Eaton-Littler stages II to III) and STT (Crosby stages II and III) radiographic osteoarthritis\n* Persistent pain and functional limitations despite conservative treatment for at least 6 months (combining intermittent immobilization of wrist and thumb + joint infiltration of the 2 joints)\n* Ability to understand and sign the informed consent form.\n\nExclusion Criteria:\n\n* History of surgery on the affected thumb.\n* Systemic inflammatory diseases (e.g. rheumatoid arthritis).\n* Active infection or history of joint infection of the upper limb.\n* Inability to participate in post-operative follow-up.",{"count":199,"type":21},300,[201],"NA","The aim of this clinical trial is to assess the functional outcomes of isolated trapeziometacarpal joint arthroplasty in adult patients requiring surgical management of trapeziometacarpal osteoarthritis, with or without associated symptoms.\n\nThe primary endpoint is the evolution of the Quick DASH functional score between inclusion (preoperative) and one year postoperatively.\n\nThe study design is a follow-up study of a multicenter cohort.",[26],"2025-11-20",{"date":206,"type":38},"2025-11-25",{"date":208,"type":38},"2025-09-09",{"date":210,"type":21},"2027-07-30",{"name":212,"class":45},"Clinique Saint Jean, France",{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":219,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":88,"enrollmentInfo":221,"targetDuration":4,"studyType":123,"phases":223,"briefSummary":224,"conditions":225,"keywords":4,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":46},"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.",{"count":222,"type":21},42,[201],"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.",[26,226,227,228],"Rhizarthrosis","MEDICAL DEVICE","Infiltrate","2025-01-13",{"date":231,"type":38},"2025-01-17",{"date":233,"type":38},"2024-11-18",{"date":235,"type":21},"2026-03-30",{"name":237,"class":139},"Guna S.p.a"]