[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Guna S.p.a\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":82},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,56],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100474945","evaluation-of-collagen-based-medical-device-treatment-combined-with-physiotherapy-in-subjects-with-achilles-tendinopathy-100474945",false,"NCT05464498","Evaluation of Collagen-based Medical Device Treatment Combined With Physiotherapy in Subjects With Achilles Tendinopathy.","Evaluation of Collagen-based Medical Device Treatment Combined With Physiotherapy in Subjects With Achilles Tendinopathy. Multicenter Randomized Clinical Investigation; AKITENMED STUDY.","AKITENMED","Inclusion Criteria:\n\n* Male and female subjects aged 18 to 70 years;\n* Subjects with tendon pain for not more than 24 weeks;\n* Subjects with clinically diagnosed and ultrasonographically confirmed insertional\u002Fnoninsertional\u002Fmystic tendinopathy;\n* Subjects with a VISA A score between 50 and 75;\n* VAS ≥ 5;\n* Subjects able to understand and answer the SF12 questionnaire;\n* Subjects able to understand and sign the informed consent.\n\nExclusion Criteria:\n\n* subjects who have had surgery in the investigated area or lower extremity;\n* subjects who have previously undergone physiotherapy.\n* subjects with autoimmune diseases;\n* subjects with peripheral neuropathy;\n* subjects with calcific tendinopathy\n* subjects with pain of direct traumatic origin;\n* subjects with local\u002Fsystemic infections;\n* subjects with neoplastic diseases;\n* subjects with gout;\n* subjects on corticosteroid treatment at the time of enrollment;\n* subjects who have used corticosteroids or fluoroquinolones in the three months prior to enrollment;\n* subjects who have used NSAIDs in the week prior to enrollment;\n* subjects who are pregnant and lactating;\n* subjects with contraindications to acetaminophen use;\n* allergy to porcine collagen.","ALL","18 Years","70 Years",{"count":21,"type":22},72,"ESTIMATED","INTERVENTIONAL",[25],"NA","Achilles tendinopathy is a condition characterized by inflammation of the Achilles tendon. Achilles tendinopathies are classified into insertional tendinitis and noninsertional tendinitis. Insertional tendinitis involves the lower part of the tendon, where the tendon inserts at the level of the calcaneus, and can affect even patients who are not particularly athletically active. Noninsertional tendinitis occurs when the fibers in the middle portion of the tendon are affected, affects young and athletic people the most, and has a high incidence (30-50%) in middle-aged individuals.\n\nConsidering that there are no strong evidence-based guidelines in the area of treatment of achilles tendinopathy, the aim of this research project is to understand through a multicenter, randomized clinical investigation the impact of treatment with a porcine collagen-based medical device administered in the peri-tendon area in combination with physiotherapy on pain reduction and functional improvement of the investigated tendon.",[28,29,30,31],"Tendinopathy","Insertional Achilles Tendinopathy","Achilles Tendinopathy","Peritendinitis",[33,34,35,36,37,38,39,40,41,42],"Eccentric strengthening","Collagene Medical Device","Physiotherapy","Peritendinous area","Infiltration","Type I collagen","Eccentric strengthening protocol","Pain Visual Analog Scale","12-Item Short Form Survey","Victorian Institute of Sport Assessment- Achilles questionnaire","RECRUITING","2025-08-01",{"date":46,"type":47},"2025-08-03","ACTUAL",{"date":49,"type":47},"2022-06-13",{"date":51,"type":22},"2026-01-13",{"name":53,"class":54},"Guna S.p.a","INDUSTRY",1,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":64,"enrollmentInfo":65,"targetDuration":4,"studyType":23,"phases":67,"briefSummary":68,"conditions":69,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":55},"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":66,"type":22},42,[25],"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.",[70,71,72,73],"Trapeziometacarpal Osteoarthritis","Rhizarthrosis","MEDICAL DEVICE","Infiltrate","2025-01-13",{"date":76,"type":47},"2025-01-17",{"date":78,"type":47},"2024-11-18",{"date":80,"type":22},"2026-03-30",{"name":53,"class":54},""]