[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cartilage-lesion\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cartilage-lesion":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100587745","a-talus-implant-in-patients-between-20-60-years-of-age-followed-up-for-a-minimum-of-2-years-after-surgery-100587745",false,"NCT06932380","A Talus Implant in Patients Between 20-60 Years of Age Followed up for a Minimum of 2 Years After Surgery","A Talus Implant in Patients Between 20-60 Years of Age Followed up for a Minimum of 2 Years After Surgery: A Pilot Study","Inclusion Criteria:\n\n* Patients aged 20-60 years with symptomatic osteochondral lesions of the ankle where conservative treatment or previous surgery has been unsatisfactory.\n* Patients with a limited cartilage defect that qualifies for Episealer implantation.\n* Patients who have provided written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Patients with an active infection in the ankle.\n* Patients with extensive cartilage damage where Episealer is not indicated.\n* Patients with osteoarthritic changes on the tibial side of the ankle joint.\n* Patients with severe joint instability.\n* Patients with severe neurological or systemic diseases.\n* Patients who smoke.\n* Patients with substance abuse issues.\n* Patients unable to attend follow-ups due to distance or other factors.","ALL","20 Years","60 Years",{"count":20,"type":21},10,"ESTIMATED","INTERVENTIONAL",[24],"NA","The project will investigate safety, feasibility and efficiency when using Episurf Episeal talus implant in patients with osteochondral ankle injuries. Assessments includes revision rate, complications, pain, function and quality of life over two years. Ten patients (aged 20-60) who have not responded to previous treatment will participate based on informed and written consent. The project uses a prospective cohort design where the patients receive a customized surgical procedure. Data on clinical function, pain and patient satisfaction collected using the AOFAS ankle score, NRS and EQ-5D-5L questionnaire at 6 weeks, 6 months, 1 year and 2 years after the operation. The study can provide valuable insight into the treatment of ankle osteoarthritis, improve the patient's quality of life and function, and represent a step forward in orthopedic surgery, especially for younger, active patients. The results are shared with it the medical community and the general public through publications and presentations.",[27],"Cartilage Lesion",[29,30,31,32],"focal cartilage injury","ankle cartilage","patient-specific implant","pilot study","RECRUITING","2025-04-24",{"date":36,"type":37},"2025-04-29","ACTUAL",{"date":39,"type":37},"2024-10-01",{"date":41,"type":21},"2030-12-31",{"name":43,"class":44},"Vestre Viken Hospital Trust","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":65,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":45},"100586437","biopoly-partial-resurfacing-knee-implant-ide-100586437","NCT06915363","BioPoly® Partial Resurfacing Knee Implant IDE","Pivotal, Prospective, Randomized, Controlled, Multicenter Clinical Trial of BioPoly® Partial Resurfacing Knee Implant for Treatment of Focal Cartilage Lesions of the Distal Femur","Inclusion Criteria:\n\n1. Patient is between 30 and 65 years of age25.\n2. KOOS quality of life score ≤ 60.\n3. In the opinion of the Investigator, the patient has the understanding and willingness to comply with all study requirements including the Post-Operative rehabilitation and follow-up protocol.\n4. Patient has cartilage lesion that has failed non-surgical conservative therapy (e,g, anti-inflammatory (NSAID), viscosupplementation, steroid injection, physical therapy, or activity modification) after at least 2 months of beginning the therapy or failed surgical conservative therapy (e.g. debridement\u002Flavage, marrow stimulation, or alignment high tibial osteotomy) that was performed at least 12 months ago in the index knee and is a candidate for surgical intervention.\n5. Patient has cartilage lesion located in the femoral condyle or trochlear facet.\n6. Patient has lesion(s) classified as ICRS grade 2, 3 or 4.\n7. Patient's lesion size may not exceed 3.1 cm2 and must be circumscribed by a 1.5 cm or 2.0 cm diameter circle, or 1.5 cm (M-L) by 2.4 cm (A-P) oval of normal or nearly normal (ICRS grade 0 or 1) cartilage, with an overall depth less than 4mm from the articulating surface.\n8. Patient has subchondral bone quality that is non-osteoporotic and is sufficient to support the implant. The quality of bone will be assessed by the surgeon intraoperatively with a surgical instrument such as an awl.\n\nExclusion Criteria:\n\n1. Patient has body mass index (BMI) ≥ 35.\n2. Patient has autoimmune arthritis, as diagnosed by Investigator.\n3. Patient has advanced degenerative osteoarthritis in index knee (Kellgren-Lawrence Grade 4 and\u002For diagnosed intraoperatively).\n4. Contralateral knee is known to have symptomatic cartilage, meniscal, or ligamentous lesions, generalized osteoarthritis, or requires surgery.\n5. Patient has gout, by Investigator diagnosis or patient-reported history within last 12 months.\n6. Patient has a cartilage lesion that is being treated with a non-surgical conservative therapy (e,g, anti-inflammatory (NSAID), viscosupplementation, steroid injection, physical therapy, or activity modification) and it has been \\\u003C 2 months since beginning treatment or the patient's cartilage lesion has failed surgical therapy (e.g. debridement\u002Flavage, marrow stimulation, alignment (high tibial osteotomy)) in the index knee and it has been \\\u003C 12 months since the surgical treatment.\n7. Patient has a cartilage lesion that is being treated that has failed ACI, OATS or Allograft treatment.\n8. Patient has malalignment of the index knee (\\>5 degrees weight bearing varus or valgus).\n9. Patient has bipolar articular cartilage involvement (or kissing lesions) of the ipsilateral compartment (i.e. greater than ICRS Grade 2 on the opposing articular surface) in the index knee.\n10. Patient has uncorrected ligamentous instability (good joint stability in the index joint with a Grade 1 Lachman or less, no pivot shift for ACL insufficiency and no posterior translation of more than grade 1; no deficits in flexion or extension of \\> 10 degrees compared to contralateral knee) in the index knee.\n11. Patient has undergone a total meniscectomy of index knee.\n12. Patient has undergone patellofemoral arthroplasty of the index knee\n13. Patient currently reports or has a documented history of uncontrolled diabetes.\n14. Patient currently has any condition, therapy, or medication known to impair bone healing.\n15. Patient has had an active systemic infection or joint infection in index knee over the last 12 months.\n16. Patient has an allergy to titanium alloy (Ti-6Al-4V), ultrahigh molecular weight polyethylene (UHMWPE), or hyaluronan\u002F hyaluronic acid (HA).\n17. Patient is pregnant or is planning to become pregnant (for female patients only) at any point during the duration of the study.\n18. Patient has legal involvement or any other issue that would hinder completion of the two-year follow-up period.\n19. Patient is participating in other studies and\u002For receiving any other simultaneous therapy in index knee.\n20. Patient has an uncorrected tear of the meniscus of the index knee. (Partial meniscectomy that retains \\>50% of the meniscus is allowed prior to or concurrently with the cartilage treatment procedure. Meniscus suture repair is allowed prior to or concurrently with the cartilage treatment procedure if \\>50% of the functional meniscus remains.).\n21. Patient has an additional cartilage lesion(s) (ICRS Grade 3 or 4) in the index knee, located on the patella, trochlea, tibia, or non-weight bearing area of index condyle that requires treatment.\n22. More than one implant is required to accommodate defect in the index knee.\n23. Patient has inadequate bone stock (e.g., cysts, osteoporosis) underlying the lesion site as determined intra-operatively by the investigator\n\n    1. As determined by the investigator through use of an awl or a similar instrument to determine if the bone quality is insufficient to support the BioPoly device.\n    2. If the cause of inadequate bone stock is due to cysts or to the boney portion of an osteochondral lesion being excessive, then the investigator may opt to fix the implant with cement rather than exclude the patient for inadequate bone stock.\n24. Patients with osteoporosis, osteopenia, Paget's disease, osteomalacia or any other metabolic bone disease; a. Osteoporosis is defined as Simple Calculated Osteoporosis Risk Estimation (SCORE) above 6 and DXA T-score \\\u003C -2.5 or QCT T-score \\\u003C 80mg\u002Fcubic cm. History of a fragility fracture requires that a DXA scan or QCT scan is completed","30 Years","65 Years",{"count":56,"type":21},152,[24],"The goal of this randomized controlled clinical trial is to demonstrate the safety and effectiveness of the BioPoly® Partial Resurfacing Knee Implant for the treatment of cartilage defects of the distal femur in adult patients with knee pain and symptoms who are candidates for surgical intervention of the knee compared to outcomes for the control group.\n\nThe primary effectiveness endpoint is Month 24 composite clinical success (CCS) defined by:\n\n* no secondary surgical intervention (SSI) and\n* an improvement from baseline in the Knee injury and Osteoarthritis Outcome Score (KOOS) total score (scaled 0 to 100) of at least 10 points.\n\nResearchers will compare the CCS for the investigational device group to a control group receiving the standard of care, either microfracture or debridement).\n\nSubjects randomized to the investigational group will receive the BioPoly Knee device and those randomized to the control group will receive the current standard of care, either microfracture or debridement.",[60,61,62,63,64,27],"Knee Pain Chronic","Knee Osteoarthritis","Cartilage Damage","Cartilage Defects of the Knee","Cartilage or Osteochondral Defects in the Knee",[66,67,68,69],"articular cartilage","cartilage lesion","focal cartilage defect","cartilage defect","2025-04-15",{"date":72,"type":37},"2025-04-17",{"date":74,"type":37},"2025-03-17",{"date":76,"type":21},"2028-12",{"name":78,"class":79},"BioPoly LLC","INDUSTRY"]