[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cartilage-defects-of-the-knee\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cartilage-defects-of-the-knee":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,42,80,106],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100642431","phase-4-study-to-evaluate-a-new-cartilage-regeneration-platform-for-knee-cartilage-repair-100642431",false,"NCT07639424","Study to Evaluate a New Cartilage Regeneration Platform for Knee Cartilage Repair","A Prospective, Randomized, Multicenter, Open-Label, Assessor-Blinded, Parallel-Group Clinical Trial to Compare the Efficacy and Safety of Microfracture Alone Versus Microfracture Combined With a Cartilage Regeneration Platform in Patients With Knee Cartilage Defects","TCW","Inclusion Criteria:\n\n* Adults aged 19 years to \\\u003C65 years at the time of consent.\n* Cartilage lesion severity of the target knee is ICRS grade 3 or 4.\n* Focal cartilage defect size in the target knee is ≥5 cm² and ≤10 cm².\n* The target knee is clinically considered to require microfracture, or microfracture with high tibial osteotomy (HTO).\n* Able and willing to provide written informed consent after receiving a full explanation of the study.\n\nExclusion Criteria:\n\n* Traumatic or secondary osteoarthritis (Secondary OA) in the target knee.\n* Inflammatory arthritis in the target knee (e.g., rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, reactive arthritis, systemic lupus erythematosus, gout, pseudogout, Behçet's disease, etc.).\n* Currently receiving immunosuppressive therapy or having a serious systemic disease (e.g., severe cardiovascular disease; long-term use of immunosuppressants; cancer patient receiving chemotherapy; systemic autoimmune disease; severe liver or kidney disease; uncontrolled endocrine disease, etc.).\n* Advanced severe osteoarthritis in the target knee (Kellgren-Lawrence \\[KL\\] grade 4).\n* Lower-limb malalignment that may affect the surgical plan (e.g., varus deformity with varus angle ≥15°).\n* Within 5 years prior to Visit 1, a history of osteomyelitis of the target knee, a diagnosis of malignancy, or recurrent malignancy (participants with benign tumors may be eligible if the investigator judges that there will be no impact on study conduct during the study period).\n* Body mass index (BMI) ≥35 kg\u002Fm².\n* Clinically significant knee instability in the target knee that is not expected to be improved by the study procedure (e.g., complete or partial tears of major ligaments such as the anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament, or lateral collateral ligament).\n* Prior surgery for treatment of a cartilage defect in the target knee (diagnostic arthroscopy only is allowed).\n* History of major structural surgery of the target knee (diagnostic arthroscopy only is allowed). Participants with prior HTO may be eligible at the investigator's discretion if the knee structure is stable without critical defects.\n* Intra-articular injection of any biologic or pharmacologic agent into the target knee within 3 months prior to Visit 1 (e.g., hyaluronic acid, corticosteroids, platelet-rich plasma, autologous cell therapy, cytokine inhibitors, etc.).\n* Use of systemic corticosteroids within 1 month prior to Visit 1.\n* Participant or partner is a woman of childbearing potential and the participant does not agree to use an effective method of contraception during the study period, including any of the following:\n\n  1. Sterilization procedure of the participant or partner (vasectomy; bilateral oophorectomy and salpingectomy\u002Ftubal ligation; hysterectomy)\n  2. Intrauterine device (IUD), including copper IUD or hormone-releasing intrauterine system\n  3. Non-oral hormonal contraception or spermicide used in combination with a barrier method\n  4. Cervical cap or diaphragm used in combination with a male condom\n* Pregnant or breastfeeding.\n* Participation in another clinical trial and receipt of an investigational medical device within 6 months prior to Visit 1.\n* Any other condition that, in the opinion of the principal investigator (or delegated study staff), makes the participant unsuitable for participation in the study.","ALL","19 Years","64 Years",{"count":21,"type":22},104,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","The goal of this clinical trial is to learn if a new treatment works to help regrow knee cartilage in people with knee cartilage damage. The main questions it aims to answer are:\n\nDoes the treatment help the knee work better and lower pain more than the standard surgery?\n\nIs the treatment safe and does it help grow stronger new cartilage?\n\nResearchers will compare participants who get the standard surgery (microfracture) to participants who get both the standard surgery and the new treatment. This is to see if the new treatment leads to a better and faster recovery.\n\nParticipants will:\n\nHave a surgery to treat their knee cartilage damage.\n\nVisit the clinic for check-ups to see how well their knee moves.\n\nTake imaging tests, like an MRI, so researchers can look at the new cartilage.",[28],"Cartilage Defects of the Knee","RECRUITING","2026-06-05",{"date":32,"type":33},"2026-06-10","ACTUAL",{"date":35,"type":33},"2025-12-29",{"date":37,"type":22},"2027-09-30",{"name":39,"class":40},"ROKIT Healthcare","INDUSTRY",13,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":19,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":55,"conditions":56,"keywords":60,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100584741","impact-of-bone-marrow-aspirate-injections-in-knee-arthroscopy-100584741","NCT06893302","Impact of Bone-Marrow Aspirate Injections in Knee Arthroscopy","Bone Marrow Aspirate Injections in Knee Arthroscopy: A Randomized, Single-Blind, Controlled Trial","BMA","Inclusion Criteria:\n\n1. Require a primary knee arthroscopy for a meniscal injury or focal chondral defect (knee debridement or meniscectomy)\n2. Have Kellgren-Lawrence grade 0 arthritis\n3. Have Outerbridge cartilage grade 2 or lower\n4. Ages 18-64\n\nExclusion Criteria:\n\n1. Have previously undergone ipsilateral knee surgery\n2. Have Kellegren-Lawrence grade 3 or greater\n3. Have received other OrthoBiologics within 3 mo of surgery\n4. Have ligament deficiencies\n5. Need meniscal repair\n6. Need a concomitant osteotomy or other realignment surgery\n7. Have used DMARDs within the last three months\n8. Have a hx of anemia, bleeding disorders, or inflammatory joint disease (rheumatoid arthritis, infectious arthritis, hemophilic arthropathy, Charcot's knee)\n9. Have a hx of metabolic bone disease (osteoporosis, osteomalacia, rickets, osteitis fibrosa cystica, Paget's disease of bone)\n10. Patients who are currently pregnant","18 Years",{"count":52,"type":22},50,[54],"NA","This study will examine whether using bone marrow aspirate (BMA) during knee arthroscopy surgery can improve patient outcomes. The investigators will enroll 50 patients who need knee arthroscopy surgery for meniscus injuries or cartilage damage. Like flipping a coin, patients will be randomly assigned to one of two groups of 25 patients each. One group will receive standard arthroscopic surgery plus an injection of bone marrow aspirate, while the other group will receive standard surgery plus a saline (salt water) injection. During surgery, for patients in the treatment group, approximately 4mL (less than one teaspoon) of bone marrow will be taken from their hip bone using a special needle system. A small amount (1mL) will be sent to the laboratory for testing. Patients will be followed for 12 months after surgery and will complete questionnaires about their pain levels and knee function at several time points: before surgery, 2 weeks, 6 weeks, 3 months, 6 months, and 12 months after surgery. These questionnaires will ask about pain, daily activities, and overall improvement.",[57,58,28,59],"Chondral Lesion of the Knee","Meniscal Injuries","Osteoarthritis (OA) of the Knee",[61,62,63,64,65,66,67,68,48],"knee arthroscopy","meniscal injury","knee debridement","meniscectomy","osteoarthritis","cartilage defect","chondral lesion","bone marrow aspirate","2026-04-23",{"date":71,"type":33},"2026-04-27",{"date":73,"type":22},"2026-06",{"date":75,"type":22},"2029-04",{"name":77,"class":78},"Hospital for Special Surgery, New York","OTHER",1,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":23,"phases":89,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"100613530","long-term-study-of-cartipro-for-knee-pain-due-to-osteoarthritis-or-cartilage-damage-100613530","NCT07267793","Long-Term Study of CartiPRO for Knee Pain Due to Osteoarthritis or Cartilage Damage","Long-term Efficacy and Safety of CartiPRO Injection to Alleviate Knee Pain in Patients With Osteoarthritis and\u002For Diverse Cartilage Defects: a Multicenter, Single-blind, Randomized, Non-inferiority, Sponsor Initiated Trial","Inclusion Criteria\n\n* Age 19 years and older\n* Diagnosed with unilateral or bilateral knee osteoarthritis according to American College of Rheumatology (ACR) criteria, with at least 3 of the following 6 features:\n\n  * Age ≥50 years\n  * Morning stiffness \\\u003C30 minutes\n  * Crepitus on active motion\n  * Bony tenderness\n  * Bony enlargement\n  * No palpable warmth\n* Radiographic evidence of Kellgren-Lawrence grade I, II, or III osteoarthritis within 6 months prior to screening or at screening visit\n* Weight-bearing pain Visual Analogue Scale (VAS) score ≥40 mm in at least one knee joint at screening\n* Able to walk without assistive devices (walkers or canes), OR if using a walking aid routinely for past 6 months, able to continue using the same device throughout the study\n* Able to understand and complete efficacy assessment questionnaires\n* Willing and able to provide written informed consent\n\nExclusion Criteria\n\n* Body Mass Index (BMI) ≥32 kg\u002Fm²\n* Chronic inflammatory joint disease (e.g., rheumatoid arthritis)\n* Inflammatory joint disease (e.g., septic arthritis)\n* Secondary knee osteoarthritis due to ochronosis, hemochromatosis, or systemic disease\n* Painful musculoskeletal conditions (e.g., Sudeck's atrophy, Paget's disease, herniated intervertebral disc)\n* Polyarticular disease with severe osteoarthritis in other joints (e.g., hip) that may affect knee pain evaluation\n* Radiographic evidence of definite loss of patellofemoral joint space\n* Moderate to severe joint effusion confirmed by positive patellar tap test or equivalent\n* History of myocardial infarction, congestive heart failure, other serious cardiac disease, or uncontrolled hypertension (≥140\u002F90 mmHg despite treatment with ≥3 antihypertensive agents)\n* History of autoimmune disease\n* Active infection requiring parenteral antibiotics\n* History of psychiatric disorder or epilepsy\n* Cancer diagnosis within 5 years prior to screening\n* Uncontrolled type 1 or type 2 diabetes mellitus (HbA1c \\>7%)\n* Surgical procedures (including arthroscopy) on target knee within 1 year (surgery on contralateral knee or hip may be exclusionary if it could affect target knee assessment)\n* Intra-articular corticosteroid injection into target knee within 12 weeks\n* Systemic corticosteroid use within 4 weeks (topical and inhaled corticosteroids permitted)\n* Surgery or radiation therapy to knee joint within 12 weeks, or not fully recovered from side effects\n* Immunosuppressive therapy (e.g., Cyclosporine A, Azathioprine) within 6 weeks\n* Intra-articular injections (e.g., hyaluronic acid) into knee joint within 6 months\n* Prohibited concomitant medications within 2 weeks (unless washout period is adequate)\n* Anticoagulants (e.g., warfarin, NOACs), antiplatelet agents (e.g., aspirin \\>100 mg\u002Fday, clopidogrel; low-dose aspirin ≤100 mg\u002Fday permitted), thrombolytic agents (e.g., urokinase, alteplase), or Vitamin E \\>1000 IU\u002Fday within 2 weeks (unless adequate washout)\n* Habitual use (≥3 months) of psychoactive drugs or narcotic analgesics that may affect pain perception\n* History of cell therapy or gene therapy to target joint\n* Planned cell therapy or gene therapy to target joint\n* Abnormal laboratory values at screening:\n* ALT, AST, BUN, or serum creatinine \\>2× upper limit of normal\n* Engaged in high-intensity aerobic or heavy anaerobic exercise that may affect the knee joint\n* Dermatological disease at injection site or site deemed unsuitable for injection\n* Ligament instability of Grade II or higher in target knee (Grade 0: none; Grade I: 0-5 mm; Grade II: 5-10 mm; Grade III: \\>10 mm)\n* Known hypersensitivity to investigational product or its components\n* Pregnant or breastfeeding women\n* Women or men of childbearing potential unwilling to use acceptable contraception during study (acceptable methods: intrauterine device, tubal ligation, sterilization surgery, condom or diaphragm with spermicide, natural family planning)\n* Participation in another clinical trial within 4 weeks\n* Cognitive impairment or dementia preventing informed consent\n* Any other condition that makes the subject unsuitable for study participation per investigator judgment",{"count":88,"type":22},194,[54],"This clinical trial aims to evaluate and compare the efficacy and safety of CartiPRO, an approved intra-articular atelocollagen injection, versus Synovian injection for the relief of knee pain in patients with knee osteoarthritis. The investigational device is administered intra-articularly, with a second injection given 24 weeks after the first dose. Primary and secondary endpoints include changes in pain scores (VAS), functional assessments (WOMAC, SF-36), and safety evaluations over a 36-week period.",[92,93,28,94,95],"Osteoarthritis","Knee Pain Arthritis","Knee Osteoarthritis","Degenerative Joint Disease of Knee","2026-01-15",{"date":98,"type":33},"2026-01-20",{"date":100,"type":33},"2025-07-03",{"date":102,"type":22},"2026-10",{"name":104,"class":40},"DALIM TISSEN Co., Ltd.",5,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":23,"phases":117,"briefSummary":118,"conditions":119,"keywords":124,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":79},"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":116,"type":22},152,[54],"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.",[120,94,121,28,122,123],"Knee Pain Chronic","Cartilage Damage","Cartilage or Osteochondral Defects in the Knee","Cartilage Lesion",[125,126,127,66],"articular cartilage","cartilage lesion","focal cartilage defect","2025-04-15",{"date":130,"type":33},"2025-04-17",{"date":132,"type":33},"2025-03-17",{"date":134,"type":22},"2028-12",{"name":136,"class":40},"BioPoly LLC"]