[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06749431":3,"trial-entities:NCT06749431":98,"trial-summary:NCT06749431":101},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":21,"study_type":23,"primary_purpose":15,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":29,"secondary_outcomes":57,"sex":62,"minimum_age":63,"maximum_age":64,"healthy_volunteers":15,"eligibility_criteria":65,"std_ages":80,"locations":84,"central_contacts":94,"overall_officials":95,"references":96,"see_also_links":97},"NCT06749431","001","Clinical Outcomes, Graft Longevity, and Chondral Protection Following Primary or Revision Meniscal Allograft Transplantation Surgery","MERCuRE (MEniscus, Restoration, Conservation, and Repair) Group Study on Clinical Outcomes, Graft Longevity, and Chondral Protection Following Primary or Revision Meniscal Allograft Transplantation Surgery","ENROLLING_BY_INVITATION","2050-01-05","2024-12","2024-12-27","2025-01-05","Joint Restoration Foundation, Inc.","OTHER",null,"The MERCuRE (MEniscus, REstoration, Conservation, and Repair) group is embarking on a 20-year follow-up study to evaluate the clinical outcomes, graft longevity, and chondral protection following primary or revision Meniscal Allograft Transplantation surgery This clinical investigation is a prospective, primary observational, open-label, non-randomized, multi-center study. It is designed to collect clinical follow-up data on patients",[18,19,20],"Meniscus Tear","Meniscus Disorder","Patient Satisfaction",[22],"Meniscal Allograft Transplant","OBSERVATIONAL",[],{"count":26,"type":27},5000,"ESTIMATED",[],[30,34,37,40,43,47,51,54],{"measure":31,"description":32,"timeFrame":33},"Evaluation of PROM: The Knee Injury and Osteoarthritis Outcome (KOOS) Score","Evaluation of knee symptoms and function, reported on a scales from 0 to 100 where 0 represents extreme knee problems and 100 represents no knee problems.","3 months, 6 months, 1 year, 2 years, 5 years, 10 years, 15 years, and 20 years post-operatively",{"measure":35,"description":36,"timeFrame":33},"Evaluation of PROM: Marx activity rating scale for patients > 18 years old","Measure of activities associated with high level knee function within the last year, scored from 0 to 16 where 0 is activities less than one time in a month and 16 is activities 4 or more times in a week.",{"measure":38,"description":39,"timeFrame":33},"Evaluation of PROM: Pediatric Functional Activity Brief Scale (Pedi-FABS) score for patients 10-18 years old","Measure of activity within the last month, scored from 0-30 where 0 is participating in activities less than one time per month and 16 is participating in activities more than 4 times per week.",{"measure":41,"description":42,"timeFrame":33},"Evaluation of PROM: Western Ontario Meniscal Evaluation Tool (WOMET) score","Measure of health-related quality of life for meniscus symptoms, scored from 0 to 100 where 0 is no physical symptoms or emotional feeling and 100 is extreme symptoms and extreme emotional feeling.",{"measure":44,"description":45,"timeFrame":46},"Clinical Success","Data on failure defined as removal of the whole or large portion of the graft (total or subtotal meniscectomy or a large irreparable radial tear), conversion to arthroplasty or revision of the meniscal transplant.","Through study completion, up to 20 years post-operatively.",{"measure":48,"description":49,"timeFrame":50},"Serial Imaging: Radiographs","Knee radiographs to determine graft longevity, status\u002Fpresence of extrusion and the post-operative chondral status of the knee.","baseline (pre-op), 3 months, 6 months, 1 year, 2 years, 5 years, 10 years, 15 years, and 20 years post-operatively",{"measure":52,"description":53,"timeFrame":50},"Serial Imaging: Ultrasound","Knee ultrasound to determine graft longevity, status\u002Fpresence of extrusion and the post-operative chondral status of the knee.",{"measure":55,"description":56,"timeFrame":50},"Serial Imaging: Magnetic Resonance Imaging (MRI)","Knee MRI to determine graft longevity, status\u002Fpresence of extrusion and the post-operative chondral status of the knee.",[58],{"measure":59,"description":60,"timeFrame":61},"Minimal Clinically Important Difference (MCID) in Patient Reported Outcomes (PROs)","To define the Minimal Clinically Important Difference (MCID) for the above mentioned PRO's in these patients, and to correlate patients' demographics and surgical status of the knee, to the MCID.","Calculated by anchor question response pre-operatively, 6 months, 1 year, 2 years, 5 years, 10 years, 15 years, and 20 years post-operatively.","ALL","10 Years","65 Years",{"inclusion":66,"exclusion":73,"raw_text":79},[67,68,69,70,71,72],"Males and females aged 10-65 years","MRI or arthroscopic images confirming the suitability for meniscus transplantation.","Patients undergoing an isolated primary\u002Frevision MAT (meniscal allograft transplant) procedure, or concomitant MAT with other knee procedures such as ligament reconstruction, realignment osteotomy, or cartilage resurfacing.","Medically suitable for meniscus transplantation.","Appropriate understanding of the language of the surgical center in terms of communication and reading.","Ability of the Patient or parent\u002Fguardian to provide informed consent.",[74,75,76,77,78],"Inability to comply with rehabilitation programs.","Patient aged less than 10 years and more than 65.","Presence of diffuse full thickness cartilage loss (widespread ICRS Grade III-IV chondral damage) and\u002For architectural remodeling of bone (i.e. flattening of condyle) in the knee of interest.","Significant medical comorbidities that limit patients from undergoing surgery.","Presence of confounding neuromuscular, genetic\u002Fcongenital, or post-traumatic conditions.","Inclusion Criteria:\n\nSubjects enrolled in this study must meet all of the following inclusion criteria:\n\n* Males and females aged 10-65 years\n* MRI or arthroscopic images confirming the suitability for meniscus transplantation.\n* Patients undergoing an isolated primary\u002Frevision MAT (meniscal allograft transplant) procedure, or concomitant MAT with other knee procedures such as ligament reconstruction, realignment osteotomy, or cartilage resurfacing.\n* Medically suitable for meniscus transplantation.\n* Appropriate understanding of the language of the surgical center in terms of communication and reading.\n* Ability of the Patient or parent\u002Fguardian to provide informed consent.\n\nExclusion Criteria:\n\n* Inability to comply with rehabilitation programs.\n* Patient aged less than 10 years and more than 65.\n* Presence of diffuse full thickness cartilage loss (widespread ICRS Grade III-IV chondral damage) and\u002For architectural remodeling of bone (i.e. flattening of condyle) in the knee of interest.\n* Significant medical comorbidities that limit patients from undergoing surgery.\n* Presence of confounding neuromuscular, genetic\u002Fcongenital, or post-traumatic conditions.",[81,82,83],"CHILD","ADULT","OLDER_ADULT",[85],{"facility":86,"city":87,"state":88,"zip":89,"country":90,"geoPoint":91},"Children's Health","Plano","Texas","75024","United States",{"lat":92,"lon":93},33.01984,-96.69889,[],[],[],[],{"nct_id":4,"conditions":99,"biomarkers":100},[19],[],{"nct_id":4,"found":102,"summary":15,"prompt_version":15},false]