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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
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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. | 3 months, 6 months, 1 year, 2 years, 5 years, 10 years, 15 years, and 20 years post-operatively |
| 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. | 3 months, 6 months, 1 year, 2 years, 5 years, 10 years, 15 years, and 20 years post-operatively |
| 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. | 3 months, 6 months, 1 year, 2 years, 5 years, 10 years, 15 years, and 20 years post-operatively |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Subjects enrolled in this study must meet all of the following inclusion criteria:
Exclusion Criteria:
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Patients with meniscal deficiency
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Health | Plano | Texas | 75024 | United States |
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| Through study completion, up to 20 years post-operatively. |
| Serial Imaging: Radiographs | Knee radiographs to determine graft longevity, status/presence 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 |
| Serial Imaging: Ultrasound | Knee ultrasound to determine graft longevity, status/presence 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 |
| Serial Imaging: Magnetic Resonance Imaging (MRI) | Knee MRI to determine graft longevity, status/presence 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 |
| ID | Term |
|---|---|
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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