Meniscus Disorder, Meniscus Tear, Patient Satisfaction
Conditions
Keywords
Meniscal Allograft Transplant
Brief summary
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
Interventions
None listed
Sponsors
Joint Restoration Foundation, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
10 Years to 65 Years
Inclusion criteria
Subjects enrolled in this study must meet all of the following inclusion criteria: * Males and females aged 10-65 years * MRI or arthroscopic images confirming the suitability for meniscus transplantation. * Patients undergoing an isolated primary/revision 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/guardian to provide informed consent.
Exclusion criteria
* 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/or 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/congenital, or post-traumatic conditions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serial Imaging: Magnetic Resonance Imaging (MRI) | baseline (pre-op), 3 months, 6 months, 1 year, 2 years, 5 years, 10 years, 15 years, and 20 years post-operatively | Knee MRI to determine graft longevity, status/presence of extrusion and the post-operative chondral status of the knee. |
| Evaluation of PROM: The Knee Injury and Osteoarthritis Outcome (KOOS) Score | 3 months, 6 months, 1 year, 2 years, 5 years, 10 years, 15 years, and 20 years post-operatively | 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. |
| Evaluation of PROM: Marx activity rating scale for patients > 18 years old | 3 months, 6 months, 1 year, 2 years, 5 years, 10 years, 15 years, and 20 years post-operatively | 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. |
| Evaluation of PROM: Pediatric Functional Activity Brief Scale (Pedi-FABS) score for patients 10-18 years old | 3 months, 6 months, 1 year, 2 years, 5 years, 10 years, 15 years, and 20 years post-operatively | 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. |
| Evaluation of PROM: Western Ontario Meniscal Evaluation Tool (WOMET) score | 3 months, 6 months, 1 year, 2 years, 5 years, 10 years, 15 years, and 20 years post-operatively | 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. |
| Clinical Success | Through study completion, up to 20 years post-operatively. | 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. |
| Serial Imaging: Radiographs | baseline (pre-op), 3 months, 6 months, 1 year, 2 years, 5 years, 10 years, 15 years, and 20 years post-operatively | Knee radiographs to determine graft longevity, status/presence of extrusion and the post-operative chondral status of the knee. |
| Serial Imaging: Ultrasound | baseline (pre-op), 3 months, 6 months, 1 year, 2 years, 5 years, 10 years, 15 years, and 20 years post-operatively | Knee ultrasound to determine graft longevity, status/presence of extrusion and the post-operative chondral status of the knee. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Minimal Clinically Important Difference (MCID) in Patient Reported Outcomes (PROs) | Calculated by anchor question response pre-operatively, 6 months, 1 year, 2 years, 5 years, 10 years, 15 years, and 20 years post-operatively. | 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. |
Countries
United States
Outcome results
None listed