Clinical Outcomes, Graft Longevity, and Chondral Protection Following Primary or Revision Meniscal Allograft Transplantation Surgery

N/AEnrolling By InvitationNCT06749431

Joint Restoration Foundation, Inc.5,000 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

5,000

Conditions

Meniscus Tear Meniscus Disorder Patient Satisfaction

Eligibility

Sex: ALLMin age: 10 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: baseline (pre-op), 3 months, 6 months, 1 year, 2 years, 5 years, 10 years, 15 years, and 20 years post-operatively

Secondary Outcomes

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.

Time frame: Calculated by anchor question response pre-operatively, 6 months, 1 year, 2 years, 5 years, 10 years, 15 years, and 20 years post-operatively.

Clinical Outcomes, Graft Longevity, and Chondral Protection Following Primary or Revision Meniscal Allograft Transplantation Surgery

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes