By InvitationNot Applicable

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

United States5,000 participantsStarted 2025-01-05

Plain-language 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

Who can participate

Age range

10 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Evaluation of PROM: The Knee Injury and Osteoarthritis Outcome (KOOS) Score

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 3 months, 6 months, 1 year, 2 years, 5 years, 10 years, 15 years, and 20 years post-operatively

Clinical Success

Timeframe: Through study completion, up to 20 years post-operatively.

Serial Imaging: Radiographs

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

Trial details

NCT IDNCT06749431

SponsorJoint Restoration Foundation, Inc.

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2030-01-05

View on ClinicalTrials.gov More Meniscus Tear trials