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

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 Overview

• Status: Enrolling by invitation
• Conditions: Patient Satisfaction; Meniscus Tear; Meniscus Disorder

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

Study Locations

• United States
  • Texas
    • Plano, Texas, United States, 75024
      • Children's Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients with meniscal deficiency

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	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

Secondary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Joint Restoration Foundation, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): January 5, 2025
• Primary Completion (Estimated): January 5, 2030
• Study Completion (Estimated): January 5, 2050

Study Registration Dates

• First Submitted: November 8, 2024
• First Submitted That Met QC Criteria: December 18, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Meniscal Allograft Transplant
• Other Study ID Numbers: 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)