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

NCT06749431 | Enrolling By Invitation

• 1 other identifier: 001
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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

Conditions

Meniscus Tear; Meniscus Disorder; Patient Satisfaction

Keywords

Meniscal Allograft Transplant

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• 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.

Eligibility Criteria

• Age: 10 Years - 65 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with meniscal deficiency

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Joint Restoration Foundation, Inc.: lead

Study Sites (1)

Children's Health

Plano, Texas, 75024, United States

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2024
• First Posted: December 27, 2024
• Study Start: January 5, 2025
• Primary Completion (Estimated): January 5, 2030
• Study Completion (Estimated): January 5, 2050
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

US (1)