Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06749431

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

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Meniscus Tear Behavior Health Behavior Meniscus Disorder Patient Satisfaction Treatment Adherence and Compliance

Age range

10 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Health

Plano, Texas, 75024, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 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.

  2. Evaluation of PROM: Marx activity rating scale for patients > 18 years old

    Time frame: 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.

  3. Evaluation of PROM: Pediatric Functional Activity Brief Scale (Pedi-FABS) score for patients 10-18 years old

    Time frame: 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.

  4. Evaluation of PROM: Western Ontario Meniscal Evaluation Tool (WOMET) score

    Time frame: 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.

  5. Clinical Success

    Time frame: 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.

  6. Serial Imaging: Radiographs

    Time frame: 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.

  7. Serial Imaging: Ultrasound

    Time frame: 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.

  8. Serial Imaging: Magnetic Resonance Imaging (MRI)

    Time frame: 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.

Secondary outcomes

  1. Minimal Clinically Important Difference (MCID) in Patient Reported Outcomes (PROs)

    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.

    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.

Sponsors and collaborators

Lead sponsor

Joint Restoration Foundation, Inc.

Other

Registry information

Official study title

MERCuRE (MEniscus, Restoration, Conservation, and Repair) Group Study on Clinical Outcomes, Graft Longevity, and Chondral Protection Following Primary or Revision Meniscal Allograft Transplantation Surgery

Important dates

Study start
2025
Primary completion
2030
Study completion
2050
First posted
Dec 27, 2024
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.