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Enrolling by invitation NCT06749431

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

— Observational Meniscus Tear Meniscus Disorder Patient Satisfaction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Meniscus Tear, Meniscus Disorder, Patient Satisfaction. Basic parameters: 10 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

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

Primary outcome measures

  • 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 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]
  • 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]
  • 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]
  • Clinical Success [Time frame: Through study completion, up to 20 years post-operatively.]
  • 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]
  • 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]
  • 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]
Secondary outcome measures (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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Children's Health — Plano

Identifiers

NCT: NCT06749431 · 001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗