Clinical trial NCT06749431: Clinical Outcomes, Graft Longevity, and Chondral Protection Following Primary or Revision Meniscal Allograft Transplantation Surgery
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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Meniscus Tear
Meniscus Disorder
Patient Satisfaction
Keywords: Meniscal Allograft Transplant
Lead sponsor: Joint Restoration Foundation, Inc.
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 5000
Sex: ALL
Minimum age (years): 10
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with meniscal deficiency

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


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.

Primary outcomes:
measure: 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
measure: 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
measure: 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
measure: 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
measure: Clinical Success
timeFrame: Through study completion, up to 20 years post-operatively.
measure: 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
measure: Serial Imaging: Ultrasound
timeFrame: baseline (pre-op), 3 months, 6 months, 1 year, 2 years, 5 years, 10 years, 15 years, and 20 years post-operatively
measure: Serial Imaging: Magnetic Resonance Imaging (MRI)
timeFrame: baseline (pre-op), 3 months, 6 months, 1 year, 2 years, 5 years, 10 years, 15 years, and 20 years post-operatively
Secondary outcomes:
measure: Minimal Clinically Important Difference (MCID) in Patient Reported Outcomes (PROs)
timeFrame: Calculated by anchor question response pre-operatively, 6 months, 1 year, 2 years, 5 years, 10 years, 15 years, and 20 years post-operatively.
Other outcomes:
Locations:
city: Plano
country: United States
facility: Children's Health
state: Texas
Study officials:
References: