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

NCT ID: NCT06749431

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-05

Study Completion Date

2050-01-05

Brief Summary

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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

Detailed Description

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Conditions

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Meniscus Tear Meniscus Disorder Patient Satisfaction

Keywords

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Meniscal Allograft Transplant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Joint Restoration Foundation, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Children's Health

Plano, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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001

Identifier Type: -

Identifier Source: org_study_id