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NCT06749431

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

Enrolling by Invitation
Not specifiedAges 10–65Observational
Joint Restoration Foundation, Inc.
~5,000 participants
Updated 2024-12-27 on ClinicalTrials.gov

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluation of PROM: The Knee Injury and Osteoarthritis Outcome (KOOS) Score
Measured over 3 months, 6 months, 1 year, 2 years, 5 years, 10 years, 15 years, and 20 years post-operatively
+7 more outcomes measured

Conditions

Meniscus Tear
Meniscus Disorder
Patient Satisfaction

Explore related trials

Meniscus Disorder

Where it's being run

1 sites across 1 states
Texas1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Evaluation of PROM: The Knee Injury and Osteoarthritis Outcome (KOOS) Score3 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.

  • Evaluation of PROM: Marx activity rating scale for patients > 18 years old3 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.

  • Evaluation of PROM: Pediatric Functional Activity Brief Scale (Pedi-FABS) score for patients 10-18 years old3 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.

  • Evaluation of PROM: Western Ontario Meniscal Evaluation Tool (WOMET) score3 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.

  • Clinical SuccessThrough 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.

  • Serial Imaging: Radiographsbaseline (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.

  • Serial Imaging: Ultrasoundbaseline (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.

  • Serial Imaging: Magnetic Resonance Imaging (MRI)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.