Cryopreserved Human Meniscus Transplantation

N/ACompletedNCT02319811

Cincinnati Sportsmedicine Research and Education Foundation76 enrolled

Overview

The purpose of this study is to determine the long-term survivorship and clinical outcomes of all cryopreserved meniscus transplants performed by Dr. Frank Noyes.

All patients receiving cryopreserved meniscus transplants will be followed at 1, 2, 5, 10, and 15 years postoperatively. Study examination will include comprehensive knee examination by Dr. Noyes, x-rays, and potentially MRI. Patients will complete the following forms of the Cincinnati Knee Rating System: Symptom Rating Form, Sports Activity and Function Form, and Occupational Rating Form. All patient identification will be kept confidential. Patient data will be entered into the Knee Registry database according to their unique study number by the clinical research assistant.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Osteoarthritis

Interventions

Cryopreserved meniscus transplantsPROCEDURE

Lateral or medial cryopreserved meniscus transplants implanted into appropriately indicated patients.

Eligibility

Sex: ALLMin age: 14 YearsMax age: 49 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient post-meniscectomy * Patient symptomatic with activities * Patient has early articular cartilage degeneration in affected tibiofemoral compartment * Patient understands goals of operation, willing to undergo lengthy rehabilitation Exclusion Criteria: * Patient has no symptoms with activities * Patient has advanced degeneration in affected tibiofemoral compartment or other compartments * Patient is obese (BMI \> 30) * Patient has uncorrected lower limb axial malalignment or knee ligament deficiency * Patient has active infection * Patient has pre-existing knee arthrofibrosis or lower limb muscular atrophy * Patient has symptomatic patellofemoral articular cartilage deterioration * Patient is unwilling to undergo lengthy rehabilitation after surgery

Outcomes

Primary Outcomes

Survivorship analysis

Time frame: 15 years postoperatively

Secondary Outcomes

Cincinnati Knee Rating System

The following factors will be scored according to the validated Cincinnati Knee Rating System: pain, swelling, giving-way, walking, stair-climbing, squatting, running, jumping, pivoting, sports activity level, occupational level, patient perception of the knee condition.

Time frame: 15 years postoperatively

International Knee Documentations Committee

The validated IKDC overall evaluation form will be used to rate knee function.

Time frame: 15 years postoperatively

Data from ClinicalTrials.gov

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