Cryopreserved Human Meniscus Transplantation

Completed

• Conditions: Osteoarthritis
• Interventions: Procedure: Cryopreserved meniscus transplants

• Registration Number: NCT02319811
• Lead Sponsor: Cincinnati Sportsmedicine Research and Education Foundation

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 1995-11
• Primary Completion: 2014-12
• Study First Submitted: 2014-12-10
• Study First Submitted QC: 2014-12-15
• Study First Posted: 2014-12-18
• Study Completion: 2015-11
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-11
• Last Update Posted: 2016-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cryopreserved meniscus transplant	Cryopreserved meniscus transplants	Intervention: Lateral or medial cryopreserved meniscus transplant implanted into appropriately indicated patients.

Primary Outcome Measures

Name	Time	Method
Survivorship analysis	15 years postoperatively

Secondary Outcome Measures

Name	Time	Method
International Knee Documentations Committee	15 years postoperatively	The validated IKDC overall evaluation form will be used to rate knee function.
Cincinnati Knee Rating System	15 years postoperatively	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.