Cryopreserved Human Meniscus Transplantation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cryopreserved meniscus transplant Intervention: Lateral or medial cryopreserved meniscus transplant implanted into appropriately indicated patients. |
Procedure: Cryopreserved meniscus transplants
Lateral or medial cryopreserved meniscus transplants implanted into appropriately indicated patients.
|
Outcome Measures
Primary Outcome Measures
- Survivorship analysis [15 years postoperatively]
Secondary Outcome Measures
- 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.
- International Knee Documentations Committee [15 years postoperatively]
The validated IKDC overall evaluation form will be used to rate knee function.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient post-meniscectomy
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Patient symptomatic with activities
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Patient has early articular cartilage degeneration in affected tibiofemoral compartment
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Patient understands goals of operation, willing to undergo lengthy rehabilitation
Exclusion Criteria:
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Patient has no symptoms with activities
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Patient has advanced degeneration in affected tibiofemoral compartment or other compartments
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Patient is obese (BMI > 30)
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Patient has uncorrected lower limb axial malalignment or knee ligament deficiency
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Patient has active infection
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Patient has pre-existing knee arthrofibrosis or lower limb muscular atrophy
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Patient has symptomatic patellofemoral articular cartilage deterioration
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Patient is unwilling to undergo lengthy rehabilitation after surgery
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Cincinnati Sportsmedicine Research and Education Foundation
Investigators
- Principal Investigator: Frank R Noyes, M.D., President, Noyes Knee Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MenisCryo-001