Cryopreserved Human Meniscus Transplantation

Meniscus Transplantation in Symptomatic Patients Under Fifty Years of Age: Survivorship Analysis

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Procedure: Cryopreserved meniscus transplants

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 Type: Observational
• Enrollment (Actual): 76

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 49 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Minimum age: 14 Years Maximum age: 49 Years Gender: Both Accepts Healthy Volunteers: No Patients post-meniscectomy, symptomatic with activities, early cartilage degeneration in affected tibiofemoral compartment.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Survivorship analysis	15 years postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	15 years postoperatively
International Knee Documentations Committee	The validated IKDC overall evaluation form will be used to rate knee function.	15 years postoperatively

Collaborators and Investigators

• Sponsor: Cincinnati Sportsmedicine Research and Education Foundation
• Investigators: Principal Investigator: Frank R Noyes, M.D., President, Noyes Knee Institute

Study record dates

Study Major Dates

• Study Start: November 1, 1995
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: December 10, 2014
• First Submitted That Met QC Criteria: December 15, 2014
• First Posted (Estimate): December 18, 2014

Study Record Updates

• Last Update Posted (Estimate): April 13, 2016
• Last Update Submitted That Met QC Criteria: April 11, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: MenisCryo-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Published results in Journal of Bone and Joint Surgery, 2015 and American Journal of Sports Medicine 2016