Cryopreserved Human Meniscus Transplantation

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02319811
• Other study ID #: MenisCryo-001
• Status: Completed
• Phase: N/A
• First received: December 10, 2014
• Last updated: April 11, 2016
• Start date: November 1995
• Est. completion date: November 2015

Study information

• Verified date: April 2016
• Source: Cincinnati Sportsmedicine Research and Education Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: November 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 49 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Procedure:
• Cryopreserved meniscus transplants
Lateral or medial cryopreserved meniscus transplants implanted into appropriately indicated patients.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cincinnati Sportsmedicine Research and Education Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survivorship analysis		15 years postoperatively	No
Secondary	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	No
Secondary	International Knee Documentations Committee	The validated IKDC overall evaluation form will be used to rate knee function.	15 years postoperatively	No