Cryopreserved Human Meniscus Transplantation

NCT02319811 | Completed

• 1 other identifier: MenisCryo-001
• Study Type: observational
• Target: 76
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Survivorship analysis

  15 years postoperatively

Secondary Outcomes (2)

• Cincinnati Knee Rating System

  15 years postoperatively

• International Knee Documentations Committee

  15 years postoperatively

Study Arms (1)

Cryopreserved meniscus transplant

Intervention: Lateral or medial cryopreserved meniscus transplant implanted into appropriately indicated patients.

Procedure: Cryopreserved meniscus transplants

Interventions

Cryopreserved meniscus transplants PROCEDURE

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

Cryopreserved meniscus transplant

Eligibility Criteria

• Age: 14 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cincinnati Sportsmedicine Research and Education Foundation: lead

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Frank R Noyes, M.D.

  President, Noyes Knee Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2014
• First Posted: December 18, 2014
• Study Start: November 1, 1995
• Primary Completion: December 1, 2014
• Study Completion: November 1, 2015
• Last Updated: April 13, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share