Cryopreserved Human Meniscus Transplantation

NCT ID: NCT02319811

Last Updated: 2016-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

1995-11-30

Study Completion Date

2015-11-30

Brief Summary

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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

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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.

Conditions

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Osteoarthritis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Cryopreserved meniscus transplant

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

Cryopreserved meniscus transplants

Intervention Type PROCEDURE

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

Interventions

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Cryopreserved meniscus transplants

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cincinnati Sportsmedicine Research and Education Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frank R Noyes, M.D.

Role: PRINCIPAL_INVESTIGATOR

President, Noyes Knee Institute

Other Identifiers

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MenisCryo-001

Identifier Type: -

Identifier Source: org_study_id

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