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OpenTrials
Completed

NCT Number: NCT02319811

Cryopreserved Human Meniscus Transplantation

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.

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Key information

Age range

14 year–49 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cryopreserved meniscus transplants

Procedure

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

Primary outcomes

  1. Survivorship analysis

    Time frame: 15 years postoperatively

Secondary outcomes

  1. Cincinnati Knee Rating System

    Time frame: 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.

  2. International Knee Documentations Committee

    Time frame: 15 years postoperatively

    The validated IKDC overall evaluation form will be used to rate knee function.

Sponsors and collaborators

Lead sponsor

Cincinnati Sportsmedicine Research and Education Foundation

Other

Registry information

Official study title

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

Important dates

Study start
1995
Primary completion
2014
Study completion
2015
First posted
Dec 18, 2014
Registry last updated
Apr 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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