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Evaluation of an Acellular Osteochondral Graft for Cartilage LEsions Pilot Trial

NCT01183637 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2015-05-25

No results posted yet for this study

Summary

The Kensey Nash Corp. Cartilage Repair Device is a bioresorbable scaffold designed to promote repair of knee cartilage and subchondral bone. Subjects with knee cartilage damage meeting eligibility criteria will be randomly assigned to receive treatment with the Cartilage Repair Device or a standard surgical technique called microfracture. The purpose of the study is to evaluate the initial safety and effectiveness of the Cartilage Repair Device compared to microfracture.

Conditions

  • Articular Cartilage Injury

Interventions

DEVICE

Kensey Nash Corp. Cartilage Repair Device

To perform the Cartilage Repair Device implantation procedure, the surgeon first removes the damaged cartilage. Then, the surgeon creates a cylindrical hole in the bone below the area of damaged cartilage. The Cartilage Repair Device is then implanted into the hole so that the surface is level with the surrounding native cartilage. The Cartilage Repair Device will then absorb blood and bone marrow from the bone to begin the healing process.

PROCEDURE

Microfracture

To perform the microfracture technique, the surgeon will first remove the damaged cartilage. Then, the surgeon will make a number of small fractures in the bone below the area of damaged cartilage. The fractures cause the bone to bleed and a clot to form over the exposed bone. Over time, the clot forms a layer of fibrocartilage over the bone.

Sponsors & Collaborators

  • Kensey Nash Corporation

    lead INDUSTRY

Principal Investigators

  • Richard C Lehman, M.D. · U.S. Center for Sports Medicine, Kirkwood, MO

  • Phillip A Davidson, M.D. · Heiden - Davidson Orthopedics, Park City, UT

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2013-12-31
Completion
2014-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01183637 on ClinicalTrials.gov