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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 February 2013 |
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Main ID: |
NCT01183637 |
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Date of registration:
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28/07/2010 |
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Primary sponsor: |
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Public title:
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Evaluation of an Acellular Osteochondral Graft for Cartilage LEsions Pilot Trial
EAGLE Pilot |
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Scientific title:
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Initial Safety and Effectiveness Study of the Kensey Nash Corp. Cartilage Repair Device for Knee Cartilage Lesion Repair |
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Date of first enrolment:
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June 2010 |
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Target sample size:
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30 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01183637 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Phillip A Davidson, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Heiden - Davidson Orthopedics, Park City, UT |
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Name:
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Richard C Lehman, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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U.S. Center for Sports Medicine, Kirkwood, MO |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 21 years old and skeletally mature
- KOOS Pain subscale score is less than 65 (i.e. moderate pain)
- KOOS Activities of Daily Living score is less than 70 (i.e. moderate functional
limitations)
- ICRS grade 3 or 4 cartilage lesion on the medial femoral condyle, lateral femoral
condyle or trochlea measuring less than or equal to 15mm in diameter
- Stable meniscus with greater than 50% remaining bilaterally
- Mental capacity and willingness to comply with the post-operative rehabilitation plan
and follow-up evaluations
- Written informed consent
Exclusion Criteria:
- Body mass index greater than 35
- Contraindication for MRI
- Previous microfracture, autograft implantation, allograft implantation or autologous
chondrocyte implantation procedure on the damaged cartilage surface
- Knee ligament surgery within the past 6 months
- Clinically significant knee malalignment
- Osteoarthritis in the knee
- Multiple cartilage lesions
- Inflammatory arthropathy (i.e. rheumatoid arthritis, systemic lupus or active gout)
- Active infection in either lower limb
- Hyaluronic acid or cortisone injections within the past 3 months
- History of substance abuse
- Current participation in a study of an investigational product for a similar purpose
- Active litigation for the knee injury
Age minimum:
21 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Articular Cartilage Injury
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Intervention(s)
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Device: Kensey Nash Corp. Cartilage Repair Device
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Procedure: Microfracture
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Primary Outcome(s)
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Patient Success
[Time Frame: 24 months]
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Secondary Outcome(s)
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Cartilage defect appearance on MRI
[Time Frame: 24 months]
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Knee Injury and Osteoarthritic Outcome Score ("KOOS")
[Time Frame: 24 months]
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Lyshom Score
[Time Frame: 24 months]
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Secondary ID(s)
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EAGLE Pilot
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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