Status:
TERMINATED
Evaluation of an Acellular Osteochondral Graft for Cartilage LEsions Pilot Trial
Lead Sponsor:
Kensey Nash Corporation
Conditions:
Articular Cartilage Injury
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief 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 cri...
Detailed Description
Damage to articular cartilage in the knee by acute or chronic injury causes pain and limits knee function. If left untreated, damage to the articular cartilage can lead to painful osteoarthritis. The ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01183637
Start Date
June 1 2010
End Date
May 1 2014
Last Update
May 25 2015
Active Locations (2)
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1
Peninsula Orthopedic Associates
Salisbury, Maryland, United States, 21804
2
U.S. Center for Sports Medicine
Kirkwood, Missouri, United States, 63122