Repair of Articular Osteochondral Defect

Study Overview
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Brief Summary
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Background: Matrix-associated autologous chondrocyte implantation (MACI) has been recently used to treat cartilage defects. The investigators had previously developed a biphasic osteochondral composite as the construct for chondrocyte implantation. The investigators further conducted this feasibility study of such device to treat patients with osteochondral lesion of the knee joints.

Detailed Description
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Methods: Ten patients with symptomatic isolated osteochondritis at the femoral condyle were treated by replacing the pathological tissue with autologous chondrocyte-laden biphasic cylindrical plug of DL-poly-lactide-co-glycolide, with its lower body impregnated with -tricalcium phosphate as the osseous phase. The osteochondral lesion was drilled to fashion a pit of identical size and shape as the plug. The chondrocyte-laden plug was press-fit to fill the pit. Outcome of repair was examined by KOOS scale at 3, 6 and 12 months postoperatively, and tissue sample was collected with second-look arthroscopic needle-biopsy at 12 months. The primary outcome parameter was the postoperative change of KOOS; and the secondary outcome parameter was the regeneration of cancellous bone and hyaline cartilage at the repair site.

Official Title
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Repair of Articular Osteochondral Defect

Conditions
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Osteochondritis Dissecans

Intervention / Treatment
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* Device: Biphasic osteochondral composite


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18   60 years Articular cartilage defect of the knee Diagnosis by X-ray and/or MRI, Arthroscopy Confined area: diameter < 3 cm Full layer cartilage damage Exclusion Criteria: Pregnancy Nonunion of fracture around the knee Diffuse degenerative arthropathy of the knee Diffuse cartilage pathology due to Rheumatism: rheumatoid, psoriatic, … Metabolic disorder: gouty, hemorrhagic, … Stiff knee from any reason Flexion < 130˚ Extension loss > 20˚

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biphasic osteochondral composite<br>feasibility study for the new medical device & technique | Device: Biphasic osteochondral composite<br>* We had previously developed a biphasic osteochondral composite as the construct for chondrocyte implantation. We further conducted this feasibility study of such device to treat patients with osteochondral lesion of the knee joints.<br>* Other names: Biphasic scaffold;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee injury and Osteoarthritis Outcome Score |  | 1 Year |