Repair of Articular Osteochondral Defect

National Taiwan University

Status: Unknown

Conditions: Osteochondritis Dissecans

Treatments: Device: Biphasic osteochondral composite

Study type: Interventional

Funder types: Other

Identifiers

NCT01409447

200707007D

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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˚

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Biphasic osteochondral composite

Experimental group

Description:

feasibility study for the new medical device \& technique

Treatment:

Device: Biphasic osteochondral composite