Repair of Articular Osteochondral Defect

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-12-31

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.

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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.

Conditions

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Osteochondritis Dissecans

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Biphasic osteochondral composite

feasibility study for the new medical device \& technique

Group Type EXPERIMENTAL

Biphasic osteochondral composite

Intervention Type DEVICE

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.

Interventions

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Biphasic osteochondral composite

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.

Intervention Type DEVICE

Other Intervention Names

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Biphasic scaffold

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˚

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No