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Repair of Articular Osteochondral Defect

Repair of Articular Osteochondral Defect

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01409447
Enrollment
10
Registered
2011-08-04
Start date
2009-03-31
Completion date
2011-12-31
Last updated
2011-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteochondritis Dissecans

Brief summary

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

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.

Interventions

DEVICEBiphasic 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.

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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˚

Design outcomes

Primary

MeasureTime frame
Knee injury and Osteoarthritis Outcome Score1 Year

Countries

Taiwan

Contacts

Primary ContactChing-Chuan Jiang
ccj@ntu.edu.tw886-23123456

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026