Repair of Articular Osteochondral Defect
Recruitment status was Recruiting
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Repair of Articular Osteochondral Defect|
- Knee injury and Osteoarthritis Outcome Score [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2009|
|Estimated Study Completion Date:||December 2011|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Experimental: Biphasic osteochondral composite
feasibility study for the new medical device & technique
Device: 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.
Other Name: Biphasic scaffold
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.
|Contact: Ching-Chuan Jiang||886-23123456 ext firstname.lastname@example.org|
|National Taiwan University Hospital||Recruiting|
|Taipei, Taiwan, 100|
|Contact: Ching-Chuan Jiang 886-23123456 ext 65273 email@example.com|
|Principal Investigator: Ching-Chuan Jiang|
|Sub-Investigator: Hongsen Chiang|
|Principal Investigator:||Chin-Chuan Jiang||National Taiwan University Hospital|