An interventional study of Biphasic osteochondral composite in Osteochondritis Dissecans, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2011-08-22.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment
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.
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.
30 studies on the registry are indexed under Osteochondritis Dissecans; 7 are open to participants now.
This study's planned enrollment of 10 is below the median of 45 across 17 interventional studies indexed under Osteochondritis Dissecans.
Browse Osteochondritis Dissecans studies →National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
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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.
Also known as: Biphasic scaffold
Knee injury and Osteoarthritis Outcome Score
Time frame: 1 Year
The record gives a start of Mar 2009, a primary completion of Dec 2011 and a completion of Dec 2011. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.
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