Repair of Articular Osteochondral Defect

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01409447
First received: August 3, 2011
Last updated: August 19, 2011
Last verified: August 2011

August 3, 2011
August 19, 2011
March 2009
December 2011   (final data collection date for primary outcome measure)
Knee injury and Osteoarthritis Outcome Score [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01409447 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Repair of Articular Osteochondral Defect
Repair of Articular Osteochondral Defect

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Osteochondritis Dissecans
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
Experimental: Biphasic osteochondral composite
feasibility study for the new medical device & technique
Intervention: Device: Biphasic osteochondral composite
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
December 2011
December 2011   (final data collection date for primary outcome measure)

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˚
Both
18 Years to 60 Years
No
Contact: Ching-Chuan Jiang 886-23123456 ext 65273 ccj@ntu.edu.tw
Taiwan
 
NCT01409447
200707007D
Yes
Ching-Chuan Jiang, National Taiwan University Hospital
National Taiwan University Hospital
Not Provided
Principal Investigator: Chin-Chuan Jiang National Taiwan University Hospital
National Taiwan University Hospital
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP