Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Repair of Articular Osteochondral Defect

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2011 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
Information provided by:
National Taiwan University Hospital Identifier:
First received: August 3, 2011
Last updated: August 19, 2011
Last verified: August 2011
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.

Condition Intervention
Osteochondritis Dissecans
Device: Biphasic osteochondral composite

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Repair of Articular Osteochondral Defect

Resource links provided by NLM:

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Knee injury and Osteoarthritis Outcome Score [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
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)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   All
Accepts 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˚
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01409447

National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Principal Investigator: Chin-Chuan Jiang National Taiwan University Hospital
  More Information

Responsible Party: Ching-Chuan Jiang, National Taiwan University Hospital Identifier: NCT01409447     History of Changes
Other Study ID Numbers: 200707007D 
Study First Received: August 3, 2011
Last Updated: August 19, 2011
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Osteochondritis Dissecans
Bone Diseases
Musculoskeletal Diseases
Cartilage Diseases
Connective Tissue Diseases processed this record on January 14, 2017