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Repair of Articular Osteochondral Defect

This study is currently recruiting participants.
Verified August 2011 by National Taiwan University Hospital
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
History of Changes
  Purpose

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:

U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01409447

Contacts
Contact: Ching-Chuan Jiang 886-23123456 ext 65273 ccj@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Ching-Chuan Jiang     886-23123456 ext 65273     ccj@ntu.edu.tw    
Principal Investigator: Ching-Chuan Jiang            
Sub-Investigator: Hongsen Chiang            
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Chin-Chuan Jiang National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Ching-Chuan Jiang, National Taiwan University Hospital
ClinicalTrials.gov 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
Osteochondritis Dissecans
Bone Diseases
 Musculoskeletal Diseases
Cartilage Diseases
Connective Tissue Diseases

ClinicalTrials.gov processed this record on June 17, 2013