Repair of Articular Osteochondral Defect

Osteochondritis Dissecans Clinical Trial

Official title:

Repair of Articular Osteochondral Defect

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01409447
• Other study ID #: 200707007D
• Status: Recruiting
• Phase: N/A
• First received: August 3, 2011
• Last updated: August 19, 2011
• Start date: March 2009
• Est. completion date: December 2011

Study information

• Verified date: August 2011
• Source: National Taiwan University Hospital
• Contact: Ching-Chuan Jiang
• Phone: 886-23123456
• Email: ccj[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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°

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteochondritis
• Osteochondritis Dissecans

Intervention

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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee injury and Osteoarthritis Outcome Score		1 Year	Yes