Repair of Articular Osteochondral Defect
Primary Purpose
Osteochondritis Dissecans
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Biphasic osteochondral composite
Sponsored by
About this trial
This is an interventional treatment trial for Osteochondritis Dissecans
Eligibility 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˚
Sites / Locations
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Biphasic osteochondral composite
Arm Description
feasibility study for the new medical device & technique
Outcomes
Primary Outcome Measures
Knee injury and Osteoarthritis Outcome Score
Secondary Outcome Measures
Full Information
NCT ID
NCT01409447
First Posted
August 3, 2011
Last Updated
August 19, 2011
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01409447
Brief Title
Repair of Articular Osteochondral Defect
Official Title
Repair of Articular Osteochondral Defect
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteochondritis Dissecans
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Biphasic osteochondral composite
Arm Type
Experimental
Arm Description
feasibility study for the new medical device & technique
Intervention Type
Device
Intervention Name(s)
Biphasic osteochondral composite
Other Intervention Name(s)
Biphasic scaffold
Intervention Description
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.
Primary Outcome Measure Information:
Title
Knee injury and Osteoarthritis Outcome Score
Time Frame
1 Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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˚
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ching-Chuan Jiang
Phone
886-23123456
Ext
65273
Email
ccj@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chin-Chuan Jiang
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ching-Chuan Jiang
Phone
886-23123456
Ext
65273
Email
ccj@ntu.edu.tw
First Name & Middle Initial & Last Name & Degree
Ching-Chuan Jiang
First Name & Middle Initial & Last Name & Degree
Hongsen Chiang
12. IPD Sharing Statement
Learn more about this trial
Repair of Articular Osteochondral Defect
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