Osteochondritis DissecansNCT01409447
Repair of Articular Osteochondral Defect
A study testing Biphasic osteochondral composite in people with Osteochondritis Dissecans, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Osteochondritis Dissecans
- What is being tested?
- Biphasic osteochondral composite
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2009to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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, …
Show all 9Show fewer
- Stiff knee from any reason
- Flexion < 130˚
- Extension loss > 20˚
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taipei, 100
Ching-Chuan Jiang, 886-23123456 ext. 65273, ccj@ntu.edu.tw
Ching-Chuan Jiang
About this study
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.
Read the 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.
- Conditions
- Osteochondritis Dissecans
- Being tested
- Biphasic osteochondral composite
- Medical subject headings
- Osteochondritis Dissecans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biphasic osteochondral compositeDevice
Also called Biphasic scaffold
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.
| Study group | Role | What they receive |
|---|---|---|
| Biphasic osteochondral composite | Experimental | feasibility study for the new medical device \& technique Receives: Device: Biphasic osteochondral composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee injury and Osteoarthritis Outcome Score
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2011 (estimated)
- Study startMar 2009
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteochondritis DissecansStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Chin-Chuan Jiang, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01409447
- Sponsor's protocol ID
- 200707007D
- Status last verified
- Aug 2011
- First submitted
- 3 Aug 2011
- Last updated
- 22 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repair of Articular Osteochondral Defect
- ClinicalTrials.gov ID
- NCT01409447
- Acronym / sponsor ID
- 200707007D
- Conditions
- Osteochondritis Dissecans
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 4 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biphasic osteochondral composite | Experimental | Device: Biphasic osteochondral compositefeasibility study for the new medical device \& technique |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- Pregnancy
- Nonunion of fracture around the knee
- Diffuse degenerative arthropathy of the knee
- Diffuse cartilage pathology due to
- Rheumatism: rheumatoid, psoriatic, …
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biphasic osteochondral compositeAlso: Biphasic scaffoldWe 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. | Device | Biphasic osteochondral composite |
Primary outcome
Knee injury and Osteoarthritis Outcome Score
Time frame: 1 Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2011.
Related trials for Osteochondritis Dissecans
RecruitingPhase 3
A Study of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee
Chondral Defect, Osteochondritis Dissecans (OCD)
Recruiting
MaioRegen Prime Study for the Treatment of Deep Osteochondral Lesion of the Knee
Osteochondral Lesions of the Knee Joint, Osteochondritis Dissecans (OCD)
RecruitingObservational study
Osteochondritis Dissecans of Knee Prospective Cohort
Osteochondritis Dissecans
Active, not recruitingObservational study
Psychological Response and Readiness Associated With OCD of the Knee
Osteochondritis Dissecans Knee, Psychological Stress
Active, not recruitingObservational study
Treatment Outcomes for Osteochondritis Dissecans of the Knee: A Cohort Study
Osteochondritis Dissecans Knee, Osteochondritis Dissecans (OCD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chin-Chuan Jiang principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biphasic osteochondral composite in people with Osteochondritis Dissecans, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ching-Chuan Jiang (886-23123456 ext. 65273, ccj@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee injury and Osteoarthritis Outcome Score (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2011.