Autologous chondrocyte implantation (ACI) in the treatment of early Osteoarthritis (OA)
| ISRCTN | ISRCTN54356626 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54356626 |
| Secondary identifying numbers | N0196127381 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 03/11/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof James Richardson
Scientific
Scientific
Institute of Orthopaedics
The Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust
Oswestry
SY10 7AG
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Autologous chondrocyte implantation (ACI) in the treatment of early Osteoarthritis (OA) |
| Study objectives | PRCT of ACI with osteotomy vs osteotomy alone. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Musculoskeletal Diseases: Osteoarthritis (OA) |
| Intervention | ACI and osteotomy vs osteotomy alone |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Knee function 2. Quality of life indicators |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 02/09/2003 |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 80 |
| Key inclusion criteria | Symptomatic bone on bone cartilage defects |
| Key exclusion criteria | Inflammatory arthritis |
| Date of first enrolment | 02/09/2003 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
The Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust
Oswestry
SY10 7AG
United Kingdom
SY10 7AG
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
The Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust (UK), NHS R&D Support Funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
03/11/2015: no publications found on PubMed.
