Autologous chondrocyte implantation (ACI) in the treatment of early Osteoarthritis (OA)
| ISRCTN | ISRCTN54356626 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54356626 |
| Protocol serial number | N0196127381 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funder | The Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust (UK), NHS R&D Support Funding |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
1. Knee function |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
The Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust
Oswestry
SY10 7AG
United Kingdom
SY10 7AG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
03/11/2015: no publications found on PubMed.
