Joint distraction in the treatment of knee osteoarthritis: efficacy and underlying mechanisms
| ISRCTN | ISRCTN92846059 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92846059 |
| Protocol serial number | N/A |
| Sponsor | University Medical Centre Utrecht (UMCU) (The Netherlands) |
| Funder | Dutch Arthritis Association (Reumafonds) (The Netherlands) |
- Submission date
- 26/02/2007
- Registration date
- 26/02/2007
- Last edited
- 20/08/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr A C A Marijnissen
Scientific
Scientific
University Medical Centre Utrecht (UMCU)
Department of Rheumatology and Clinical Immunology, F02.127
P.O. Box 85500
Utrecht
3508 GA
Netherlands
| Phone | +31 (0)30 250 9758 |
|---|---|
| a.c.a.marijnissen@umcutrecht.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised, non-controlled, interventional clinical trial |
| Secondary study design | Single-centre |
| Scientific title | Joint distraction in the treatment of knee osteoarthritis: efficacy and underlying mechanisms |
| Study objectives | Joint distraction is a relatively new approach in the treatment of severe Osteoarthritis (OA). Clinical efficacy has been proven for hip and ankle OA. Hypothesis: A two month distraction period results in similar clinical beneficial effects as a three month distraction period. |
| Ethics approval(s) | Approval received from the Medical Ethical Committee of the University Medical Centre Utrecht on the 28th July 2004. |
| Health condition(s) or problem(s) studied | Osteoarthritis |
| Intervention | Joint distraction applies temporary (two months) relief of mechanical wear and tear of the articular cartilage surfaces forming a joint. Nutrition of the cartilage is maintained due to intra-articular fluid pressure changes during treatment. Additionally subchondral sclerosis is diminished, diminishing mechanical stresses on the cartilage after treatment. |
| Intervention type | Other |
| Primary outcome measure(s) |
Pain (according to the The Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]) |
| Key secondary outcome measure(s) |
Functional disability (according to the WOMAC) |
| Completion date | 01/03/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 3 |
| Key inclusion criteria | 1. Age less than 55 years 2. Osteoarthritis, primary in the tibio-femoral joint, uni or bilateral 3. Severe osteoarthritis considered for joint replacement surgery/osteotomy |
| Key exclusion criteria | 1. Osteoarthritis in both knees 2. Primary retro-patellar osteoarthritis 3. Deviation of the mechanical axis greater than 10 º (independent of cartilage damage) 4. Primary intra-articular inflammation 5. Psychological problems, not allowing two months distraction |
| Date of first enrolment | 28/07/2004 |
| Date of final enrolment | 01/03/2010 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Centre Utrecht (UMCU)
Utrecht
3508 GA
Netherlands
3508 GA
Netherlands
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? |
|---|---|---|---|---|---|
| Results article | 12/05/2011 | 20/08/2021 | Yes | No |
Editorial Notes
20/08/2021: Publication reference added.
