Valgus knee bracing for medical compartment osteoarthritis (OA)
| ISRCTN | ISRCTN68112133 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68112133 |
| Secondary identifying numbers | N0436151092 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 30/08/2012
- Recruitment status
- Stopped
- Overall study status
- Stopped
- 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
Mr Simon Boyle
Scientific
Scientific
Orthopaedic Surgery
Leeds Teaching Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
| Phone | +44 (0)7739 490649 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | The aim of this project is to ascertain the improvements in function and pain in patients with osteoarthritis of the knee, using valgus offloading knee braces. These braces are currently use for osteoarthritis within the department of orthopaedics in Leeds by some surgeons, however we do not have a prospective controlled trial to determine the benefit, if any, of using the braces available to us. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Musculoskeletal Diseases: Osteoarthritis of the knee |
| Intervention | Questionnaire; Randomised controlled trial 30/08/2012: Please note that this trial was abandoned before starting due to a lack of funding |
| Intervention type | Other |
| Primary outcome measure | The patients will be assessed using one of the most internationally validated scoring systems, the WOMAC score, and also a Visual Analogue Pain Scale |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 21/06/2004 |
| Completion date | 21/11/2005 |
| Reason abandoned (if study stopped) | Lack of funding/sponsorship |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 20 |
| Key inclusion criteria | The patients will be selected from new patient referrals seen in the orthopaedic outpatient clinic under Mr Calder at Leeds General Infirmary. They will be patients diagnosed with knee arthritis. If they fulfil the inclusion criteria then they will be given the option of taking part in the study and be consented accordingly. |
| Key exclusion criteria | 1. Previous knee surgery in last 12 months 2. Arthritis other than OA 3. Hip disease 4. Previous tibial/femoral fracture 5. Morbid obesity BMI>35 (difficulty in brace fitting) 6. PVD or skin disorder preventing brace use |
| Date of first enrolment | 21/06/2004 |
| Date of final enrolment | 21/11/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Orthopaedic Surgery
Leeds
LS9 7TF
United Kingdom
LS9 7TF
United Kingdom
Sponsor information
Department of Health
Government
Government
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
Leeds Teaching Hospitals NHS Trust (UK)
No information available
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 |
