| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN68112133 |
| Date ISRCTN assigned | 30/09/2005 |
| Local reference number(s) | N0436151092 |
| Public title | Valgus knee bracing for medical compartment osteoarthritis (OA) |
| Scientific title |
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| Acronym | N/A |
| Disease/condition/study domain | Musculoskeletal Diseases: Osteoarthritis of the knee |
| Study hypothesis | 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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. |
| Participants - exclusion criteria | Previous knee surgery in last 12 months, arthritis other than OA, hip disease, previous tibial/femoral fracture, morbid obesity BMI>35 (difficulty in brace fitting), PVD or skin disorder preventing brace use. |
| Patient information material |
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| Anticipated start date | 21/06/2004 |
| Anticipated end date | 21/11/2005 |
| Status of trial | Completed |
| Target number of participants | 20 |
| Interventions | Questionnaire; Randomised controlled trial
|
| Primary outcome measure(s) | 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 measure(s) | See Primary outcome measures |
| Sources of funding | Leeds Teaching Hospitals NHS Trust
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK) |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Mr Simon Boyle |
| Contact details | Orthopaedic Surgery
Leeds Teaching Hospital
Beckett Street
Leeds
United Kingdom
LS9 7TF |
| Contact telephone | +44 (0)7739 490649 |
| Contact fax | +44 |
| Contact email | r&d@leedsth.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN68112133 |
| Date last extracted from ISRCTN register | 17/04/2008 |
