Valgus knee bracing for medical compartment osteoarthritis (OA)

ISRCTN	ISRCTN68112133
DOI	https://doi.org/10.1186/ISRCTN68112133
Protocol serial number	N0436151092
Sponsor	Department of Health
Funders	Leeds Teaching Hospitals NHS Trust (UK), NHS R&D Support Funding

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

Mr Simon Boyle
Scientific

Orthopaedic Surgery
Leeds Teaching Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom

Phone	+44 (0)7739 490649

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	21/11/2005
Reason abandoned (if study stopped)	Lack of funding/sponsorship

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Orthopaedic Surgery

Leeds
LS9 7TF
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan