Efficacy and cost effectiveness of day surgery for knee replacement: a randomised controlled trial

ISRCTN	ISRCTN02138359
DOI	https://doi.org/10.1186/ISRCTN02138359
Protocol serial number	SEO193
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive South East (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr David Beard
Scientific

Nuffield Orthopaedic Centre
NHS Trust
Physiotherapy Research Unit
Windmill Road
Headington
Oxford
OX3 7LD
United Kingdom

Phone	+44 (0)1865 227233

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To examine the difference in outcome and cost effectiveness between patients undergoing Unicompartmental knee arthroplasty (UKA) using an accelerated protocol (pain management, physiotherapy advice and discharge within 24 hours) and standard protocol (inpatient physiotherapy & discharge at 6-10 days).
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Musculoskeletal diseases: Arthritis (rheumatoid and osteo)
Intervention	Accelerated recovery protocol versus standard management.
Intervention type	Other
Primary outcome measure(s)	1. Oxford Knee Score, American Knee Society Score, pain, complications, range of movement, function 2. Patient satisfaction at 6 months 3. EuroQol quality of life questionnaire to examine cost effectiveness
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/11/2002

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	40
Key inclusion criteria	1. 40 patients with unicompartmental degenerative knee joint disease undergoing unicompartmental knee arthroplasty (UKA). 2. Unicompartmental degenerative knee joint disease 3. Good anaesthetic risk 4. Tolerance to nonsteroidal anti-inflammatory drugs (NSAIDs) 5. Appropriate social circumstances (for early discharge) 6. Within 45 min travel of Oxford
Key exclusion criteria	1. Likely to require total knee replacement (TKR) 2. Poor general health 3. Poor understanding of procedure 4. Apprehensive/nervous disposition 5. Severe anaesthetic risk 6. Unable to tolerate large doses of NSAIDs 7. Severe problems on contralateral limb 8. Unable to use crutches 9. Unsuitable social circumstances 10. Geographically inaccessible
Date of first enrolment	01/11/2000
Date of final enrolment	01/11/2002

Nuffield Orthopaedic Centre

Oxford
OX3 7LD
United Kingdom

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2005		Yes	No