Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SEO193
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Condition
Musculoskeletal diseases: Arthritis (rheumatoid and osteo)
Intervention
Accelerated recovery protocol versus standard management.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/11/2000
Overall trial end date
01/11/2002
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant 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
Recruitment start date
01/11/2000
Recruitment end date
01/11/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Nuffield Orthopaedic Centre
Oxford
OX3 7LD
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive South East (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2005 results on http://www.ncbi.nlm.nih.gov/pubmed/15994082
Publication citations
-
Results
Reilly KA, Beard DJ, Barker KL, Dodd CA, Price AJ, Murray DW, Efficacy of an accelerated recovery protocol for Oxford unicompartmental knee arthroplasty--a randomised controlled trial., Knee, 2005, 12, 5, 351-357, doi: 10.1016/j.knee.2005.01.002.