Efficacy and cost effectiveness of day surgery for knee replacement: a randomised controlled trial
| ISRCTN | ISRCTN02138359 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN02138359 |
| Secondary identifying numbers | SEO193 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 15/05/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr David Beard
Scientific
Scientific
Nuffield Orthopaedic Centre
NHS Trust
Physiotherapy Research Unit
Windmill Road
Headington
Oxford
OX3 7LD
United Kingdom
| Phone | +44 (0)1865 227233 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Quality of life |
| 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 | 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 study start date | 01/11/2000 |
| Completion date | 01/11/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Nuffield Orthopaedic Centre
Oxford
OX3 7LD
United Kingdom
OX3 7LD
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive South East (UK)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2005 | Yes | No |
