Condition category
Musculoskeletal Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
15/05/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr David Beard

ORCID ID

Contact details

Nuffield Orthopaedic Centre
NHS Trust
Physiotherapy Research Unit
Windmill Road
Headington
Oxford
OX3 7LD
United Kingdom
+44 (0)1865 227233

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes