To determine the optimal resting leg position in the first 24 h following Total Knee Replacement (TKR) in terms of pain, swelling and restoration of function
| ISRCTN | ISRCTN62675337 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62675337 |
| Protocol serial number | M0010095651 |
| Sponsor | Department of Health (UK) |
| Funder | Bolton Hospitals NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 01/05/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
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
Contact information
Mr GJ Shepard
Scientific
Scientific
Specialist Registrar
Orthopaedics
Royal Bolton Hospital
Farnworth
Bolton
BL4 0JR
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | To determine the optimal resting leg position in the first 24 h following Total Knee Replacement (TKR) in terms of pain, swelling and restoration of function |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Total knee replacement (TKR) |
| Intervention | Patients in this study will be randomised into either spending the first 24 h post-operatively with their operated leg on a Continuous Passive Motion (CPM) machine locked at 90 degrees or in an extension splint. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Pain, swelling and restoration of function |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/06/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 30 |
| Key inclusion criteria | 30 patients at the top of the department waiting list for total knee replacement |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/06/2002 |
| Date of final enrolment | 01/06/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Royal Bolton Hospital
Bolton
BL4 0JR
United Kingdom
BL4 0JR
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
