Effect of post-operative weight bearing status on clinical and radiological outcome of cementless femoral component
| ISRCTN | ISRCTN53323735 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53323735 |
| Secondary identifying numbers | N0234156280 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 13/03/2014
- 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 Mahesh Kulkarni
Scientific
Scientific
Orthopaedics
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | Does full weight bearing after cementless hip replacement lead to more subsidence or migration of femoral stem? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Total hip replacement |
| Intervention | Patients undergoing THR included. Receive info sheet at pre-op assessment. Randomised into partial or full weight bearing group. Visits at 6 weeks, 6mths, 1 yr, 2 yrs. Clinical follow up: Harris hip score, WOMAC and SF36 scores. Radiological: plain radiographs which will be digitised and calculations for subsidence of the stem performed using computer-aided software. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Radiological measurement for migration of the stem |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2005 |
| Completion date | 01/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 40 (20 in each group) |
| Key inclusion criteria | Patients following uncemented total hip replacement |
| Key exclusion criteria | Patients who have had intra-operative complication |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 01/01/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Orthopaedics
Bristol
BS10 5NB
United Kingdom
BS10 5NB
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
North Bristol NHS Trust (UK), NHS R&D Support Funding
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 |
