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 |
| Protocol serial number | N0234156280 |
| Sponsor | Department of Health |
| Funder | North Bristol NHS Trust (UK), NHS R&D Support Funding |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Radiological measurement for migration of the stem |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 40 |
| 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
- United Kingdom
- England
Study participating centre
Orthopaedics
Bristol
BS10 5NB
United Kingdom
BS10 5NB
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 |
