Does a small incision at the time of total hip replacement confer an advantage to patients by comparison to a standard incision?
| ISRCTN | ISRCTN90825575 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90825575 |
| Secondary identifying numbers | N0203132067 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 18/10/2017
- 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 John Timperley
Scientific
Scientific
Royal Devon & Exeter Hospital (Wonford)
Barrack Road
Exeter
EX2 5DW
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Does a small incision at the time of total hip replacement confer an advantage to patients by comparison to a standard incision? |
| Study objectives | Does a small incision at the time of total hip replacement (THR) surgery confer any advantage to patients by comparison to a standard incision? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Total hip replacement |
| Intervention | Randomised controlled trial - 128 patients undergoing primary total hip replacement will be randomised at time of surgery. They will undergo the gold standard Exeter hip replacement in the usual fashion. Half of the patients will have a standard incision (length no less than 14 cm) and half will have an incision not to exceed 10 cm in length. Peri-operative blood loss will be measured as will a comparison between pre and post-operative haemoglobin levels. Post-operative limb swelling will be measured on the third post-operative day and at follow-up clinics at 6 weeks and 6 months post-op. Pain scores will be taken at 3 days post-op, and at 6 weeks and 6 months. Length of hospital stay will be measured from the day of surgery. Routine hip scores using the Charnley scoring system, and Oxford and Harris Hip scores will also be taken at the 6 month follow-up period. To avoid bias, the post-operative limb measurements will be performed by a non-surgeon clinical assistant, who will be blinded to the wound size as it will be covered by an identical sized dressing in both arms of the study. The patient will be unaware of their wound size at the time of the third post-operative day pain scoring as again, the wound will be covered at this stage. At the end of the study all data will be analysed and reported. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | The aim of the study is to provide an evidence base regarding the most appropriate wound size in primary hip replacement. If significant benefit is found in one arm of the trial compared to the other, this practise will be adopted across the HIP Unit in primary THR. Thus, the research question that is being asked is: Does a small incision confer any greater benefit to patients when compared to use of a standard incision in primary total hip replacement? We plan to perform a randomised, controlled prospective trial to answer this question. Study endpoints: Comparison of peri-operative blood loss, post-operative haemoglobin levels and need for transfusion, length of hospital stay, comparison of operated limb swelling, pain measurement. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 18/09/2003 |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Any patient undergoing routine primary total hip replacement will be eligible. They will be approached at pre-assessment clinic and offered the opportunity to be involved in the research. Informed written consent to partake will be mandatory for inclusion and any patient who declines will be excluded. If they are happy to consent at this stage, consent will be given. If they require an opportunity to discuss the study with their family or GP, they may do so, and at time of admission to hospital for surgery will sign the consent form if they are happy to be included. Adult subjects only - of any age. |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 18/09/2003 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal Devon & Exeter Hospital (Wonford)
Exeter
EX2 5DW
United Kingdom
EX2 5DW
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Hospital/treatment centre
Royal Devon and Exeter NHS Trust (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 |
Editorial Notes
18/10/2017: No publications found in PubMed, verifying study status with principal investigator.
