Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
24/08/2015
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 John Timperley

ORCID ID

Contact details

Royal Devon & Exeter Hospital (Wonford)
Barrack Road
Exeter
EX2 5DW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0203132067

Study information

Scientific title

Does a small incision at the time of total hip replacement confer an advantage to patients by comparison to a standard incision?

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

18/09/2003

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

18/09/2003

Recruitment end date

31/12/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Devon & Exeter Hospital (Wonford)
Exeter
EX2 5DW
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

Royal Devon and Exeter NHS Trust (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

Publication citations

Additional files

Editorial Notes