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 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 trial start date
18/09/2003
Overall trial end date
31/12/2005
Reason abandoned (if study stopped)
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
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
Basic results (scientific)
Publication list