Contact information
Type
Scientific
Primary contact
Mr James Calder
ORCID ID
Contact details
North Hampshire Hospital NHS Trust
Aldermaston Road
Basingstoke
RG24 9NA
United Kingdom
+44 (0)1256 313156
j.calder@ic.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0360178753
Study information
Scientific title
Clinical evaluation comparing minimally invasive and standard skin incisions in cementless total hip arthroplasty using the Bimetric Hip system with the 38mm M2A cup. Clinical evaluation of incision size in total hip replacement
Acronym
Study hypothesis
1. Does a small incision (minimally invasive) provide an improved recovery for patients following total hip arthoplasty?
2. Specifically, is the patient able to mobilise more rapidly, leading to an early discharge from the hospital and does it require less analgesia for control of pain?
3. Are there any complications of performing this procedure that are not observed when using the 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: Arthroplasty
Intervention
Patients will be randomised into either the control or test group (small incision) using randomisation envelopes. The envelope will be opened to reveal the study group only when the patient is in the anaesthetic room being prepared for surgery.
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measure
Clinical results following minimal incision hip surgery with regards to clinical scores at 6 weeks to 2 years post-operatively.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
19/07/2005
Overall trial end date
31/01/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. <75 years of age
2. Eligible for a cementless primary total hip replacement
3. Pre-op level of pain and function for conventional joint replacement
4. Likelihood of obtaining relief of pain and improved function
5. Full skeletal maturity
6. Ability to follow instructions
7. Good general health for age
8. Willing to return for follow-up evaluations
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
19/07/2005
Recruitment end date
31/01/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
North Hampshire Hospital NHS Trust
Basingstoke
RG24 9NA
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
North Hampshire Hospitals 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