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

ISRCTN	ISRCTN17429244
DOI	https://doi.org/10.1186/ISRCTN17429244
Secondary identifying numbers	N0360178753

Submission date: 28/09/2007
Registration date: 28/09/2007
Last edited: 18/05/2017

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 James Calder
Scientific

North Hampshire Hospital NHS Trust
Aldermaston Road
Basingstoke
RG24 9NA
United Kingdom

Phone	+44 (0)1256 313156
Email	j.calder@ic.ac.uk

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	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
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
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 study start date	19/07/2005
Completion date	31/01/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Not provided at time of registration
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	19/07/2005
Date of final enrolment	31/01/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

North Hampshire Hospital NHS Trust

Basingstoke
RG24 9NA
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2007 Update - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

North Hampshire Hospitals 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

18/05/2017: No publications found in PubMed, verifying study status with principal investigator.