Condition category
Surgery
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
08/10/2014
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 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

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 measures

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

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

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes