Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
13/03/2014
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 Mahesh Kulkarni

ORCID ID

Contact details

Orthopaedics
Southmead Hospital
Bristol
BS10 5NB
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0234156280

Study information

Scientific title

Acronym

Study hypothesis

Does full weight bearing after cementless hip replacement lead to more subsidence or migration of femoral stem?

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

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Surgery: Total hip replacement

Intervention

Patients undergoing THR included. Receive info sheet at pre-op assessment. Randomised into partial or full weight bearing group. Visits at 6 weeks, 6mths, 1 yr, 2 yrs. Clinical follow up: Harris hip score, WOMAC and SF36 scores. Radiological: plain radiographs which will be digitised and calculations for subsidence of the stem performed using computer-aided software.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Radiological measurement for migration of the stem

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2005

Overall trial end date

01/01/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Patients following uncemented total hip replacement

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

40 (20 in each group)

Participant exclusion criteria

Patients who have had intra-operative complication

Recruitment start date

01/01/2005

Recruitment end date

01/01/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Orthopaedics
Bristol
BS10 5NB
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

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 Bristol NHS Trust (UK), NHS R&D Support Funding

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