Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
14/11/2014
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 J Skinner

ORCID ID

Contact details

Royal National Orthopaedic Hospital
Brockley Hill
Stanmore
HA7 4LP
United Kingdom
+44 (0)20 8909 5314

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0209132499

Study information

Scientific title

Acronym

Study hypothesis

1. How is bone remodelled around the cemented femoral head of three different designs of hip: triple tapered collarless (C Stems), double tapered collarless stems (TPS) and collared stems (Stanmore)?
2. To what extent do each type tend to conserve bone stock?

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

Condition

Surgery: Total hip replacement

Intervention

Patients will be randomised to receive one of the three types of hip:
1. Triple tapered collarless (C Stems)
2. Double tapered collarless stems (TPS)
3. Collared stems (Stanmore)

Pre-surgery, blood will be analysed for vitamin D, parathyroidhormone, and bone profile assay will be performed. Dual X-ray absorptiometry (DEXA) will be done preoperatively than at 3-5 days post-op, and at 3, 6, 12 and 24 months post-op.

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

Is there any difference between the bone loss secondary to bone remodelling in each type of hip?

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/2003

Overall trial end date

01/06/2005

Reason abandoned

Eligibility

Participant inclusion criteria

60 patients undergoing primary total hip replacement

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

60

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/04/2003

Recruitment end date

01/06/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal National Orthopaedic Hospital
Stanmore
HA7 4LP
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Government

Funder name

Royal National Orthopaedic Hospital 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