Assessment of bone remodeling by dual energy X-ray absorptiometry after cemented total hip replacement: a prospective randomized study comparing three different designs

ISRCTN ISRCTN43978921
DOI https://doi.org/10.1186/ISRCTN43978921
Secondary identifying numbers N0209132499
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
14/11/2014
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 J Skinner
Scientific

Royal National Orthopaedic Hospital
Brockley Hill
Stanmore
HA7 4LP
United Kingdom

Phone +44 (0)20 8909 5314

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectives1. 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSurgery: Total hip replacement
InterventionPatients 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 typeProcedure/Surgery
Primary outcome measureIs there any difference between the bone loss secondary to bone remodelling in each type of hip?
Secondary outcome measuresNot provided at time of registration
Overall study start date01/04/2003
Completion date01/06/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants60
Key inclusion criteria60 patients undergoing primary total hip replacement
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/04/2003
Date of final enrolment01/06/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Royal National Orthopaedic Hospital
Stanmore
HA7 4LP
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

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

Funders

Funder type

Government

Royal National Orthopaedic Hospital NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan