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
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