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 |
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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
Scientific
Royal National Orthopaedic Hospital
Brockley Hill
Stanmore
HA7 4LP
United Kingdom
Phone | +44 (0)20 8909 5314 |
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Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study objectives | 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(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | 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 |
Primary outcome measure | 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 study start date | 01/04/2003 |
Completion date | 01/06/2005 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | 60 |
Key inclusion criteria | 60 patients undergoing primary total hip replacement |
Key exclusion criteria | Not provided at time of registration |
Date of first enrolment | 01/04/2003 |
Date of final enrolment | 01/06/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal National Orthopaedic Hospital
Stanmore
HA7 4LP
United Kingdom
HA7 4LP
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Website | http://www.dh.gov.uk/Home/fs/en |
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Funders
Funder type
Government
Royal National Orthopaedic Hospital NHS Trust (UK)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |