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 |
| Protocol serial number | N0209132499 |
| Sponsor | Department of Health |
| Funder | Royal National Orthopaedic Hospital NHS Trust (UK) |
- 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 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Is there any difference between the bone loss secondary to bone remodelling in each type of hip? |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Royal National Orthopaedic Hospital
Stanmore
HA7 4LP
United Kingdom
HA7 4LP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
