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

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

Mr J Skinner
Scientific

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

Phone	+44 (0)20 8909 5314

Study design	Randomised controlled trial
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

Participant type(s)	Patient
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

Royal National Orthopaedic Hospital

Stanmore
HA7 4LP
United Kingdom

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

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

Government

Royal National Orthopaedic Hospital NHS Trust (UK)

No information available

Intention to publish date
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