Improving the bearing surface in total hip replacement (THR): the use of oxidised zirconium and highly cross-linked polyethylene

ISRCTN	ISRCTN48522433
DOI	https://doi.org/10.1186/ISRCTN48522433
Secondary identifying numbers	04/Q0505/71

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Fares Haddad
Scientific

Princess Grace Hospital
42-52 Nottingham Place
London
W1U 5NY
United Kingdom

Phone	+44 (0)20 7935 6083
Email	fareshaddad@aol.com

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Improving the bearing surface in total hip replacement (THR): the use of oxidised zirconium and highly cross-linked polyethylene - a randomised controlled trial
Study objectives	Does the use of oxidised zirconium femoral heads in total hip replacement reduce the rate of volumetric and linear wear as compared to conventional material heads, whilst providing comparable outcome measures?
Ethics approval(s)	Joint UCL/UCLH Committees on the Ethics of Human Research (Committee A), 14/01/2005, ref: 04/Q0505/71
Health condition(s) or problem(s) studied	Arthritis of the hip
Intervention	Primary total hip replacement, using either cobalt chrome or oxinium femoral heads and either standard or highly cross-linked polyethylene liners.
Intervention type	Procedure/Surgery
Primary outcome measure	Radiographic wear; measuring linear & volumetric wear based on standardised AP & lateral radiographs of the pelvis then analysed with an automated edge detection technique
Secondary outcome measures	Not provided at time of registration
Overall study start date	14/01/2009
Completion date	01/09/2009

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	200
Key inclusion criteria	1. The patient and surgeon agree that primary THR is necessary 2. The patient is 18 years of age or older (either sex) on the day of signing the Study Consent Form 3. The patient is capable of participating in the study: 3.1. Fluent in English, or has a capable proxy 3.2. Mentally intact 3.3. Emotionally stable 3.4. A permanent resident in an area accessible to the study site
Key exclusion criteria	1. Current medical conditions such as: 1.1. Metastatic or primary tumor of the hip 1.2. Implantation into a previously resected hip (i.e. conversion to THR) 1.3. Neurologic deficit impairing the affected limb 2. History of medical conditions such as: 2.1. Septic arthritis in the affected hip 2.2. Reflex sympathetic dystrophy of the affected leg 2.3. Progressive muscular condition causing deterioration of the abductor muscles 2.4. Hip pain associated with back pathology such as spinal stenosis or vascular occlusion
Date of first enrolment	14/01/2009
Date of final enrolment	01/09/2009

Princess Grace Hospital

London
W1U 5NY
United Kingdom

University College London Hospitals NHS Trust (UK)
University/education

The Middlesex Hospital
Mortimer Street
London
W1T 3AA
England
United Kingdom

Industry

Smith & Nephew (UK) - discretionary grant to fund salary of MD student only

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2015		Yes	No

10/05/2016: Publication reference added.
11/02/2009: The overall trial start date was changed from 01/09/2004 to 14/01/2009.