A randomised controlled trial to assess the effect of bone graft extender added to allograft in revision hip replacement

ISRCTN	ISRCTN77586369
DOI	https://doi.org/10.1186/ISRCTN77586369
Secondary identifying numbers	N0203114901

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 13/10/2017

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 John Timperley
Scientific

Royal Devon & Exeter Hospital (Wonford)
Barrack Road
Exeter, Devon
EX2 5BW
United Kingdom

Study information

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	A randomised controlled trial to assess the effect of bone graft extender added to allograft in revision hip replacement
Study objectives	Does the addition of bone graft extender material to morcellised allograft in revision surgery of the femoral or acetabular component of a total hip replacement improve the clinical or radiological result when compared to allograft alone?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Surgery: Revision hip replacement
Intervention	A randomised prospective clinical trial is to be set up to test the efficacy of bone graft extenders in comparison with 100% allograft (to study the effect of the addition of a synthetic bone graft extender material to allograft bone used in impaction grafting at revision hip arthroplasty). Patients who fulfill the entry criteria will be randomized into two groups: one group will have the morcellised bone for their reconstruction mixed with bone graft extender in a 50:50 ratio, and the other group will not. The patients will be followed up for 5 years. Twelve patients to be initially included into each arm of the trial. The numbers needed for the study have been calculated from previous discussions with Dr Greco at the RDSU regarding a project with similar endpoints and expectation outcomes. Based on the analysis of operating schedules over a 12 month period (July 2000-2001), 40 patients were identified who would have been considered as suitable for inclusion in this study.
Intervention type	Procedure/Surgery
Primary outcome measure	Outcome measures include complications, clinical scores and gross radiological appearances. In addition movement of the construct at each interface will be assessed by the technique of Radio Stereometric Analysis (RSA). Study endpoints: Life Tables and Survival Curves with confidence limits for different definitions of failure including implant loosening and radiological evidence of failure including implant migration (as defined by RSA), excessive wear, radiolucencies etc. Log rank comparison.
Secondary outcome measures	Not provided at time of registration
Overall study start date	30/08/2002
Completion date	29/08/2007

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Not Specified
Target number of participants	40
Key inclusion criteria	1. Patients requiring revision hip arthroplasty for aseptic femoral or acebular component loosening. 2. Age less then 85 3. Femoral bone stock loss equivalent to Endoklinik 2 or 3 (loss of cancellous bone in the proximal femur, possible parosteal increase in dimension but essentially a cavitary defect only with no need for reconstruction meshes or long stems). Therapeutic research.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	30/08/2002
Date of final enrolment	29/08/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Royal Devon & Exeter Hospital (Wonford)

Exeter, Devon
EX2 5BW
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Royal Devon and Exeter NHS Trust (UK)

No information available

Results and Publications

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

Editorial Notes

13/10/2017: No publications found in PubMed, verifying study status with principal investigator.