Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
04/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr John Timperley

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0203114901

Study information

Scientific title

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

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

30/08/2002

Overall trial end date

29/08/2007

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Senior

Gender

Not Specified

Target number of participants

40

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

30/08/2002

Recruitment end date

29/08/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Royal Devon and Exeter NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes