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 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 trial start date
30/08/2002
Overall trial end date
29/08/2007
Reason abandoned (if study stopped)
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
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
Basic results (scientific)
Publication list