Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0203096531
Study information
Scientific title
Acronym
Study hypothesis
Does the use of washed morcellised allograft in revision surgery of the femoral component of a total hip replacement improve the clinical or radiological result when compared with the use of unwashed material?
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
Condition
Surgery: revision hip replacement
Intervention
Initial patient selection followed by consent to be included in trial. Randomisation by sealed envelope in theatre when condition of femur established and operative procedure decided upon. Tantalum balls to be inserted into femur. Adapted radiostereometric analysis (RSA) Exeter stems and distal plugs to be implanted.
Beads to be inserted in cement and in graft. Post-op RSA and plain X-rays. Routine Exeter post-op mobilization protocol to be followed. Routine follow-up at 6 weeks, 6 months, 1 year and then yearly for 5 years (this is the routine follow-up protocol). RSA films to be taken at each appointment. Routine standard anteroposterior (A-P) films to be taken bi-annually. Dual energy X-ray absortiometry (DEXA) scan to be repeated at each routine post-op appointment until completion of trial.
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measure
To conduct a randomised trial to study the effect of washing the allograft bone used in impaction grafting at revision hip arthroplasty. Patients undergoing revision hip surgery will be randomised into two groups at the time of their operation. An identical surgical procedure will be carried out except that one group will have the morcellised allograft washed and the other group will have unwashed graft used as is the present practice. The patients will be followed up for 5 years.
Outcome measures include complications, clinical scores, bone healing as quantified on DEXA scanning and gross radiological appearances. In addition, movement of the construct at each interface will be assessed by the technique of RSA.
Study end points: 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
04/06/2001
Overall trial end date
30/06/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients requiring revision hip arthroplasty for aseptic femoral component loosening
2. Age less than 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).
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
04/06/2001
Recruitment end date
30/06/2006
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
Government
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