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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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20 November 2017 |
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Main ID: |
ISRCTN14542389 |
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Date of registration:
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24/05/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A radiostereometry assessment of bone graft in hip revision surgery
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Scientific title:
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A radiostereometry assessment of bone graft processed with novel sterilisation techniques (a study of patients undergoing acetabular impaction grafting hip revision surgery). |
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Date of first enrolment:
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20/09/2014 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN14542389 |
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Study type:
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Interventional |
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Study design:
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Randomised, single centre, blinded (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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George
Ashcroft |
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Address:
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Polwarth Building
University of Aberdeen
Foresterhill
AB25 2ZD
Aberdeen
United Kingdom |
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Telephone:
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- |
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Email:
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g.p.ashcroft@abdn.ac.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Age 50-80
2. First revision of cemented THR
3. Acetabular defects suitable for Impaction grafting
Exclusion criteria: 1. Previous surgery for inflammatory arthritis of the hip
2. Renal transplant or significant renal impairment
3. Immunosuppressive condition or recent high dose steroids
4. Known or suspected ipsilateral hip infection
5. Neurological disease limiting rehabilitation e.g. Parkinson?s
6. Psychosocial disorders likely to limit rehabilitation
7. Geographical factors making follow up impractical
8. Other condition severely limiting life expectancy
9. Dementia or other condition affecting ability to give consent
10. Revision for periprosthetic fracture or dislocation
11. Facility for intraoperative exclusion (e.g. periprosthetic fracture, uncontained defect, suspected sepsis
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Revision Hip replacement surgery
Musculoskeletal Diseases
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Intervention(s)
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A prospective study is being carried out on 50 patients undergoing impaction revision of the acetabulum for aseptic loosening of primary total hip replacement for osteoarthritis. Patients are randomised to impaction using standard fresh frozen allograft or processed bone.
Radiostereometry is used to measure the movement of the cup in terms of migration and rotation over a two year follow up period. Increased migration will imply poorer incorporation of bone graft and hence a significant change in either biological or mechanical properties.
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Primary Outcome(s)
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Migration and inducible movement of cemented acetabular components impacted. Each patient will be evaluated using standard weight bearing and non-weight bearing RSA radiographs at time of discharge, at six weeks, three months, six months, one year and two years after surgery. In addition, each patient will receive one repeat examination for clinical precision estimate in accordance with RSA guidelines.
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Secondary Outcome(s)
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1. Joint function, assessed using the Oxford Hip Score before surgery and again 12 months after surgery
2. General health,assessed using the Euroquol 5D score before surgery, 12 months after surgery and 24 months after surgery
3. Assessment of a hip arthroplasty via plain x-ray - radiolucency before surgery, just after surgery, then again at 12 months and 24 months
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Source(s) of Monetary Support
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Chief Scientists Office (Scotland) ETM/206
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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