A radiostereometry assessment of bone graft in hip revision surgery
| ISRCTN | ISRCTN14542389 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14542389 |
| Secondary identifying numbers | 3/015/13 |
- Submission date
- 06/08/2014
- Registration date
- 24/05/2016
- Last edited
- 18/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
When hip replacements fail and have to be changed , there has usually been a significant amount of bone lost from around the implants. Often at the time of surgery, this lost bone is replaced with bone from a bone bank , where bone has been donated from patients who were undergoing hip replacement for the first time. Just like blood donation, the patients are screened for all known viral and prion (mad cow disease) infections before the bone is used. As with blood there remains a very small chance that new viruses or prions may be transmitted by the bone to patients. In order to increase the safety of the bone still further, a new means of sterilizing the bone to remove almost completely such a risk has been developed. The safety of the new bone and its mechanical properties in the laboratory has already been checked. As a final test, what happens to the bone in patients will be looked at using a special x-ray technique called radiostereometry. This technique of measuring whether the cup and bone graft move after they have been implanted can identify whether the bone is healthy and healing in place.
Who can participate?
Men and women aged between 50 and 80 who are having their hip replacements changed.
What does the study involve?
The two parts of the old hip replacement are removed. Bone is then be packed into the cup part (acetabulum) of the pelvis and a new cup cemented in place. The bone is chosen randomly immediately before the operation to be either the standard frozen bone or bone sterilized by the new method. The stem part of the hip replacement is then replaced and the hip put back into joint. During the operation, some tiny metal beads are placed into the two bones around the hip replacement. The beads are very small (less than 1mm across) and have been used to study joint replacements for almost 40 years. These beads allow medical staff to accurately identify the bone on radiostereometry radiographs. Radiostereometry radiographs are different from normal radiographs, in that two pictures are taken at the same time from different angles with a special cage holding the x-ray plates in position. Using special computer software, a three dimensional picture of the joint can be created with great accuracy. (This functions a bit like the 3D films seen in the cinema). The movement between the hip replacement and the beads in the bone are then measured, either when weight is put upon the leg or over time. The tiny movements seen can predict success or failure.
What are the possible benefits and risks of participating?
There is a slight increase in the amount of x-rays the patients receive. The study may benefit the patient were they to have any problems after surgery where the information collected would be given to the surgeon and might help in planning further treatment.
Where is the study run from?
Woodend Hospital, Aberdeen (UK)
When is the study starting and how long is it expected to run for?
September 2014 to October 2017
Who is funding the study?
Chief Scientists Office (Scotland)
Who is the main contact?
Mr George P Ashcroft
g.p.ashcroft@abdn.ac.uk
Contact information
Scientific
Polwarth Building
University of Aberdeen
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
 ORCID ID |
0000-0002-5374-624X |
|---|---|
| g.p.ashcroft@abdn.ac.uk |
Study information
| Study design | Randomised, single centre, blinded |
|---|---|
| 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 to request a patient information sheet. |
| Scientific title | A radiostereometry assessment of bone graft processed with novel sterilisation techniques (a study of patients undergoing acetabular impaction grafting hip revision surgery). |
| Study acronym | N/A |
| Study objectives | That chemical sterilisation used to reduce potential infection risk from allograft bone used in impaction grafting revision hip surgery will not alter the biological properties of the allograft. Hence graft incorporation and therefore migration over 2 years as measured by RSA will be the same as that for non processed bone. |
| Ethics approval(s) | North of Scotland, 16/04/2013, ref: 13/NS/0029 |
| Health condition(s) or problem(s) studied | Revision Hip replacement surgery |
| Intervention | 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. |
| Intervention type | |
| Primary outcome measure | 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. |
| Secondary outcome measures | 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 |
| Overall study start date | 20/09/2014 |
| Completion date | 01/10/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 50 |
| Key inclusion criteria | 1. Age 50-80 2. First revision of cemented THR 3. Acetabular defects suitable for Impaction grafting |
| Key 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. Parkinsons 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 |
| Date of first enrolment | 20/09/2014 |
| Date of final enrolment | 01/10/2017 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
AB252ZD
United Kingdom
Sponsor information
Hospital/treatment centre
R&D Office
Foresterhill House Annexe
Foresterhill
Aberdeen
Aberdeen
AB25 2ZB
Scotland
United Kingdom
"ROR" |
https://ror.org/016476m91 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/10/2018 |
|---|---|
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
18/10/2017: Internal review.
