Comparison of washed and unwashed allograft in revision hip replacement
| ISRCTN | ISRCTN00466379 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN00466379 |
| Secondary identifying numbers | N0203096531 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 22/09/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr John Timperley
Scientific
Scientific
Royal Devon & Exeter Hospital (Wonford)
Barrack Road
Exeter, Devon
EX2 5BW
United Kingdom
| Phone | +44 (0)1392 403544 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 04/06/2001 |
| Completion date | 30/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Not provided at time of registration |
| Key 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). |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 04/06/2001 |
| Date of final enrolment | 30/06/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal Devon & Exeter Hospital (Wonford)
Exeter, Devon
EX2 5BW
United Kingdom
EX2 5BW
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
Royal Devon and Exeter NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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 |
