Comparison of washed and unwashed allograft in revision hip replacement
| ISRCTN | ISRCTN00466379 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN00466379 |
| Protocol serial number | N0203096531 |
| Sponsor | Department of Health (UK) |
| Funder | Royal Devon and Exeter NHS Trust (UK) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Royal Devon & Exeter Hospital (Wonford)
Barrack Road
Exeter, Devon
EX2 5BW
United Kingdom
| Phone | +44 (0)1392 403544 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| 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
- United Kingdom
- England
Study participating centre
EX2 5BW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
