Surgery: revision hip replacement Surgery Revision hip replacement
Conditions
Interventions
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 ba
Sponsors
Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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).
Exclusion criteria
Exclusion criteria: Not provided at time of registration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed