Revision of hip prostheses with osteolysis
Conditions
Interventions
Trade Name: Bonefos
Pharmaceutical Form: Solution for injection
INN or Proposed INN: DISODIUM CLODRONATE
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the place
Sponsors
Lund University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with symptomatic prosthetic loosening with osteolysis scheduled for hip revision, between 45 and 80 years of age. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Kidney disease, rheumatism, previously on bisphosphonate treatment, hyperparathyroidism, scheduled for teeth extraction, dementia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate if clodronate mixed in the morsellized bone graft will decrease the early (0-12 mths) micromotion of the prosthesis relative the bone, thereby decreasing the risk of future reloosening;Secondary Objective: To investigate if the frequency of reloosening and a second revision is decreased.;Primary end point(s): Prosthetic micromotion as measured with radiostereoradiophotogrammetry. | — |
Countries
Sweden
Outcome results
None listed