Aseptic Loosening of the Hip Prosthesis
Conditions
Keywords
Surgical procedures operative, Prosthesis implantation, Arthroplasty replacement
Brief summary
The primary focus of this study is to investigate whether increased bone density of the graft in revision arthroplasty of the hip can cause a decreased micromotion of the implant relative to the femur.
Detailed description
Morsellized compacted bone allograft can be used for revision arthroplasty of the hip. Treating the graft locally with an antiresorptive substance such as a bisphosphonate has decreased the graft resorption in animal studies and led to a remained bone density in a human series of 16 patients. In the present study we investigate if this increased bone density of the graft also causes a decreased micromotion of the implant relative the femur. 36 patients are planned to participate in a 1:1 randomized and prospective study comparing the bisphosphonate Clodronate to saline. Primary outcome will be micromotion over the first year but also secondary parameters such as late micromotion (between 12 and 24 months), re-loosening subjective outcome and safety. We hypothesize that rinsing the graft in a bisphosphonate solution prevents its resorption and therefore may reduce the risk of mechanical failure. Patients are followed with radiograms, RSA (radiostereography) preop, postop, at 6 weeks, at 12 and 24 months and subjective months and subjective parameters including Womac and SF 12. The treatment is simple, cheap and appears virtually risk-free.
Interventions
DRUGClodronate
60 mg/ml, 10 ml, single dose mixed in bone graft at operation
DRUGPlacebo
10 ml, single dose mixed in bone graft at operation
Sponsors
Region Skane
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with aseptic loosening and osteolysis scheduled for hip revision using allograft and impaction technique * Obtained informed consent * Pregnancy excluded in women of childbearing age
Exclusion criteria
* Patients with known renal disease or S-creatinine \>175 mcmol/L * Patients with S-calcium 2.75 mmol/L * Patients with diagnosed Rheumatoid arthritis * Patients with active primary hyperparathyroidism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrease of prosthetic micromotion from 2.7 mm to 1.7 mm as measured by RSA (0-24 months) | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Decrease of prosthetic micromotion from 2.7 mm to 1.7 mm as measured by RSA (late micromotion) | 12-24 months |
Countries
Sweden
Outcome results
None listed