Clinical trial NCT03803839: Locally Administered Clodronate in the Prevention of Aseptic Implant Loosening
Official title: Could the Intra-operative Clodronate Rinsing Improve the Integration of the Femoral Stem in a Prospective, Double-blinded, Randomized, Placebo-controlled Clinical RSA-study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Hip Arthrosis
Keywords: RSA
DXA
Bisphosphonates
Migration of stem
Aseptic loosening of prosthesis
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 19
Sex: ALL
Maximum age (years): 73
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this prospective, double-blinded, randomized, placebo-controlled clinical trial with two years follow-up period the investigators rinsed the proximal intramedullary cavity of the femur with either clodronate (60 mg clodronate in 1000 ml saline) or saline (1000 ml saline) prior to the application of the femoral stem.
Primary purpose: TREATMENT

Brief summary: Periprosthetic bone-loss after total hip arthroplasty (THA), detected as an early migration of the prosthesis, may predict later loosening. The investigators hypothesized that by reducing bone resorption after THA with bisphosphonates, it might be possible to achieve better early fixation of the implant.

Nineteen patients suffering arthrosis were recruited to a prospective, double-blinded, randomized, placebo-controlled clinical pilot trial. Patients were operated with an uncemented Bimetric stem with tantalum markers, the acetabular cup and liner were chosen by the surgeon. The femoral proximal intramedullary canal was rinsed with 1mM (millimole) clodronate, that was done by adding the clodronate to the 1000 ml 0.9% NaCl (sodium chloride) in nine patients and rinsing solution was the pure 0.9% NaCl for 10 patients. These rinsing packages were labeled only with the code from the pharmacy of the hospital. These patients were followed for two years using radiostereometric analysis (RSA), dual energy x-ray absorptiometry (DXA) and the Harris hip score (HHS).

The purpose of the investigator's study was to examine whether the local intraoperative administration of clodronate could reduce periprosthetic bone loss and further stem migration after primary THA.


Eligibility criteria: Inclusion Criteria:

* hip arthrosis and
* a primary THA was planned

Exclusion Criteria:

* renal insufficiency
* hypercalcemia
* malignant tumors
* contemporaneously treatment with another bisphosphonate or aminoglycoside

Primary outcomes:
measure: Maximal total point motion (MTPM) - migration of the femoral stem
timeFrame: 0 to 24 months
Secondary outcomes:
measure: Bone mineral density (BMD) in 7 Gruen zones
timeFrame: 0 to 24 months
Other outcomes:
measure: Migration of femoral stem
timeFrame: 0 to 24 months
measure: The maximal (MTPM) maximal total point motion
timeFrame: 3 to 24 months
measure: Correlation between baseline BMD and the maximal MTPM
timeFrame: BMD (0 month) - the maximal MTPM 3 to 24 months
measure: Harris Hip Score (HHS)
timeFrame: 0 to 24 months
Locations:
Study officials:
References: