Locally Administered Clodronate in the Prevention of Aseptic Implant Loosening

University of Oulu

Status and phase: Completed; Early Phase 1

Conditions: Hip Arthrosis

Treatments: Drug: Saline; Drug: Clodronate

Study type: Interventional

Funder types: Other

Identifiers

NCT03803839

Ei tiedossa

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: Under 73 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• hip arthrosis and
• a primary THA was planned

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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19 participants in 2 patient groups, including a placebo group

Clodronate

Active Comparator group

Description:

1 mM clodronate (60 mg in 1000 ml saline) was used intraoperatively during total hip arthroplasty: before installation of the prosthesis, the rinsing was performed with pulsatile lavage using the clodronate solution. The time for rinsing was about one minute.

Treatment:

Drug: Clodronate

Saline

Placebo Comparator group

Description:

1000 ml saline was used intraoperatively during total hip arthroplasty: before installation of the prosthesis, the rinsing was performed with pulsatile lavage using the saline solution. The time for rinsing was about one minute.

Treatment:

Drug: Saline