A single bisphosphonate infusion does not accelerate fracture healing in high tibial osteotomies

Abstract

Background: Bisphosphonates increase the callus size and strength in animal fracture studies. In a human non-randomized pilot study of high tibial osteotomies in knee osteoarthritis, using the hemicallotasis (HCO) technique, bisphosphonates shortened the healing time by 12 days. In the present randomized study, we wanted to determine whether a single infusion of zoledronic acid reduces the time to clinical osteotomy healing. Results from the same trial, showing improved pin fixation with zoledronate, have been published separately.

Methods: 46 consecutive patients (aged 35-65 years) were operated. At 4 weeks postoperatively, the patients were randomized to an intravenous infusion of either zoledronic acid or sodium chloride. Dual-energy X-ray absorptiometry (DEXA) was performed 10 weeks postoperatively. Radiographs were taken at 10 weeks and every second week until there was radiographic and clinical healing. Healing was evaluated blind, with extraction of the external fixator as the endpoint. At 1.5 years, an additional radiograph was taken and the hip-knee-ankle (HKA) angle measured to evaluate whether correction had been retained.

Results: All osteotomies healed with no difference in healing time between the groups (77 (SD 7) days). Bone mineral density and bone mineral content, as assessed with DEXA, were similar between the groups. Radiographically, both groups had retained the acquired correction at the 1.5-year follow-up.

Interpretation: In this randomized comparison, a single infusion of zoledronic acid increased the pin fixation of the external frame but did not shorten the healing time. In both groups, the external fixator was extracted almost 2 weeks earlier than in previous studies. The early extraction did not cause a loss of correction in either group.

Figure 1.

A CONSORT flow diagram depicting patient recruitment, randomization, patient flow, and follow-up in the study.

Figure 2.

Hemicallotasis osteotomy using the Orthofix T-garche as external fixator. A. Successive lengthening takes place. The HKA angle is slowly normalized and the frame is locked at the desired angle. The frame is kept until bone healing. B. When sufficient callus appears to be present by ultrasound and radiography, the frame is removed temporarily. The patient is allowed to bear weight before the final decision to remove the frame. This decision is made blind regarding the pharmacological treatment. C. Radiograph showing a healed osteotomy at 1.5 years.