Effects of growth hormone in patients with tibial fracture: a randomised, double-blind, placebo-controlled clinical trial

Abstract

Objective: Investigate whether intervention with GH after tibial fracture enhances fracture healing. Design: Randomised, double-blind, placebo-controlled study in 406 patients (93 women, 313 men, age: 18–64 years) with tibial fracture. Methods: Patients were stratified by tibial fracture (open or closed) and allocated to placebo or GH treatment (15, 30 or 60 μg/kg daily, until clinically assessed healing or until 16 weeks post-surgery). Primary outcome was time from surgery until fracture healing and assessment of healing was done centrally and observer blinded. Patients reported for evaluation every 4 weeks until 24 weeks, and at 9 and 12 months. Results: GH did not accelerate time to healing in the combined group of open and closed fractures. When separately analysing the closed and open fractures, a significant difference in time to healing was observed between treatment groups, exclusively in the closed fractures (PPConclusions: In the overall group of open and closed tibial fractures, no significant enhancement of fracture healing was observed with GH, whereas in closed tibial fractures, GH accelerated healing significantly.