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 mug/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 (P<0.05; subgroup analysis revealed that the 60 microg/kg group was significantly different from placebo). The relative risk of fracture healing for 60 microg/kg versus placebo during the 12 month was: all fractures, 1.16; 95% CI: (0.86; 1.57) (ns); closed fractures, 1.44; 95% CI: (1.01; 2.05; P<0.05); open fractures, 0.75; 95% CI: (0.42; 1.31) (ns). The estimated median number of days before fracture healing in closed fractures was 95 with 60 microg/kg versus 129 with placebo (95% CI: (94; 129) and (94; 249)) corresponding to approximately 26% decrease in healing time. CONCLUSIONS: 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.