Effects of growth hormone in patients with tibial fracture: a randomised, double-blind, placebo-controlled clinical trial.
OBJECTIVE
Investigate whether intervention with GH after tibial fracture enhances fracture healing.


METHODS
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.
Raschke
Michael
M
Department of Trauma-, Hand and Reconstructive Surgery, University Hospital of Münster, Münster, Germany.
Rasmussen
Michael Højby
MH
Govender
Shunmugam
S
Segal
David
D
Suntum
Mette
M
Christiansen
Jens Sandahl
JS
D000293:Adolescent; D000328:Adult; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D017102:Fracture Healing / Q000187:drug effects*; D005596:Fractures, Closed / Q000188:drug therapy; D005597:Fractures, Open / Q000188:drug therapy; D019382:Human Growth Hormone / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D013978:Tibial Fractures / Q000188:drug therapy*; D013997:Time Factors; D016896:Treatment Outcome
D019382:Human Growth Hormone