Evaluation of the Effectiveness of the Angular Stable Locking System in Patients with Distal Tibial Fractures Treated with Intramedullary Nailing

A Multicenter Randomized Controlled Trial

Abstract

Background: 

Angular stable locking of intramedullary nails has been shown to enhance fixation stability of tibial fractures in biomechanical and animal studies. The aim of our study was to assess whether use of the angular stable locking system or conventional locking resulted in earlier full weight-bearing with minimum pain for patients with a distal tibial fracture treated with an intramedullary nail.

Methods: 

A prospective multicenter, randomized, patient-blinded trial was conducted with adults who had a distal tibial fracture. Patients’ fractures were managed with an intramedullary nail locked with either an angular stable locking system or conventional locking screws. Outcomes were evaluated at six weeks, twelve weeks, six months, and one year after surgery. Time to full weight-bearing with minimum pain was calculated with use of daily entries from patient diaries. Secondary outcomes included pain at the fracture site under load, quality of life, gait analysis, mobility, radiographic findings, and adverse events.

Results: 

One hundred and forty-two patients were randomly allocated to two treatment groups: seventy-five to the group receiving intramedullary nailing with the angular stable locking system and sixty-seven to the group receiving conventional intramedullary nailing. No clinically important differences were found for either the primary or secondary outcome parameters between the groups during the entire follow-up period.

Conclusions: 

Use of an angular stable locking system with intramedullary nailing did not improve the outcome compared with conventional locking screws in the treatment of distal tibial fractures.

Level of Evidence: 

Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.