NCT00038129

SPRINT - Randomized Trial of Tibial Fracture Fixation

Study to Prospectively Evaluate Reamed Intramedullary Nails in Tibial Shaft Fractures (SPRINT)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,200 (estimated)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if there is a difference in the rate of healing of a tibia fracture treated with an intramedullary nail based on whether or not the bone was reamed prior to nail insertion.

Detailed description

Patients with tibia fractures that are amenable to being treated with both a reamed and an unreamed nail will be randomized via telephone to one of the two groups. These patients then will be followed for a year with clinical, as well as subjective, outcome follow-up questionnaires. Time to healing, as well as repeat interventions and adverse events, will be tracked. The rationale for doing a large sample size multi-center trial is the hope that a clear answer to whether or not one of these two methods is significantly better than the other will become apparent and thus aid surgeons in making a more informed operative treatment choice.

Conditions

• Tibial Fracture

Interventions

Type	Name	Description
PROCEDURE	Intramedullary nail implant	Insertion of an intramedullary nail during tibial fracture fixation with or without prior reaming of the intramedullary canal.

Timeline

• Start date: 2002-05-01
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 2002-05-30
• Last updated: 2019-11-01

Locations

16 sites across 1 country: United States