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

University of Minnesota16 sites in 1 country1,200 target enrollmentMay 2002

ConditionsTibial Fracture

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Tibial Fracture
Sponsor: University of Minnesota
Enrollment: 1200
Locations: 16
Primary Endpoint: Necessity for additional operation
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

May 2002

End Date

November 2006

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel