SPRINT - Randomized Trial of Tibial Fracture Fixation

Tibial Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00038129
• Other study ID #: 0105M00481
• Secondary ID: R01AR048529NIAMS
• Status: Completed
• Phase: N/A
• Start date: May 2002
• Est. completion date: November 2006

Study information

• Verified date: October 2019
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Fractured tibia requiring fixation using an intramedullary nail

Related Conditions & MeSH terms

• Fractures, Bone
• Tibial Fracture
• Tibial Fractures

Intervention

Procedure:
• Intramedullary nail implant
Insertion of an intramedullary nail during tibial fracture fixation with or without prior reaming of the intramedullary canal.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts
United States	University of Buffalo	Buffalo	New York
United States	Metrohealth Medical Center	Cleveland	Ohio
United States	Detroit Receiving Hospital	Detroit	Michigan
United States	Deaconess Hospital	Evansville	Indiana
United States	Memorial Hermann Hospital	Houston	Texas
United States	University of Florida - Jacksonville	Jacksonville	Florida
United States	Jamaica Hospital	Jamaica	New York
United States	University of Louisville	Louisville	Kentucky
United States	Vanderbilt University	Nashville	Tennessee
United States	University of Oklahoma	Oklahoma City	Oklahoma
United States	Oregon Health & Science Univesity	Portland	Oregon
United States	Wake Medical Center	Raleigh	North Carolina
United States	Regions Hospital	Saint Paul	Minnesota
United States	San Francisco General Hospital	San Francisco	California
United States	Wake Forest Medical Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Necessity for additional operation		Months 6, 9, and 12
Secondary	Return to work, functional status, and health-related quality of life		Months 6, 9, and 12