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Study to Prospectively Evaluate Reamed Intramedullary Nails in Tibial Shaft Fractures (SPRINT)
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.
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.
Age
16 - No limit years
Sex
ALL
Healthy Volunteers
No
San Francisco General Hospital
San Francisco, California, United States
University of Florida - Jacksonville
Jacksonville, Florida, United States
Deaconess Hospital
Evansville, Indiana, United States
University of Louisville
Louisville, Kentucky, United States
Boston Medical Center
Boston, Massachusetts, United States
Detroit Receiving Hospital
Detroit, Michigan, United States
Regions Hospital
Saint Paul, Minnesota, United States
University of Buffalo
Buffalo, New York, United States
Jamaica Hospital
Jamaica, New York, United States
Wake Medical Center
Raleigh, North Carolina, United States
Start Date
May 1, 2002
Primary Completion Date
November 1, 2006
Completion Date
November 1, 2006
Last Updated
November 1, 2019
1,200
ESTIMATED participants
Intramedullary nail implant
PROCEDURE
Lead Sponsor
University of Minnesota
Collaborators
NCT05022485
NCT06976801
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07006675