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Home > "S" Clinical Trials Conditions > SPRINT - Randomized Trial of Tibial Fracture Fixation  SPRINT - Randomized Trial of Tibial Fracture Fixation
SPRINT - Randomized Trial of Tibial Fracture Fixation
For Condition: Tibial Fracture
Status: Recruiting
Sponsor(s): National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Fractured tibia requiring fixation using an intramedullary nail
Total Enrollment: 1200
Location and Contact Information:
Vanderbilt University *Recruiting*
Nashville, Tennessee, 37232
United States
Recruiting Phil Kregor 615-936-0112
University of Louisville *Recruiting*
Louisville, Kentucky, 40202
United States
Recruiting David Seligson 502-852-6902
Wake Medical Center *Recruiting*
Raleigh, North Carolina, 27610
United States
Recruiting Eric Meinberg 919-350-8797
Wake Forest Medical Center *Recruiting*
Winston Salem, North Carolina, 27157
United States
Recruiting Larry Webb 366-716-6432
Detroit Receiving Hospital *No longer recruiting*
Detroit, Michigan, 48201
United States
No longer recruiting
Oregon Health & Science Univesity *Not yet recruiting*
Portland, Oregon, 97201
United States
Not yet recruiting Tom Ellis 503-494-6992
Regions Hospital *Recruiting*
St. Paul, Minnesota, 55101
United States
Recruiting Peter Cole 651-254-1513
University of Buffalo *Recruiting*
Buffalo, New York, 14215
United States
Recruiting Mark Anders 716-898-4756
University of Florida - Jacksonville *Recruiting*
Jacksonville, Florida, 32209
United States
Recruiting Stephen Augustine 419-383-3590
University of Oklahoma *Recruiting*
Oklahoma City, Oklahoma, 73190
United States
Recruiting David Teague 405-271-4426
San Francisco General Hospital *Recruiting*
San Francisco, California, 94110
United States
Recruiting Theodore Miclau 415-206-8812
Orthopedics Indianapolis *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting Bradley Jelen 317-917-4366
Jamaica Hospital *Recruiting*
Jamaica, New York, 11418
United States
Recruiting Kenneth Egol 718-206-6923
Memorial Hermann Hospital *No longer recruiting*
Houston, Texas, 77030
United States
No longer recruiting
Boston Medical Center *Recruiting*
Boston, Massachusetts, 02118
United States
Recruiting Paul Tornetta 617-414-6295
Additional Information:
Study ID Numbers: NIAMS-072; R01 AR48529
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00038129
Other Tibial Fracture Studies:
1. SPRINT - Randomized Trial of Tibial Fracture Fixation
Related Studies:
Other Tibial Fracture Clinical Trials
Other Kentucky Clinical Trials
Other Louisville Clinical Trials
SPRINT - Randomized Trial of Tibial Fracture Fixation
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