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SPRINT - Randomized Trial of Tibial Fracture Fixation
This study has been completed.
Study NCT00038129   Information provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First Received: May 29, 2002   Last Updated: December 24, 2007   History of Changes

May 29, 2002
December 24, 2007
May 2002
November 2006   (final data collection date for primary outcome measure)
Necessity for additional operation [ Time Frame: Months 6, 9, and 12 ] [ Designated as safety issue: No ]
Necessity for additional operation
Complete list of historical versions of study NCT00038129 on ClinicalTrials.gov Archive Site
Return to work, functional status, and health-related quality of life [ Time Frame: Months 6, 9, and 12 ] [ Designated as safety issue: No ]
Same as current
 
SPRINT - Randomized Trial of Tibial Fracture Fixation
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.

 
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Tibial Fracture
Procedure: Intramedullary nail implant
  • Experimental: Participants will receive reaming of the intramedullary canal prior to insertion of an intramedullary nail.
  • Experimental: Participants will receive insertion of an intramedullary nail without prior reaming of the intramedullary canal.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
1200
November 2006
November 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Fractured tibia requiring fixation using an intramedullary nail
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00038129
Mark Swiontkowski, University of Minnesota Twin Cities
R01 AR48529, NIAMS-072
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
 
Study Chair: Marc F. Swiontkowski, MD Department of Orthopaedic Surgery, University of Minnesota
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP