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Sponsored by: |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
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Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
ClinicalTrials.gov Identifier: | NCT00038129 |
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.
Condition | Intervention |
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Tibial Fracture |
Procedure: Intramedullary nail implant |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Study to Prospectively Evaluate Reamed Intramedullary Nails in Tibial Shaft Fractures (SPRINT) |
Estimated Enrollment: | 1200 |
Study Start Date: | May 2002 |
Study Completion Date: | November 2006 |
Primary Completion Date: | November 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Participants will receive reaming of the intramedullary canal prior to insertion of an intramedullary nail.
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Procedure: Intramedullary nail implant
Insertion of an intramedullary nail during tibial fracture fixation with or without prior reaming of the intramedullary canal.
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2: Experimental
Participants will receive insertion of an intramedullary nail without prior reaming of the intramedullary canal.
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Procedure: Intramedullary nail implant
Insertion of an intramedullary nail during tibial fracture fixation with or without prior reaming of the intramedullary canal.
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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.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
United States, California | |
San Francisco General Hospital | |
San Francisco, California, United States, 94110 | |
United States, Florida | |
University of Florida - Jacksonville | |
Jacksonville, Florida, United States, 32209 | |
United States, Indiana | |
Deaconess Hospital | |
Evansville, Indiana, United States, 47710 | |
United States, Kentucky | |
University of Louisville | |
Lousiville, Kentucky, United States, 40202 | |
United States, Massachusetts | |
Boston Medical Center | |
Boston, Massachusetts, United States, 02118 | |
United States, Michigan | |
Detroit Receiving Hospital | |
Detroit, Michigan, United States, 48201 | |
United States, Minnesota | |
Regions Hospital | |
St. Paul, Minnesota, United States, 55101 | |
United States, New York | |
University of Buffalo | |
Buffalo, New York, United States, 14215 | |
Jamaica Hospital | |
Jamaica, New York, United States, 11418 | |
United States, North Carolina | |
Wake Forest Medical Center | |
Winston-Salem, North Carolina, United States, 27157 | |
Wake Medical Center | |
Raleigh, North Carolina, United States, 27610 | |
United States, Ohio | |
Metrohealth Medical Center | |
Cleveland, Ohio, United States, 44109 | |
United States, Oklahoma | |
University of Oklahoma | |
Oklahoma City, Oklahoma, United States, 73190 | |
United States, Oregon | |
Oregon Health & Science Univesity | |
Portland, Oregon, United States, 97201 | |
United States, Tennessee | |
Vanderbilt University | |
Nashville, Tennessee, United States, 37232 | |
United States, Texas | |
Memorial Hermann Hospital | |
Houston, Texas, United States, 77030 |
Study Chair: | Marc F. Swiontkowski, MD | Department of Orthopaedic Surgery, University of Minnesota |
Responsible Party: | University of Minnesota Twin Cities ( Mark Swiontkowski ) |
Study ID Numbers: | R01 AR48529, NIAMS-072 |
Study First Received: | May 29, 2002 |
Last Updated: | December 24, 2007 |
ClinicalTrials.gov Identifier: | NCT00038129 History of Changes |
Health Authority: | United States: Federal Government |
Fractures, Bone Wounds and Injuries Disorders of Environmental Origin Leg Injuries Tibial Fractures |
Fractures, Bone Wounds and Injuries Disorders of Environmental Origin Leg Injuries Tibial Fractures |