SPRINT - Randomized Trial of Tibial Fracture Fixation

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00038129
First received: May 29, 2002
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

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
Tibial Fracture
Procedure: Intramedullary nail implant

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study to Prospectively Evaluate Reamed Intramedullary Nails in Tibial Shaft Fractures (SPRINT)

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Necessity for additional operation [ Time Frame: Months 6, 9, and 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Return to work, functional status, and health-related quality of life [ Time Frame: Months 6, 9, and 12 ] [ Designated as safety issue: No ]

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
Experimental: 1
Participants will receive reaming of the intramedullary canal prior to insertion of an intramedullary nail.
Procedure: Intramedullary nail implant
Insertion of an intramedullary nail during tibial fracture fixation with or without prior reaming of the intramedullary canal.
Experimental: 2
Participants will receive insertion of an intramedullary nail without prior reaming of the intramedullary canal.
Procedure: Intramedullary nail implant
Insertion of an intramedullary nail during tibial fracture fixation with or without prior reaming of the intramedullary canal.

Detailed 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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fractured tibia requiring fixation using an intramedullary nail
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038129

Locations
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 Medical Center
Raleigh, North Carolina, United States, 27610
Wake Forest Medical Center
Winston-Salem, North Carolina, United States, 27157
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
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Study Chair: Marc F. Swiontkowski, MD Department of Orthopaedic Surgery, University of Minnesota
  More Information

No publications provided by University of Minnesota - Clinical and Translational Science Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00038129     History of Changes
Other Study ID Numbers: R01 AR48529, R01AR048529, NIAMS-072
Study First Received: May 29, 2002
Last Updated: June 17, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Fractures, Bone
Tibial Fractures
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on September 16, 2014