SPRINT - Randomized Trial of Tibial Fracture Fixation

October 30, 2019 updated by: University of Minnesota

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94110
        • San Francisco General Hospital
    • Florida
      • Jacksonville, Florida, United States, 32209
        • University of Florida - Jacksonville
    • Indiana
      • Evansville, Indiana, United States, 47710
        • Deaconess Hospital
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University Of Louisville
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Detroit Receiving Hospital
    • Minnesota
      • Saint Paul, Minnesota, United States, 55101
        • Regions Hospital
    • New York
      • Buffalo, New York, United States, 14215
        • University of Buffalo
      • Jamaica, New York, United States, 11418
        • Jamaica Hospital
    • North Carolina
      • Raleigh, North Carolina, United States, 27610
        • Wake Medical Center
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73190
        • University of Oklahoma
    • Oregon
      • Portland, Oregon, United States, 97201
        • Oregon Health & Science Univesity
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University
    • Texas
      • Houston, Texas, United States, 77030
        • Memorial Hermann Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Fractured tibia requiring fixation using an intramedullary nail

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Necessity for additional operation
Time Frame: Months 6, 9, and 12
Months 6, 9, and 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Return to work, functional status, and health-related quality of life
Time Frame: Months 6, 9, and 12
Months 6, 9, and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

  • Study Chair: Marc F. Swiontkowski, MD, Department of Orthopaedic Surgery, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2002

Primary Completion (ACTUAL)

November 1, 2006

Study Completion (ACTUAL)

November 1, 2006

Study Registration Dates

First Submitted

May 29, 2002

First Submitted That Met QC Criteria

May 29, 2002

First Posted (ESTIMATE)

May 30, 2002

Study Record Updates

Last Update Posted (ACTUAL)

November 1, 2019

Last Update Submitted That Met QC Criteria

October 30, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0105M00481
  • R01AR048529 (NIH)
  • NIAMS-072

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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