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Completed

NCT Number: NCT00038129

SPRINT - Randomized Trial of Tibial Fracture Fixation

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.

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Key information

Conditions

Tibial Fracture Fractures, Bone Leg Injuries Tibial Fractures Wounds and Injuries

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Francisco General Hospital, San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Fractured tibia requiring fixation using an intramedullary nail

Treatment and study plan

Intramedullary nail implant

Procedure

Insertion of an intramedullary nail during tibial fracture fixation with or without prior reaming of the intramedullary canal.

Primary outcomes

  1. Necessity for additional operation

    Time frame: Months 6, 9, and 12

Secondary outcomes

  1. Return to work, functional status, and health-related quality of life

    Time frame: Months 6, 9, and 12

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

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

Registry information

Official study title

Study to Prospectively Evaluate Reamed Intramedullary Nails in Tibial Shaft Fractures (SPRINT)

Important dates

Study start
2002
Primary completion
2006
Study completion
2006
First posted
May 30, 2002
Registry last updated
Nov 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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