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A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation in Distal Femur Fractures

NCT00429663 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2017-05-11

Study results available
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Summary

This study looks at two (2) types of surgical treatments and hopes to answer the question, "which is the best way to surgically treat a distal femur fracture?" Both procedures being studied are standard of care (used routinely) and use FDA approved devices. All medical and surgical treatment will be the same for participants as non-participants.

Conditions

  • Femoral Fractures

Interventions

DEVICE

reamed, interlocking intramedullary nail

Standard of care device for femur fracture repair

DEVICE

locking periarticular plate

Standard of care device for femur fractures

Sponsors & Collaborators

  • Boston Medical Center

    lead OTHER

Principal Investigators

  • Paul Tornetta, M.D. · Boston University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2014-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00429663 on ClinicalTrials.gov