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A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation in Proximal Tibial Fractures

NCT00429585 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2021-11-02

Study results available
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Summary

This study looks at two types of surgical treatments and hopes to answer the question: which is the best way to surgically treat a proximal tibia 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

  • Tibial Fractures

Interventions

DEVICE

reamed, interlocking intramedullary nail

Standard of care device for tibia fracture repair; Randomized Treatment - Nail

DEVICE

locking periarticular plate

Standard of care device for tibia fracture repair; Randomized Treatment - Plate

Sponsors & Collaborators

  • Orthopaedic Trauma Association

    collaborator OTHER

  • Boston Medical Center

    lead OTHER

Principal Investigators

  • Paul Tornetta, M.D. · Boston University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2020-11-30
Completion
2020-12-16
FDA Device
Yes

Countries

  • United States
  • Canada

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 NCT00429585 on ClinicalTrials.gov