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Distal Locking Using an Electromagnetic Field Guided Computer Based Real Time System for Orthopaedic Trauma Patients

NCT01183078 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2023-05-16

No results posted yet for this study

Summary

Hypothesis: Utilization of the "wand" method will enhance improvements in drill placement, locking nail placement during tibia and femur fracture repairs, and offer less radiation exposure and less operative time. The purpose of this research study is to compare the efficacy of distal locking of intramedullary nails using a standard free-hand technique with the guided wand technique. Distal locking is the placement of screws through the intramedullary rod to hold it in place and prevent rotation. Currently, the free-hand technique is most often utilized. With this technique, the surgeon uses intraoperative x-rays in order to find the holes in the intramedullary rod to place the screws. The wand technique uses electromagnetic fields rather than x-rays to find these screw holes. The utilization of the wand technique could result in improvements in drill placement and locking nail placement as well as decrease operative time and radiation exposure.

Conditions

  • Tibial Fractures
  • Femoral Fractures

Interventions

PROCEDURE

free-hand

Free-hand technique utilizes x-rays to find screw holes.

PROCEDURE

Wand technique

Wand technique is utilized to find screw holes.

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    collaborator INDUSTRY

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Riyaz H. Jinnah, MD, FRCS · Wake Forest University Health Sciences

  • Eben A. Carroll, MD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2013-09-30
Completion
2013-09-30

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 NCT01183078 on ClinicalTrials.gov