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Completed

NCT Number: NCT01183078

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences - CompRehab

Winston-Salem, North Carolina, 27157, United States

About this study

Methods and Measures Patients 18 years of age and older presenting through the emergency room at Wake Forest University Baptist Medical Center with tibial and femoral fractures suitable for operative repair will be prospectively enrolled. Inclusion criteria will include any patient with a tibia fracture or femur fracture requiring intramedullary nailing. Retrograde intramedullary nails will be excluded as will nails which are not interlocked. The goal for enrollment is 24 tibial and 24 femoral fractures. Data including operative time, C-arm time, and "nail misses" will be obtained in the operating room for 24 tibial and 24 femoral nails. Surgeons who perform the procedure will have had experience using the freehand technique and will be trained with the guided wand prior to the experiment. Locking will be performed with the freehand and the wand technique in alternating order for the two interlocking screws. The order of which technique is utilized first will be randomly assigned. All procedures will be timed, and fluoroscopy time, radiation time, and any "nail misses" will be documented. All tibial nails will be locked with 2 mediolateral screws and all femurs with 2 lateral to medial screws.

Patients will receive follow-up for complications for a 6 month period after surgical procedure. Intervals of follow-up will be at 2 weeks, 6 weeks, 3 months and 6 months. Anterior-posterior and lateral images will be performed as are already customary and usual at these time intervals.

Outcome Measure(s) The goal is to prospectively assess the "wand" technique as a reliable alternative to standard interlocking screw placement which reduced operative time, C-arm exposure and inadvertent "nail misses." Additionally, it is expected that there will exist no complications related to the use of this technique.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years and older with tibial or femoral fracture suitable for operative repair with intramedullary nailing.

Exclusion criteria

  • Fractures requiring repair by retrograde intramedullary nails and interlocking nails.

Treatment and study plan

free-hand

Procedure

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

Wand technique

Procedure

Wand technique is utilized to find screw holes.

Primary outcomes

  1. Reduced operative time.

    Time frame: Six months post surgery

    The goal is to prospectively assess the "wand" technique as a reliable alternative to standard interlocking screw placement which reduces operative time.

  2. Reduced C-arm exposure

    Time frame: Six months post surgery

    The goal is to prospectively assess the "wand" technique as a reliable alternative to standard interlocking screw placement, which reduces C-arm exposure.

  3. Reduces inadvertent nail misses.

    Time frame: Six months post surgery

    The goal is to prospectively assess the "wand" technique as a reliable alternative to standard interlocking screw placement, which reduces inadvertent "nail misses."

  4. No complications

    Time frame: Six months post surgery

    The goal is to prospectively assess the "wand" technique as a reliable alternative to standard interlocking screw placement. It is expected that there will exist no complications related to the use of this technique.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Smith & Nephew, Inc.

Registry information

Acronym: Sure Shot

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Aug 17, 2010
Registry last updated
May 16, 2023

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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