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

This study has been completed.
Sponsor:
Collaborator:
Smith & Nephew, Inc.
Information provided by (Responsible Party):
Riyaz H. Jinnah, Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT01183078
First received: August 11, 2010
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Tibial Fractures
Femoral Fractures
Procedure: free-hand
Procedure: Wand technique

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Distal Locking Using an Electromagnetic Field Guided Computer Based Real Time System for Orthopaedic Trauma Patients

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • Reduced operative time. [ Time Frame: Six months post surgery ] [ Designated as safety issue: No ]
    The goal is to prospectively assess the "wand" technique as a reliable alternative to standard interlocking screw placement which reduces operative time.

  • Reduced C-arm exposure [ Time Frame: Six months post surgery ] [ Designated as safety issue: No ]
    The goal is to prospectively assess the "wand" technique as a reliable alternative to standard interlocking screw placement, which reduces C-arm exposure.

  • Reduces inadvertent nail misses. [ Time Frame: Six months post surgery ] [ Designated as safety issue: No ]
    The goal is to prospectively assess the "wand" technique as a reliable alternative to standard interlocking screw placement, which reduces inadvertent "nail misses."

  • No complications [ Time Frame: Six months post surgery ] [ Designated as safety issue: No ]
    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.


Enrollment: 55
Study Start Date: August 2010
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Free-hand technique
Free-hand technique utilized to find screw holes.
Procedure: free-hand
Free-hand technique utilizes x-rays to find screw holes.
Wand technique
Wand technique is utilized to find screw holes.
Procedure: Wand technique
Wand technique is utilized to find screw holes.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01183078

Locations
United States, North Carolina
Wake Forest University Health Sciences - CompRehab
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest School of Medicine
Smith & Nephew, Inc.
Investigators
Principal Investigator: Riyaz H. Jinnah, MD, FRCS Wake Forest School of Medicine
Principal Investigator: Eben A. Carroll, MD Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Riyaz H. Jinnah, Professor, Wake Forest School of Medicine
ClinicalTrials.gov Identifier: NCT01183078     History of Changes
Other Study ID Numbers: IRB00012034
Study First Received: August 11, 2010
Last Updated: January 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
efficacy
drill placement
nail placement
radiation
Operative time
Reduction in exposure to radiation
Accuracy for nail placement

Additional relevant MeSH terms:
Femoral Fractures
Fractures, Bone
Tibial Fractures
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on October 28, 2014