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

Primary Purpose

Tibial Fractures, Femoral Fractures

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
free-hand
Wand technique
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tibial Fractures focused on measuring efficacy, drill placement, nail placement, radiation, Operative time, Reduction in exposure to radiation, Accuracy for nail placement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Wake Forest University Health Sciences - CompRehab

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Free-hand technique

Wand technique

Arm Description

Free-hand technique utilized to find screw holes.

Wand technique is utilized to find screw holes.

Outcomes

Primary Outcome Measures

Reduced operative time.
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
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.
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
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.

Secondary Outcome Measures

Full Information

First Posted
August 11, 2010
Last Updated
May 15, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
Smith & Nephew, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01183078
Brief Title
Distal Locking Using an Electromagnetic Field Guided Computer Based Real Time System for Orthopaedic Trauma Patients
Acronym
Sure Shot
Official Title
Distal Locking Using an Electromagnetic Field Guided Computer Based Real Time System for Orthopaedic Trauma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
Smith & Nephew, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tibial Fractures, Femoral Fractures
Keywords
efficacy, drill placement, nail placement, radiation, Operative time, Reduction in exposure to radiation, Accuracy for nail placement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Free-hand technique
Arm Type
Other
Arm Description
Free-hand technique utilized to find screw holes.
Arm Title
Wand technique
Arm Type
Other
Arm Description
Wand technique is utilized to find screw holes.
Intervention Type
Procedure
Intervention Name(s)
free-hand
Intervention Description
Free-hand technique utilizes x-rays to find screw holes.
Intervention Type
Procedure
Intervention Name(s)
Wand technique
Intervention Description
Wand technique is utilized to find screw holes.
Primary Outcome Measure Information:
Title
Reduced operative time.
Description
The goal is to prospectively assess the "wand" technique as a reliable alternative to standard interlocking screw placement which reduces operative time.
Time Frame
Six months post surgery
Title
Reduced C-arm exposure
Description
The goal is to prospectively assess the "wand" technique as a reliable alternative to standard interlocking screw placement, which reduces C-arm exposure.
Time Frame
Six months post surgery
Title
Reduces inadvertent nail misses.
Description
The goal is to prospectively assess the "wand" technique as a reliable alternative to standard interlocking screw placement, which reduces inadvertent "nail misses."
Time Frame
Six months post surgery
Title
No complications
Description
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.
Time Frame
Six months post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Riyaz H. Jinnah, MD, FRCS
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eben A. Carroll, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences - CompRehab
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

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

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