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

Tibial Fractures Clinical Trial

— Sure Shot  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01183078
• Other study ID #: IRB00012034
• Status: Completed
• Phase: N/A
• Start date: August 2010
• Est. completion date: September 2013

Study information

• Verified date: July 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Femoral Fractures
• Fractures, Bone
• Tibial Fractures

Intervention

Procedure:
• free-hand
Free-hand technique utilizes x-rays to find screw holes.
• Wand technique
Wand technique is utilized to find screw holes.

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences - CompRehab	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Smith & Nephew, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Six months post surgery
Primary	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.	Six months post surgery
Primary	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."	Six months post surgery
Primary	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.	Six months post surgery