Distal Locking Using an Electromagnetic Field Guided Computer Based Real Time System for Orthopaedic Trauma Patients
| Status: | Completed |
|---|---|
| Conditions: | Orthopedic, Orthopedic, Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/3/2018 |
| Start Date: | August 2010 |
| End Date: | September 2013 |
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.
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.
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.
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.
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.
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