Cervical Disk Disease Clinical Trial
Official title:
Improvement of Trans-operatory X-ray Visualization During Anterior Cervical Surgery. Comparison of the Podalic Compression and Shoulder Traction Maneuvers
The purpose of this study is to establish which of five different maneuvers could bring the best trans-operatory x-ray exposure during anterior cervical surgeries with the higher security
Anterior cervical spine surgery (ACSS) is one of the most common spine surgery performed by
neurosurgeons. One of the challenging aspects during ACSS is to achieve a correct
visualization and identification of the lower levels specifically below the fifth and sixth
cervical vertebras due to the difficulty of penetrating X-ray beams through the shoulders.
Several methods such as taping the shoulders throughout the entire case or tying straps
around the wrists and pulling them caudally temporally while shooting X-rays have been used
trying to improve visualization during surgery. Both of these methods may cause problems
such as brachial plexus injury, shoulder dislocations and peripheral nerve injuries.
The feet compression maneuver will be tested in terms of it's efficacy and security, as well
as compared with four previous described maneuvers, using intra-operative neurophysiology
monitoring (IONM).
50 consecutive patients programmed for elective ACSS that could meet inclusion criteria will
be monitored with IONM using transcranial electric motor evoked potentials (tceMEPs),
somatosensory evoked potentials (SSEPs) and spontaneous electromyography (EMG) after total
endovenous anesthesia. On the operating table, a basal lateral x-ray picture and a first
determination of IONM will be performed and used for comparison. Five maneuvers will be
sequentially performed: 1) Feet compression, 2) Arm traction, 3) Arm traction plus feet
compression combined, 4) Shoulder taping and 5) Shoulder taping plus feet compression.
All five maneuvers will be maintained for 1 min, time during IONM will test for changes in
voltage amplitude and duration that potentially could be risky (risky is defined as a change
in determinations more than 50% compared to basal determinations). Lateral x-rays will be
performed during each maneuver to measure changes in segments visualization and levels
exposed.
After all maneuvers are completed, we will proceed as the surgery was scheduled.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care