Clinical trial NCT01342575: Improvement of Trans-operatory X-ray Visualization During Anterior Cervical Surgery
Official title: Improvement of Trans-operatory X-ray Visualization During Anterior Cervical Surgery. Comparison of the Podalic Compression and Shoulder Traction Maneuvers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Disk Disease
Keywords: ACDF
Lead sponsor: American British Cowdray Medical Center
Sponsor class: OTHER
First posted: 2011-04-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients with any stable biomechanically cervical pathology (like disk herniations, vertebral tumors, etc.), scheduled for ACSS

Exclusion Criteria:

* Any cervical pathology associated with segmental instability
* History of shoulder, arm, elbow or wrist pathology, including surgery or implants.
* Radiological signs of myelopathy by MRI or clinically detected
* Preoperative identified neurological deficit

Primary outcomes:
measure: Intra operative neurophysiological monitoring (IONM) alert
timeFrame: Participants will be followed for the duration of the surgical procedure, an expected average of 3-4 hours
Secondary outcomes:
measure: Percent of segmental exposure on cervical spine lateral x-rays
timeFrame: Participants will be followed for the duration of surgical procedure, an expected average of 3-4 hours
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: American British Cowdray Medical Center, Neurological Center
state: D.F
Study officials:
affiliation: American British Cowdray Medical Center, Neurological Center
name: Ernesto E Galvan Hernandez, MD, MsC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee JY, Hilibrand AS, Lim MR, Zavatsky J, Zeiller S, Schwartz DM, Vaccaro AR, Anderson DG, Albert TJ. Characterization of neurophysiologic alerts during anterior cervical spine surgery. Spine (Phila Pa 1976). 2006 Aug 1;31(17):1916-22. doi: 10.1097/01.brs.0000228724.01795.a2.
citation: Schwartz DM, Sestokas AK, Hilibrand AS, Vaccaro AR, Bose B, Li M, Albert TJ. Neurophysiological identification of position-induced neurologic injury during anterior cervical spine surgery. J Clin Monit Comput. 2006 Dec;20(6):437-44. doi: 10.1007/s10877-006-9032-1. Epub 2006 Sep 8.
citation: Collado-Corona MA, de Leo-Vargas R, Sandoval-Sanchez V, Diaz-Hernandez A, Gutierrez-Sougarret BJ, Shkurovich-Bialik P. Neurophysiological monitoring in spinal cord surgery. Cir Cir. 2009 Sep-Oct;77(5):385-90.