Improvement of Trans-operatory X-ray Visualization During Anterior Cervical Surgery

Tracking Information
First Submitted Date ICMJE	April 20, 2011
First Posted Date ICMJE	April 27, 2011
Last Update Posted Date	March 20, 2012
Study Start Date ICMJE	December 2010
Estimated Primary Completion Date	May 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: April 26, 2011)	Intra operative neurophysiological monitoring (IONM) alert [ Time Frame: Participants will be followed for the duration of the surgical procedure, an expected average of 3-4 hours ]; - Real time neurophysiological monitoring will be performed using evoked potentials during the whole case, specially registered during all five maneuvers. This continuous electrical surveillance let us identify any potential risk to spinal cord or nerves, founded like an IONM alert (defined as nerve irritation or a decrease in voltage and/or amplitude response). This is a single and immediate measurement obtained at surgery and it is a safety issue.
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01342575 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: April 26, 2011)	Percent of segmental exposure on cervical spine lateral x-rays [ Time Frame: Participants will be followed for the duration of surgical procedure, an expected average of 3-4 hours ]; During surgery, on each of the five maneuvers, a lateral x-ray will be taken to assess the percent of visualization of the more inferior vertebra possible to see. At the surgical room, with the basal and the 5 experimental X-rays on hands, percent of exposure will be measured. Results will be recorded at the time of the surgery and presented showing any electrical change registered by IONM during the 5 maneuvers.
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Improvement of Trans-operatory X-ray Visualization During Anterior Cervical Surgery
Official Title ICMJE	Improvement of Trans-operatory X-ray Visualization During Anterior Cervical Surgery. Comparison of the Podalic Compression and Shoulder Traction Maneuvers
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.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
Condition ICMJE	Cervical Disk Disease
Intervention ICMJE	Procedure: Intra-operative exposure maneuvers; Feet compression maneuver: Taking feet from the ankles, gentle pressure will be applied toward the cranium and maintained for 1 minute. X-rays and IONM will be performed; Arm traction maneuver: Holding two strips around the wrists and using a dynamometer adjusted to 8 kg per side, sustained traction will be maintained for 1 minute. X-rays and IONM will be performed.; Shoulder taping maneuver: Both shoulders will be pulled caudally with adhesive tape adjusted for a tension of 8 kg on each side. X-rays and IONM will be performed; Arm traction plus feet compression maneuvers: Simultaneous combination of both maneuvers as described before. X-rays and IONM will be performed; Shoulder taping plus feet compression maneuvers: Simultaneous combination of both maneuvers as described before. X-rays and IONM will be performed
Study Arms	Experimental: Intra-operative maneuver group; Intervention: Procedure: Intra-operative exposure maneuvers
Publications *	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.; 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. Epub 2006 Sep 8.; Collado-Corona MA, de Leo-Vargas R, Sandoval-Sánchez V, Díaz-Hernández A, Gutiérrez-Sougarret BJ, Shkurovich-Bialik P. Neurophysiological monitoring in spinal cord surgery. Cir Cir. 2009 Sep-Oct;77(5):385-90.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: April 26, 2011)	50
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	August 2012
Estimated Primary Completion Date	May 2012 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 70 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Mexico
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01342575
Other Study ID Numbers ICMJE	ABC-11-02
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Galvan Ernesto Eduardo, American British Cowdray Medical Center
Study Sponsor ICMJE	American British Cowdray Medical Center
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Ernesto E Galvan Hernandez, MD, MsC American British Cowdray Medical Center, Neurological Center
PRS Account	American British Cowdray Medical Center
Verification Date	March 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP