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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by American British Cowdray Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Galvan Ernesto Eduardo, American British Cowdray Medical Center
ClinicalTrials.gov Identifier:
NCT01342575
First received: April 20, 2011
Last updated: March 16, 2012
Last verified: March 2012
History of Changes

April 20, 2011
March 16, 2012
December 2010
May 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
- 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.
Same as current
Complete list of historical versions of study NCT01342575 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]

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.
Same as current
Not Provided
Not Provided
 
Improvement of Trans-operatory X-ray Visualization During Anterior Cervical Surgery
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.
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Cervical Disk Disease
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
Experimental: Intra-operative maneuver group
Intervention: Procedure: Intra-operative exposure maneuvers

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
August 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years   (Adult, Senior)
No
Contact: Ernesto E Galvan Hernandez, MD, MsC 52 (55) 16647205 ext 4155 egalh@yahoo.com
Mexico
 
NCT01342575
ABC-11-02
No
Not Provided
Not Provided
Galvan Ernesto Eduardo, American British Cowdray Medical Center
American British Cowdray Medical Center
Not Provided
Principal Investigator: Ernesto E Galvan Hernandez, MD, MsC American British Cowdray Medical Center, Neurological Center
American British Cowdray Medical Center
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP