NCT01342575

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 27, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

March 20, 2012

Status Verified

March 1, 2012

Enrollment Period

1.4 years

First QC Date

April 20, 2011

Last Update Submit

March 16, 2012

Conditions

Cervical Disk Disease

Keywords

ACDF

Outcome Measures

Primary Outcomes (1)

  • Intra operative neurophysiological monitoring (IONM) alert

    \- 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.

    Participants will be followed for the duration of the surgical procedure, an expected average of 3-4 hours

Secondary Outcomes (1)

  • Percent of segmental exposure on cervical spine lateral x-rays

    Participants will be followed for the duration of surgical procedure, an expected average of 3-4 hours

Study Arms (1)

Intra-operative maneuver group

EXPERIMENTAL
Procedure: Intra-operative exposure maneuvers

Interventions

Intra-operative exposure maneuversPROCEDURE

* 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

Intra-operative maneuver group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American British Cowdray Medical Center, Neurological Center

Mexico City, D.F, 05300, Mexico

RECRUITING

Related Publications (3)

  • 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.

    PMID: 16924208BACKGROUND

  • 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.

    PMID: 16960753BACKGROUND

  • 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.

    PMID: 19944028BACKGROUND

Study Officials

  • Ernesto E Galvan Hernandez, MD, MsC

    American British Cowdray Medical Center, Neurological Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ernesto E Galvan Hernandez, MD, MsC

CONTACT

52 (55) 16647205egalh@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 20, 2011

First Posted

April 27, 2011

Study Start

December 1, 2010

Primary Completion

May 1, 2012

Study Completion

August 1, 2012

Last Updated

March 20, 2012

Record last verified: 2012-03

Locations

ME(1)