Clinical trial NCT01342588: Accuracy of Lumbar Pedicle Screw Placement Assisted With Continuous Pulse-train Stimulation
Official title: Accuracy of Lumbar Pedicle Screw Placement Assisted With Continuous Pulse-train Stimulation During Track Creation and Screw Insertion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spine Pedicle Screw Placement
Keywords: Pedicle screws
safety
Lead sponsor: American British Cowdray Medical Center
Sponsor class: OTHER
First posted: 2011-04-27
Enrollment: 60
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 the accuracy of pedicle positioning using continuous electrical pulse during screwing. Additionally, the investigators evaluate if this maneuver can prevent neurological injury during track creation and screwing in lumbar and thoracic spine instrumentation surgery

Detailed description: Pedicle screw instrumentation as part of spine surgery is a recurrent technique used for most of spine surgeons. Since its description by Boucher in 1959 and its popularization later by Roy-Camille, has been considered a technique that demands great anatomy knowledge and some grade of expertise. Even in experienced hands the misplacement of pedicle screws could have an incidence of 10-40% (average of 20%). Medially misplacements during track creation and screw insertion are the most feared complications, because the anatomic relationship between medial pedicle wall and neural structures. The first attempt to use continuous electrical stimulation during pedicle track creation and screw insertion was communicated in 1997 by Welch WC, et al. In that study they used the bone impedance as a direct measurement of pedicle wall integrity; unfortunately they used inhaled anesthetics and assessed the final screw position with plain X-rays. They reported a sensibility and specificity of 98% and 99% respectively. The great limitation for this study is its assessment of screw accuracy performed by plain X-rays, now a days the best way to do it is with computed tomography (CT).

After the Welch report, a couple of studies more have used similar techniques in the thoracic spine trying to avoid neurological injuries during pedicle screw insertion, but none described the use of continuous train pulses during screwing.

The present study pretends to evaluate the final accuracy and trans-operative usefulness of the pulse train stimulation during track creation and screw insertion using intra venous anesthetic agents and CT scans to assess the integrity of pedicle walls

Eligibility criteria: Inclusion Criteria:

* Any patient who needs pedicle screw placement for any spine condition

Exclusion Criteria:

* Previous spine surgery
* Pedicle fracture documented before or during surgery.
* Preoperative identified neurological deficit of the nerve roots close to the instrumented levels

Primary outcomes:
measure: Intra operative neurophysiological monitoring (IONM) alert
timeFrame: Participants will be followed for the duration of surgical procedure, an expected average of 3-4 hours
Secondary outcomes:
measure: Pedicle screw accuracy
timeFrame: On day 2 after surgery before patient discharge, a CT scan will be performed
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: American British Cowdray Medical Center
state: Mexico DF
Study officials:
affiliation: American British Cowdray Medical Center, Neurological Center
name: Ernesto E Galvan Hernandez, MD, MsC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roy-Camille R, Saillant G, Mazel C. Internal fixation of the lumbar spine with pedicle screw plating. Clin Orthop Relat Res. 1986 Feb;(203):7-17.
citation: Donohue ML, Murtagh-Schaffer C, Basta J, Moquin RR, Bashir A, Calancie B. Pulse-train stimulation for detecting medial malpositioning of thoracic pedicle screws. Spine (Phila Pa 1976). 2008 May 20;33(12):E378-85. doi: 10.1097/BRS.0b013e31817343c1.
citation: Welch WC, Rose RD, Balzer JR, Jacobs GB. Evaluation with evoked and spontaneous electromyography during lumbar instrumentation: a prospective study. J Neurosurg. 1997 Sep;87(3):397-402. doi: 10.3171/jns.1997.87.3.0397.
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.