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Trial record 5 of 27 for:    Nuvasive

Advanced XLIF Monitoring Pilot Study

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02192112
First Posted: July 16, 2014
Last Update Posted: March 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
NuVasive
  Purpose

Though the utility of NVM5 neuromonitoring by stimulating within the surgical site during XLIF has been demonstrated, it is hypothesized that more information may be gathered if a greater section of the motor neural pathway was monitored (i.e., stimulation above the surgical site and recording the subsequent muscle response in the lower limbs). Currently, there has not been demonstrated a practical method of stimulating the lumbosacral nerve roots locally, but well-above the surgical site in this fashion.

This protocol is intended to evaluate the feasibility and reproducibility of using surface stimulation and return (anode) electrodes to stimulate the lumbosacral nerve roots, and record responses from the relevant innervated muscle groups of the lower limbs.


Condition
Degenerative Lumbar Disc Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Transcutaneous Stimulation of Lumbosacral Nerve Roots: A Pilot Study

Further study details as provided by NuVasive:

Primary Outcome Measures:
  • Reproducibility of obtaining reliable responses and response thresholds monitored over the course of surgery. [ Time Frame: Intraoperative ]

Secondary Outcome Measures:
  • Correlation of any observed changes in the response or response thresholds with surgical events. [ Time Frame: Intraoperative ]
  • Correlation between patient characteristics and the ability to generate and reliably record responses and response thresholds. [ Time Frame: Intraoperative ]
  • Correlation between observed changes in the response or response threshold and postoperative neural status. [ Time Frame: 6 weeks postoperative ]

Estimated Enrollment: 20
Study Start Date: June 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
At least 20 subjects will be consecutively enrolled in this prospective pilot study from up to three (3) participating centers. Patients who, in the surgeon investigator's opinion, require lateral approach spinal fusion surgery at spinal level L4-5 (though may include any number of levels from L2 through L5), and have consented to XLIF surgery for their condition will be included. The following eligibility criteria are designed to identify existing clinic patients for whom study under this protocol is considered appropriate. All subjects must meet the inclusion/exclusion criteria below in order to be considered for enrollment.
Criteria

Inclusion Criteria:

  1. Male and female spine surgery patients who are at least 18 years of age
  2. Surgical candidates for lateral approach lumbar spine surgery at spinal levels L2 to L5, inclusive of L4-5
  3. Patients who understand the conditions of enrollment and are willing to sign an informed consent to participate in the evaluation

Exclusion Criteria:

  1. Currently undergoing surgical treatment at any spinal level other than L2 to L5, including S1
  2. Pregnant women
  3. Implanted pacemaker, defibrillator, or other electronic devices
  4. Involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested)
  5. Underlying neurological disease or neurological deficit that is not associated with the condition for which he/she is seeking surgical intervention (e.g., diabetic peripheral neuropathy)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02192112


Locations
United States, Colorado
Durango Orthopaedics Associates/Spine Colorado
Durango, Colorado, United States, 81301
United States, Georgia
Pinnacle Orthopaedics & Sports Medicine Specialists
Marrietta, Georgia, United States, 30060
Sponsors and Collaborators
NuVasive
Investigators
Study Director: Kelli Howell, MS NuVasive
  More Information

Additional Information:
Responsible Party: NuVasive
ClinicalTrials.gov Identifier: NCT02192112     History of Changes
Other Study ID Numbers: NUVA.NV1301
First Submitted: July 1, 2014
First Posted: July 16, 2014
Last Update Posted: March 23, 2017
Last Verified: March 2017