Recruiting

Intraoperative Monitoring

Sponsor:

Alphatec Spine, Inc.

Code:

NCT05648474

Conditions

Intervertebral Disc Degeneration

Stenosis, Spinal

Spondylolisthesis

Spinal Deformity

Spinal Instability

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Somatosensory evoked potential [SSEP] intraoperative monitoring

Study Details

Brief summary:

This study is designed to evaluate the clinical utility of a known intraoperative neuromonitoring modality (SSEP) using saphenous nerve as the site of stimulation to identify changes to the lumbar nerves which may be at risk during the lateral lumbar interbody fusion (LLIF) procedure.

Conditions

Intervertebral Disc Degeneration

Stenosis, Spinal

Spondylolisthesis

Spinal Deformity

Spinal Instability

Study ID

NCT05648474

Start date

Jul 13, 2022

Status verified date

Oct, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Aug 28, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • At least 18 years of age at the time of planned surgery.
  • Indicated for 1- or 2-level instrumented LLIF surgery (in either prone or lateral decubitus positions), inclusive of the L4-5 disc space.
  • Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

  • Patients requiring surgical treatment at more than 2 lumbar levels.
  • Patients with peripheral neuropathy such as from diabetes or other conditions that might affect the reliability of intraoperative neuromonitoring.
  • Patients with prior history of partial/full hip or knee joint replacement surgery (i.e., arthroplasty or resurfacing) on the leg targeted for saphenous monitoring and electrode placement.
  • Patients with presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
  • Female patients who are pregnant or wanting to become pregnant during the timeframe of study participation.
  • Patients participating in another clinical study which may compromise this study's results or compliance with this study's procedures.

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

Adult undergoing 1- or 2-level lateral lumbar interbody fusion surgery, inclusive of the L4-5 level

Interventions

Somatosensory evoked potential [SSEP] intraoperative monitoring

No study specific intervention is performed. Intraoperative neuromonitoring system that is observed in this study is for assessing the health of the lumbar plexus during lateral lumbar interbody fusion surgery

Primary outcome measure

  • Sensitivity and specificity of SSEP neuromonitoring in post-operative clinical diagnosis of motor/sensory deficits [ Time Frame: 6 weeks or until new or worsened neural deficits are resolved, but not exceeding 12 months. ]

Central Contacts and Locations

Locations

Alphatec Spine Inc.

Recruiting

Carlsbad, California, United States, 92008

Contacts

Saba Pasha, PhD

7603566639spasha@atecspine.com

More Information

Sponsor

Alphatec Spine, Inc.

Last update posted

Oct 24, 2024

Last verified

Oct, 2024

Keywords

  • Spine
  • Surgery
  • Adult
  • Neuromonitoring
  • Electromyography
  • Somatosensory evoked potentials

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Alphatec Spine, Inc. on 2024-10-24.