Intervertebral Disc DegenerationNCT05648474
Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure
An observational study of Intervertebral Disc Degeneration and Stenosis, Spinal, run by Alphatec Spine, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intervertebral Disc Degeneration, Stenosis, Spinal, Spondylolisthesis
- What is being tested?
- Somatosensory evoked potential [SSEP] intraoperative monitoring
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of both sexes undergoing LLIF surgery atone or two levels inclusive of the L4-5 level.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Alphatec Spine Inc.
Carlsbad, California, 92008
Saba Pasha, PhD, 7603566639, spasha@atecspine.com
About this study
Official title: Advanced Techniques in Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure: a Utility Study
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
- Being tested
- Somatosensory evoked potential [SSEP] intraoperative monitoring
- Keywords
- Spine, Surgery, Adult, Neuromonitoring, Electromyography, Somatosensory evoked potentials
- Medical subject headings
- Intervertebral Disc Degeneration, Spinal Stenosis, Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Somatosensory evoked potential [SSEP] intraoperative monitoringDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| Adult undergoing 1- or 2-level lateral lumbar interbody fusion surgery, inclusive of the L4-5 level | Not described Receives: Diagnostic Test: Somatosensory evoked potential [SSEP] intraoperative monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of SSEP neuromonitoring in post-operative clinical diagnosis of motor/sensory deficits
This outcome measure determines the utility of the saphenous nerve SSEP monitoring based on the correlation of intraoperative neuromonitoring results with new or worsened postoperative neural deficits, as measured by motor and sensory physical exam.
Measured: 6 weeks or until new or worsened neural deficits are resolved, but not exceeding 12 months.
Secondary outcomes (1)
Determination of the positive predictive value (PPV) and negative predictive value (NPV) of free run and SSEP monitoring modalities.
This outcome measure includes:
- Correlating specific monitoring findings with incidence of new or worsened motor or sensory deficits post-operatively and their correlation with patient-specific and surgical factors.
- Correlating patient and surgical factors with new and worsened postoperative neural deficits.
Measured: 6 weeks or until new or worsened neural deficits are resolved, but not exceeding 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start13 Jul 2022
- Primary completion28 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intervertebral Disc DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alphatec Spine, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648474
- Sponsor's protocol ID
- ATEC.AI-2001
- Status last verified
- Oct 2024
- First submitted
- 5 Dec 2022
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Techniques in Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure: a Utility Study
- ClinicalTrials.gov ID
- NCT05648474
- Acronym / sponsor ID
- ATEC.AI-2001
- Conditions
- Intervertebral Disc Degeneration, Stenosis, Spinal, Spondylolisthesis, Spinal Deformity, Spinal Instability
- Keywords
- Spine, Surgery, Adult, Neuromonitoring, Electromyography, Somatosensory evoked potentials
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Alphatec Spine, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- 28 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult undergoing 1- or 2-level lateral lumbar interbody fusion surgery, inclusive of the L4-5 level | – | Diagnostic Test: Somatosensory evoked potential [SSEP] intraoperative monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of both sexes undergoing LLIF surgery atone or two levels inclusive of the L4-5 level.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Somatosensory evoked potential [SSEP] intraoperative monitoringNo 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 | Diagnostic test | Adult undergoing 1- or 2-level lateral lumbar interbody fusion surgery, inclusive of the L4-5 level |
Primary outcome
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.
This outcome measure determines the utility of the saphenous nerve SSEP monitoring based on the correlation of intraoperative neuromonitoring results with new or worsened postoperative neural deficits, as measured by motor and sensory physical exam.
1 secondary outcome
Determination of the positive predictive value (PPV) and negative predictive value (NPV) of free run and SSEP monitoring modalities.
Time frame: 6 weeks or until new or worsened neural deficits are resolved, but not exceeding 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
Related trials for Intervertebral Disc Degeneration
Not yet recruiting
CANLINK: Evaluation of the Intralink Intradiscal Device for Low Back Pain Due to Degenerative Disc Disease
Degenerative Disc Disease(DDD)
Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Not yet recruitingObservational study
Relationship Between Disability, Flexibility, Back Muscles, and Thoracolumbar Fascia in Patients With Lumbar Disc Degeneration
Intervertebral Disc Degeneration
Active, not recruiting
ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
Degenerative Disc Disease, Disc Degeneration
Active, not recruiting
The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery
Cervical Degenerative Disc Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intervertebral Disc Degeneration and Stenosis, Spinal, run by Alphatec Spine, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2024.