Spondylolisthesis Clinical Trial
Official title:
Advanced Techniques in Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure: A Utility Study
Verified date | November 2022 |
Source | Alphatec Spine, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | December 31, 2025 |
Est. primary completion date | February 28, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Alphatec Spine Inc. | Carlsbad | California |
Lead Sponsor | Collaborator |
---|---|
Alphatec Spine, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 6 weeks or until new or worsened neural deficits are resolved, but not exceeding 12 months. | |
Secondary | 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. |
6 weeks or until new or worsened neural deficits are resolved, but not exceeding 12 months. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03883022 -
Vancomycin Powder Combined With Autogenous Bone Graft as a Prevention for Post-operative Infection for Spine Surgery
|
N/A | |
Active, not recruiting |
NCT04542577 -
PMCF Study on the Safety and Performance of PROSPACE 3D / PROSPACE 3D OBLIQUE / TSPACE 3D
|
||
Recruiting |
NCT04477447 -
PMCF Study on the Safety and Performance of CESPACE 3D
|
||
Completed |
NCT02558621 -
New Robotic Assistance System for Spinal Fusion Surgery
|
N/A | |
Terminated |
NCT01461005 -
A Postmarket Surveillance Study of the Paradigm Spine Dynamic Stabilization System (DSS)
|
N/A | |
Completed |
NCT00405691 -
Safety and Effectiveness Study of the TOPS System, a Total Posterior Arthroplasty Implant Designed to Alleviate Pain Resulting From Moderate to Severe Lumbar Stenosis
|
Phase 3 | |
Completed |
NCT00205101 -
Clinical Outcome Study of the Triad Allograft for Posterior Lumbar Fusion
|
||
Enrolling by invitation |
NCT04204135 -
The Course of Hip Flexion Weakness Following LLIF or ALIF
|
||
Recruiting |
NCT05238740 -
Comparison of Standalone Anterior Lumbar Interbody Fusion (ALIF) L5/S1 Performed With Either rhBMP-2 or ViviGen®
|
N/A | |
Completed |
NCT02966639 -
Validation of Appropriateness Criteria for the Surgical Treatment of Lumbar Degenerative Spondylolisthesis
|
||
Not yet recruiting |
NCT02805985 -
Post-market Surveillance Study of FLXfit™ TLIF Interbody Fusion Device
|
N/A | |
Completed |
NCT02931279 -
PASS OCT® Post-market Clinical Follow-up
|
||
Active, not recruiting |
NCT02057744 -
MIS ReFRESH: Robotic vs. Freehand Minimally Invasive Spinal Surgeries
|
||
Completed |
NCT01711203 -
The Addition of a Pilates Program for Short-Term Improvements in Patients With Spondylolysis or Spondylolisthesis
|
N/A | |
Completed |
NCT00549913 -
Study of 3 Doses of NeoFuse Combined With MasterGraft Granules in Subjects Requiring Posterolateral Lumbar Fusion (PLF)
|
Phase 1/Phase 2 | |
Terminated |
NCT00254852 -
Evaluation of Radiographic and Patient Outcomes Following Lumbar Spine Fusion Using Demineralized Bone Matrix (DBM) Mixed With Autograft
|
N/A | |
Terminated |
NCT00095095 -
Lumbar Interbody Fusion Using the Telamon® Peek™ Versus the Telamon® Hydrosorb™ Fusion Device
|
Phase 4 | |
Active, not recruiting |
NCT03956537 -
PMCF Neo Pedicle Screw and Cage Systems
|
||
Recruiting |
NCT05182489 -
Adaptix RCT Evaluating Adaptix™ Versus PEEK Cages
|
N/A | |
Completed |
NCT02884440 -
Transverse Abdominis Plane Block for Anterior Approach Spine Surgery
|
Phase 2 |