Spinal Stenosis Clinical Trial
Official title:
A Prospective, Single Arm Clinical Trial Evaluating Clinical Outcome and Fusion Results Using the VerteLoc® Facet Fixation Device
The purpose of this clinical study is to evaluate fusion of the facet joints in a prospective cohort of patients utilizing the VerteLoc facet fixation device in patients receiving lumbar laminectomy (L1-S1), without ancillary stabilization devices such as pedicle and transfacet screws.
Study Design: Non-randomized, prospective, single arm clinical trial
Patient Population and Sample Size: Patients (n=25) from up to 2 clinical site, who have been
medically evaluated, found appropriate for, and have agreed to treatment by lumbar
decompressive laminectomy and facet fixation, including unilateral and/or bilateral
posterolateral fusion according to accepted medical standards.
Objectives:
The primary objective of this study is to:
1. Evaluate the fusion status of facet joints following laminectomy and facet fixation
using the VerteLoc system in combination with unilateral and/or bilateral posterolateral
fusion.
2. Subject success / Clinical outcome: Evaluate the reduction in baseline VAS back pain
score at 2-3 weeks, 3 months, and 12 months.
The secondary objectives of this study are to:
1. Explore the effect of preoperative bone density on facet fusion status;
2. Assess the ease of use of the VerteLoc system;
3. Record operative time using the VerteLoc system;
4. Monitor the occurrence of adverse events related or possibly related to the use of the
VerteLoc system;
5. Monitor the occurrence of subsequent surgical intervention at the target level(s).
6. Subject success/Clinical outcome (Assess additional improvement criteria)
7. Evaluate Fusion rate in relations to DEXA value
Inclusion Criteria: Candidates must meet ALL of the following:
1. Have provided consent for research by signing the Institutional Review Board approved
Informed Consent;
2. Have given appropriate operative consent for a decompressive lumbar (L1-S1) laminectomy
procedure as standard of care;
3. Are skeletally mature, and are at least 18 years of age;
4. If female, are not pregnant;
5. Agree to adhere to post-surgical medically prescribed activity limitations and/or
physical rehabilitation.
Exclusion Criteria:
1. Previous surgery at the target or adjacent vertebral levels;
2. More than two intervertebral levels to be treated by the laminectomy procedure;
3. Found to be inappropriate candidates for facet fixation using the VerteLoc system;
4. Require additional and/or other surgical technique and/or approach to the laminectomy at
the index level(s), which may in the opinion of the Primary Investigator confound
measurement of outcome variables;
5. Has a medical disorder or is receiving medications that would be expected to interfere
with osteogeneses,
6. Active malignancy or patient with a history of any malignancy (except non-melanoma skin
cancer) with recurrence within 5 years of surgery;
7. Active local or systemic infection or history of local or systemic infection,
immune-deficiency, uncontrolled medical conditions, which in the opinion of the
Investigator may increase patient risk or confound fusion results;
8. BMI >40% ;
9. History of tobacco smoking within the past 6 months;
10. Has a history of alcoholism, medication or drug abuse, psychosis, is a prisoner, and/or
has a personality disorder, poor motivation, emotional or intellectual issues that would
likely make the patient unreliable for participation in the study;
11. Are participating in any other clinical trial. Study Duration : 12 months
Study Outcomes:
The primary study outcomes of this study are:
1. Fusion grade at 12 month follow-up using CT scans with a grading system based on:
1. Complete fusion;
2. Partial fusion;
3. No fusion;
2. Subject success / Clinical outcome:
Evaluate the reduction in baseline VAS back pain score at:
1. 2-3 weeks
2. 3 months
3. 12 months.
The secondary outcomes of this study are:
1. Statistical correlation of DEXA scan bone mass density score to CT and radiographic
fusion status;
2. Surgeon opinion of "ease of use" utilizing the VerteLoc system (0-10);
3. Operative time (minutes) from surgical access to completion of device placement
4. Occurrence and prevalence of adverse events related or possibly related to the use of
the VerteLoc System;
5. Occurrence of subsequent surgical intervention at the target level(s).
Study Assessments
- Intraoperative: Post-placement radiograph;
- 12 months: A/P and lateral flexion and extension lumbar radiograph and lumbar CT scan.
Statistical Analysis
• Student t-tests
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT06290908 -
RPE-P/TLIF for Lumbar Spinal Stenosis With Instability
|
||
Withdrawn |
NCT03223701 -
Efficacy of Using Solum IV and BMC With GFC in TLIF
|
Phase 4 | |
Recruiting |
NCT03883022 -
Vancomycin Powder Combined With Autogenous Bone Graft as a Prevention for Post-operative Infection for Spine Surgery
|
N/A | |
Completed |
NCT02902380 -
The Effect of Dexmedetomidine on Neuroendocrine Stress Hormone Release and Heart Rate Variability in Patients Undergoing Major Spinal Surgery
|
N/A | |
Not yet recruiting |
NCT06024785 -
Vertebropexy - Randomized-controlled Trial
|
N/A | |
Not yet recruiting |
NCT06000319 -
Natural Matrix Protein™ (NMP™) Fibers in Cervical and Lumbar Interbody Fusion
|
||
Completed |
NCT02558621 -
New Robotic Assistance System for Spinal Fusion Surgery
|
N/A | |
Completed |
NCT02454400 -
Pre-surgery Physiotherapy for Patients With Specific Low Back Pain
|
N/A | |
Completed |
NCT01377623 -
Pilot Study on the Effect of Dexmedetomidine on Inflammatory Responses in Patients Undergoing Lumbar Spinal Fusion
|
N/A | |
Completed |
NCT00996073 -
Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion
|
Phase 2 | |
Terminated |
NCT00974623 -
Bone Graft Materials Observational Registry
|
N/A | |
Completed |
NCT00022776 -
Surgical Versus Nonsurgical Treatment for Spinal Stenosis
|
Phase 3 | |
Completed |
NCT00320619 -
Epsilon-Aminocaproaic Acid to Reduce the Need for Blood Transfusions During and Following Spine Surgery
|
N/A | |
Completed |
NCT06060821 -
Validity and Reliability of the 2-minute Step Test in Patients With Lumbar Spinal Stenosis
|
||
Recruiting |
NCT04552145 -
Physical Therapy vs Surgical Decompression for Lumbar Spinal Stenosis
|
N/A | |
Active, not recruiting |
NCT04379921 -
Improving Spine Surgical Care With Real-Time Objective Patient Tracking Using the Apple Watch
|
N/A | |
Withdrawn |
NCT04315090 -
Post-surgical Outcomes Measure Using the ERAS Protocol for Posterior Cervical Decompression and Fusion
|
||
Completed |
NCT04591249 -
Physical Activity Intervention for Patients Following Lumbar Spine Surgery
|
N/A | |
Recruiting |
NCT04601363 -
Personalized Spine Study Group (PSSG) Registry
|
||
Completed |
NCT04193488 -
Mid-Transverse Process to Pleural (MTP) Block and Erector Spinal Plan (ESP) Block in Spinal Surgery
|
N/A |