Clinical Outcome and Fusion Results Using the VerteLoc® Facet Fixation Device

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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. 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: Explore the effect of preoperative bone density on facet fusion status; Assess the ease of use of the VerteLoc system; Record operative time using the VerteLoc system; Monitor the occurrence of adverse events related or possibly related to the use of the VerteLoc system; Monitor the occurrence of subsequent surgical intervention at the target level(s). Subject success/Clinical outcome (Assess additional improvement criteria) Evaluate Fusion rate in relations to DEXA value Inclusion Criteria: Candidates must meet ALL of the following: Have provided consent for research by signing the Institutional Review Board approved Informed Consent; Have given appropriate operative consent for a decompressive lumbar (L1-S1) laminectomy procedure as standard of care; Are skeletally mature, and are at least 18 years of age; If female, are not pregnant; Agree to adhere to post-surgical medically prescribed activity limitations and/or physical rehabilitation. Exclusion Criteria: Previous surgery at the target or adjacent vertebral levels; More than two intervertebral levels to be treated by the laminectomy procedure; Found to be inappropriate candidates for facet fixation using the VerteLoc system; 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; Has a medical disorder or is receiving medications that would be expected to interfere with osteogeneses, Active malignancy or patient with a history of any malignancy (except non-melanoma skin cancer) with recurrence within 5 years of surgery; 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; BMI >40% ; History of tobacco smoking within the past 6 months; 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; Are participating in any other clinical trial. Study Duration : 12 months Study Outcomes: The primary study outcomes of this study are: Fusion grade at 12 month follow-up using CT scans with a grading system based on: Complete fusion; Partial fusion; No fusion; Subject success / Clinical outcome: Evaluate the reduction in baseline VAS back pain score at: 2-3 weeks 3 months 12 months. The secondary outcomes of this study are: Statistical correlation of DEXA scan bone mass density score to CT and radiographic fusion status; Surgeon opinion of ease of use utilizing the VerteLoc system (0-10); Operative time (minutes) from surgical access to completion of device placement Occurrence and prevalence of adverse events related or possibly related to the use of the VerteLoc System; 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

Official Title
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A Prospective, Single Arm Clinical Trial Evaluating Clinical Outcome and Fusion Results Using the VerteLoc® Facet Fixation Device

Conditions
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Spinal Stenosis

Intervention / Treatment
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* Procedure: VerteLoc


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have provided consent for research by signing the Institutional Review Board approved Informed Consent; Have given appropriate operative consent for a decompressive lumbar (L1-S1) laminectomy procedure as standard of care; Are skeletally mature, and are at least 18 years of age; If female, are not pregnant; Agree to adhere to post-surgical medically prescribed activity limitations and/or physical rehabilitation. Exclusion Criteria: Previous surgery at the target or adjacent vertebral levels; More than two intervertebral levels to be treated by the laminectomy procedure; Found to be inappropriate candidates for facet fixation using the VerteLoc system; 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; Has a medical disorder or is receiving medications that would be expected to interfere with osteogeneses, Active malignancy or patient with a history of any malignancy (except non-melanoma skin cancer) with recurrence within 5 years of surgery; 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; BMI >40% ; History of tobacco smoking within the past 6 months; 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; Are participating in any other clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single Arm Study<br>All patients will receive treatment | Procedure: VerteLoc<br>* Single Arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fusion grade at 12 month follow-up using CT scans | Fusion grade at 12 month follow-up using CT scans with a grading system based on: Complete fusion; Partial fusion; No fusion; | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject success / Clinical outcome | Subject success / Clinical outcome: Evaluate the reduction in baseline VAS back pain score. | 2-3 weeks, 3 months and 12 months |