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

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 Overview

• Status: Withdrawn
• Conditions: Spinal Stenosis
• Intervention / Treatment: Procedure: VerteLoc

Detailed Description

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

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Grand Blanc, Michigan, United States, 48439
      • Genesys Regional Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Single Arm Study; All patients will receive treatment	Procedure: VerteLoc; Single Arm

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: VG Innovations, LLC
• Investigators: Principal Investigator: Lisa Guyot, MD, Ascension Genesys Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (ANTICIPATED): July 1, 2015
• Study Completion (ANTICIPATED): January 1, 2016

Study Registration Dates

• First Submitted: July 1, 2013
• First Submitted That Met QC Criteria: July 1, 2013
• First Posted (ESTIMATE): July 8, 2013

Study Record Updates

• Last Update Posted (ACTUAL): March 16, 2018
• Last Update Submitted That Met QC Criteria: March 14, 2018
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Stenosis
• Other Study ID Numbers: VGI-002