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

Spinal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01892878
• Other study ID #: VGI-002
• Status: Withdrawn
• Phase: N/A
• First received: July 1, 2013
• Last updated: March 14, 2018
• Start date: July 2013
• Est. completion date: January 1, 2016

Study information

• Verified date: July 2013
• Source: VG Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 1, 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Stenosis

Intervention

Procedure:
• VerteLoc
Single Arm

Locations

Country	Name	City	State
United States	Genesys Regional Medical Center	Grand Blanc	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
VG Innovations, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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