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

VG Innovations

Status

Withdrawn

Conditions

Spinal Stenosis

Treatments

Procedure: VerteLoc

Study type

Interventional

Funder types

Industry

Identifiers

NCT01892878

VGI-002

Details and patient eligibility

About

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.

Full 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:

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.