Patient case: 72-year-old male with lung adenocarcinoma; genetic feature: EZR-ROS1 fusion

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

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.

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

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.

Relevance to patient case: not relevant