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