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

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ClinicalTrials.gov Identifier: NCT01892878
Recruitment Status : Withdrawn
First Posted : July 8, 2013
Last Update Posted : March 16, 2018
Information provided by (Responsible Party):
VG Innovations, LLC

Brief 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.

Condition or disease Intervention/treatment
Spinal Stenosis Procedure: VerteLoc

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Single Arm Clinical Trial Evaluating Clinical Outcome and Fusion Results Using the VerteLoc® Facet Fixation Device
Study Start Date : July 2013
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : January 1, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis
U.S. FDA Resources

Arm Intervention/treatment
Single Arm Study
All patients will receive treatment
Procedure: VerteLoc
Single Arm

Primary Outcome Measures :
  1. Fusion grade at 12 month follow-up using CT scans [ Time Frame: 12 months ]

    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;

Secondary Outcome Measures :
  1. Subject success / Clinical outcome [ Time Frame: 2-3 weeks, 3 months and 12 months ]

    Subject success / Clinical outcome:

    Evaluate the reduction in baseline VAS back pain score.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01892878

United States, Michigan
Genesys Regional Medical Center
Grand Blanc, Michigan, United States, 48439
Sponsors and Collaborators
VG Innovations, LLC
Principal Investigator: Lisa Guyot, MD Genesys Regional Medical Center

Responsible Party: VG Innovations, LLC
ClinicalTrials.gov Identifier: NCT01892878     History of Changes
Other Study ID Numbers: VGI-002
First Posted: July 8, 2013    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: July 2013

Additional relevant MeSH terms:
Spinal Stenosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases