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

This study is not yet open for participant recruitment.
Verified July 2013 by VG Innovations, LLC
Sponsor:
Information provided by (Responsible Party):
VG Innovations, LLC
ClinicalTrials.gov Identifier:
NCT01892878
First received: July 1, 2013
Last updated: NA
Last verified: July 2013
History: No changes posted
  Purpose

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 Intervention
Spinal Stenosis
Procedure: VerteLoc

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by VG Innovations, LLC:

Primary Outcome Measures:
  • Fusion grade at 12 month follow-up using CT scans [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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:
  • Subject success / Clinical outcome [ Time Frame: 2-3 weeks, 3 months and 12 months ] [ Designated as safety issue: No ]

    Subject success / Clinical outcome:

    Evaluate the reduction in baseline VAS back pain score.



Estimated Enrollment: 25
Study Start Date: July 2013
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single Arm Study
All patients will receive treatment
Procedure: VerteLoc
Single Arm

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01892878

Contacts
Contact: Lisa Guyot, MD (810) 606-7340 llguyot@aol.com

Locations
United States, Michigan
Genesys Regional Medical Center Not yet recruiting
Grand Blanc, Michigan, United States, 48439
Contact: Lisa Guyot, MD    810-606-7340      
Principal Investigator: Lisa Guyot, MD         
Sponsors and Collaborators
VG Innovations, LLC
Investigators
Principal Investigator: Lisa Guyot, MD Genesys Regional Medical Center
  More Information

No publications provided

Responsible Party: VG Innovations, LLC
ClinicalTrials.gov Identifier: NCT01892878     History of Changes
Other Study ID Numbers: VGI-002
Study First Received: July 1, 2013
Last Updated: July 1, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 14, 2014