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

This study is not yet open for participant recruitment. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases

ClinicalTrials.gov processed this record on October 22, 2014