Status:
WITHDRAWN
Clinical Outcome and Fusion Results Using the VerteLoc® Facet Fixation Device
Lead Sponsor:
VG Innovations, LLC
Conditions:
Spinal Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
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 (...
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 appropria...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01892878
Start Date
July 1 2013
End Date
January 1 2016
Last Update
March 16 2018
Active Locations (1)
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1
Genesys Regional Medical Center
Grand Blanc, Michigan, United States, 48439