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

Withdrawn before enrolling · Not applicable

Conditions studied: Spinal Stenosis

In brief

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.

Key facts

Study ID

NCT01892878

Run by

VG Innovations, LLC

People needed

0

Starts

2013-07-01

Expected to finish

2016-01-01

Last updated by the study team

2018-03-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Genesys Regional Medical Center — Grand Blanc, Michigan, United States

Full record on ClinicalTrials.gov

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