Clinical Outcome and Fusion Results Using the VerteLoc® Facet Fixation Device
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2013 by VG Innovations, LLC.
Recruitment status was Not yet recruiting
Information provided by (Responsible Party):
VG Innovations, LLC
First received: July 1, 2013
Last updated: NA
Last verified: July 2013
History: No changes posted
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.
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Prospective, Single Arm Clinical Trial Evaluating Clinical Outcome and Fusion Results Using the VerteLoc® Facet Fixation Device
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:
- Complete fusion;
- Partial fusion;
- 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:
| Study Start Date:
| Estimated Primary Completion Date:
||July 2015 (Final data collection date for primary outcome measure)
Single Arm Study
All patients will receive treatment
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01892878
|Genesys Regional Medical Center
|Grand Blanc, Michigan, United States, 48439 |
|Contact: Lisa Guyot, MD 810-606-7340 |
|Principal Investigator: Lisa Guyot, MD |
VG Innovations, LLC
||Lisa Guyot, MD
||Genesys Regional Medical Center
No publications provided
||VG Innovations, LLC
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 1, 2013
||July 1, 2013
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 01, 2015