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

NCT01892878 | Withdrawn

• 1 other identifier: VGI-002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 (L1-S1), without ancillary stabilization devices such as pedicle and transfacet screws.

Conditions

Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

• Fusion grade at 12 month follow-up using CT scans

  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;

  12 months

Secondary Outcomes (1)

• Subject success / Clinical outcome

  2-3 weeks, 3 months and 12 months

Study Arms (1)

Single Arm Study

OTHER

All patients will receive treatment

Procedure: VerteLoc

Interventions

VerteLoc PROCEDURE

Single Arm

Single Arm Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• VG Innovations, LLC: lead

Study Sites (1)

Genesys Regional Medical Center

Grand Blanc, Michigan, 48439, United States

Location

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Lisa Guyot, MD

  Ascension Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2013
• First Posted: July 8, 2013
• Study Start: July 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: January 1, 2016
• Last Updated: March 16, 2018

Record last verified: 2013-07

Locations

US (1)