MIS MiLIF Versus Open

Completed

• Conditions: Chronic Low Back Pain; Leg Pain
• Interventions: Device: The Atavi System

• Registration Number: NCT00792129
• Lead Sponsor: Zimmer Biomet

Brief Summary

This study is being undertaken to compare the clinical outcomes of patients that have unilateral posterolateral lumbar interbody fusion using a traditional open approach versus the MiLIF procedure based on the MiCOR Precision Bone Allograft, specialized Atavi instrumentation, and minimally invasive visualization capabilities.

Detailed Description

This is a prospective, multi-center, non-randomized cohort design clinical study to evaluate the clinical outcomes of patients that have a minimally invasive lumbar interbody fusion (MiLIF) through the Atavi system compared to traditional unilateral open lumbar interbody fusion through a midline incision. the study will involve up to approximately 12 investigational sites and enroll up to 126 patients.

Study Timeline

• Study Start: 2004-04
• Primary Completion: 2006-03
• Study First Submitted: 2008-11-13
• Study First Submitted QC: 2008-11-14
• Study First Posted: 2008-11-17
• Study Completion: 2009-06
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-14
• Last Update Posted: 2012-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

Inclusion Criteria

• Patient is between 18 and 75 years of age

• Patient is scheduled for an elective spinal lumbar interbody single level fusion

• Patient is a candidate for posterior unilateral lumbar fusion through a midline incision

• Indication for surgery and dominant symptom of chronic low back and/or leg pain

• Diagnosis of one or more of the following:

  • Primary symptomatic degenerative disc disease confirmed with appropriate imaging studies and/or positive lumbar discography
  • Spondylolisthesis Grade I/II

• The affected motion segment reside in L2-S1 and are adjacent segments

• Patient, or authorized representative, signs a written Informed Consent form to participate in the study, prior to any study mandated determinations or procedure.

Exclusion Criteria

• Patient has a known fracture in the lumbar spine
• Patient has systemic infection or evidence of any surgical site infection (superficial or organ space)
• Patient has compromised immune system or autoimmune disease (WBC<4000 or >20,000)
• Patient has uncontrolled diabetes
• Patient has a known malignancy
• Prior lumbar fusion attempt; prior laminectomy and/or discectomy are allowed
• Known medical or anatomical condition that would preclude a posterior lumbar fusion using metallic instrumentation (e.g., severe osteopenia)
• Patient with a planned placement of an electric bone stimulator
• Patient with a planned placement of indwelling epidural catheter for a long term pain management
• Patient is pregnant or wishes to become pregnant during the length of the study participation
• Patient is currently in litigation
• Patient is not likely to comply with the follow-up evaluation schedule
• Patient is participating in a clinical trial of another investigational drug or device.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	The Atavi System	Posterior unilateral interbody fusion using an open approach midline incision (TLIF)
Experimental	The Atavi System	MiLIF procedure with specialized Atavi instrumentation and minimally invasive visualization capabilities

Primary Outcome Measures

Name	Time	Method
Clinical Outcomes	MiLIF and Open groups at 3 months post-procedure as defined by the mean Oswestry score

Secondary Outcome Measures

Name	Time	Method
Clinical Outcomes	The percent of patients that have a successful fusion at one year post-procedure as measured by radiographs

Trial Locations

Locations (9)

Williamette Neurosurgery; 🇺🇸 Salem, Oregon, United States

Sharp Rees-Stealy Medical Group; 🇺🇸 San Diego, California, United States

Southeastern Spine Center; 🇺🇸 Sarasota, Florida, United States

Kennedy-White Orthopedic; 🇺🇸 Sarasota, Florida, United States

Oregon Brain & Spinal Institute; 🇺🇸 Portland, Oregon, United States

Naval Medical Center; 🇺🇸 Portsmouth, Virginia, United States

La Jolla Spine Institute; 🇺🇸 La Jolla, California, United States

William Beaumont Army Medical Center; 🇺🇸 El Paso, Texas, United States

Advanced Orthopedic Center; 🇺🇸 Port Charlotte, Florida, United States