MIS MiLIF Versus Open

Chronic Low Back Pain Clinical Trial

Official title:

A Multi-Center Study to Evaluate MiLIF(R) Versus Open Posterior Unilateral Lumbar Interbody Fusion (TLIF)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00792129
• Other study ID #: ATV-03-002
• Secondary ID: 2007-003
• Status: Completed
• Phase: N/A
• First received: November 13, 2008
• Last updated: February 14, 2012
• Start date: April 2004
• Est. completion date: June 2009

Study information

• Verified date: February 2012
• Source: Zimmer, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: June 2009
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Low Back Pain
• Leg Pain
• Low Back Pain

Intervention

Device:
• The Atavi System
The primary device in the Atavi system is the Flex Posture retractor and accessories such as dilators and an Expander Instrument. The Atavi System includes instruments used to access the spine by dilation of the overlying tissues, as well as a retracting device that is used to maintain the access. Once the retractor is in place, the visualization components of the system may be used.

Locations

Country	Name	City	State
United States	William Beaumont Army Medical Center	El Paso	Texas
United States	La Jolla Spine Institute	La Jolla	California
United States	Advanced Orthopedic Center	Port Charlotte	Florida
United States	Oregon Brain & Spinal Institute	Portland	Oregon
United States	Naval Medical Center	Portsmouth	Virginia
United States	Williamette Neurosurgery	Salem	Oregon
United States	Sharp Rees-Stealy Medical Group	San Diego	California
United States	Kennedy-White Orthopedic	Sarasota	Florida
United States	Southeastern Spine Center	Sarasota	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Outcomes		MiLIF and Open groups at 3 months post-procedure as defined by the mean Oswestry score	No
Secondary	Clinical Outcomes		The percent of patients that have a successful fusion at one year post-procedure as measured by radiographs	No