MIS MiLIF Versus Open

Sponsor

Zimmer Biomet (Industry)

Overall Status

Completed

CT.gov ID

NCT00792129

Collaborator

(none)

113

Enrollment

Locations

Duration (Months)

12.6

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Low Back Pain Leg Pain	Device: The Atavi System

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 Design

Study Type:

Observational

Actual Enrollment :

113 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Apr 1, 2004

Actual Primary Completion Date :

Mar 1, 2006

Actual Study Completion Date :

Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Control Posterior unilateral interbody fusion using an open approach midline incision (TLIF)	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. Other Names: MIS Minimally invasive Atavi Flex Posure retractor
Experimental MiLIF procedure with specialized Atavi instrumentation and minimally invasive visualization capabilities	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. Other Names: MIS Minimally invasive Atavi Flex Posure retractor

Arm

Intervention/Treatment

Control

Posterior unilateral interbody fusion using an open approach midline incision (TLIF)

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.

Other Names:

MIS

Minimally invasive

Atavi

Flex Posure

retractor

Experimental

MiLIF procedure with specialized Atavi instrumentation and minimally invasive visualization capabilities

Device: The Atavi System

Other Names:

MIS

Minimally invasive

Atavi

Flex Posure

retractor

Outcome Measures

Primary Outcome Measures

Clinical Outcomes [MiLIF and Open groups at 3 months post-procedure as defined by the mean Oswestry score]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	La Jolla Spine Institute	La Jolla	California	United States	92037
2	Sharp Rees-Stealy Medical Group	San Diego	California	United States	92123
3	Advanced Orthopedic Center	Port Charlotte	Florida	United States	33948
4	Southeastern Spine Center	Sarasota	Florida	United States	34232
5	Kennedy-White Orthopedic	Sarasota	Florida	United States	34233
6	Oregon Brain & Spinal Institute	Portland	Oregon	United States	97225
7	Williamette Neurosurgery	Salem	Oregon	United States	97302
8	William Beaumont Army Medical Center	El Paso	Texas	United States	97720-5001
9	Naval Medical Center	Portsmouth	Virginia	United States	23708