MIS MiLIF Versus Open - Full Text View

Sponsored by:	Zimmer, Inc.
Information provided by:	Zimmer, Inc.
ClinicalTrials.gov Identifier:	NCT00792129

Purpose

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	Intervention
Chronic Low Back Pain Leg Pain	Device: The Atavi System

MedlinePlus related topics: Back Pain

Drug Information available for: Benzocaine

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	A Multi-Center Study to Evaluate MiLIF(R) Versus Open Posterior Unilateral Lumbar Interbody Fusion (TLIF)

Further study details as provided by Zimmer, Inc.:

Primary Outcome Measures:

Clinical Outcomes [ Time Frame: MiLIF and Open groups at 3 months post-procedure as defined by the mean Oswestry score ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical Outcomes [ Time Frame: The percent of patients that have a successful fusion at one year post-procedure as measured by radiographs ] [ Designated as safety issue: No ]

Estimated Enrollment:	110
Study Start Date:	April 2004
Estimated Study Completion Date:	May 2009
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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.
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.

Groups/Cohorts

Assigned Interventions

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.

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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with chronic low back and/or leg pain who are candiates for elective lumbar interbody fusion through a postierior unilateral approach, that present to either group of surgeons, will be screened for inclusion in the study. If the patient meets all of the eligibility criteria, they wil be enrolled into the study and have either the MiLIF or open procedure depending on the surgoen they present to (i.e., what group their surgeon agreed to participate in).

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00792129

Locations

United States, California
La Jolla Spine Institute
La Jolla, California, United States, 92037
Sharp Rees-Stealy Medical Group
San Diego, California, United States, 92123
United States, Florida
Southeastern Spine Center
Sarasota, Florida, United States, 34232
Kennedy-White Orthopedic
Sarasota, Florida, United States, 34233
Advanced Orthopedic Center
Port Charlotte, Florida, United States, 33948
United States, Oregon
Williamette Neurosurgery
Salem, Oregon, United States, 97302
Oregon Brain & Spinal Institute
Portland, Oregon, United States, 97225
United States, Texas
William Beaumont Army Medical Center
El Paso, Texas, United States, 97720-5001
United States, Virginia
Naval Medical Center
Portsmouth, Virginia, United States, 23708

Sponsors and Collaborators

Zimmer, Inc.

More Information

Responsible Party:	Zimmer Spine ( M Mason Macenski, Director of Clinical Affairs )
Study ID Numbers:	ATV-03-002, 2007-003
Study First Received:	November 13, 2008
Last Updated:	November 14, 2008
ClinicalTrials.gov Identifier:	NCT00792129
Health Authority:	United States: Institutional Review Board

Keywords provided by Zimmer, Inc.:

MIS
Minimally invasive
Atavi
Flex Posure
retractor

Patients with chronic low back and/or leg pain who are candidates for elective lumbar interbody fusion through a posterior unilateral approach,
for inclusion in the study.
If the patient meets all of the eligibility criteria,
they will be enrolled into the study and have either the MiLIF or open procedure depending on the surgeon they present to
(i.e., what group their surgeon agreed to participate in.)

Study placed in the following topic categories:

Signs and Symptoms
Benzocaine
Neurologic Manifestations

Low Back Pain
Pain
Back Pain

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009