MIS MiLIF Versus Open

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zimmer, Inc.
ClinicalTrials.gov Identifier:
NCT00792129
First received: November 13, 2008
Last updated: February 14, 2012
Last verified: February 2012
  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

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

Resource links provided by NLM:


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 ]

Enrollment: 113
Study Start Date: April 2004
Study Completion Date: June 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.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Advanced Orthopedic Center
Port Charlotte, Florida, United States, 33948
Kennedy-White Orthopedic
Sarasota, Florida, United States, 34233
Southeastern Spine Center
Sarasota, Florida, United States, 34232
United States, Oregon
Oregon Brain & Spinal Institute
Portland, Oregon, United States, 97225
Williamette Neurosurgery
Salem, Oregon, United States, 97302
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.
Investigators
Study Director: Joe Murar, M.D. Zimmer Spine
  More Information

No publications provided

Responsible Party: Zimmer, Inc.
ClinicalTrials.gov Identifier: NCT00792129     History of Changes
Other Study ID Numbers: ATV-03-002, 2007-003
Study First Received: November 13, 2008
Last Updated: February 14, 2012
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.)

Additional relevant MeSH terms:
Low Back Pain
Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014