MIS MiLIF Versus Open

NCT00792129 | Completed

• 2 other identifiers: ATV-03-0022007-003
• Study Type: observational
• Target: 113
• Locations: 1 country
• Sites: 9

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.

Conditions

Chronic Low Back Pain; Leg Pain

Keywords

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.)

Outcome Measures

Primary Outcomes (1)

• Clinical Outcomes

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

Secondary Outcomes (1)

• Clinical Outcomes

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

Study Arms (2)

Control

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

Device: The Atavi System

Experimental

MiLIF procedure with specialized Atavi instrumentation and minimally invasive visualization capabilities

Device: The Atavi System

Interventions

The Atavi System DEVICE

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.

Also known as: MIS, Minimally invasive, Atavi, Flex Posure, retractor

Control; Experimental

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (9)

La Jolla Spine Institute

La Jolla, California, 92037, United States

Location

Sharp Rees-Stealy Medical Group

San Diego, California, 92123, United States

Location

Advanced Orthopedic Center

Port Charlotte, Florida, 33948, United States

Location

Southeastern Spine Center

Sarasota, Florida, 34232, United States

Location

Kennedy-White Orthopedic

Sarasota, Florida, 34233, United States

Location

Oregon Brain & Spinal Institute

Portland, Oregon, 97225, United States

Location

Williamette Neurosurgery

Salem, Oregon, 97302, United States

Location

William Beaumont Army Medical Center

El Paso, Texas, 97720-5001, United States

Location

Naval Medical Center

Portsmouth, Virginia, 23708, United States

Location

Study Officials

• Joe Murar, M.D.

  Zimmer Spine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2008
• First Posted: November 17, 2008
• Study Start: April 1, 2004
• Primary Completion: March 1, 2006
• Study Completion: June 1, 2009
• Last Updated: February 16, 2012

Record last verified: 2012-02

Locations

US (9)