MIS MiLIF Versus Open

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

113 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-04-30

Study Completion Date

2009-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Low Back Pain Leg Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Control

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

The Atavi System

Intervention Type 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.

Experimental

MiLIF procedure with specialized Atavi instrumentation and minimally invasive visualization capabilities

The Atavi System

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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MIS Minimally invasive Atavi Flex Posure retractor

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No