MIS MiLIF Versus Open

Zimmer Biomet

Status

Completed

Conditions

Chronic Low Back Pain

Leg Pain

Treatments

Device: The Atavi System

Study type

Observational

Funder types

Industry

Identifiers

NCT00792129

2007-003

ATV-03-002

Details and patient eligibility

About

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.

Full 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.

Enrollment

113 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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.