Chronic Low Back Pain, Leg Pain
Conditions
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.)
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.
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.
Interventions
DEVICEThe 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.
Sponsors
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Outcomes | MiLIF and Open groups at 3 months post-procedure as defined by the mean Oswestry score |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Outcomes | The percent of patients that have a successful fusion at one year post-procedure as measured by radiographs |
Countries
United States
Outcome results
None listed