MIS MiLIF Versus Open
- Conditions
- Chronic Low Back PainLeg Pain
- Registration Number
- NCT00792129
- Lead Sponsor
- Zimmer Biomet
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 113
-
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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical Outcomes MiLIF and Open groups at 3 months post-procedure as defined by the mean Oswestry score
- Secondary Outcome Measures
Name Time Method Clinical Outcomes The percent of patients that have a successful fusion at one year post-procedure as measured by radiographs
Trial Locations
- Locations (9)
La Jolla Spine Institute
🇺🇸La Jolla, California, United States
Sharp Rees-Stealy Medical Group
🇺🇸San Diego, California, United States
Advanced Orthopedic Center
🇺🇸Port Charlotte, Florida, United States
Southeastern Spine Center
🇺🇸Sarasota, Florida, United States
Kennedy-White Orthopedic
🇺🇸Sarasota, Florida, United States
Oregon Brain & Spinal Institute
🇺🇸Portland, Oregon, United States
Williamette Neurosurgery
🇺🇸Salem, Oregon, United States
William Beaumont Army Medical Center
🇺🇸El Paso, Texas, United States
Naval Medical Center
🇺🇸Portsmouth, Virginia, United States
La Jolla Spine Institute🇺🇸La Jolla, California, United States