MIS MiLIF Versus Open
Completed
Conditions studied: Chronic Low Back Pain, Leg Pain
In brief
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.
Key facts
- Study ID
- NCT00792129
- Run by
- Zimmer Biomet
- People needed
- 113
- Starts
- 2004-04-01
- Expected to finish
- 2009-06-01
- Last updated by the study team
- 2012-02-16
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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