Status:
COMPLETED
MIS MiLIF Versus Open
Lead Sponsor:
Zimmer Biomet
Conditions:
Chronic Low Back Pain
Leg Pain
Eligibility:
All Genders
18-75 years
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 bas...
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 th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT00792129
Start Date
April 1 2004
End Date
June 1 2009
Last Update
February 16 2012
Active Locations (9)
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1
La Jolla Spine Institute
La Jolla, California, United States, 92037
2
Sharp Rees-Stealy Medical Group
San Diego, California, United States, 92123
3
Advanced Orthopedic Center
Port Charlotte, Florida, United States, 33948
4
Southeastern Spine Center
Sarasota, Florida, United States, 34232