Clinical trial NCT00792129: MIS MiLIF Versus Open
Official title: A Multi-Center Study to Evaluate MiLIF(R) Versus Open Posterior Unilateral Lumbar Interbody Fusion (TLIF)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Low Back Pain
Leg Pain
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.)
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2008-11-17
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic low back and/or leg pain who are candiates for elective lumbar interbody fusion through a postierior unilateral approach, that present to either group of surgeons, will be screened for inclusion in the study. If the patient meets all of the eligibility criteria, they wil be enrolled into the study and have either the MiLIF or open procedure depending on the surgoen 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical Outcomes
timeFrame: MiLIF and Open groups at 3 months post-procedure as defined by the mean Oswestry score
Secondary outcomes:
measure: Clinical Outcomes
timeFrame: The percent of patients that have a successful fusion at one year post-procedure as measured by radiographs
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: La Jolla Spine Institute
state: California
city: San Diego
country: United States
facility: Sharp Rees-Stealy Medical Group
state: California
city: Port Charlotte
country: United States
facility: Advanced Orthopedic Center
state: Florida
city: Sarasota
country: United States
facility: Southeastern Spine Center
state: Florida
city: Sarasota
country: United States
facility: Kennedy-White Orthopedic
state: Florida
city: Portland
country: United States
facility: Oregon Brain & Spinal Institute
state: Oregon
city: Salem
country: United States
facility: Williamette Neurosurgery
state: Oregon
city: El Paso
country: United States
facility: William Beaumont Army Medical Center
state: Texas
city: Portsmouth
country: United States
facility: Naval Medical Center
state: Virginia
Study officials:
affiliation: Zimmer Spine
name: Joe Murar, M.D.
role: STUDY_DIRECTOR
References: