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MIS MiLIF Versus Open

CompletedNCT00792129
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
A Multi-Center Study to Evaluate MiLIF(R) Versus Open Posterior Unilateral Lumbar Interbody Fusion (TLIF)
Conditions
Interventions
  • Device: The Atavi System
Sponsor
Zimmer Biomet
Start date
2004-04
Primary completion
2006-03
Sex
All
Age range
from 18 Years to 75 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
9

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00792129