Chronic Low Back PainNCT00792129
MIS MiLIF Versus Open
An observational study of Chronic Low Back Pain and Leg Pain, run by Zimmer Biomet at 9 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Low Back Pain, Leg Pain
- What is being tested?
- The Atavi System
- Type of treatment
- Medical device
- How many people
- 113 participants
- Where
- 9 sitesUnited States
- Study dates
- Apr 2004to Jun 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
William Beaumont Army Medical Center
El Paso, Texas, 97720-5001
La Jolla Spine Institute
La Jolla, California, 92037
Advanced Orthopedic Center
Port Charlotte, Florida, 33948
Oregon Brain & Spinal Institute
Portland, Oregon, 97225
Naval Medical Center
Portsmouth, Virginia, 23708
Williamette Neurosurgery
Salem, Oregon, 97302
Sharp Rees-Stealy Medical Group
San Diego, California, 92123
Southeastern Spine Center
Sarasota, Florida, 34232
Kennedy-White Orthopedic
Sarasota, Florida, 34233
About this study
Official title: A Multi-Center Study to Evaluate MiLIF(R) Versus Open Posterior Unilateral Lumbar Interbody Fusion (TLIF)
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.
Read the 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.
- Conditions
- Chronic Low Back Pain, Leg Pain
- Being tested
- The Atavi System
- 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.)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Atavi SystemDevice
Also called MIS, Minimally invasive, Atavi, Flex Posure
The primary device in the Atavi system is the Flex Posture retractor and accessories such as dilators and an Expander Instrument.
The Atavi System includes instruments used to access the spine by dilation of the overlying tissues, as well as a retracting device that is used to maintain the access. Once the retractor is in place, the visualization components of the system may be used.
| Study group | Role | What they receive |
|---|---|---|
| Control | Posterior unilateral interbody fusion using an open approach midline incision (TLIF) Receives: Device: The Atavi System | |
| Experimental | MiLIF procedure with specialized Atavi instrumentation and minimally invasive visualization capabilities Receives: Device: The Atavi System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Outcomes
Measured: MiLIF and Open groups at 3 months post-procedure as defined by the mean Oswestry score
Secondary outcomes (1)
Clinical Outcomes
Measured: The percent of patients that have a successful fusion at one year post-procedure as measured by radiographs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2008 (estimated)
- Study startApr 2004
- Primary completionMar 2006
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joe Murar, M.D., Study director, Zimmer Spine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00792129
- Sponsor's protocol ID
- ATV-03-002
- Other IDs
- 2007-003
- Status last verified
- Feb 2012
- First submitted
- 13 Nov 2008
- Last updated
- 16 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Study to Evaluate MiLIF(R) Versus Open Posterior Unilateral Lumbar Interbody Fusion (TLIF)
- ClinicalTrials.gov ID
- NCT00792129
- Acronym / sponsor ID
- ATV-03-002
- 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,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- Mar 2006 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 17 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Device: The Atavi SystemPosterior unilateral interbody fusion using an open approach midline incision (TLIF) |
| Experimental | – | Device: The Atavi SystemMiLIF procedure with specialized Atavi instrumentation and minimally invasive visualization capabilities |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Atavi SystemAlso: MIS, Minimally invasive, Atavi, Flex PosureThe primary device in the Atavi system is the Flex Posture retractor and accessories such as dilators and an Expander Instrument. The Atavi System includes instruments used to access the spine by dilation of the overlying tissues, as well as a retracting device that is used to maintain the access. Once the retractor is in place, the visualization components of the system may be used. | Device | Control, Experimental |
Primary outcome
Clinical Outcomes
Time frame: MiLIF and Open groups at 3 months post-procedure as defined by the mean Oswestry score
1 secondary outcome
Clinical Outcomes
Time frame: The percent of patients that have a successful fusion at one year post-procedure as measured by radiographs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joe Murar, M.D. study director
Zimmer Spine
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Low Back Pain and Leg Pain, run by Zimmer Biomet at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Outcomes (time frame: MiLIF and Open groups at 3 months post-procedure as defined by the mean Oswestry score). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2012.