Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
577 participants
INTERVENTIONAL
2003-04-30
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MAVERICK™ Disc
MAVERICK™ Disc
The MAVERICK™ disc is a spinal arthroplasty system and is intended to replace a damaged disc in the lumbar spine. It is a permanent implant used to maintain motion at the treated level and is inserted using an anterior surgical approach.
Fusion
LT-CAGE® Lumbar Tapered Fusion Device and INFUSE® Bone Graft
The control is the treatment with LT-CAGE® Lumbar Tapered Fusion Device and INFUSE® Bone Graft. It is commercially available for anterior lumbar spine interbody fusion procedures.
Interventions
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MAVERICK™ Disc
The MAVERICK™ disc is a spinal arthroplasty system and is intended to replace a damaged disc in the lumbar spine. It is a permanent implant used to maintain motion at the treated level and is inserted using an anterior surgical approach.
LT-CAGE® Lumbar Tapered Fusion Device and INFUSE® Bone Graft
The control is the treatment with LT-CAGE® Lumbar Tapered Fusion Device and INFUSE® Bone Graft. It is commercially available for anterior lumbar spine interbody fusion procedures.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has 1 or more of the following documented by CT, MRI, or plain x-rays: modic changes, high intensity zones in the annulus, loss of disc height, decreased hydration of the disc
* Has documented annular pathology
* Has single-level symptomatic degenerative involvement from L4-S1 requiring surgical treatment
* Has intact facet joints at the involved vertebral levels documented by CT and/or MRI
* Has preop Oswestry score≥30
* Has preop back pain score ≥20
* Age 18 to 70 yrs who are skeletally, mature, inclusive
* Has not responded to non-operative treatment for 6 mos
* If child-bearing potential, patient is non-pregnant, non-nursing, and agrees not to become pregnant for 1 yr after surgery
* Is willing and able to comply with the study plan and sign the Patient Informed Consent Form
Exclusion Criteria
* Had previous posterior lumbar spinal fusion surgical procedure at involved level
* Had prior posterior lumbar surgery resulting in significant muscle/ligament morbidity, not including facet saving techniques
* Had previous anterior lumbar spinal surgery at involved level
* Requires spinal fusion and/or arthroplasty at more than 1 lumbar level
* Has severe pathology of facet joints of involved vertebral bodies
* Has any posterior element insufficiency
* Has spondylolisthesis
* Has spinal canal stenosis
* Has rotatory scoliosis at involved level
* Level treated has fractures secondary to trauma
* Has any of the following that may be associated with a diagnosis of osteoporosis (if Yes, a DEXA Scan is required): Postmenopausal Non-Black female over 60 yrs of age and weighs less than 140 pounds; Postmenopausal female that has sustained a non-traumatic hip, spine or wrist fracture; Male over the age of 60 that has sustained a non-traumatic hip or spine fracture. If level of BMD is -3.5 or lower or -2.5 or lower with vertebral crush fracture, the patient is excluded
* Has fever (temp \> 101°F oral) at time of surgery
* Has a condition that requires postop medications that interfere with fusion, such as steroids or prolonged use of non-steroidal anti-inflammatory drugs, excluding routine perioperative, non-steroidal anti-inflammatory drugs. Does not include low dose aspirin for prophylactic anticoagulation
* Has overt or active bacterial infection, either local or systemic and/or potential for bacteremia
* Has presence or prior history of malignancy (except for basal cell carcinoma of skin)
* Has documented metal allergy, titanium alloy intolerance or cobalt-chrome-molybdenum alloy
* Is mentally incompetent. If questionable, obtain psych consult
* Has a Waddell Signs of Inorganic Behavior score of 3 or greater
* Has chronic or acute renal and/or hepatic failure or prior history of renal and/or hepatic parenchymal disease
* Is prisoner
* Is pregnant
* Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse
* Has received drugs that may interfere with bone metabolism within 2 weeks prior to the surgery date, excluding routine perioperative, non-steroidal anti-inflammatory drugs
* Has history of autoimmune disease
* Has history of exposure to injectable collagen implants
* Has history of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen
* Has received treatment with an investigational therapy within 30 days prior to implantation surgery or treatment is planned during 24 months following the implantation surgery
* Has received any previous exposure to any/all BMP's of either human or animal extraction
* Has history of allergy to bovine products or a history of anaphylaxis
* Has history of any endocrine or metabolic disorder known to affect osteogenesis
* Has any disease that would preclude accurate clinical evaluation
18 Years
70 Years
ALL
No
Sponsors
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Medtronic Spinal and Biologics
INDUSTRY
Responsible Party
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Locations
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The Spine Center at TOC
Huntsville, Alabama, United States
Spine Care Medical Group
Daly City, California, United States
Little Company of Mary Hospital
Los Angeles, California, United States
Newport Orthopedic Institute
Newport Beach, California, United States
Orthopaedic Specialty Institute
Orange, California, United States
Boulder Neurosurgical Associates
Boulder, Colorado, United States
Rocky Mountain Associates in Orthopaedic Medicine
Loveland, Colorado, United States
Orthopaedic & Sports Medicine Center
Trumbull, Connecticut, United States
First State Orthopaedics, P.A.
Newark, Delaware, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
The B.A.C.K. Center
Melbourne, Florida, United States
Hughston Clinic
Columbus, Georgia, United States
Spine Institute of Idaho
Meridian, Idaho, United States
Northwestern Orthopedic Institute
Chicago, Illinois, United States
Illinois Bone and Joint Institute
Morton Grove, Illinois, United States
Fort Wayne Orthopaedics
Fort Wayne, Indiana, United States
Orthopedics of Indianapolis
Indianapolis, Indiana, United States
Institute for Low Back & Neck Care
Minneapolis, Minnesota, United States
Orthopedic Center of St. Louis
Chesterfield, Missouri, United States
Nebraska Spine Center, LLC
Omaha, Nebraska, United States
New Hampshire Spine Institute
Bedford, New Hampshire, United States
Hospital for Special Surgery
New York, New York, United States
Spine Carolina
Asheville, North Carolina, United States
Oklahoma Sports Science & Ortho
Oklahoma City, Oklahoma, United States
Southeastern Spine Institute
Mt. Pleasant, South Carolina, United States
Central Texas Spine
Austin, Texas, United States
The Center for Spine Care
Dallas, Texas, United States
Advanced Neurosurgical Center
El Paso, Texas, United States
Virginia Spine Institute
Reston, Virginia, United States
Neurosurgical Associates, PC
Richmond, Virginia, United States
Inland Neurosurgery and Spine Associates, PS
Spokane, Washington, United States
University of Wisconsin Orthopedic Department
Madison, Wisconsin, United States
Countries
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References
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Gornet MF, Burkus JK, Dryer RF, Peloza JH, Schranck FW, Copay AG. Lumbar disc arthroplasty versus anterior lumbar interbody fusion: 5-year outcomes for patients in the Maverick disc investigational device exemption study. J Neurosurg Spine. 2019 May 17;31(3):347-356. doi: 10.3171/2019.2.SPINE181037. Print 2019 Sep 1.
Burkus JK, Dryer RF, Peloza JH. Retrograde ejaculation following single-level anterior lumbar surgery with or without recombinant human bone morphogenetic protein-2 in 5 randomized controlled trials: clinical article. J Neurosurg Spine. 2013 Feb;18(2):112-21. doi: 10.3171/2012.10.SPINE11908. Epub 2012 Nov 30.
Other Identifiers
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P01-08
Identifier Type: -
Identifier Source: org_study_id