MAVERICK™ Total Disc Replacement- Pivotal Study
"A Prospective, Randomized Controlled Clinical Investigation of MAVERICK™ Total Disc Replacement in Patients With Degenerative Disc Disease"
1 other identifier
interventional
577
1 country
32
Brief Summary
The purpose of this clinical trial is to assess the safety and effectiveness of the MAVERICK™ Total Disc Replacement as a method of treating patients with lumbar degenerative disc disease at one level from L4-S1, with overall success being the primary endpoint of the clinical trial. The primary objective is to show non-inferiority of the investigational device to the control treatment. If non-inferiority is established, superiority will be examined.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2003
Longer than P75 for phase_3
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 7, 2008
CompletedFirst Posted
Study publicly available on registry
March 14, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedAugust 2, 2013
October 1, 2011
3.5 years
March 7, 2008
August 1, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Success
A patient will be considered an overall success if all of the following conditions are met: 1. pain/disability(Oswestry)success; 2. neurological status success; 3. disc height success; 4. no serious adverse event classified as "implant associated" or "implant/surgical procedure associated"; 5. no additional surgical procedure classified as a "failure".
24 Months
Secondary Outcomes (11)
Pain/Disability Status
24 Months
Neurological Status
24 months
Disc Height Measurement
24 months
General Health Status
24 months
Back Pain
24 months
- +6 more secondary outcomes
Study Arms (2)
MAVERICK™ Disc
EXPERIMENTALFusion
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- Has DDD as noted by back pain of discogenic origin, with or without leg pain, with degeneration of the disc confirmed by patient history
- 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
You may not qualify if:
- Has primary diagnosis of a spinal disorder other than DDD at involved level
- 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
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
The Spine Center at TOC
Huntsville, Alabama, 35801, United States
Spine Care Medical Group
Daly City, California, 94015, United States
Little Company of Mary Hospital
Los Angeles, California, 90045, United States
Newport Orthopedic Institute
Newport Beach, California, 92660, United States
Orthopaedic Specialty Institute
Orange, California, 92868, United States
Boulder Neurosurgical Associates
Boulder, Colorado, 80304, United States
Rocky Mountain Associates in Orthopaedic Medicine
Loveland, Colorado, 80538, United States
Orthopaedic & Sports Medicine Center
Trumbull, Connecticut, 06611, United States
First State Orthopaedics, P.A.
Newark, Delaware, 19713, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307, United States
The B.A.C.K. Center
Melbourne, Florida, 32901-1937, United States
Hughston Clinic
Columbus, Georgia, 31908, United States
Spine Institute of Idaho
Meridian, Idaho, 83642, United States
Northwestern Orthopedic Institute
Chicago, Illinois, 60611, United States
Illinois Bone and Joint Institute
Morton Grove, Illinois, 60053, United States
Fort Wayne Orthopaedics
Fort Wayne, Indiana, 46804, United States
Orthopedics of Indianapolis
Indianapolis, Indiana, 46278, United States
Institute for Low Back & Neck Care
Minneapolis, Minnesota, 55407, United States
Orthopedic Center of St. Louis
Chesterfield, Missouri, 63017, United States
Nebraska Spine Center, LLC
Omaha, Nebraska, 68154-4428, United States
New Hampshire Spine Institute
Bedford, New Hampshire, 03110-4201, United States
Hospital for Special Surgery
New York, New York, 10021, United States
Spine Carolina
Asheville, North Carolina, 28803, United States
Oklahoma Sports Science & Ortho
Oklahoma City, Oklahoma, 73139, United States
Southeastern Spine Institute
Mt. Pleasant, South Carolina, 29464, United States
Central Texas Spine
Austin, Texas, 78731, United States
The Center for Spine Care
Dallas, Texas, 75231, United States
Advanced Neurosurgical Center
El Paso, Texas, 79902, United States
Virginia Spine Institute
Reston, Virginia, 20190, United States
Neurosurgical Associates, PC
Richmond, Virginia, 23229, United States
Inland Neurosurgery and Spine Associates, PS
Spokane, Washington, 99204, United States
University of Wisconsin Orthopedic Department
Madison, Wisconsin, 53792-7375, United States
Related Publications (2)
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.
PMID: 31100723DERIVEDBurkus 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.
PMID: 23199378DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2008
First Posted
March 14, 2008
Study Start
April 1, 2003
Primary Completion
October 1, 2006
Study Completion
November 1, 2010
Last Updated
August 2, 2013
Record last verified: 2011-10