- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00635843
MAVERICK™ Total Disc Replacement- Pivotal Study
"A Prospective, Randomized Controlled Clinical Investigation of MAVERICK™ Total Disc Replacement in Patients With Degenerative Disc Disease"
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Alabama
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Huntsville, Alabama, United States, 35801
- The Spine Center at TOC
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California
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Daly City, California, United States, 94015
- Spine Care Medical Group
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Los Angeles, California, United States, 90045
- Little Company of Mary Hospital
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Newport Beach, California, United States, 92660
- Newport Orthopedic Institute
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Orange, California, United States, 92868
- Orthopaedic Specialty Institute
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Colorado
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Boulder, Colorado, United States, 80304
- Boulder Neurosurgical Associates
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Loveland, Colorado, United States, 80538
- Rocky Mountain Associates in Orthopaedic Medicine
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Connecticut
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Trumbull, Connecticut, United States, 06611
- Orthopaedic & Sports Medicine Center
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Delaware
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Newark, Delaware, United States, 19713
- First State Orthopaedics, P.A.
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District of Columbia
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Washington, District of Columbia, United States, 20307
- Walter Reed Army Medical Center
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Florida
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Melbourne, Florida, United States, 32901-1937
- The B.A.C.K. Center
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Georgia
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Columbus, Georgia, United States, 31908
- Hughston Clinic
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Idaho
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Meridian, Idaho, United States, 83642
- Spine Institute of Idaho
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern Orthopedic Institute
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Morton Grove, Illinois, United States, 60053
- Illinois Bone And Joint Institute
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Indiana
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Fort Wayne, Indiana, United States, 46804
- Fort Wayne Orthopaedics
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Indianapolis, Indiana, United States, 46278
- Orthopedics of Indianapolis
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Minnesota
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Minneapolis, Minnesota, United States, 55407
- Institute for Low Back & Neck Care
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Missouri
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Chesterfield, Missouri, United States, 63017
- Orthopedic Center of St. Louis
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Nebraska
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Omaha, Nebraska, United States, 68154-4428
- Nebraska Spine Center, LLC
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New Hampshire
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Bedford, New Hampshire, United States, 03110-4201
- New Hampshire Spine Institute
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New York
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New York, New York, United States, 10021
- Hospital for Special Surgery
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North Carolina
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Asheville, North Carolina, United States, 28803
- Spine Carolina
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73139
- Oklahoma Sports Science & Ortho
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South Carolina
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Mt. Pleasant, South Carolina, United States, 29464
- Southeastern Spine Institute
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Texas
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Austin, Texas, United States, 78731
- Central Texas Spine
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Dallas, Texas, United States, 75231
- The Center for Spine Care
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El Paso, Texas, United States, 79902
- Advanced Neurosurgical Center
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Virginia
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Reston, Virginia, United States, 20190
- Virginia Spine Institute
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Richmond, Virginia, United States, 23229
- Neurosurgical Associates, PC
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Washington
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Spokane, Washington, United States, 99204
- Inland Neurosurgery and Spine Associates, PS
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Wisconsin
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Madison, Wisconsin, United States, 53792-7375
- University of Wisconsin Orthopedic Department
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
Other Names:
|
ACTIVE_COMPARATOR: Fusion
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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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Success
Time Frame: 24 Months
|
A patient will be considered an overall success if all of the following conditions are met:
|
24 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Satisfaction
Time Frame: 24 months
|
24 months
|
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Patient Global Perceived Effect
Time Frame: 24 months
|
24 months
|
|
Blood Loss
Time Frame: At the time of operation
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At the time of operation
|
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Pain/Disability Status
Time Frame: 24 Months
|
The self-administered Oswestry Low Back pain Disability Questionnaire will be used. Success will be defined as pain/disability improvement postoperatively according to the following definition: Preoperative Score - Postoperative Score >= 15 |
24 Months
|
Neurological Status
Time Frame: 24 months
|
Neurological status will be evaluated preoperatively and postoperatively.
Neurological status is based on four types of measurements (sections): motor, sensory, reflexes, and straight leg raise.
Each of the categories is comprised of a number of elements.
Postoperative evaluations on each element on the Neurological status case report form will be compared to the preoperative evaluations.
Success will be defined as maintenance or improvement in each element for the time period evaluated.
|
24 months
|
Disc Height Measurement
Time Frame: 24 months
|
Disc height will be measured postoperatively at each visit and compared to the measurement at 6 weeks postoperatively. Disc height success is based on either the anterior or posterior measurements meeting the following criterion: Postoperative Disc Height- 6 Week Postoperative Disc Height >= -2mm |
24 months
|
General Health Status
Time Frame: 24 months
|
The Medical Outcomes Study 36-item Short Form Health Survey (SF-36) will be used to assess general health status. The SF-36 results can be summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). Success will be defined as a maintenance or improvement in status postoperatively as compared to the preoperative condition. To be classified as a success, the following criteria must be met: PCSPostop - PCSPreop >= 0; MCSPostop - MCSPreop >= 0 |
24 months
|
Back Pain
Time Frame: 24 months
|
Numerical rating scales will be used to evaluate pain intensity and duration. The pain score (0 min, 20 Max) is derived by adding the numerical rating scores from the pain intensity (0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be.") and duration scales (0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time"). Success for back and leg pain is described as follows: Preoperative Score - Postoperative Score >0 |
24 months
|
Leg Pain
Time Frame: 24 months
|
Numerical rating scales will be used to evaluate pain intensity and duration. The pain score (0 min, 20 Max) is derived by adding the numerical rating scores from the pain intensity (0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be.") and duration scales (0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time"). Success for back and leg pain is described as follows: Preoperative Score - Postoperative Score >0 |
24 months
|
Operative Time
Time Frame: At the time of operation
|
At the time of operation
|
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Number of Hospital Days
Time Frame: At the time of discharge
|
At the time of discharge
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P01-08
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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