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MAVERICK™ Total Disc Replacement- Pivotal Study

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ClinicalTrials.gov Identifier: NCT00635843
Recruitment Status : Completed
First Posted : March 14, 2008
Last Update Posted : August 2, 2013
Sponsor:
Information provided by (Responsible Party):
Medtronic Spinal and Biologics

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.

Condition or disease Intervention/treatment Phase
Spinal Diseases Device: MAVERICK™ Disc Device: LT-CAGE® Lumbar Tapered Fusion Device and INFUSE® Bone Graft Phase 3

Detailed Description:
For this clinical trial, there are two treatment groups, i.e., investigational patients who receive the MAVERICK™ Total Disc Replacement and control patients who receive the anterior lumbar interbody fusion procedure with INFUSE® Bone Graft/LT-CAGE® Lumbar Tapered Fusion Device. Each investigational site will enroll patients in a 2:1 investigational:control treatment randomization scheme.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 577 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: "A Prospective, Randomized Controlled Clinical Investigation of MAVERICK™ Total Disc Replacement in Patients With Degenerative Disc Disease"
Study Start Date : April 2003
Actual Primary Completion Date : October 2006
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MAVERICK™ Disc Device: 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 Name: MAVERICK™

Active Comparator: Fusion Device: 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 Name: Fusion




Primary Outcome Measures :
  1. Overall Success [ Time Frame: 24 Months ]

    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".


Secondary Outcome Measures :
  1. 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


  2. 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.

  3. 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


  4. 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


  5. 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


  6. 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


  7. Patient Satisfaction [ Time Frame: 24 months ]
  8. Patient Global Perceived Effect [ Time Frame: 24 months ]
  9. Operative Time [ Time Frame: At the time of operation ]
  10. Blood Loss [ Time Frame: At the time of operation ]
  11. Number of Hospital Days [ Time Frame: At the time of discharge ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00635843


  Hide Study Locations
Locations
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United States, Alabama
The Spine Center at TOC
Huntsville, Alabama, United States, 35801
United States, California
Spine Care Medical Group
Daly City, California, United States, 94015
Little Company of Mary Hospital
Los Angeles, California, United States, 90045
Newport Orthopedic Institute
Newport Beach, California, United States, 92660
Orthopaedic Specialty Institute
Orange, California, United States, 92868
United States, Colorado
Boulder Neurosurgical Associates
Boulder, Colorado, United States, 80304
Rocky Mountain Associates in Orthopaedic Medicine
Loveland, Colorado, United States, 80538
United States, Connecticut
Orthopaedic & Sports Medicine Center
Trumbull, Connecticut, United States, 06611
United States, Delaware
First State Orthopaedics, P.A.
Newark, Delaware, United States, 19713
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307
United States, Florida
The B.A.C.K. Center
Melbourne, Florida, United States, 32901-1937
United States, Georgia
Hughston Clinic
Columbus, Georgia, United States, 31908
United States, Idaho
Spine Institute of Idaho
Meridian, Idaho, United States, 83642
United States, Illinois
Northwestern Orthopedic Institute
Chicago, Illinois, United States, 60611
Illinois Bone and Joint Institute
Morton Grove, Illinois, United States, 60053
United States, Indiana
Fort Wayne Orthopaedics
Fort Wayne, Indiana, United States, 46804
Orthopedics of Indianapolis
Indianapolis, Indiana, United States, 46278
United States, Minnesota
Institute for Low Back & Neck Care
Minneapolis, Minnesota, United States, 55407
United States, Missouri
Orthopedic Center of St. Louis
Chesterfield, Missouri, United States, 63017
United States, Nebraska
Nebraska Spine Center, LLC
Omaha, Nebraska, United States, 68154-4428
United States, New Hampshire
New Hampshire Spine Institute
Bedford, New Hampshire, United States, 03110-4201
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
United States, North Carolina
Spine Carolina
Asheville, North Carolina, United States, 28803
United States, Oklahoma
Oklahoma Sports Science & Ortho
Oklahoma City, Oklahoma, United States, 73139
United States, South Carolina
Southeastern Spine Institute
Mt. Pleasant, South Carolina, United States, 29464
United States, Texas
Central Texas Spine
Austin, Texas, United States, 78731
The Center for Spine Care
Dallas, Texas, United States, 75231
Advanced Neurosurgical Center
El Paso, Texas, United States, 79902
United States, Virginia
Virginia Spine Institute
Reston, Virginia, United States, 20190
Neurosurgical Associates, PC
Richmond, Virginia, United States, 23229
United States, Washington
Inland Neurosurgery and Spine Associates, PS
Spokane, Washington, United States, 99204
United States, Wisconsin
University of Wisconsin Orthopedic Department
Madison, Wisconsin, United States, 53792-7375
Sponsors and Collaborators
Medtronic Spinal and Biologics

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier: NCT00635843     History of Changes
Other Study ID Numbers: P01-08
First Posted: March 14, 2008    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: October 2011
Keywords provided by Medtronic Spinal and Biologics:
Lumbar degenerative disc disease at one level from L4-S1
Additional relevant MeSH terms:
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Spinal Diseases
Bone Diseases
Musculoskeletal Diseases