MAVERICK™ Total Disc Replacement- Pivotal Study

August 1, 2013 updated by: Medtronic Spinal and Biologics

"A Prospective, Randomized Controlled Clinical Investigation of MAVERICK™ Total Disc Replacement in Patients With Degenerative Disc Disease"

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

577

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • MAVERICK™
ACTIVE_COMPARATOR: Fusion
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:
  • Fusion

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:

  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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction
Time Frame: 24 months
24 months
Patient Global Perceived Effect
Time Frame: 24 months
24 months
Blood Loss
Time Frame: At the time of operation
At the time of operation
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
Number of Hospital Days
Time Frame: At the time of discharge
At the time of discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (ACTUAL)

October 1, 2006

Study Completion (ACTUAL)

November 1, 2010

Study Registration Dates

First Submitted

March 7, 2008

First Submitted That Met QC Criteria

March 13, 2008

First Posted (ESTIMATE)

March 14, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 2, 2013

Last Update Submitted That Met QC Criteria

August 1, 2013

Last Verified

October 1, 2011

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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