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Spinal DiseasesPhase 3NCT00635843

MAVERICK™ Total Disc Replacement- Pivotal Study

A Phase 3 study testing MAVERICK™ Disc and LT-CAGE® Lumbar Tapered Fusion Device and INFUSE® Bone Graft in people with Spinal Diseases, run by Medtronic Spinal and Biologics at 32 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Spinal Diseases
What is being tested?
MAVERICK™ Disc and LT-CAGE® Lumbar Tapered Fusion Device and INFUSE® Bone Graft
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
577 participants
Where
32 sitesUnited States
Study dates
Apr 2003to Nov 2010
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 32Show fewer
  • 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

Trial locations and contacts

32 sites in 1 country.

32 sites in 1 country

United States32 sites

  • Spine Carolina

    Asheville, North Carolina, 28803

  • Central Texas Spine

    Austin, Texas, 78731

  • New Hampshire Spine Institute

    Bedford, New Hampshire, 03110-4201

  • Boulder Neurosurgical Associates

    Boulder, Colorado, 80304

  • Orthopedic Center of St. Louis

    Chesterfield, Missouri, 63017

  • Northwestern Orthopedic Institute

    Chicago, Illinois, 60611

  • Hughston Clinic

    Columbus, Georgia, 31908

  • The Center for Spine Care

    Dallas, Texas, 75231

  • Spine Care Medical Group

    Daly City, California, 94015

  • Advanced Neurosurgical Center

    El Paso, Texas, 79902

  • Fort Wayne Orthopaedics

    Fort Wayne, Indiana, 46804

  • The Spine Center at TOC

    Huntsville, Alabama, 35801

  • Orthopedics of Indianapolis

    Indianapolis, Indiana, 46278

  • Little Company of Mary Hospital

    Los Angeles, California, 90045

  • Rocky Mountain Associates in Orthopaedic Medicine

    Loveland, Colorado, 80538

  • University of Wisconsin Orthopedic Department

    Madison, Wisconsin, 53792-7375

  • The B.A.C.K. Center

    Melbourne, Florida, 32901-1937

  • Spine Institute of Idaho

    Meridian, Idaho, 83642

  • Institute for Low Back & Neck Care

    Minneapolis, Minnesota, 55407

  • Illinois Bone and Joint Institute

    Morton Grove, Illinois, 60053

  • Southeastern Spine Institute

    Mt. Pleasant, South Carolina, 29464

  • Hospital for Special Surgery

    New York, New York, 10021

  • First State Orthopaedics, P.A.

    Newark, Delaware, 19713

  • Newport Orthopedic Institute

    Newport Beach, California, 92660

  • Oklahoma Sports Science & Ortho

    Oklahoma City, Oklahoma, 73139

  • Nebraska Spine Center, LLC

    Omaha, Nebraska, 68154-4428

  • Orthopaedic Specialty Institute

    Orange, California, 92868

  • Virginia Spine Institute

    Reston, Virginia, 20190

  • Neurosurgical Associates, PC

    Richmond, Virginia, 23229

  • Inland Neurosurgery and Spine Associates, PS

    Spokane, Washington, 99204

  • Orthopaedic & Sports Medicine Center

    Trumbull, Connecticut, 06611

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, 20307

Other trials in United States

About this study

Official title: "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.

Read the 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.

Conditions
Spinal Diseases
Being tested
MAVERICK™ Disc, LT-CAGE® Lumbar Tapered Fusion Device and INFUSE® Bone Graft
Keywords
Lumbar degenerative disc disease at one level from L4-S1
Medical subject headings
Spinal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MAVERICK™ DiscDevice

    Also called MAVERICK™

    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 GraftDevice

    Also called 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.

Study groups in NCT00635843
Study groupRoleWhat they receive
MAVERICK™ DiscExperimentalNot described
Receives: Device: MAVERICK™ Disc
FusionActive comparatorNot described
Receives: Device: LT-CAGE® Lumbar Tapered Fusion Device and INFUSE® Bone Graft

What is being measured

The primary outcome is the main question the study is designed to answer.

  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".

    Measured: 24 Months

Secondary outcomes (11)

  1. Pain/Disability Status

    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

    Measured: 24 Months

  2. Neurological Status

    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.

    Measured: 24 months

  3. Disc Height Measurement

    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

    Measured: 24 months

  4. General Health Status

    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

    Measured: 24 months

  5. Back Pain

    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

    Measured: 24 months

  6. Leg Pain

    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

    Measured: 24 months

  7. Patient Satisfaction

    Measured: 24 months

  8. Patient Global Perceived Effect

    Measured: 24 months

  9. Operative Time

    Measured: At the time of operation

  10. Blood Loss

    Measured: At the time of operation

  11. Number of Hospital Days

    Measured: At the time of discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2008 (estimated)
  2. Study startApr 2003
  3. Primary completionOct 2006
  4. Study completionNov 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
577 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00635843
Sponsor's protocol ID
P01-08
Status last verified
Oct 2011
First submitted
7 Mar 2008
Last updated
2 Aug 2013
Results posted
No
Data monitoring committee
Yes

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. Print 2019 Sep 1.

    PubMed 31100723

  • 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.

    PubMed 23199378

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MAVERICK™ Disc and LT-CAGE® Lumbar Tapered Fusion Device and INFUSE® Bone Graft in people with Spinal Diseases, run by Medtronic Spinal and Biologics at 32 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Success (time frame: 24 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00635843, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2013.

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