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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

Tracking Information
First Submitted Date  ICMJE March 7, 2008
First Posted Date  ICMJE March 14, 2008
Last Update Posted Date August 2, 2013
Study Start Date  ICMJE April 2003
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2012)
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".
Original Primary Outcome Measures  ICMJE
 (submitted: March 13, 2008)
Overall Success= Oswestry Disability Index success; Maintenance/improvement in neurological status; Disc height success; No serious AE classified as implant or implant/surgical procedure associated; No additional surgical procedure classified as failure [ Time Frame: 24 Months ]
Change History Complete list of historical versions of study NCT00635843 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2012)
  • 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
  • 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.
  • 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
  • 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
  • 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
  • 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
  • Patient Satisfaction [ Time Frame: 24 months ]
  • Patient Global Perceived Effect [ Time Frame: 24 months ]
  • Operative Time [ Time Frame: At the time of operation ]
  • Blood Loss [ Time Frame: At the time of operation ]
  • Number of Hospital Days [ Time Frame: At the time of discharge ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2008)
SF-36; Back Pain Status; Leg Pain Status; Patient Satisfaction; Patient Global Perceived Effect; Other Measurements- Radiographic; Return to Work; Doctor's Perception of Results [ Time Frame: 24 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MAVERICK™ Total Disc Replacement- Pivotal Study
Official Title  ICMJE "A Prospective, Randomized Controlled Clinical Investigation of MAVERICK™ Total Disc Replacement in Patients With Degenerative Disc Disease"
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Spinal Diseases
Intervention  ICMJE
  • 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™
  • 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
Study Arms  ICMJE
  • Experimental: MAVERICK™ Disc
    Intervention: Device: MAVERICK™ Disc
  • Active Comparator: Fusion
    Intervention: Device: LT-CAGE® Lumbar Tapered Fusion Device and INFUSE® Bone Graft
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 13, 2008)
577
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00635843
Other Study ID Numbers  ICMJE P01-08
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medtronic Spinal and Biologics
Study Sponsor  ICMJE Medtronic Spinal and Biologics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medtronic Spinal and Biologics
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP