MAVERICK™ Total Disc Replacement- Pivotal Study
- Conditions
- Spinal Diseases
- Interventions
- Device: MAVERICK™ DiscDevice: LT-CAGE® Lumbar Tapered Fusion Device and INFUSE® Bone Graft
- Registration Number
- NCT00635843
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 577
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MAVERICK™ Disc MAVERICK™ Disc - Fusion LT-CAGE® Lumbar Tapered Fusion Device and INFUSE® Bone Graft -
- Primary Outcome Measures
Name Time Method Overall Success 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
Name Time Method Pain/Disability Status 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 \>= 15Neurological Status 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 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 \>= -2mmGeneral Health Status 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 \>= 0Back Pain 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 \>0Leg Pain 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 \>0Patient Satisfaction 24 months Patient Global Perceived Effect 24 months Operative Time At the time of operation Blood Loss At the time of operation Number of Hospital Days At the time of discharge
Trial Locations
- Locations (32)
Rocky Mountain Associates in Orthopaedic Medicine
🇺🇸Loveland, Colorado, United States
Spine Care Medical Group
🇺🇸Daly City, California, United States
Boulder Neurosurgical Associates
🇺🇸Boulder, Colorado, United States
Spine Institute of Idaho
🇺🇸Meridian, Idaho, United States
Southeastern Spine Institute
🇺🇸Mt. Pleasant, South Carolina, United States
Virginia Spine Institute
🇺🇸Reston, Virginia, United States
Orthopaedic & Sports Medicine Center
🇺🇸Trumbull, Connecticut, United States
University of Wisconsin Orthopedic Department
🇺🇸Madison, Wisconsin, United States
The B.A.C.K. Center
🇺🇸Melbourne, Florida, United States
First State Orthopaedics, P.A.
🇺🇸Newark, Delaware, United States
The Spine Center at TOC
🇺🇸Huntsville, Alabama, United States
Inland Neurosurgery and Spine Associates, PS
🇺🇸Spokane, Washington, United States
Central Texas Spine
🇺🇸Austin, Texas, United States
Hughston Clinic
🇺🇸Columbus, Georgia, United States
Advanced Neurosurgical Center
🇺🇸El Paso, Texas, United States
New Hampshire Spine Institute
🇺🇸Bedford, New Hampshire, United States
Orthopaedic Specialty Institute
🇺🇸Orange, California, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Illinois Bone and Joint Institute
🇺🇸Morton Grove, Illinois, United States
Hospital for Special Surgery
🇺🇸New York, New York, United States
Nebraska Spine Center, LLC
🇺🇸Omaha, Nebraska, United States
Spine Carolina
🇺🇸Asheville, North Carolina, United States
The Center for Spine Care
🇺🇸Dallas, Texas, United States
Newport Orthopedic Institute
🇺🇸Newport Beach, California, United States
Little Company of Mary Hospital
🇺🇸Los Angeles, California, United States
Northwestern Orthopedic Institute
🇺🇸Chicago, Illinois, United States
Orthopedics of Indianapolis
🇺🇸Indianapolis, Indiana, United States
Institute for Low Back & Neck Care
🇺🇸Minneapolis, Minnesota, United States
Orthopedic Center of St. Louis
🇺🇸Chesterfield, Missouri, United States
Fort Wayne Orthopaedics
🇺🇸Fort Wayne, Indiana, United States
Oklahoma Sports Science & Ortho
🇺🇸Oklahoma City, Oklahoma, United States
Neurosurgical Associates, PC
🇺🇸Richmond, Virginia, United States