MAVERICK™ Total Disc Replacement- Pivotal Study

Completed · Phase 3

Conditions studied: Spinal Diseases

In brief

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.

Key facts

Study ID: NCT00635843
Run by: Medtronic Spinal and Biologics
People needed: 577
Starts: 2003-04-01
Expected to finish: 2010-11-01
Last updated by the study team: 2013-08-02

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

The Spine Center at TOC — Huntsville, Alabama, United States
Spine Care Medical Group — Daly City, California, United States
Little Company of Mary Hospital — Los Angeles, California, United States
Newport Orthopedic Institute — Newport Beach, California, United States
Orthopaedic Specialty Institute — Orange, California, United States
Boulder Neurosurgical Associates — Boulder, Colorado, United States
Rocky Mountain Associates in Orthopaedic Medicine — Loveland, Colorado, United States
Orthopaedic & Sports Medicine Center — Trumbull, Connecticut, United States
First State Orthopaedics, P.A. — Newark, Delaware, United States
Walter Reed Army Medical Center — Washington D.C., District of Columbia, United States
The B.A.C.K. Center — Melbourne, Florida, United States
Hughston Clinic — Columbus, Georgia, United States
Spine Institute of Idaho — Meridian, Idaho, United States
Northwestern Orthopedic Institute — Chicago, Illinois, United States
Illinois Bone and Joint Institute — Morton Grove, Illinois, United States
Fort Wayne Orthopaedics — Fort Wayne, Indiana, 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
Nebraska Spine Center, LLC — Omaha, Nebraska, United States
New Hampshire Spine Institute — Bedford, New Hampshire, United States
Hospital for Special Surgery — New York, New York, United States
Spine Carolina — Asheville, North Carolina, United States
Oklahoma Sports Science & Ortho — Oklahoma City, Oklahoma, United States
Southeastern Spine Institute — Mt. Pleasant, South Carolina, United States

Full record on ClinicalTrials.gov

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