MAVERICK™ Total Disc Replacement- Pivotal Study

"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.

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.

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