maverick™ total disc replacement- pivotal study

Conditions: Spinal Diseases

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.

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.

Eligibility criteria:
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

Keywords: lumbar degenerative disc disease at one level from l4-s1