Status:
COMPLETED
MAVERICK™ Total Disc Replacement- Pivotal Study
Lead Sponsor:
Medtronic Spinal and Biologics
Conditions:
Spinal Diseases
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
577 Patients enrolled
Trial Details
Trial ID
NCT00635843
Start Date
April 1 2003
End Date
November 1 2010
Last Update
August 2 2013
Active Locations (32)
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1
The Spine Center at TOC
Huntsville, Alabama, United States, 35801
2
Spine Care Medical Group
Daly City, California, United States, 94015
3
Little Company of Mary Hospital
Los Angeles, California, United States, 90045
4
Newport Orthopedic Institute
Newport Beach, California, United States, 92660