Clinical trial NCT00635843: MAVERICK™ Total Disc Replacement- Pivotal Study
Official title: "A Prospective, Randomized Controlled Clinical Investigation of MAVERICK™ Total Disc Replacement in Patients With Degenerative Disc Disease"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Spinal Diseases
Keywords: Lumbar degenerative disc disease at one level from L4-S1
Lead sponsor: Medtronic Spinal and Biologics
Sponsor class: INDUSTRY
First posted: 2008-03-14
Enrollment: 577
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Overall Success
timeFrame: 24 Months
Secondary outcomes:
measure: Pain/Disability Status
timeFrame: 24 Months
measure: Neurological Status
timeFrame: 24 months
measure: Disc Height Measurement
timeFrame: 24 months
measure: General Health Status
timeFrame: 24 months
measure: Back Pain
timeFrame: 24 months
measure: Leg Pain
timeFrame: 24 months
measure: Patient Satisfaction
timeFrame: 24 months
measure: Patient Global Perceived Effect
timeFrame: 24 months
measure: Operative Time
timeFrame: At the time of operation
measure: Blood Loss
timeFrame: At the time of operation
measure: Number of Hospital Days
timeFrame: At the time of discharge
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: The Spine Center at TOC
state: Alabama
city: Daly City
country: United States
facility: Spine Care Medical Group
state: California
city: Los Angeles
country: United States
facility: Little Company of Mary Hospital
state: California
city: Newport Beach
country: United States
facility: Newport Orthopedic Institute
state: California
city: Orange
country: United States
facility: Orthopaedic Specialty Institute
state: California
city: Boulder
country: United States
facility: Boulder Neurosurgical Associates
state: Colorado
city: Loveland
country: United States
facility: Rocky Mountain Associates in Orthopaedic Medicine
state: Colorado
city: Trumbull
country: United States
facility: Orthopaedic & Sports Medicine Center
state: Connecticut
city: Newark
country: United States
facility: First State Orthopaedics, P.A.
state: Delaware
city: Washington
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
city: Melbourne
country: United States
facility: The B.A.C.K. Center
state: Florida
city: Columbus
country: United States
facility: Hughston Clinic
state: Georgia
city: Meridian
country: United States
facility: Spine Institute of Idaho
state: Idaho
city: Chicago
country: United States
facility: Northwestern Orthopedic Institute
state: Illinois
city: Morton Grove
country: United States
facility: Illinois Bone and Joint Institute
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Orthopaedics
state: Indiana
city: Indianapolis
country: United States
facility: Orthopedics of Indianapolis
state: Indiana
city: Minneapolis
country: United States
facility: Institute for Low Back & Neck Care
state: Minnesota
city: Chesterfield
country: United States
facility: Orthopedic Center of St. Louis
state: Missouri
city: Omaha
country: United States
facility: Nebraska Spine Center, LLC
state: Nebraska
city: Bedford
country: United States
facility: New Hampshire Spine Institute
state: New Hampshire
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Asheville
country: United States
facility: Spine Carolina
state: North Carolina
city: Oklahoma City
country: United States
facility: Oklahoma Sports Science & Ortho
state: Oklahoma
city: Mt. Pleasant
country: United States
facility: Southeastern Spine Institute
state: South Carolina
city: Austin
country: United States
facility: Central Texas Spine
state: Texas
city: Dallas
country: United States
facility: The Center for Spine Care
state: Texas
city: El Paso
country: United States
facility: Advanced Neurosurgical Center
state: Texas
city: Reston
country: United States
facility: Virginia Spine Institute
state: Virginia
city: Richmond
country: United States
facility: Neurosurgical Associates, PC
state: Virginia
city: Spokane
country: United States
facility: Inland Neurosurgery and Spine Associates, PS
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Orthopedic Department
state: Wisconsin
Study officials:
References:
citation: Gornet MF, Burkus JK, Dryer RF, Peloza JH, Schranck FW, Copay AG. Lumbar disc arthroplasty versus anterior lumbar interbody fusion: 5-year outcomes for patients in the Maverick disc investigational device exemption study. J Neurosurg Spine. 2019 May 17;31(3):347-356. doi: 10.3171/2019.2.SPINE181037. Print 2019 Sep 1.
citation: Burkus JK, Dryer RF, Peloza JH. Retrograde ejaculation following single-level anterior lumbar surgery with or without recombinant human bone morphogenetic protein-2 in 5 randomized controlled trials: clinical article. J Neurosurg Spine. 2013 Feb;18(2):112-21. doi: 10.3171/2012.10.SPINE11908. Epub 2012 Nov 30.