MAVERICK™ Total Disc Replacement- Pivotal Study

Medtronic

Status and phase

Completed

Phase 3

Conditions

Spinal Diseases

Treatments

Device: LT-CAGE® Lumbar Tapered Fusion Device and INFUSE® Bone Graft

Device: MAVERICK™ Disc

Study type

Interventional

Funder types

Industry

Identifiers

NCT00635843

P01-08

Details and patient eligibility

About

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.

Full 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.

Enrollment

577 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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