MAVERICK™ Total Disc Replacement- Pivotal Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective, Randomized Controlled Clinical Investigation of MAVERICK™ Total Disc Replacement in Patients With Degenerative Disc Disease

Conditions
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Spinal Diseases

Intervention / Treatment
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* Device: MAVERICK™ Disc
* Device: LT-CAGE® Lumbar Tapered Fusion Device and INFUSE® Bone Graft


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MAVERICK™ Disc<br> | Device: MAVERICK™ Disc<br>* The MAVERICK™ disc is a spinal arthroplasty system and is intended to replace a damaged disc in the lumbar spine. It is a permanent implant used to maintain motion at the treated level and is inserted using an anterior surgical approach.<br>* Other names: MAVERICK™;|
| Active Comparator: Fusion<br> | Device: LT-CAGE® Lumbar Tapered Fusion Device and INFUSE® Bone Graft<br>* The control is the treatment with LT-CAGE® Lumbar Tapered Fusion Device and INFUSE® Bone Graft. It is commercially available for anterior lumbar spine interbody fusion procedures.<br>* Other names: Fusion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Success | A patient will be considered an overall success if all of the following conditions are met: pain/disability(Oswestry)success; neurological status success; disc height success; no serious adverse event classified as implant associated or implant/surgical procedure associated; no additional surgical procedure classified as a failure. | 24 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain/Disability Status | The self-administered Oswestry Low Back pain Disability Questionnaire will be used. Success will be defined as pain/disability improvement postoperatively according to the following definition: Preoperative Score - Postoperative Score >= 15 | 24 Months | 
| Neurological Status | Neurological status will be evaluated preoperatively and postoperatively. Neurological status is based on four types of measurements (sections): motor, sensory, reflexes, and straight leg raise. Each of the categories is comprised of a number of elements. Postoperative evaluations on each element on the Neurological status case report form will be compared to the preoperative evaluations. Success will be defined as maintenance or improvement in each element for the time period evaluated. | 24 months | 
| Disc Height Measurement | Disc height will be measured postoperatively at each visit and compared to the measurement at 6 weeks postoperatively. Disc height success is based on either the anterior or posterior measurements meeting the following criterion: Postoperative Disc Height- 6 Week Postoperative Disc Height >= -2mm | 24 months | 
| General Health Status | The Medical Outcomes Study 36-item Short Form Health Survey (SF-36) will be used to assess general health status. The SF-36 results can be summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). Success will be defined as a maintenance or improvement in status postoperatively as compared to the preoperative condition. To be classified as a success, the following criteria must be met: PCSPostop - PCSPreop >= 0; MCSPostop - MCSPreop >= 0 | 24 months | 
| Back Pain | Numerical rating scales will be used to evaluate pain intensity and duration. The pain score (0 min, 20 Max) is derived by adding the numerical rating scores from the pain intensity (0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be.) and duration scales (0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time). Success for back and leg pain is described as follows: Preoperative Score - Postoperative Score >0 | 24 months | 
| Leg Pain | Numerical rating scales will be used to evaluate pain intensity and duration. The pain score (0 min, 20 Max) is derived by adding the numerical rating scores from the pain intensity (0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be.) and duration scales (0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time). Success for back and leg pain is described as follows: Preoperative Score - Postoperative Score >0 | 24 months | 
| Patient Satisfaction |  | 24 months | 
| Patient Global Perceived Effect |  | 24 months | 
| Operative Time |  | At the time of operation | 
| Blood Loss |  | At the time of operation | 
| Number of Hospital Days |  | At the time of discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumbar degenerative disc disease at one level from L4-S1