Study of the Safety and Effectiveness of the Artificial Cervical Disc - Low Profile Device at Two Adjacent Levels

Study Overview
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Brief Summary
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The purpose of this clinical investigation is to assess the safety and effectiveness of using the PRESTIGE-LP device in the treatment of patients with symptomatic degenerative disc disease at two adjacent levels of the cervical spine, 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 also be examined as the secondary objective.

Detailed Description
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This clinical investigation is being conducted to evaluate the PRESTIGE-LP device's performance at two adjacent cervical levels (C3-C7) in the treatment of patients with symptomatic degenerative disc disease. One-half of the patients in this randomized pivotal clinical trial will be treated at two adjacent cervical levels with the PRESTIGE-LP device. The remaining patients will receive a bi-level anterior cervical discectomy and fusion with cortical ring allografts and the ATLANTIS Cervical Plate System.

Official Title
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A Prospective, Randomized, Controlled, Multicenter Pivotal Clinical Trial of the Artificial Cervical Disc-LP at Two Levels for Symptomatic Cervical Disc Disease

Conditions
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Cervical Degenerative Disc Disease, Radiculopathy, Myelopathy

Intervention / Treatment
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* Device: PRESTIGE LP device at two adjacent levels
* Device: Bi-level fusion with ATLANTIS Cervical Plate System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has cervical DDD at 2 adjacent cervical levels (C3-C7) requiring surgical treatment & involving intractable radiculopathy, myelopathy, or both Has a herniated disc and/or osteophyte formation at each level to be treated that is producing symptomatic nerve root and/or spinal cord compression. The condition is documented by patient history, and the requirement for surgical treatment is evidenced by radiographic studies Unresponsive to non-operative treatment for approximately 6 weeks or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management Has no previous surgical intervention at the involved levels or any subsequent planned/staged surgical procedure at the involved or adjacent level(s) Must be ≥ 18 years; skeletally mature at time of surgery Preoperative NDI score ≥ 30 Preoperative neck pain score ≥ 8 based on the preoperative Neck and Arm Pain Questionnaire If a female of childbearing potential, patient is non-pregnant, non-nursing, and agrees not to become pregnant during the study period Is willing to comply with the study plan and sign Patient Informed Consent Form Exclusion Criteria: Has a cervical spinal condition other than symptomatic cervical DDD requiring surgical treatment at the involved levels Has documented or diagnosed cervical instability relative to adjacent segments at either level, defined by dynamic (flexion/extension) radiographs showing: Sagittal plane translation > 3.5 mm, or Sagittal plane angulation > 20 degrees. Has more than two cervical levels requiring surgical treatment Has a fused level adjacent to the levels to be treated Has severe pathology of the facet joints of the involved vertebral bodies Has had previous surgical intervention at either one or both of the involved levels or at adjacent levels Has been previously diagnosed with osteopenia or osteomalacia Has any of the following that may be associated with a diagnosis of osteoporosis (If Yes to any of the below a DEXA Scan will be required to determine eligibility.) Postmenopausal non-Black female over age of 60 who weighs < 140 pounds Postmenopausal female who has sustained a non-traumatic hip, spine, or wrist fracture Male > 70 years Male > 60 years who has sustained a non-traumatic hip or spine fracture If the level of BMD is a T score of -3.5 or lower or a T score of -2.5 or lower with vertebral crush fracture, then the patient is excluded from the study Has presence of spinal metastases Has overt or active bacterial infection, either local or systemic Has insulin dependent diabetes Is a tobacco user who does not agree to suspend smoking prior to surgery Has chronic or acute renal failure or prior history of renal disease Has a documented allergy or intolerance to stainless steel, titanium, or a titanium alloy Is mentally incompetent (If questionable, obtain psychiatric consult) Is a prisoner Is pregnant Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse Is involved with current or pending litigation regarding a spinal condition Has received drugs that may interfere with bone metabolism within two weeks prior to the planned date of spinal surgery (e.g., steroids or methotrexate), excluding routine perioperative anti-inflammatory drugs Has a history of an endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's Disease, renal osteodystrophy, Ehlers-Danlos Syndrome, or osteogenesis imperfecta) Has a condition that requires postoperative medications that interfere with the stability of the implant, such as steroids. (This does not include low-dose aspirin for prophylactic anticoagulation and routine perioperative anti-inflammatory drugs.) Has received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following implantation

Ages Eligible for Study
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Minimum Age: 18 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: PRESTIGE LP Device<br> | Device: PRESTIGE LP device at two adjacent levels<br>* PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.<br>* Other names: cervical disc;|
| Other: ATLANTIS Cervical Plate System<br> | Device: Bi-level fusion with ATLANTIS Cervical Plate System<br>* Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.<br>* Other names: cervical fusion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Overall Success | Rate of overall success is reported as the percentage of participants who met all of the following criteria: Postoperative Neck Disability Index (NDI) score improvement of at least a 15-point increase from preoperative; Maintenance or improvement in neurological status; No serious adverse event classified as implant associated or implant/surgical procedure associated; and No additional surgical procedure classified as a failure. | 24 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success Rate of Neck Disability Index | Success rate of Neck Disability Index is reported as the percentage of participants whose neck disability index score met the following criterion: Pre-treatment Score - Post-treatment Score ≥ 15. | 24 months | 
| Success Rate of Neurological Status | Success rate of neurological status is reported as the percentage of participants who met neurological success defined as maintenance or improvement in all sections (motor, sensory, and reflexes) for the time period evaluated. In order for a section to be considered a success, each element in the section must either remain the same or improve from the time of the preoperative evaluation to the time period evaluated. | 24 months | 
| Neck Pain Success Rate | Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 20 max) was 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 frequency 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). Neck pain success rate is reported as the percentage of participants whose neck pain improvement met the following criterion: Preoperative Score - Postoperative Score > 0. | 24 months | 
| Arm Pain Success Rate | Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 20 max) was 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 frequency 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). Arm pain success rate is reported as the percentage of participants whose arm pain improvement met the following criterion: Preoperative Score - Postoperative Score > 0. | 24 months | 
| Success Rate of SF-36 PCS | Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success of SF-36 PCS was defined as: Post Score - Pre Score >= 0. The Success rate of SF-36 PCS is reported as the percentage of the participants who were classified as a success for SF-36 PCS. | 24 months | 
| Success Rate of SF-36 MCS | Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success of SF-36 MCS were defined as: Post Score - Pre Score >= 0. The Success rate of SF-36 MCS is reported as the percentage of the participants who were classified as a success for SF-36 MCS. | 24 months | 
| Rate of Disc Height Success | Disc height was assessed by determining the Functional Spinal Unit (FSU) height. The rate of disc height success is reported as the percentage of participants whose disc height for each level based on either the anterior or posterior measurements met the following criterion: Postoperative Height - 6 Week Postoperative Height >= -2mm | 24 months | 
| Gait Success Rate | Patient's gait was assessed by using Nurick's classification, and indicated either as normal or graded on a scale of 0 to 5. Success was defined as maintenance or improvement in the postoperative status as compared to the preoperative condition: Preoperative Score - Postoperative Score >= 0. The gait success rate is reported as the percentage of participants who had gait success. | 24 months | 
| Operative Time | Operative time was recorded from skin incision to wound closure. | Time of operation, an average of 1.7-2.1hrs | 
| Blood Loss |  | During the time of operation, an average of 1.7-2.1 hrs | 
| Hospital Stay |  | From admission to discharge, an average of 1.0-1.5 day | 
| Rate of Secondary Surgery at Index Level | Secondary surgical procedures at the index level included revisions, removals, supplemental fixations and reoperations. Rate of secondary surgery at index level is reported as percentage of subjects who had secondary surgeries at index level. | 24 months | 
| Change of Neck Disability Index Score From Baseline | The self-administered Neck Disability Index (NDI) Questionnaire was used to assess patient neck pain and ability to function. The NDI scale ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability). Change of NDI was defined as NDI at 24 month minus NDI at baseline. | Baseline and 24 months post-operation | 
| Change of Neck Pain Score From Baseline | Numerical rating scales were used to evaluate neck pain intensity and frequency. Subjects rated their neck pain intensity on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be. Similarly, subjects recorded their neck pain frequency on a scale from 0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time. The total neck pain score (0 to 20) was the addition of pain intensity and frequency scores. Change of neck pain score was defined as neck pain score at 24 months minus neck pain score at baseline. | Baseline and 24 months post-operation | 
| Change of Arm Pain Score From Baseline | Numerical rating scales were also used to evaluate arm pain intensity and frequency. Subjects rated their arm pain intensity on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be. Similarly, subjects recorded their arm pain frequency on a scale from 0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time. The total arm pain score (0 to 20) was the addition of pain intensity and frequency scores. Change of arm pain score was defined as arm pain score at 24 months minus arm pain score at baseline. | Baseline and 24 months post-operation | 
| Change of General Health Status -- SF-36 PCS From Baseline | The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 PCS score was defined as PCS score at 24 months minus PCS score at baseline. | Baseline and 24 months post-operation | 
| Change of General Health Status -- SF-36 MCS From Baseline | The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for MCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 MCS score was defined as MCS score at 24 months minus MCS score at baseline. | Baseline and 24 months post-operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Symptomatic DDD at Two Adjacent Levels of cervical spine