Comparison of DISCOVER™ Artificial Cervical Disc and ACDF for Treatment of Cervical DDD (IDE Study)

Study Overview
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Brief Summary
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This study is intended to treat patients with symptomatic degenerative disc disease at one level of the cervical spine. The patients will be randomized to the DISCOVER Artificial Cervical Disc (total disc replacement) or SLIM-LOC™ (cervical fusion) to determine the safety and efficacy at 2 years post operative. Follow-up on patients treated with total disc replacement will be continued to 5 years post operative.

Detailed Description
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This study is designed as a multicenter, prospective, randomized, controlled trial. Subjects will be stratified by the number of levels to be treated then assigned treatment in a randomized 1:1 ratio. Participants in the treatment group will undergo cervical total disc replacement with the DISCOVER Artificial Cervical Disc. Participants in the control group will undergo anterior cervical discectomy and fusion with the SLIM-LOC™ Anterior Cervical Plate System with a cortical or cortico-cancellous allograft spacer. Follow-up visits will occur at 2 weeks, 3 and 6 months and 1, and 2 years for all randomized subjects. Subjects that received the control treatment will complete their required study participation at 2 years post operative and subjects assigned the Discover treatment will complete their participation at 5 years post operative. Follow-up for the Discover treatment group will be via a telephone administered questionnaire at 3, 4 and 5 years post operative.

Official Title
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A Multi-Center, Prospective, Randomized Controlled Trial Comparing Cervical Arthroplasty to Anterior Cervical Discectomy and Fusion for the Treatment of Cervical Degenerative Disc Disease

Conditions
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Cervical Degenerative Disc Disease

Intervention / Treatment
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* Device: Cervical TDR
* Device: ACDF with plate


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Objective evidence of cervical disc disease in 1 vertebral level between C3-C7 defined as (a) shoulder and/or arm pain in a documented radicular distribution resulting from herniated disc or bony osteophytes or (b)myeloradiculopathy resulting from mild spinal cord compression and nerve root impingement Unresponsiveness to documented non-surgical management for greater than or equal to 6 weeks and/or presentation with progressive symptoms of nerve root or spinal cord compression in the face of continued non-surgical management Moderate Neck Disability Index (NDI) score Able to give informed consent for study participation Able and willing to return for all follow-up visits Key Exclusion Criteria: Significant cervical degenerative disc disease Prior fusion procedure at any level(s) (C1-T1) Marked cervical instability on lateral or flexion/extension radiographs Presence of systemic infection or infection at the surgical site Diagnosis of a condition, or requires postoperative medication(s), which may interfere with bony/soft tissue healing History of alcohol and/or drug abuse Any known allergy to a metal alloy or polyethylene Morbid obesity Any significant general illness (e.g., metastatic cancer, HIV)

Ages Eligible for Study
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Minimum Age: 21 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1-level Cervical TDR<br>Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. | Device: Cervical TDR<br>* Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.<br>* Other names: DISCOVER disc;|
| Active Comparator: 1-level ACDF with plate<br>Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. | Device: ACDF with plate<br>* Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.<br>* Other names: Anterior cervical discectomy and fusion with plate;|
| Experimental: 2-level Cervical TDR<br>Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. | Device: Cervical TDR<br>* Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.<br>* Other names: DISCOVER disc;|
| Active Comparator: 2-level ACDF<br>Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. | Device: ACDF with plate<br>* Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.<br>* Other names: Anterior cervical discectomy and fusion with plate;|
| Experimental: Training: 1 & 2-level Cervical TDR<br>Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. | Device: Cervical TDR<br>* Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.<br>* Other names: DISCOVER disc;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Success | Subject must show 15 point improvement in the Neck Disability Index from baseline to 24 months post operative as well as have no device related SAE, Secondary Surgical Interventions at the index level or any new permanent neurological deterioration. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NDI Success | 15 point improvement in NDI. NDI has a max score of 50, which is calculated based on the 6 answers to each of the 10 questions. Each answer within a question is given a numerical value 0 to 5. | 24 months | 
| Neurological Component of Success | no new clinically significant permanent abnormalities in neurological function | 24 months | 
| Subsequent Secondary Surgery Component of Success | no subsequent secondary surgical intervention at the index level | 24 months | 
| Device-Related SAE Component of Success | no device related serious adverse events | 24 months | 
| NDI - Change From Baseline | Change from baseline of the Neck Disability Index. NDI has a minimum score of 0 (no disability) and a maximum score of 50 (complete disability) , which is calculated based on the 6 answers to each of the 10 questions. Each answer within a question is given a numerical value 0 to 5. | 24 months | 
| Neck Pain VAS Scores - Change From Baseline | Change from baseline of the Neck Pain VAS Scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their neck. | 24 months | 
| Maximum Arm Pain VAS - Change From Baseline | Change from baseline in maximum value of the left and right arm VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their arm. | 24 months | 
| Average Arm Pain VAS - Change From Baseline | Change from baseline in average of the left and right arm VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their arm. | 24 months | 
| Maximum Shoulder Pain VAS - Change From Baseline | Change from baseline in Maximum value of the left and right shoulder VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their shoulder. | 24 months | 
| Average Shoulder Pain VAS - Change From Baseline | Change from baseline in Average of the left and right shoulder VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their shoulder. | 24 months | 
| Dysphagia Disability Index - Change From Baseline | Change from baseline in Dysphagia Disability Index (DDI). The DDI is designed to evaluate dysphagia, difficulty in swallowing, using a 25-item questionnaire. Responses from the questionnaire were scored as always 4, sometimes 2, or never 0, and summed to provide a total score (range 0-100). Higher DDI scores suggest greater subjective signs of dysphagia. | 24 months | 
| SF-36 - Physical Composite Scores (PCS) - Change From Baseline | Change from baseline in Quality of Life - Physical Composite Scores. SF-36 is based on units on a scale; where 0 is severe disability and 100 is no disability. The scores are scaled (based on weighted sum of the questions) | 24 months | 
| SF-36 - Mental Composite Scores (MCS) - Change From Baseline | Change from baseline in Quality of Life - Mental Composite Scores. SF-36 is based on units on a scale; where 0 is severe disability and 100 is no disability. The scores are scaled (based on weighted sum of the questions) | 24 months | 
| Work Status Assessment |  | 24 months | 
| Return to Work | Estimated Proportion of Subjects Returning to Work | 24 months | 
| Activity | Clinical Assessment of Activity | 24 months | 
| Subject Satisfaction | Subject Satisfaction (Would you have this procedure again?) | 24 months | 
| Global Cervical Range of Motion - Change From Baseline |  | 24 months | 
| Average Radiographic Disc Height (mm) - Change From Post-op |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical, spinal, arthroplasty, disc, surgical, ACDF, DDD