Post Market Data Collection Protocol to Evaluate the Performance of the Synergy Disc

Study Overview
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Brief Summary
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This is a real world data collection observational study at a single site. There are both prospective and retrospective cohorts. The study will examine the safety and effectiveness of the Synergy cervical disc system in patients with degenerative cervical disc disease.

Official Title
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A Single Site Post-Market Data Collection Protocol to Evaluate the Performance of Synergy Spine Solutions Synergy Disc®

Conditions
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Cervical Degenerative Disc Disease

Intervention / Treatment
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* Device: Synergy cervical disc system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 21 or above at the time of the surgery. Have had (retrospective cohort) or the decision has been made to have (prospective cohort) the Synergy Disc implanted Skeletally mature patients for reconstruction of the disc from C3-C7 following a single or multiple level discectomy for intractable radiculopathy Intractable radiculopathy and/or myelopathy with at least one of the following producing symptomatic nerve root and/or spinal cord compression: herniated disc and/or osteophyte formation Symptomatic nerve root and/or spinal cord compression documented by patient history (arm or neck pain and/or neurologic deficit) and imaging (CT, MRI, x-rays, etc.) Failed a minimum of 6 weeks conservative treatment Written informed consent given by subject. Exclusion Criteria: Exclusion Criteria: All answers must be NO to be eligible for the study. Moderate to advanced spondylosis Diagnosis of osteoporosis Active systemic infection or infection at the operative site Pregnancy Marked cervical instability on lateral, coronal, or flexion/extension radiographs Cervical spine condition other than symptomatic cervical disc disease requiring surgical treatment at the involved level Severe pathology of the facet joints of the involved vertebral bodies Previous diagnosis of osteopenia or osteomalacia More than one immobile vertebral level between C1 and T1 from any cause Morbid obesity Vulnerable person (pregnant patients, emergency cases, children, prisoners and people without mental capacity)

Ages Eligible for Study
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Minimum Age: 21 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prospective<br>All patients for whom the decision has been made to have the Synergy Disc system implanted and give informed consent will be enrolled in this study, following country-specific requirements. | Device: Synergy cervical disc system<br>* motion preservation disc<br>|
| Retrospective<br>Patients who have previously received the Synergy Disc system in the last ten years are eligible for inclusion in the retrospective data collection; a waiver of consent, or an informed consent, for the retrospective data collection from the medical records of the implanting surgeon will be sought per country-specific regulations. | Device: Synergy cervical disc system<br>* motion preservation disc<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neck Disability Index (NDI) | Neck disability Index improvement of >15 pts (out of 100) in subjects by 12 months post operative compared with baseline. A lower score is a better score. | 12 months | 
| Device Related or Device Procedure Related Adverse Events | Absence of major device related adverse events defined as radiographic failure, neurologic failure or failure by adverse event | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neck and Arm Pain Measurement | Pain will evaluated by the Visual analog scale (VAS) (place a line from zero where there is no pain to 10 which is the worst pain imaginable), by NRS (circle a number from zero to ten where zero equals no pain and ten is worst imaginable) to or a verbal description that the doctor writes down, per the site's Standard of Care. A change of at least 20 mm will be considered clinically significant. Neck pain as measured on a 100mm VAS at baseline and at each follow-up timepoint. Left and Right arm/shoulder pain as measured on a 100 mm VAS at baseline and at each follow up time-point. | pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month | 
| Patient Satisfaction | patient completed questionnaire on their satisfaction with the disc replacement surgery | 6 week, 3 month, 6 month, 12 month, 24 month | 
| Motor and Sensory Function in the Arm | maintenance or improvement in neurologic status compared with baseline will be assessed using a defined numeric scale ranging from 0 (normal) to 5 (deficit) | pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month | 
| Nurick's Criteria | Disease status as characterized by physician at each time point | pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month | 
| Odom's criteria | surgical outcome characterized by physician at each post operative visit | 6 week, 3 month, 6 month, 12 month, 24 month |