Real World Data Collection on the Synergy Cervical Disc

Study Overview
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Brief Summary
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This trial is a real world data (RWD) collection observational study, comprised of both prospective and retrospective arms, that 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 Multi-Center Post-Market Data Collection Protocol to Evaluate the Performance of Synergy Spine Solutions Synergy Disc

Conditions
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Cervical Disc Degeneration

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: Over the age of 21 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, as applicable. Exclusion Criteria: 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 Currently a prisoner

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 implanted at participating investigative centers and give informed consent to participate in the prospective segment of this protocol, per country-specific requirements, will be enrolled in the prospective portion of this protocol. | Device: Synergy Cervical Disc System<br>* motion preservation disc<br>* Other names: Synergy Disc;|
| Retrospective<br>Patients who have previously had a Synergy Spine Solutions Synergy Disc implanted will be eligible for inclusion in the retrospective data collection; a waiver of consent, or informed consent, for retrospective data collection from the medical records of the implanting surgeon will be sought per country-specific regulations as applicable. | Device: Synergy Cervical Disc System<br>* motion preservation disc<br>* Other names: Synergy Disc;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog (VAS) pain | Visual analogue scale (VAS) will be used to evaluate pain where a change of at least 20mm will be considered clinically significant. Neck pain as measured on a 100mm VAS at baseline and at each follow-up time-point. Left and Right arm/shoulder pain as measured on a 100mm VAS at baseline and at each follow-up time-point. | pre-operative and 6 week, 3 months, 6 months, 12 months, annually post operatively | 
| Patient Satisfaction | patient completed questionnaire on satisfaction with disc replacement surgery | 6 weeks, 3 months, 6 months, 12 months, annually post operatively | 
| Nurick's Criteria | disease status characterized by physician at each visit | pre-operative and 6 weeks, 3 months, 6 months, 12 months, annually post operatively | 
| Odom's Criteria | surgical outcome characterized by physician at each post operative visit | 6 weeks, 3 months, 6 months, 12 months, annually post operatively | 
| Neurologic Function | maintenance or improvement in neurologic status compared to baseline | 6 weeks, 3 months, 6 months, 12 months, annually post operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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degenerative disc, cervical, radiculopathy, myelopathy, motion preservation