Post Market Data Collection Protocol to Evaluate the Performance of the Synergy Disc
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Prospective 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
motion preservation disc
|
| Retrospective 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
motion preservation disc
|
Outcome Measures
Primary Outcome Measures
- Neck Disability Index (NDI) [12 months]
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.
- Device Related or Device Procedure Related Adverse Events [12 months]
Absence of major device related adverse events defined as radiographic failure, neurologic failure or failure by adverse event
Secondary Outcome Measures
- Neck and Arm Pain Measurement [pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month]
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.
- Patient Satisfaction [6 week, 3 month, 6 month, 12 month, 24 month]
patient completed questionnaire on their satisfaction with the disc replacement surgery
- Motor and Sensory Function in the Arm [pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month]
maintenance or improvement in neurologic status compared with baseline will be assessed using a defined numeric scale ranging from 0 (normal) to 5 (deficit)
- Nurick's Criteria [pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month]
Disease status as characterized by physician at each time point
- Odom's criteria [6 week, 3 month, 6 month, 12 month, 24 month]
surgical outcome characterized by physician at each post operative visit
Eligibility Criteria
Criteria
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
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Skeletally mature patients for reconstruction of the disc from C3-C7 following a single or multiple level discectomy for intractable radiculopathy
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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
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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.)
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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.
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Moderate to advanced spondylosis
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Diagnosis of osteoporosis
-
Active systemic infection or infection at the operative site
-
Pregnancy
-
Marked cervical instability on lateral, coronal, or flexion/extension radiographs
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Cervical spine condition other than symptomatic cervical disc disease requiring surgical treatment at the involved level
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Severe pathology of the facet joints of the involved vertebral bodies
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Previous diagnosis of osteopenia or osteomalacia
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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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Neurochirurgie am Gasteig | Munich | Bavaria | Germany | 81669 |
Sponsors and Collaborators
- Synergy Spine Solutions
- MCRA
Investigators
- Study Director: Jane M Jacob, PhD, Synergy Spine Solutions
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CP 21-001-GER01