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Multiple sites in the UK, went to EC for multicenter approval after this record was written
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| Name | Class |
|---|---|
| MCRA | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synergy cervical disc system | Device | motion preservation disc |
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| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale 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. |
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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:
Written informed consent given by subject
Exclusion Criteria:
Inclusion Criteria: All answers must be YES to be eligible for the study.
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:
Written informed consent given by subject
Exclusion Criteria: All answers must be NO to be eligible for the study.
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People over the age of 21 diagnosed with cervical degenerative disc disease and for whom the Synergy Disc device is an option (prospective cohort) or has already been implanted (retrospective cohort).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Orthopedic Hospital | Birmingham | United Kingdom | ||||
| Kings College Hospital |
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| ID | Term |
|---|---|
| D011843 | Radiculopathy |
| D013118 | Spinal Cord Diseases |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D002493 | Central Nervous System Diseases |
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| pre-operative, 6 week, 3 month, 6 month, 12 month, annually post-operatively |
| Patient Satisfaction | patient completed questionnaire on their satisfaction with the disc replacement surgery | 6 week, 3 month, 6 month, 12 month, annually post-operatively |
| 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, annually post-operatively |
| Nurick's Criteria | Disease status as characterized by physician at each time point | pre-operative, 6 week, 3 month, 6 month, 12 month, annually post-operatively |
| Odom's criteria | surgical outcome characterized by physician at each post operative visit | 6 week, 3 month, 6 month, 12 month, annually post-operatively |
| London |
| United Kingdom |