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| Name | Class |
|---|---|
| Pacific Clinical Research Group | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective | 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. |
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| Retrospective | 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. |
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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 | >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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Both retrospective and prospective study subjects that have cervical degenerative disc disease requiring treatment with the Synergy Spine Solutions Synergy Disc.
Prospective study cohort: All patients for whom it has been decided that the Synergy Spine Solutions Synergy Disc will be implanted at participating investigative centers and give informed consent to participate in the prospective segment of this protocol.
Retrospective study cohort: Patients who have previously had a Synergy Spine Solutions Synergy Disc implanted. If required by local regulations, informed consent will be sought and received from the participating patient prior to data collection from the medical records per country-specific regulations.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robyn Capobianco, PhD | Contact | +1-647-692-3493 | robync@synergyspinesolutions.com | |
| Christine Nimalasiri | Contact | christine.nimalasiri@pcrg.com.au |
| Name | Affiliation | Role |
|---|---|---|
| Robyn Capobianco, PhD | Sponsor GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spine and Scoliosis Research Associates Australia Ltd | Recruiting | Windsor | Victoria | Australia |
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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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| 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 |