Cervical Degenerative Disc Disease
Conditions
Keywords
radiculopathy, myelopathy, disc replacement, motion preservation
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.
Interventions
motion preservation disc
Sponsors
MCRA
Synergy Spine Solutions
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 21 or above at the time of the surgery. 2. Have had (retrospective cohort) or the decision has been made to have (prospective cohort) the Synergy Disc implanted 3. Skeletally mature patients for reconstruction of the disc from C3-C7 following a single or multiple level discectomy for intractable radiculopathy 4. Intractable radiculopathy and/or myelopathy with at least one of the following producing symptomatic nerve root and/or spinal cord compression: 1. herniated disc and/or osteophyte formation 2. 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.) 3. Failed a minimum of 6 weeks conservative treatment 5. Written informed consent given by subject
Exclusion criteria
* Inclusion Criteria: All answers must be YES to be eligible for the study. 1. Age 21 or above at the time of the surgery. 2. Have had (retrospective cohort) or the decision has been made to have (prospective cohort) the Synergy Disc implanted 3. Skeletally mature patients for reconstruction of the disc from C3-C7 following a single or multiple level discectomy for intractable radiculopathy 4. Intractable radiculopathy and/or myelopathy with at least one of the following producing symptomatic nerve root and/or spinal cord compression: 1. herniated disc and/or osteophyte formation 2. 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.) 3. Failed a minimum of 6 weeks conservative treatment 5. Written informed consent given by subject
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Motor and Sensory Function in the Arm | pre-operative, 6 week, 3 month, 6 month, 12 month, annually post-operatively | maintenance or improvement in neurologic status compared with baseline will be assessed using a defined numeric scale ranging from 0 (normal) to 5 (deficit) |
| Visual Analog Scale Neck and Arm Pain Measurement | pre-operative, 6 week, 3 month, 6 month, 12 month, annually post-operatively | 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. |
| Odom's criteria | 6 week, 3 month, 6 month, 12 month, annually post-operatively | surgical outcome characterized by physician at each post operative visit |
| Nurick's Criteria | pre-operative, 6 week, 3 month, 6 month, 12 month, annually post-operatively | Disease status as characterized by physician at each time point |
| Patient Satisfaction | 6 week, 3 month, 6 month, 12 month, annually post-operatively | patient completed questionnaire on their satisfaction with the disc replacement surgery |
Countries
United Kingdom
Outcome results
None listed