Cervical Disc Degeneration
Conditions
Keywords
degenerative disc, cervical, radiculopathy, myelopathy, motion preservation
Brief summary
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.
Interventions
motion preservation disc
Sponsors
Synergy Spine Solutions
Pacific Clinical Research Group
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Over the age of 21 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: herniated disc and/or osteophyte formation 5. 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.) 6. Failed a minimum of 6 weeks conservative treatment 7. Written informed consent given by subject, as applicable.
Exclusion criteria
1. Moderate to advanced spondylosis 2. Diagnosis of osteoporosis 3. Active systemic infection or infection at the operative site 4. Pregnancy 5. Marked cervical instability on lateral, coronal, or flexion/extension radiographs 6. Cervical spine condition other than symptomatic cervical disc disease requiring surgical treatment at the involved level 7. Severe pathology of the facet joints of the involved vertebral bodies 8. Previous diagnosis of osteopenia or osteomalacia 9. More than one immobile vertebral level between C1 and T1 from any cause 10. Morbid obesity 11. Currently a prisoner
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neck Disability Index | 12 months | \>15 improvement in NDI score (out of 100) in subjects by 12 mo. post operative compared with baseline |
| Device Related or Device Procedure Related Adverse Events | 12 months | Absence of major device related adverse events defined as radiographic failure, neurological failure, or failure by adverse event |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog (VAS) pain | pre-operative and 6 week, 3 months, 6 months, 12 months, annually post operatively | 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. |
| Patient Satisfaction | 6 weeks, 3 months, 6 months, 12 months, annually post operatively | patient completed questionnaire on satisfaction with disc replacement surgery |
| Nurick's Criteria | pre-operative and 6 weeks, 3 months, 6 months, 12 months, annually post operatively | disease status characterized by physician at each visit |
| Odom's Criteria | 6 weeks, 3 months, 6 months, 12 months, annually post operatively | surgical outcome characterized by physician at each post operative visit |
| Neurologic Function | 6 weeks, 3 months, 6 months, 12 months, annually post operatively | maintenance or improvement in neurologic status compared to baseline |
Countries
Australia
Contacts
CONTACTRobyn Capobianco, PhD
CONTACTChristine Nimalasiri
STUDY_DIRECTORRobyn Capobianco, PhD
Sponsor GmbH
Outcome results
None listed