Recruiting
Observational
Real World Data Collection on the Synergy Cervical Disc
Condition(s) studied
Cervical Disc Degeneration
Investigational drug(s) / intervention(s)
Synergy Cervical Disc System
Synergy Cervical Disc System: motion preservation disc
Study 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.
Eligibility
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
Primary outcome measure(s)
- 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
Trial sites (1)
| Facility | City | Region | Status |
| Spine and Scoliosis Research Associates Australia Ltd |
Windsor |
Victoria |
Recruiting |