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Recruiting NCT05305430

Real World Data Collection on the Synergy Cervical Disc

Conditions: Cervical Disc Degeneration

Sponsor: Synergy Spine Solutions

trial.available_in: БГ
Overview
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.
Who can participate
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
Locations 1
Australia (1)
Greenslopes Private Hospital
Brisbane , Queensland
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
21 Years
Healthy volunteers
No
Start date
01.05.2022
Completion date
01.12.2029
Registry ID
NCT05305430
Source
anzctr
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