Real World Data Collection on the Synergy Cervical Disc (NCT05305430) | Clinical Trial Compass
RecruitingNot Applicable
Real World Data Collection on the Synergy Cervical Disc
Australia200 participantsStarted 2022-05-01
Plain-language 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.
Who can participate
Age range21 Years
SexALL
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Inclusion criteria
✓. Over the age of 21 at the time of the surgery.
✓. Have had (retrospective cohort) or the decision has been made to have (prospective cohort) the Synergy Disc implanted
✓. Skeletally mature patients for reconstruction of the disc from C3-C7 following a single or multiple level discectomy for intractable radiculopathy
✓. 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
✓. 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.)
✓. Failed a minimum of 6 weeks conservative treatment
✓. Written informed consent given by subject, as applicable.
Exclusion criteria
✕. Moderate to advanced spondylosis
✕. Diagnosis of osteoporosis
✕. Active systemic infection or infection at the operative site
✕. Pregnancy
✕. Marked cervical instability on lateral, coronal, or flexion/extension radiographs
✕. Cervical spine condition other than symptomatic cervical disc disease requiring surgical treatment at the involved level
What they're measuring
1
Neck Disability Index
Timeframe: 12 months
2
Device Related or Device Procedure Related Adverse Events