Multi-Centre Post-Market Data Collection (NCT06413225) | Clinical Trial Compass
WithdrawnNot Applicable
Multi-Centre Post-Market Data Collection
Stopped: Multiple sites in the UK, went to EC for multicenter approval after this record was written
United Kingdom0Started 2024-09-25
Plain-language 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.
Who can participate
Age range21 Years
SexALL
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Inclusion criteria
✓. Age 21 or above 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
Exclusion criteria
✕. Age 21 or above 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:
What they're measuring
1
Neck Disability Index (NDI)
Timeframe: 12 months
2
device Related or Device Procedure Related Adverse Events