A Single Site Post-Market Data Collection Protocol to Evaluate the Performance of Synergy Spine Solutions Synergy Disc®
Overview
- Phase
- Not Applicable
- Intervention
- Synergy Cervical Disc system
- Conditions
- Cervical Degenerative Disc Disease
- Sponsor
- Synergy Spine Solutions
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Neck Disability Index (NDI)
- Status
- Recruiting
- Last Updated
- 3 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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
- •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 Severe pathology of the facet joints of the involved vertebral bodies Previous diagnosis of osteopenia or osteomalacia More than one immobile vertebral level between C1 and T1 from any cause Morbid obesity Vulnerable person (pregnant patients, emergency cases, children, prisoners and people without mental capacity)-
Arms & Interventions
Prospective
All patients for whom the decision has been made to have the Synergy Disc system implanted and give informed consent will be enrolled in this study, following country-specific requirements.
Intervention: Synergy Cervical Disc system
Retrospective
Patients who have previously received the Synergy Disc system in the last ten years are eligible for inclusion in the retrospective data collection; a waiver of consent, or an informed consent, for the retrospective data collection from the medical records of the implanting surgeon will be sought per country-specific regulations.
Intervention: Synergy Cervical Disc system
Outcomes
Primary Outcomes
Neck Disability Index (NDI)
Time Frame: 12 months
Neck disability Index improvement of \>15 pts (out of 100) in subjects by 12 months post operative compared with baseline. A lower score is a better score.
Device Related or Device Procedure Related Adverse Events
Time Frame: 12 months
Absence of major device related adverse events defined as radiographic failure, neurologic failure or failure by adverse event
Secondary Outcomes
- Nurick's Criteria(pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month)
- Patient Satisfaction(6 week, 3 month, 6 month, 12 month, 24 month)
- Motor and Sensory Function in the Arm(pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month)
- Neck and Arm Pain Measurement(pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month)
- Odom's criteria(6 week, 3 month, 6 month, 12 month, 24 month)