Post-Market Data Collection to Evaluate the Performance of the Synergy Disc®
- Conditions
- Cervical Degenerative Disc Disease
- Interventions
- Device: Synergy cervical spine disc replacement
- Registration Number
- NCT06383962
- Lead Sponsor
- Synergy Spine Solutions
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
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: All answers must be NO to be eligible for the study. 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Retrospective Synergy cervical spine disc replacement 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. Prospective Synergy cervical spine disc replacement 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.
- Primary Outcome Measures
Name Time Method Neck Disability Index (NDI) 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 12 months Absence of major device related adverse events defined as radiographic failure, neurologic failure or failure by adverse event
- Secondary Outcome Measures
Name Time Method Neck and Arm Pain Measurement pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month Pain will evaluated by the Visual analog scale (VAS) (place a line from zero where there is no pain to 10 which is the worst pain imaginable), by NRS (circle a number from zero to ten where zero equals no pain and ten is worst imaginable) to or a verbal description that the doctor writes down, per the site's Standard of Care. A change of at least 20 mm will be considered clinically significant. Neck pain as measured on a 100mm VAS at baseline and at each follow-up timepoint. Left and Right arm/shoulder pain as measured on a 100 mm VAS at baseline and at each follow up time-point.
Nurick's Criteria pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month Disease status as characterized by physician at each time point
Patient Satisfaction 6 week, 3 month, 6 month, 12 month, 24 month patient completed questionnaire on their satisfaction with the disc replacement surgery
Odom's criteria pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month surgical outcome characterized by physician at each post operative visit
Motor and Sensory Function in the Arm pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month maintenance or improvement in neurologic status compared with baseline will be assessed using a defined numeric scale ranging from 0 (normal) to 5 (deficit)
Trial Locations
- Locations (1)
Royal Orthopaedic Hospital
🇬🇧Birmingham, United Kingdom