Real World Data Collection on the Synergy Disc
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Synergy Cervical Disc system.
- Who it may be relevant to
- Registry conditions: Cervical Degenerative Disc Disease. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Ireland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Single Site Post-Market Data Collection Protocol to Evaluate the Performance of Synergy Spine Solutions Synergy Disc®
Overview
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.
Interventions
- Device Synergy Cervical Disc system
motion preservation disc
Primary outcome measures
- Neck Disability Index (NDI) [Time frame: 12 months]
- Device Related or Device Procedure Related Adverse Events [Time frame: 12 months]
Secondary outcome measures (5)
- Neck and Arm Pain Measurement [Time frame: pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month]
- Patient Satisfaction [Time frame: 6 week, 3 month, 6 month, 12 month, 24 month]
- Motor and Sensory Function in the Arm [Time frame: pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month]
- Nurick's Criteria [Time frame: pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month]
- Odom's criteria [Time frame: 6 week, 3 month, 6 month, 12 month, 24 month]
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)-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Ireland · 1 center
- Mater Misericordiae University Hospital — Dublin
Identifiers
NCT: NCT06383949 · CP 21-001-IRE01