Multi-Centre Post-Market Data Collection

Synergy Spine Solutions

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.

Study Type

OBSERVATIONAL

Conditions

Cervical Degenerative Disc Disease

Interventions

Synergy cervical disc systemDEVICE

motion preservation disc

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 21 or above at the time of the surgery. 2. Have had (retrospective cohort) or the decision has been made to have (prospective cohort) the Synergy Disc implanted 3. Skeletally mature patients for reconstruction of the disc from C3-C7 following a single or multiple level discectomy for intractable radiculopathy 4. Intractable radiculopathy and/or myelopathy with at least one of the following producing symptomatic nerve root and/or spinal cord compression: 1. herniated disc and/or osteophyte formation 2. 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.) 3. Failed a minimum of 6 weeks conservative treatment 5. Written informed consent given by subject Exclusion Criteria: * Inclusion Criteria: All answers must be YES to be eligible for the study. 1. Age 21 or above at the time of the surgery. 2. Have had (retrospective cohort) or the decision has been made to have (prospective cohort) the Synergy Disc implanted 3. Skeletally mature patients for reconstruction of the disc from C3-C7 following a single or multiple level discectomy for intractable radiculopathy 4. Intractable radiculopathy and/or myelopathy with at least one of the following producing symptomatic nerve root and/or spinal cord compression: 1. herniated disc and/or osteophyte formation 2. 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.) 3. Failed a minimum of 6 weeks conservative treatment 5. Written informed consent given by subject Exclusion Criteria: All answers must be NO to be eligible for the study. 1. Moderate to advanced spondylosis 2. Diagnosis of osteoporosis 3. Active systemic infection or infection at the operative site 4. Pregnancy 5. Marked cervical instability on lateral, coronal, or flexion/extension radiographs 6. Cervical spine condition other than symptomatic cervical disc disease requiring surgical treatment at the involved level 7. Severe pathology of the facet joints of the involved vertebral bodies 8. Previous diagnosis of osteopenia or osteomalacia 9. More than one immobile vertebral level between C1 and T1 from any cause 10. Morbid obesity 11. Vulnerable person (pregnant patients, emergency cases, children, prisoners and people without mental capacity)

Locations (2)

Royal Orthopedic Hospital

Birmingham, United Kingdom

Kings College Hospital

London, United Kingdom

Outcomes

Primary Outcomes

Neck Disability Index (NDI)

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.

Time frame: 12 months

device Related or Device Procedure Related Adverse Events

Absence of major device related adverse events defined as radiographic failure, neurologic failure or failure by adverse event

Time frame: 12 months

Secondary Outcomes

Visual Analog Scale Neck and Arm Pain Measurement

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.

Time frame: pre-operative, 6 week, 3 month, 6 month, 12 month, annually post-operatively

Patient Satisfaction

patient completed questionnaire on their satisfaction with the disc replacement surgery

Time frame: 6 week, 3 month, 6 month, 12 month, annually post-operatively

Motor and Sensory Function in the Arm

maintenance or improvement in neurologic status compared with baseline will be assessed using a defined numeric scale ranging from 0 (normal) to 5 (deficit)

Time frame: pre-operative, 6 week, 3 month, 6 month, 12 month, annually post-operatively

Nurick's Criteria

Data from ClinicalTrials.gov

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