A Multi-Center Post-Market Data Collection Protocol to Evaluate the Performance of Synergy Spine Solutions Synergy Disc

Synergy Spine Solutions3 sites in 1 country200 target enrollmentMay 1, 2022

ConditionsCervical Disc Degeneration

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cervical Disc Degeneration
Sponsor: Synergy Spine Solutions
Enrollment: 200
Locations: 3
Primary Endpoint: Neck Disability Index
Status: Recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This trial is a real world data (RWD) collection observational study, comprised of both prospective and retrospective arms, that will examine the safety and effectiveness of the Synergy Cervical Disc System in patients with degenerative cervical disc disease.

Registry

clinicaltrials.gov

Start Date

May 1, 2022

End Date

December 1, 2029

Last Updated

5 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Synergy Spine Solutions

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Over the age of 21 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, as applicable.

Exclusion Criteria

•Moderate to advanced spondylosis
•Diagnosis of osteoporosis
•Active systemic infection or infection at the operative site
•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
•Currently a prisoner

Outcomes

Primary Outcomes

Neck Disability Index

Time Frame: 12 months

\>15 improvement in NDI score (out of 100) in subjects by 12 mo. post operative compared with baseline

Device Related or Device Procedure Related Adverse Events

Time Frame: 12 months

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

Secondary Outcomes

Patient Satisfaction(6 weeks, 3 months, 6 months, 12 months, annually post operatively)
Nurick's Criteria(pre-operative and 6 weeks, 3 months, 6 months, 12 months, annually post operatively)
Neurologic Function(6 weeks, 3 months, 6 months, 12 months, annually post operatively)
Visual Analog (VAS) pain(pre-operative and 6 week, 3 months, 6 months, 12 months, annually post operatively)
Odom's Criteria(6 weeks, 3 months, 6 months, 12 months, annually post operatively)