RecruitingNCT05305430

Real World Data Collection on the Synergy Cervical Disc

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

Sponsor

Synergy Spine Solutions

Enrollment

200 participants

Start Date

May 1, 2022

Study Type

OBSERVATIONAL

Conditions

Cervical disc degeneration

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.

Eligibility

Min Age: 21 Years

Inclusion Criteria7

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 Criteria11

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
Currently a prisoner