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Real World Data Collection on the Synergy Disc

Real World Data Collection on the Synergy Disc

Recruiting
21 years and older
All
Phase N/A

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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.

Eligibility

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)-

Study details
    Cervical Degenerative Disc Disease

NCT06383949

Synergy Spine Solutions

3 May 2024

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