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Post Market Data Collection Protocol to Evaluate the Performance of the Synergy Disc | Clinical Trials | Clareo Health

RECRUITING

Post Market Data Collection Protocol to Evaluate the Performance of the Synergy Disc

A Single Site Post-Market Data Collection Protocol to Evaluate the Performance of Synergy Spine Solutions Synergy Disc®

NCT05880823•Synergy Spine Solutions

Summary

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

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

Locations (1)

Neurochirurgie am Gasteig

Munich, Bavaria, Germany

Key Dates

Start Date

January 1, 2024

Primary Completion Date

May 1, 2029

Completion Date

May 1, 2034

Last Updated

November 18, 2025

Enrollment

ESTIMATED participants

Conditions

Cervical Degenerative Disc Disease

Interventions

Synergy cervical disc system

DEVICE

Contacts

Jane M Jacob, PhD

CONTACT

+1 5122895370 janejacob@synergyspinesolutions.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Post Market Data Collection Protocol to Evaluate the Performance of the Synergy Disc

Inclusion Criteria

Exclusion Criteria

Real World Data Collection on the Synergy Disc

The Synergy Disc To Anterior Cervical Discectomy and Fusion

M6-C Post Approval Study (PAS)

Study of Safety & Effectiveness of PRESTIGE® LP Cervical Disc vs. Anterior Cervical Fusion in Cervical DDD

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Safety and Preliminary Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy