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Real World Data Collection on the Synergy Cervical Disc | Clinical Trials | Clareo Health

RECRUITING

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

NCT05305430•Synergy Spine Solutions

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

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Over the age of 21 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: herniated disc and/or osteophyte formation
•5. 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.)
•6. Failed a minimum of 6 weeks conservative treatment
•7. Written informed consent given by subject, as applicable.

Exclusion Criteria

•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
+1 more criteria

Locations (3)

Greenslopes Private Hospital

Brisbane, Queensland, Australia

Dr. Greg Malham

Melbourne, Victoria, Australia

Spine and Scoliosis Research Associates Australia Ltd

Windsor, Victoria, Australia

Key Dates

Start Date

May 1, 2022

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2029

Last Updated

November 18, 2025

Enrollment

200

ESTIMATED participants

Conditions

Cervical Disc Degeneration

Interventions

Synergy Cervical Disc System

DEVICE

Contacts

Jane M Jacob, PhD

CONTACT

+1 512-289-5370 janejacob@synergyspinesolutions.com

Christine Nimalasiri

CONTACT

christine.nimalasiri@pcrg.com.au