RecruitingNCT06383962

Post-Market Data Collection 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®


Sponsor

Synergy Spine Solutions

Enrollment

50 participants

Start Date

Mar 1, 2026

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 21 Years

Inclusion Criteria3

  • 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.

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Interventions

DEVICESynergy cervical spine disc replacement

motion preservation disc


Locations(2)

Royal Orthopaedic Hospital

Birmingham, United Kingdom

Kings College Hospital

London, United Kingdom

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NCT06383962


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