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Recruiting Observational

Post-Market Data Collection to Evaluate the Performance of the Synergy Disc®

NCT06383962 · tracked via the Priya Life Science UK tracker
Phase
Observational
Started
2025-03-17
Last updated
2026-05-01

Condition(s) studied

Cervical Degenerative Disc Disease

Investigational drug(s) / intervention(s)

Synergy cervical spine disc replacement

Synergy cervical spine disc replacement: motion preservation disc

Study 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

Sex
ALL
Min age
21 Years
Max age
—
Healthy volunteers
No
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: Exclusion Criteria: All answers must be NO to be eligible for the study. 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)

Primary outcome measure(s)

  • Neck Disability Index (NDI) — 12 months
    Neck disability Index improvement of \>15 pts (out of 100) in subjects by 12 months post operative compared with baseline. A lower score is a better score.
  • Device Related or Device Procedure Related Adverse Events — 12 months
    Absence of major device related adverse events defined as radiographic failure, neurologic failure or failure by adverse event

Trial sites (2)

FacilityCityRegionStatus
Royal Orthopaedic Hospital Birmingham United Kingdom Recruiting
Kings College Hospital London United Kingdom Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06383962 on ClinicalTrials.gov ↗ ← All trials in the UK