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NCT Number: NCT05305430

Real World Data Collection on the Synergy Cervical Disc

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.

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Key information

Conditions

Cervical Disc Degeneration Central Nervous System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Radiculopathy Spinal Cord Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Spine and Scoliosis Research Associates Australia Ltd

Windsor, Victoria, Australia

Location status: Recruiting

Location contact

Aaron Buckland, MD

PRINCIPAL_INVESTIGATOR

Sophie Cahir

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Over the age of 21 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, as applicable.

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
  • Currently a prisoner

Treatment and study plan

Synergy Cervical Disc system

Device

motion preservation disc

Other names: Synergy Disc

Primary outcomes

  1. Neck Disability Index

    Time frame: 12 months

    >15 improvement in NDI score (out of 100) in subjects by 12 mo. post operative compared with baseline

  2. Device Related or Device Procedure Related Adverse Events

    Time frame: 12 months

    Absence of major device related adverse events defined as radiographic failure, neurological failure, or failure by adverse event

Secondary outcomes

  1. Visual Analog (VAS) pain

    Time frame: pre-operative and 6 week, 3 months, 6 months, 12 months, annually post operatively

    Visual analogue scale (VAS) will be used to evaluate pain where a change of at least 20mm will be considered clinically significant. Neck pain as measured on a 100mm VAS at baseline and at each follow-up time-point. Left and Right arm/shoulder pain as measured on a 100mm VAS at baseline and at each follow-up time-point.

  2. Patient Satisfaction

    Time frame: 6 weeks, 3 months, 6 months, 12 months, annually post operatively

    patient completed questionnaire on satisfaction with disc replacement surgery

  3. Nurick's Criteria

    Time frame: pre-operative and 6 weeks, 3 months, 6 months, 12 months, annually post operatively

    disease status characterized by physician at each visit

  4. Odom's Criteria

    Time frame: 6 weeks, 3 months, 6 months, 12 months, annually post operatively

    surgical outcome characterized by physician at each post operative visit

  5. Neurologic Function

    Time frame: 6 weeks, 3 months, 6 months, 12 months, annually post operatively

    maintenance or improvement in neurologic status compared to baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Christine Nimalasiri

CONTACT

[email protected]

Robyn Capobianco, PhD

CONTACT

[email protected]

+1-647-692-3493

Sponsors and collaborators

Lead sponsor

Synergy Spine Solutions

Industry

Collaborators

  • Pacific Clinical Research Group

Registry information

Official study title

A Multi-Center Post-Market Data Collection Protocol to Evaluate the Performance of Synergy Spine Solutions Synergy Disc

Important dates

Study start
2022
Primary completion
2030
Study completion
2032
First posted
Mar 31, 2022
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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