Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06383949

Real World Data Collection on the Synergy Disc

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Cervical Degenerative Disc Disease 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

Mater Misericordiae University Hospital

Dublin, Ireland

Location status: Recruiting

Location contact

Jake McDonnell, MD

CONTACT

[email protected]

Joseph Butler, MD

PRINCIPAL_INVESTIGATOR

Stacy Darwish, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

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 Vulnerable person (pregnant patients, emergency cases, children, prisoners and people without mental capacity)-

Treatment and study plan

Synergy Cervical Disc system

Device

motion preservation disc

Primary outcomes

  1. Neck Disability Index (NDI)

    Time frame: 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.

  2. Device Related or Device Procedure Related Adverse Events

    Time frame: 12 months

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

Secondary outcomes

  1. Neck and Arm Pain Measurement

    Time frame: pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month

    Pain will evaluated by the Visual analog scale (VAS) (place a line from zero where there is no pain to 10 which is the worst pain imaginable), by NRS (circle a number from zero to ten where zero equals no pain and ten is worst imaginable) to or a verbal description that the doctor writes down, per the site's Standard of Care. A change of at least 20 mm will be considered clinically significant. Neck pain as measured on a 100mm VAS at baseline and at each follow-up timepoint. Left and Right arm/shoulder pain as measured on a 100 mm VAS at baseline and at each follow up time-point.

  2. Patient Satisfaction

    Time frame: 6 week, 3 month, 6 month, 12 month, 24 month

    patient completed questionnaire on their satisfaction with the disc replacement surgery

  3. Motor and Sensory Function in the Arm

    Time frame: pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month

    maintenance or improvement in neurologic status compared with baseline will be assessed using a defined numeric scale ranging from 0 (normal) to 5 (deficit)

  4. Nurick's Criteria

    Time frame: pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month

    Disease status as characterized by physician at each time point

  5. Odom's criteria

    Time frame: 6 week, 3 month, 6 month, 12 month, 24 month

    surgical outcome characterized by physician at each post operative visit

Study contacts

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

Robyn Capobianco, PhD

CONTACT

[email protected]

(720) 787-9063

Stacy Gardner

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Synergy Spine Solutions

Industry

Collaborators

  • MCRA

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2033
First posted
Apr 25, 2024
Registry last updated
Jan 9, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.