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Recruiting NCT05305430

Real World Data Collection on the Synergy Cervical Disc

— Observational Cervical Disc Degeneration

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Synergy Cervical Disc System.
Who it may be relevant to
Registry conditions: Cervical Disc Degeneration. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device Synergy Cervical Disc System
    motion preservation disc

Primary outcome measures

  • Neck Disability Index [Time frame: 12 months]
  • Device Related or Device Procedure Related Adverse Events [Time frame: 12 months]
Secondary outcome measures (5)
  • Visual Analog (VAS) pain [Time frame: pre-operative and 6 week, 3 months, 6 months, 12 months, annually post operatively]
  • Patient Satisfaction [Time frame: 6 weeks, 3 months, 6 months, 12 months, annually post operatively]
  • Nurick's Criteria [Time frame: pre-operative and 6 weeks, 3 months, 6 months, 12 months, annually post operatively]
  • Odom's Criteria [Time frame: 6 weeks, 3 months, 6 months, 12 months, annually post operatively]
  • Neurologic Function [Time frame: 6 weeks, 3 months, 6 months, 12 months, annually post operatively]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Australia · 1 center
  • Spine and Scoliosis Research Associates Australia Ltd — Windsor

Identifiers

NCT: NCT05305430 · CP 21-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗