Status:
RECRUITING
Real World Data Collection on the Synergy Cervical Disc
Lead Sponsor:
Synergy Spine Solutions
Collaborating Sponsors:
Pacific Clinical Research Group
Conditions:
Cervical Disc Degeneration
Eligibility:
All Genders
21+ years
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05305430
Start Date
May 1 2022
End Date
December 1 2029
Last Update
November 18 2025
Active Locations (3)
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1
Greenslopes Private Hospital
Brisbane, Queensland, Australia
2
Dr. Greg Malham
Melbourne, Victoria, Australia
3
Spine and Scoliosis Research Associates Australia Ltd
Windsor, Victoria, Australia