Real World Data Collection on the Synergy Cervical Disc
ConditionCervical Disc Degeneration
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorSynergy Spine Solutions
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Moderate to advanced spondylosis
Diagnosis of osteoporosis
Active systemic infection or infection at the operative site
Pregnancy
Trial design
Treatments tested in this trial
- Synergy Cervical Disc System
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Synergy Spine Solutions
Lead sponsor
Pacific Clinical Research Group
Collaborator
Source ClinicalTrials.gov