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
This trial does not accept healthy volunteersQualifiers
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 population
Both retrospective and prospective study subjects that have cervical degenerative disc disease requiring treatment with the Synergy Spine Solutions Synergy Disc. Prospective study cohort: All patients for whom it has been decided that the Synergy Spine Solutions Synergy Disc will be implanted at participating investigative centers and give informed consent to participate in the prospective segment of this protocol. Retrospective study cohort: Patients who have previously had a Synergy Spine Solutions Synergy Disc implanted. If required by local regulations, informed consent will be sought and received from the participating patient prior to data collection from the medical records per country-specific regulations.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Synergy Cervical Disc System
Devicemotion preservation disc
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Prospective1 intervention
Group B: Retrospective1 intervention
Trial outcomes
Primary outcomes
1
Neck Disability Index
\>15 improvement in NDI score (out of 100) in subjects by 12 mo. post operative compared with baseline
Time frame
12 months2
Device Related or Device Procedure Related Adverse Events
Absence of major device related adverse events defined as radiographic failure, neurological failure, or failure by adverse event
Time frame
12 monthsSecondary outcomes
1
Visual Analog (VAS) pain
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.
Time frame
pre-operative and 6 week, 3 months, 6 months, 12 months, annually post operatively2
Patient Satisfaction
patient completed questionnaire on satisfaction with disc replacement surgery
Time frame
6 weeks, 3 months, 6 months, 12 months, annually post operatively3
Nurick's Criteria
disease status characterized by physician at each visit
Time frame
pre-operative and 6 weeks, 3 months, 6 months, 12 months, annually post operatively4
Odom's Criteria
surgical outcome characterized by physician at each post operative visit
Time frame
6 weeks, 3 months, 6 months, 12 months, annually post operativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Synergy Spine Solutions
Lead sponsor
Pacific Clinical Research Group
Collaborator
Source ClinicalTrials.gov