Post-Market Data Collection to Evaluate the Performance of the Synergy Disc®
ConditionCervical Degenerative Disc Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorSynergy Spine Solutions
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Patients who have had (retrospective cohort) or who are going to (prospective cohort) the Synergy cervical disc and have cervical degenerative disc disease that has been unresponsive to conservative treatment.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Synergy cervical spine disc replacement
Devicemotion preservation disc
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Prospective1 intervention
Group B: Retrospective1 intervention
Trial outcomes
Primary outcomes
1
Neck Disability Index (NDI)
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.
Time frame
12 months2
Device Related or Device Procedure Related Adverse Events
Absence of major device related adverse events defined as radiographic failure, neurologic failure or failure by adverse event
Time frame
12 monthsSecondary outcomes
1
Neck and Arm Pain Measurement
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.
Time frame
pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month2
Patient Satisfaction
patient completed questionnaire on their satisfaction with the disc replacement surgery
Time frame
6 week, 3 month, 6 month, 12 month, 24 month3
Motor and Sensory Function in the Arm
maintenance or improvement in neurologic status compared with baseline will be assessed using a defined numeric scale ranging from 0 (normal) to 5 (deficit)
Time frame
pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month4
Nurick's Criteria
Disease status as characterized by physician at each time point
Time frame
pre-operative, 6 week, 3 month, 6 month, 12 month, 24 monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Synergy Spine Solutions
Lead sponsor
MCRA
Collaborator
Source ClinicalTrials.gov