A Single Site Post-Market Data Collection Protocol to Evaluate the Performance of Synergy Spine Solutions Synergy Disc®

Synergy Spine Solutions1 site in 1 country50 target enrollmentJanuary 1, 2024

ConditionsCervical Degenerative Disc Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cervical Degenerative Disc Disease
Sponsor: Synergy Spine Solutions
Enrollment: 50
Locations: 1
Primary Endpoint: Neck Disability Index (NDI)
Status: Recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 1, 2024

End Date

May 1, 2034

Last Updated

5 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Synergy Spine Solutions

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 21 or above 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.

Exclusion Criteria

•Exclusion Criteria: All answers must be NO to be eligible for the study.
•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

Outcomes

Primary Outcomes

Neck Disability Index (NDI)

Time Frame: 12 months

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.

Device Related or Device Procedure Related Adverse Events

Time Frame: 12 months

Absence of major device related adverse events defined as radiographic failure, neurologic failure or failure by adverse event

Secondary Outcomes

Odom's criteria(6 week, 3 month, 6 month, 12 month, 24 month)
Neck and Arm Pain Measurement(pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month)
Nurick's Criteria(pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month)
Patient Satisfaction(6 week, 3 month, 6 month, 12 month, 24 month)
Motor and Sensory Function in the Arm(pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month)