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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Germany
Neurochirurgie am Gasteig
RECRUITING
Munich
Contact Information
Primary
Jane M Jacob, PhD
janejacob@synergyspinesolutions.com
+1 5122895370
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2034-05
Participants
Target number of participants: 50
Treatments
Prospective
All patients for whom the decision has been made to have the Synergy Disc system implanted and give informed consent will be enrolled in this study, following country-specific requirements.
Retrospective
Patients who have previously received the Synergy Disc system in the last ten years are eligible for inclusion in the retrospective data collection; a waiver of consent, or an informed consent, for the retrospective data collection from the medical records of the implanting surgeon will be sought per country-specific regulations.
Related Therapeutic Areas
Sponsors
Leads: Synergy Spine Solutions
Collaborators: MCRA

This content was sourced from clinicaltrials.gov