Post Market Data Collection Protocol to Evaluate the Performance of the Synergy Disc

Cervical Degenerative Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05880823
• Other study ID #: CP 21-001-GER01
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: May 2033

Study information

• Verified date: April 2024
• Source: Synergy Spine Solutions
• Contact: Jane M Jacob, PhD
• Phone: +1 5122895370
• Email: janejacob[@]synergyspinesolutions.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2033
• Est. primary completion date: May 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

• Morbid obesity

• Vulnerable person (pregnant patients, emergency cases, children, prisoners and people without mental capacity)

Related Conditions & MeSH terms

• Cervical Degenerative Disc Disease
• Intervertebral Disc Degeneration

Intervention

Device:
• Synergy cervical disc system
motion preservation disc

Locations

Country	Name	City	State
Germany	Neurochirurgie am Gasteig	Munich	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
Synergy Spine Solutions	MCRA

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Primary	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	12 months
Secondary	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.	pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month
Secondary	Patient Satisfaction	patient completed questionnaire on their satisfaction with the disc replacement surgery	6 week, 3 month, 6 month, 12 month, 24 month
Secondary	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)	pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month
Secondary	Nurick's Criteria	Disease status as characterized by physician at each time point	pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month
Secondary	Odom's criteria	surgical outcome characterized by physician at each post operative visit	6 week, 3 month, 6 month, 12 month, 24 month