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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cervical Degenerative Disc Disease
• Intervention / Treatment: Device: Synergy cervical disc system

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Jane M Jacob, PhD; Phone Number: +1 5122895370; Email: janejacob@synergyspinesolutions.com

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 81669
      • Recruiting
      • Neurochirurgie am Gasteig
      • Contact: Ardavan Ardeshiri, MD; Email: ardeshiri@neurochirurgie-am-gasteig.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The patients for this study will be recruited from the physician's practice.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Synergy cervical disc system; motion preservation disc
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.	Device: Synergy cervical disc system; motion preservation disc

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Patient Satisfaction	patient completed questionnaire on their satisfaction with the disc replacement surgery	6 week, 3 month, 6 month, 12 month, 24 month
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
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
Odom's criteria	surgical outcome characterized by physician at each post operative visit	6 week, 3 month, 6 month, 12 month, 24 month

Collaborators and Investigators

• Sponsor: Synergy Spine Solutions
• Collaborators: MCRA
• Investigators: Study Director: Jane M Jacob, PhD, Synergy Spine Solutions

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2033

Study Registration Dates

• First Submitted: April 24, 2023
• First Submitted That Met QC Criteria: May 25, 2023
• First Posted (Actual): May 30, 2023

Study Record Updates

• Last Update Posted (Estimated): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: CP 21-001-GER01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No