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

NCT05880823 | Withdrawn

• 1 other identifier: CP 21-001-GER01
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Degenerative Disc Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Neck and Arm Pain Measurement

  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

• Nurick's Criteria

  pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month

• Odom's criteria

  6 week, 3 month, 6 month, 12 month, 24 month

Study Arms (2)

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

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

Interventions

Synergy cervical disc system DEVICE

motion preservation disc

Prospective; Retrospective

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• MCRA: collaborator
• Synergy Spine Solutions: lead

Study Sites (1)

Neurochirurgie am Gasteig

Munich, Bavaria, 81669, Germany

Location

Study Officials

• Jane M Jacob, PhD

  Synergy Spine Solutions

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 30, 2023
• Study Start: April 15, 2024
• Primary Completion: April 15, 2026
• Study Completion: April 15, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)