Real World Data Collection on the Synergy Cervical Disc

NCT05305430 | Recruiting

• 1 other identifier: CP 21-001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 3

Brief Summary

This trial is a real world data (RWD) collection observational study, comprised of both prospective and retrospective arms, that will examine the safety and effectiveness of the Synergy Cervical Disc System in patients with degenerative cervical disc disease.

Conditions

Cervical Disc Degeneration

Keywords

degenerative disc; cervical; radiculopathy; myelopathy; motion preservation

Outcome Measures

Primary Outcomes (2)

• Neck Disability Index

  \>15 improvement in NDI score (out of 100) in subjects by 12 mo. post operative compared with baseline

  12 months

• Device Related or Device Procedure Related Adverse Events

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

  12 months

Secondary Outcomes (5)

• Visual Analog (VAS) pain

  pre-operative and 6 week, 3 months, 6 months, 12 months, annually post operatively

• Patient Satisfaction

  6 weeks, 3 months, 6 months, 12 months, annually post operatively

• Nurick's Criteria

  pre-operative and 6 weeks, 3 months, 6 months, 12 months, annually post operatively

• Odom's Criteria

  6 weeks, 3 months, 6 months, 12 months, annually post operatively

• Neurologic Function

  6 weeks, 3 months, 6 months, 12 months, annually post operatively

Study Arms (2)

Prospective

All patients for whom the decision has been made to have the Synergy Disc implanted at participating investigative centers and give informed consent to participate in the prospective segment of this protocol, per country-specific requirements, will be enrolled in the prospective portion of this protocol.

Device: Synergy Cervical Disc System

Retrospective

Patients who have previously had a Synergy Spine Solutions Synergy Disc implanted will be eligible for inclusion in the retrospective data collection; a waiver of consent, or informed consent, for retrospective data collection from the medical records of the implanting surgeon will be sought per country-specific regulations as applicable.

Device: Synergy Cervical Disc System

Interventions

Synergy Cervical Disc System DEVICE

motion preservation disc

Also known as: Synergy 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

Both retrospective and prospective study subjects that have cervical degenerative disc disease requiring treatment with the Synergy Spine Solutions Synergy Disc. Prospective study cohort: All patients for whom it has been decided that the Synergy Spine Solutions Synergy Disc will be implanted at participating investigative centers and give informed consent to participate in the prospective segment of this protocol. Retrospective study cohort: Patients who have previously had a Synergy Spine Solutions Synergy Disc implanted. If required by local regulations, informed consent will be sought and received from the participating patient prior to data collection from the medical records per country-specific regulations.

You may qualify if:

• Over the age of 21 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, as applicable.

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
• Currently a prisoner

Sponsors & Collaborators

• Synergy Spine Solutions: lead
• Pacific Clinical Research Group: collaborator

Study Sites (3)

Greenslopes Private Hospital

Brisbane, Queensland, Australia

RECRUITING

Dr. Greg Malham

Melbourne, Victoria, Australia

RECRUITING

Spine and Scoliosis Research Associates Australia Ltd

Windsor, Victoria, Australia

RECRUITING

MeSH Terms

Conditions

Radiculopathy; Spinal Cord Diseases

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Central Nervous System Diseases

Study Officials

• Jane M Jacob, PhD

  Sponsor GmbH

  STUDY DIRECTOR

Central Study Contacts

Jane M Jacob, PhD

CONTACT

+1 512-289-5370; janejacob@synergyspinesolutions.com

Christine Nimalasiri

CONTACT

christine.nimalasiri@pcrg.com.au

Study Design

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

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: March 31, 2022
• Study Start: May 1, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2029
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)