Real World Data Collection on the Synergy Cervical Disc

February 25, 2024 updated by: Synergy Spine Solutions

A Multi-Center Post-Market Data Collection Protocol to Evaluate the Performance of Synergy Spine Solutions Synergy Disc

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • Queensland
      • Brisbane, Queensland, Australia
        • Recruiting
        • Greenslopes Private Hospital
        • Principal Investigator:
          • Bruce I Hall, MD
        • Contact:
          • BBS
    • Victoria
      • Melbourne, Victoria, Australia
      • Windsor, Victoria, Australia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  1. Over the age of 21 at the time of the surgery.
  2. Have had (retrospective cohort) or the decision has been made to have (prospective cohort) the Synergy Disc implanted
  3. Skeletally mature patients for reconstruction of the disc from C3-C7 following a single or multiple level discectomy for intractable radiculopathy
  4. 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
  5. 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.)
  6. Failed a minimum of 6 weeks conservative treatment
  7. Written informed consent given by subject, as applicable.

Exclusion Criteria:

  1. Moderate to advanced spondylosis
  2. Diagnosis of osteoporosis
  3. Active systemic infection or infection at the operative site
  4. Pregnancy
  5. Marked cervical instability on lateral, coronal, or flexion/extension radiographs
  6. Cervical spine condition other than symptomatic cervical disc disease requiring surgical treatment at the involved level
  7. Severe pathology of the facet joints of the involved vertebral bodies
  8. Previous diagnosis of osteopenia or osteomalacia
  9. More than one immobile vertebral level between C1 and T1 from any cause
  10. Morbid obesity
  11. Currently a prisoner

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
motion preservation disc
Other Names:
  • Synergy Disc
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
motion preservation disc
Other Names:
  • Synergy Disc

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neck Disability Index
Time Frame: 12 months
>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
Time Frame: 12 months
Absence of major device related adverse events defined as radiographic failure, neurological failure, or failure by adverse event
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog (VAS) pain
Time Frame: pre-operative and 6 week, 3 months, 6 months, 12 months, annually post operatively
Visual analogue scale (VAS) will be used to evaluate pain where a change of at least 20mm will be considered clinically significant. Neck pain as measured on a 100mm VAS at baseline and at each follow-up time-point. Left and Right arm/shoulder pain as measured on a 100mm VAS at baseline and at each follow-up time-point.
pre-operative and 6 week, 3 months, 6 months, 12 months, annually post operatively
Patient Satisfaction
Time Frame: 6 weeks, 3 months, 6 months, 12 months, annually post operatively
patient completed questionnaire on satisfaction with disc replacement surgery
6 weeks, 3 months, 6 months, 12 months, annually post operatively
Nurick's Criteria
Time Frame: pre-operative and 6 weeks, 3 months, 6 months, 12 months, annually post operatively
disease status characterized by physician at each visit
pre-operative and 6 weeks, 3 months, 6 months, 12 months, annually post operatively
Odom's Criteria
Time Frame: 6 weeks, 3 months, 6 months, 12 months, annually post operatively
surgical outcome characterized by physician at each post operative visit
6 weeks, 3 months, 6 months, 12 months, annually post operatively
Neurologic Function
Time Frame: 6 weeks, 3 months, 6 months, 12 months, annually post operatively
maintenance or improvement in neurologic status compared to baseline
6 weeks, 3 months, 6 months, 12 months, annually post operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Synergy Spine Solutions

Collaborators

Pacific Clinical Research Group

Investigators

  • Study Director: Jane M Jacob, PhD, Sponsor GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

March 22, 2022

First Submitted That Met QC Criteria

March 22, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 25, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP 21-001

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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