Real World Data Collection on the Synergy Cervical Disc
NCT ID: NCT05305430
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2022-05-01
2029-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Synergy Cervical Disc System
motion preservation 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.
Synergy Cervical Disc System
motion preservation disc
Interventions
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Synergy Cervical Disc System
motion preservation disc
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
21 Years
ALL
No
Sponsors
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Pacific Clinical Research Group
OTHER
Synergy Spine Solutions
INDUSTRY
Responsible Party
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Principal Investigators
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Jane M Jacob, PhD
Role: STUDY_DIRECTOR
Sponsor GmbH
Locations
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Greenslopes Private Hospital
Brisbane, Queensland, Australia
Dr. Greg Malham
Melbourne, Victoria, Australia
Spine and Scoliosis Research Associates Australia Ltd
Windsor, Victoria, Australia
Countries
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Central Contacts
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Facility Contacts
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BBS
Role: primary
Other Identifiers
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CP 21-001
Identifier Type: -
Identifier Source: org_study_id
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