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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WITHDRAWN
OBSERVATIONAL
2024-09-25
2034-09-25
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 system implanted and give informed consent will be enrolled in this study, following country-specific requirements.
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.
Synergy cervical disc system
motion preservation disc
Interventions
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Synergy cervical disc system
motion preservation disc
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:
1. herniated disc and/or osteophyte formation
2. 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.)
3. Failed a minimum of 6 weeks conservative treatment
5. Written informed consent given by subject
1. Age 21 or above 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:
1. herniated disc and/or osteophyte formation
2. 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.)
3. Failed a minimum of 6 weeks conservative treatment
5. Written informed consent given by subject
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. Vulnerable person (pregnant patients, emergency cases, children, prisoners and people without mental capacity)
21 Years
ALL
No
Sponsors
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MCRA
INDUSTRY
Synergy Spine Solutions
INDUSTRY
Responsible Party
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Locations
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Royal Orthopedic Hospital
Birmingham, , United Kingdom
Kings College Hospital
London, , United Kingdom
Countries
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Other Identifiers
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CP 21-001-UK01
Identifier Type: -
Identifier Source: org_study_id
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