Multi-Centre Post-Market Data Collection

NCT06413225 | Withdrawn

• 1 other identifier: CP 21-001-UK01
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

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

Keywords

radiculopathy; myelopathy; disc replacement; motion preservation

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)

• Visual Analog Scale Neck and Arm Pain Measurement

  pre-operative, 6 week, 3 month, 6 month, 12 month, annually post-operatively

• Patient Satisfaction

  6 week, 3 month, 6 month, 12 month, annually post-operatively

• Motor and Sensory Function in the Arm

  pre-operative, 6 week, 3 month, 6 month, 12 month, annually post-operatively

• Nurick's Criteria

  pre-operative, 6 week, 3 month, 6 month, 12 month, annually post-operatively

• Odom's criteria

  6 week, 3 month, 6 month, 12 month, annually post-operatively

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

People over the age of 21 diagnosed with cervical degenerative disc disease and for whom the Synergy Disc device is an option (prospective cohort) or has already been implanted (retrospective cohort).

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:

• 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
• 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

Sponsors & Collaborators

• Synergy Spine Solutions: lead
• MCRA: collaborator

Study Sites (2)

Royal Orthopedic Hospital

Birmingham, United Kingdom

Location

Kings College Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Radiculopathy; Spinal Cord Diseases

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: May 14, 2024
• Study Start: September 25, 2024
• Primary Completion (Estimated): September 25, 2029
• Study Completion (Estimated): September 25, 2034
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)