Real World Data Collection on the Synergy Cervical Disc

Recruiting

• Conditions: Cervical Disc Degeneration
• Interventions: Device: Synergy Cervical Disc System

• Registration Number: NCT05305430
• Lead Sponsor: Synergy Spine Solutions

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-22
• Study First Submitted QC: 2022-03-22
• Study First Posted: 2022-03-31
• Study Start: 2022-05-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-25
• Last Update Posted: 2024-02-28
• Primary Completion: 2025-03
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospective	Synergy Cervical Disc System	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.
Retrospective	Synergy Cervical Disc System	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.

Primary Outcome Measures

Name	Time	Method
Neck Disability Index	12 months	\>15 improvement in NDI score (out of 100) in subjects by 12 mo. post operative compared with baseline
Device Related or Device Procedure Related Adverse Events	12 months	Absence of major device related adverse events defined as radiographic failure, neurological failure, or failure by adverse event

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction	6 weeks, 3 months, 6 months, 12 months, annually post operatively	patient completed questionnaire on satisfaction with disc replacement surgery
Nurick's Criteria	pre-operative and 6 weeks, 3 months, 6 months, 12 months, annually post operatively	disease status characterized by physician at each visit
Neurologic Function	6 weeks, 3 months, 6 months, 12 months, annually post operatively	maintenance or improvement in neurologic status compared to baseline
Visual Analog (VAS) pain	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.
Odom's Criteria	6 weeks, 3 months, 6 months, 12 months, annually post operatively	surgical outcome characterized by physician at each post operative visit

Trial Locations

Locations (3)

Spine and Scoliosis Research Associates Australia Ltd; 🇦🇺 Windsor, Victoria, Australia

Greenslopes Private Hospital; 🇦🇺 Brisbane, Queensland, Australia

Dr. Greg Malham; 🇦🇺 Melbourne, Victoria, Australia