Multi-Centre Post-Market Data Collection

Withdrawn

• Conditions: Cervical Degenerative Disc Disease

• Registration Number: NCT06413225
• Lead Sponsor: Synergy Spine Solutions

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-22
• Study First Submitted QC: 2024-05-09
• Study First Posted: 2024-05-14
• Study Start: 2024-09-25
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-12
• Last Update Posted: 2025-06-17
• Primary Completion: 2029-09-25
• Study Completion: 2034-09-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

• Inclusion Criteria: All answers must be YES to be eligible for the study.

  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: All answers must be NO to be eligible for the study.

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. Vulnerable person (pregnant patients, emergency cases, children, prisoners and people without mental capacity)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neck Disability Index (NDI)	12 months	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.
device Related or Device Procedure Related Adverse Events	12 months	Absence of major device related adverse events defined as radiographic failure, neurologic failure or failure by adverse event

Secondary Outcome Measures

Name	Time	Method
Visual Analog Scale Neck and Arm Pain Measurement	pre-operative, 6 week, 3 month, 6 month, 12 month, annually post-operatively	Pain will evaluated by the Visual analog scale (VAS) (place a line from zero where there is no pain to 10 which is the worst pain imaginable), by NRS (circle a number from zero to ten where zero equals no pain and ten is worst imaginable) to or a verbal description that the doctor writes down, per the site's Standard of Care. A change of at least 20 mm will be considered clinically significant. Neck pain as measured on a 100mm VAS at baseline and at each follow-up timepoint. Left and Right arm/shoulder pain as measured on a 100 mm VAS at baseline and at each follow up time-point.
Patient Satisfaction	6 week, 3 month, 6 month, 12 month, annually post-operatively	patient completed questionnaire on their satisfaction with the disc replacement surgery
Motor and Sensory Function in the Arm	pre-operative, 6 week, 3 month, 6 month, 12 month, annually post-operatively	maintenance or improvement in neurologic status compared with baseline will be assessed using a defined numeric scale ranging from 0 (normal) to 5 (deficit)
Nurick's Criteria	pre-operative, 6 week, 3 month, 6 month, 12 month, annually post-operatively	Disease status as characterized by physician at each time point
Odom's criteria	6 week, 3 month, 6 month, 12 month, annually post-operatively	surgical outcome characterized by physician at each post operative visit

Trial Locations

Locations (2)

Royal Orthopedic Hospital; 🇬🇧 Birmingham, United Kingdom

Kings College Hospital; 🇬🇧 London, United Kingdom