Post Market Data Collection Protocol to Evaluate the Performance of the Synergy Disc

Synergy Spine Solutions

Status: Enrolling

Conditions: Cervical Degenerative Disc Disease

Treatments: Device: Synergy cervical disc system

Study type: Observational

Funder types: Industry

Identifiers

NCT05880823

CP 21-001-GER01

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Exclusion Criteria: All answers must be NO to be eligible for the study.
• 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
• Previous diagnosis of osteopenia or osteomalacia
• More than one immobile vertebral level between C1 and T1 from any cause
• Morbid obesity
• Vulnerable person (pregnant patients, emergency cases, children, prisoners and people without mental capacity)

Trial design

50 participants in 2 patient groups

Prospective

Description:

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.

Treatment:

Device: Synergy cervical disc system

Retrospective

Description:

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.

Treatment:

Device: Synergy cervical disc system