Post-Market Data Collection to Evaluate the Performance of the Synergy Disc®

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-03-31

Study Completion Date

2034-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Real World Data Collection on the Synergy Disc

NCT06383949

Cervical Degenerative Disc Disease

RECRUITING

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

NCT05880823

Cervical Degenerative Disc Disease

RECRUITING

Multi-Centre Post-Market Data Collection

NCT06413225

Cervical Degenerative Disc Disease

WITHDRAWN

Real World Data Collection on the Synergy Cervical Disc

NCT05305430

Cervical Disc Degeneration

RECRUITING

The Synergy Disc To Anterior Cervical Discectomy and Fusion

NCT04469231

Cervical Degenerative Disc Disease

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cervical Degenerative Disc Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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 spine disc replacement

Intervention Type DEVICE

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 spine disc replacement

Intervention Type DEVICE

motion preservation disc

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Synergy cervical spine disc replacement

motion preservation disc

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No