MedTrace Logo

The Synergy Disc To Anterior Cervical Discectomy and Fusion

NCT04469231 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2025-11-19

No results posted yet for this study

Summary

A multicenter, prospective, non-randomized, historically controlled study. Demonstrate the Synergy Disc is at least as safe and effective as conventional anterior cervical discectomy and fusion (ACDF) to treat cervical degenerative disc disease (DDD) in subjects who are symptomatic at only one level from C3 to C7 that are unresponsive to conservative management. Patients will be evaluated preoperatively, at the time of surgery, and at 6 weeks, 3, 6, 12, and 24 months after surgery. Follow-up will continue annually until the last patient reaches 24-month follow-up. The primary analysis will occur at 24 months.

Conditions

  • Cervical Degenerative Disc Disease

Interventions

DEVICE

Anterior Cervical Discectomy & Fusion

ACDF

Sponsors & Collaborators

  • MCRA

    collaborator INDUSTRY

  • Synergy Spine Solutions

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-30
Primary Completion
2025-06-19
Completion
2026-01-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04469231 on ClinicalTrials.gov