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NCT04469231 · ClinicalTrials.gov registry record · NA
The Synergy Disc To Anterior Cervical Discectomy and Fusion
A NA study of Cervical Degenerative Disc Disease, sponsored by Synergy Spine Solutions.
- Active
- Registry status
- NA
- Development phase
- 175
- Enrollment target
- 20
- Study locations
NCT04469231: Active NA study of Cervical Degenerative Disc Disease, sponsored by Synergy Spine Solutions.
NCT04469231 is a NA study of Cervical Degenerative Disc Disease that is active but no longer recruiting, run by Synergy Spine Solutions. The registered enrollment target is 175 participants, below the 251-participant average among 4 other Cervical Degenerative Disc Disease trials with a reported enrollment target (30% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04469231, a NA study of Cervical Degenerative Disc Disease, is active but no longer recruiting, sponsored by Synergy Spine Solutions.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 175 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
≥ 15-point improvement in NDI Score (out of 100) in subjects at 24 months compared with baseline
Conditions Studied
Interventions
- DEVICE Anterior Cervical Discectomy & Fusion
Study Locations (20)
California
- Todd H. Lanman, M.D. - Beverly Hills
- Orthopedic Specialty Institute - Orange
- Institute of Neuro Innovation - Santa Monica
Texas
- Central Texas Brain & Spine - Austin
- Austin Neurosurgeons - Austin
- Texas Spine Care Center - San Antonio
Arizona
- Barrow Brain and Spine - Phoenix
- HonorHealth Research Institute/Barrow Brain and Spine - Scottsdale
Michigan
- Michigan Orthopedic Surgeons (2) - Southfield
- Michigan Orthopedic Surgeons - Southfield
New York
- Upstate Medical University - East Syracuse
- Hospital for Special Surgery - New York
Colorado
- Anschutz Medical Center - Aurora
Florida
- Kennedy White Orthopaedic Center - Sarasota
Indiana
- Indiana Spine Group - Carmel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 175 participants |
| Start Date | 2020-10-30 |
| Est. Completion | 2026-01-01 |
| Phase | NA |
What the registry record for NCT04469231 still lists
NCT04469231 is an interventional study that assigns participants to a tested intervention. The registered 175 participants enrollment target is mid-sized for trials with a published cap, below the 251-participant average among 4 other Cervical Degenerative Disc Disease trials with a reported enrollment target (30% lower).
The record links to 1 condition, with Cervical Degenerative Disc Disease appearing as the primary indexed condition, and to 1 intervention - of which Anterior Cervical Discectomy & Fusion is the first listed.
NCT04469231 names 20 study sites across 13 states, led by California, Texas, Arizona.
Frequently Asked Questions
What is clinical trial NCT04469231 about?
NCT04469231 is a clinical study titled "The Synergy Disc To Anterior Cervical Discectomy and Fusion". 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...
What is the current status of trial NCT04469231?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 175 participants. The study started on 2020-10-30. Estimated completion is 2026-01-01.
What conditions does trial NCT04469231 study?
This clinical trial studies the following conditions: Cervical Degenerative Disc Disease.
What interventions are being tested in trial NCT04469231?
The interventions under investigation include: Anterior Cervical Discectomy & Fusion (DEVICE).
Who is sponsoring clinical trial NCT04469231?
This trial is sponsored by Synergy Spine Solutions, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04469231 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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