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NCT05740176 · ClinicalTrials.gov registry record · NA

The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery

A NA study of Cervical Degenerative Disc Disease, sponsored by Synergy Spine Solutions.

Active
Registry status
NA
Development phase
200
Enrollment target
20
Study locations

NCT05740176: Active NA study of Cervical Degenerative Disc Disease, sponsored by Synergy Spine Solutions.

NCT05740176 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 200 participants, below the 244-participant average among 4 other Cervical Degenerative Disc Disease trials with a reported enrollment target (18% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05740176, 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
200 participants
Enrollment target
20
Study locations

Study Summary

A multicenter, prospective, non-randomized, historically controlled study. To 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 two levels from C3 to C7 are and are unresponsive to conservative management. Patients will be evaluated preoperatively, at the time of surgery, and at 6 weeks, and 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

Cervical Degenerative Disc Disease

Interventions

  • DEVICE Anterior Cervical Discectomy and Fusion

Study Locations (20)

California

  • Todd Lanman, MD - Beverly Hills
  • DOCS Health Management LLC - Los Angeles
  • Institute of Neuro Innovation - Santa Monica

North Carolina

  • Carolina NeuroSurgery and Spine Associates, PA - Charlotte
  • M3 Emerging Medical Research - Durham
  • Pinehurst Surgical Clinic - Pinehurst

Florida

  • Brain and Spine Center of South Florida - Delray Beach
  • Kennedy-White Orthopaedic Center - Sarasota

Indiana

  • Indiana Spine Group - Carmel
  • Orthopedics Northeast - Fort Wayne

Louisiana

  • Bone and Joint Clinic of Baton Rouge - Baton Rouge
  • Louisiana Spine Institute - Shreveport

Oregon

  • Summit Spine - Portland
  • Oregon Spine Care - Tualatin

Texas

  • Austin Neurosurgeons - Austin
  • DFW Center for Spinal Disorders - Fort Worth

Arizona

  • HonorHealth - Scottsdale

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2023-06-01
Est. Completion 2026-12
Phase NA
Synergy Spine Solutions

2 total trials

What the registry record for NCT05740176 still lists

NCT05740176 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 244-participant average among 4 other Cervical Degenerative Disc Disease trials with a reported enrollment target (18% 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 and Fusion is the first listed.

NCT05740176 names 20 study sites across 11 states, led by California, North Carolina, Florida.

Frequently Asked Questions

What is clinical trial NCT05740176 about?

NCT05740176 is a clinical study titled "The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery". A multicenter, prospective, non-randomized, historically controlled study. To 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 two levels ...

What is the current status of trial NCT05740176?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 200 participants. The study started on 2023-06-01. Estimated completion is 2026-12.

What conditions does trial NCT05740176 study?

This clinical trial studies the following conditions: Cervical Degenerative Disc Disease.

What interventions are being tested in trial NCT05740176?

The interventions under investigation include: Anterior Cervical Discectomy and Fusion (DEVICE).

Who is sponsoring clinical trial NCT05740176?

This trial is sponsored by Synergy Spine Solutions, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05740176 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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Related registry views

Source: ClinicalTrials.gov NCT05740176, the US trial registry maintained by the National Library of Medicine. NCT05740176 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.