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

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 6, 2026 (before its estimated September 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 24 to 23
    • Study description expanded, about 131 words
    v13
  2. Study sites: 23 to 24
    • Study completion date: Dec 1, 2026 to Dec 2026
    v12
  3. Primary completion date: Jun 2025 to Sep 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Dec 1, 2025 to Dec 1, 2026
    • Site details revised at 23 of 23 sites
    v11
  4. Study sites: 20 to 23v10
  5. Site details revised at 4 of 20 sitesv9
Show 7 earlier versionsHide 7 earlier versions
  1. Study sites: 13 to 20v8
  2. Site contacts updated at 13 of 13 sitesv7
  3. Re-verified, no change to tracked fieldsv6
  4. Site details revised at 1 of 13 sitesv5
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 2023 to Jun 1, 2023
    • Site details revised at 13 of 13 sites
    v4
  6. Start date: Apr 1, 2023 to Jun 2023
    • Study sites: 0 to 13
    • Primary completion date: Dec 1, 2025 to Jun 2025
    v3
  7. Lead sponsor: [Redacted] to Synergy Spine Solutionsv2 Show 5 more changesShow less
    • Trial status: Withheld to Not Yet Recruiting
    • Primary and study completion dates: Dec 1, 2025
    • Start date: Apr 1, 2023
    • Collaborators expanded, about 1 word
    • Study title expanded, about 5 words
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05740176
Lead Sponsor Synergy Spine Solutions
Collaborators: MCRA
Conditions
(from sponsor)		 Cervical Degenerative Disc Disease
Related terms Intervertebral Disc Degeneration
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov