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The Synergy Disc To Anterior Cervical Discectomy and Fusion

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Study sites: 19 to 20
    • Primary completion date changed from estimate of Jan 1, 2025 to Jun 19, 2025
    • Eligibility criteria expanded, about 11 words
    • Study description shortened, about 6 words
    v19
  2. Primary completion date: Jan 1, 2024 to Jan 1, 2025v18
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 190 to confirmed 175
    • Study sites: 22 to 19
    v17
  4. Study sites revised (22)v16
  5. Study sites: 21 to 22v15
Show 13 earlier versionsHide 13 earlier versions
  1. Site contacts updated at 3 of 21 sitesv14
  2. Study sites: 20 to 21v13
  3. Re-verified, no change to tracked fieldsv12
  4. Site details revised at 5 of 20 sitesv11
  5. Study sites: 18 to 20v10
  6. Study sites: 12 to 18v9
  7. Study sites: 9 to 12v8
  8. Site details revised at 2 of 9 sitesv7
  9. Study sites: 8 to 9v6
  10. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 15, 2020 to Oct 30, 2020
    • Site details revised at 8 of 8 sites
    v5
  11. Study sites: 0 to 8
    • Start date: Oct 1, 2020 to Oct 15, 2020
    v4
  12. Start date: Aug 1, 2020 to Oct 1, 2020v3
  13. Study description shortened, about 13 wordsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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. 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.
Trial Details
NCT Number NCT04469231
Lead Sponsor Synergy Spine Solutions
Collaborators: MCRA
Conditions
(from sponsor)		 Cervical Degenerative Disc Disease
Enrollment 175 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov