Clinical Study of Bone Graft Substitutes in Orthopaedic and Spinal Applications.

Study acronym: ROSA
StatusActive, Not Recruiting
PhaseNot specified
Started

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Trial flagged as At Risk
Primary completion moved at least 8 months later Mar 2026 → Nov 30, 2026
See other at-risk trials from Ceramisys Ltd

Record History

  1. Primary and study completion dates pushed to Nov 30, 2026
    • Site details revised at 1 of 7 sites
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 7 of 7 sites
    v9
  3. Site details revised at 1 of 7 sitesv8
  4. Site details revised at 3 of 7 sitesv7
  5. Primary completion date: Mar 2024 to Mar 2026
    • Study sites: 6 to 7
    • Study completion date: Mar 2024 to Jun 2026
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Primary and study completion dates: Mar 2023 to Mar 2024
    • Enrollment target: 175 to 220
    v5
  2. Primary and study completion dates pushed to Mar 2023
    • Study sites: 5 to 6
    v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Jun 2019 to Aug 2021
    • Start date changed from estimate of Feb 2019 to Jun 13, 2019
    • Study completion date: Sep 2020 to Sep 2021
    v3
  4. Start date: Jul 2018 to Feb 2019
    • Primary completion date: Jan 2019 to Jun 2019
    • Study completion date: Mar 2020 to Sep 2020
    v2
  1. Study First Submitted
  • 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.
This is an observational, prospective, non-randomised, multi-centred post market clinical follow-up study to compile real world clinical data on safety and efficacy of the synthetic bone graft substitutes in a commercial clinical setting in long bone and extremity defects and in spinal fusion procedures.
Trial Details
NCT Number NCT03570606
Lead Sponsor Ceramisys Ltd
Conditions
(from sponsor)		 Bone Deformity
Enrollment 220 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov