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X-BS Ortho Bone Graft Study

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later Mar 2027 → Oct 2027
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Advanced Medical Solutions Ltd.

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion pushed from Mar 2027 to Oct 2027 Show 12 more changesShow less
    • Primary endpoint(s) modified
    • Phase changed: not specified → not applicable
    • Enrollment increased: 100 → 200 participants
    • Start date: Mar 2025 to Oct 2026
    • Study completion pushed from Mar 2027 to Oct 2028
    • Interventions modified
    • Trial arms changed: 1 → 2
    • Eligibility criteria expanded, about 61 words
    • Secondary endpoints: 5 to 6
    • Study description shortened, about 39 words
    • Collaborators expanded, about 4 words
    • Study title expanded, about 1 word
  2. Notable Start date: Sep 2024 to Mar 2025
    • Primary and study completion dates: Sep 2026 to Mar 2027
    v4
  3. Notable Start date: May 2024 to Sep 2024
    • Primary completion date: May 2026 to Sep 2026
    • Study completion date: Aug 2026 to Sep 2026
    • Secondary endpoints: 4 to 5
    v3
  4. Notable Primary endpoint revised
    • Secondary endpoints revised (4)
    v2
  5. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Randomised investigation of the osteoconductive performance and safety of CE-marked FDBS bone graft (GraftR3®), with contextual reference to CE-marked IBS (MBCP® Putty), in the filling of orthopaedic bone defects.
Trial Details
NCT Number NCT06326827
Lead Sponsor Advanced Medical Solutions Ltd.
Collaborators: Advanced Medical Solutions (Nantes)
Conditions
(from sponsor)
Orthopedic Disorder, Trauma Injury, Extremity Injury
Related terms Accidental Injuries, Fractures, Bone, Musculoskeletal Diseases
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov