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Enhancement of Bone Regeneration and Healing in the Extremities by the Use of Autologous BonoFill-II

StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Enrollment target: 20 to 40
    • Study description expanded, about 7 words
    • Site details revised at 1 of 6 sites
    v6
  2. Primary completion date: Jun 2022 to Mar 2027v5 Show 5 more changesShow less
    • Primary endpoints: 1 to 3
    • Study sites: 5 to 6
    • Study completion date: Sep 2022 to Jun 2027
    • Eligibility criteria expanded, about 59 words
    • Secondary endpoints shortened, about 15 words
  3. Enrollment target: 10 to 20v4 Show 6 more changesShow less
    • Primary completion date: Sep 2019 to Jun 2022
    • Study sites: 1 to 5
    • Study completion date: Dec 2019 to Sep 2022
    • Eligibility criteria shortened, about 78 words
    • Secondary endpoints revised (4)
    • Study description shortened, about 52 words
  4. Primary completion date: Feb 2018 to Sep 2019v3 Show 4 more changesShow less
    • Start date: Jan 2017 to Jul 27, 2017
    • Study completion date: Aug 2019 to Dec 2019
    • Eligibility criteria expanded, about 9 words
    • Site contact updated
  5. Trial status: Not Yet Recruiting to Recruiting
    • Primary endpoints: 6 to 1
    • Eligibility criteria expanded, about 18 words
    • Site details revised
    v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this clinical study is to evaluate the safety and the efficacy of BonoFill-II as an autologous bone-regenerating graft in the reconstruction of deficient bone in two clinical indications: 1. Long and short bone extra-articular comminuted fracture 2. Long and short bones extra and intra articular defect /Gap or non-union, incapable of self-regeneration
Trial Details
NCT Number NCT03024008
Lead Sponsor BonusBio Group Ltd
Conditions
(from sponsor)		 Bone Fracture
Related terms Fractures, Bone, Fractures, Comminuted
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov