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Case Series on the Clinical Performance of VA Clavicle and Clavicle Hook Plate 2.7 Systems

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Study sites: 8 to 7v12
  2. Site details revised at 1 of 8 sitesv11
  3. Site details revised at 2 of 8 sitesv10
  4. Study sites revised (8)v9
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 8, 2024 to Jul 10, 2024
    • Site details revised at 8 of 8 sites
    v8
Show 6 earlier versionsHide 6 earlier versions
  1. Start date: Apr 30, 2024 to Jul 8, 2024
    • Study sites: 2 to 8
    v7
  2. Primary completion date: Jan 31, 2026 to Jan 31, 2027
    • Start date: Oct 1, 2023 to Apr 30, 2024
    • Study completion date: Jul 31, 2026 to Sep 30, 2029
    v6
  3. Re-verified, no change to tracked fieldsv5
  4. Primary completion date: Jan 31, 2025 to Jan 31, 2026
    • Start date: Jul 1, 2022 to Oct 1, 2023
    • Study completion date: Jul 31, 2025 to Jul 31, 2026
    v4
  5. Re-verified, no change to tracked fieldsv3
  6. Start date: Oct 1, 2021 to Jul 1, 2022
    • Study title shortened, about 6 words
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to gather early and mid- to long-term evidence to confirm the clinical performance, safety and use of the Clavicle Plate and Clavicle Hook Plate System. A minimum of 76 patients with clavicle fractures or dislocations of the AC joint surgically treated with any plate from the DPS VA-LCP Clavicle System will be enrolled in this observational post-market clinical investigation. Outcomes will be collected until up to 2 years after surgery.
Trial Details
NCT Number NCT04921865
Lead Sponsor AO Innovation Translation Center
Conditions
(from sponsor)		 Clavicle, Acromioclavicular Joint, Fracture
Related terms Fractures, Bone
Enrollment 76 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov