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Outcomes Following Combined Adductoplasty™ and Lapiplasty® (MTA3D)

Study acronym: MTA3D
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Primary completion date: Dec 31, 2025 to Dec 31, 2026
    • Study completion date: Dec 31, 2029 to Dec 31, 2030
    • Eligibility criteria expanded, about 4 words
    v16
  2. Minor Site contacts updated at 1 of 9 sitesv15
  3. Minor Site contacts updated at 3 of 9 sitesv14
  4. Minor Site contacts updated at 1 of 9 sitesv13
  5. Notable Primary completion date: Dec 31, 2024 to Dec 31, 2025
    • Eligibility criteria expanded, about 7 words
    v12
Show 10 earlier versionsHide 10 earlier versions
  1. Minor Study sites: 8 to 9v11
  2. Notable Primary endpoint revised
    • Eligibility criteria revised
    • Secondary endpoints: 10 to 11
    v10
  3. Minor Re-verified, no change to tracked fieldsv9
  4. Minor Eligibility criteria expanded, about 1 wordv8
  5. Minor Study sites: 7 to 8v7
  6. Minor Study sites: 5 to 7v6
  7. Minor Secondary endpoints: details revised at 1 of 10 entries
    • Site contacts updated at 1 of 5 sites
    v5
  8. Minor Study sites: 4 to 5v4
  9. Minor Study sites: 3 to 4v3
  10. Notable Trial status: Active, Not Recruiting to Recruiting
    • Study sites: 1 to 3
    • Eligibility criteria expanded, about 24 words
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Prospective, multicenter, unblinded study to evaluate outcomes of the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure for patients in need of metatarsus adductus and hallux valgus correction. Up to 80 subjects will be treated in this study at up to 13 clinical sites. Patients 14 years of age or older with symptomatic metatarsus adductus and hallux valgus will be eligible to participate based on the inclusion and exclusion criteria defined in the study protocol.
Trial Details
NCT Number NCT05587569
Lead Sponsor Treace Medical Concepts, Inc.
Conditions
(from sponsor)
Metatarsus Adductus, Hallux Valgus
Related terms Hallux Valgus, Metatarsus Varus
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov