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Early Weight-Bearing After the Lapiplasty Procedure

Study acronym: ALIGN3D
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. 5 versions Re-verified since Nov 19, 2024, no change to tracked fieldsv20-v24
  2. Primary completion date changed from estimate of Sep 30, 2023 to May 1, 2023v19
  3. Re-verified, no change to tracked fieldsv18
  4. Primary completion date: May 31, 2023 to Sep 30, 2023v17
  5. 2 versions Re-verified since Sep 14, 2021, no change to tracked fieldsv15-v16
Show 13 earlier versionsHide 13 earlier versions
  1. Primary completion date: Dec 31, 2021 to May 31, 2023v14 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 200 to confirmed 183
    • Study completion date: Dec 31, 2024 to May 31, 2026
    • Site details revised at 7 of 7 sites
  2. Site contacts updated at 4 of 7 sitesv13
  3. Secondary endpoints: 12 to 11v12
  4. Secondary endpoints: 11 to 12v11
  5. Re-verified, no change to tracked fieldsv10
  6. Site contacts updated at 1 of 7 sitesv9
  7. Study sites: 5 to 7
    • Eligibility criteria shortened, about 1 word
    v8
  8. Site contacts updated at 4 of 5 sitesv7
  9. Eligibility criteria shortened, about 12 words
    • Secondary endpoints: 10 to 11
    v6
  10. Study sites revised (5)v5
  11. Study sites: 3 to 5v4
  12. Study sites: 2 to 3v3
  13. Eligibility criteria expanded, about 11 wordsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 objectives of this study are to evaluate the following outcomes of the Lapiplasty® Procedure for patients in need of hallux valgus surgery: * The study will determine the radiographic recurrence of hallux valgus and the timing of failure following hallux valgus correction with the Lapiplasty® Procedure. * The study will determine whether the Lapiplasty® Procedure effectively corrects anatomical alignment of the 1st metatarsal and sesamoids in all three planes. * The study will assess whether early weight-bearing after the Lapiplasty® Procedure affects the union rates or causes loss of 3-plane correction. * The study will evaluate the quality of life and pain scores following the Lapiplasty® Procedure.
Trial Details
NCT Number NCT03740282
Lead Sponsor Treace Medical Concepts, Inc.
Conditions
(from sponsor)		 Hallux Valgus, Bunion
Related terms Ankylosis, Bunion, Hallux Valgus
Enrollment 183 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov