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NCT05082012 · ClinicalTrials.gov registry record · NA
Early Weight-Bearing After the Lapiplasty Mini-Incision Procedure (Mini3D)
A NA study, sponsored by Treace Medical Concepts.
- Terminated
- Registry status
- NA
- Development phase
- 123
- Enrollment target
NCT05082012: Clinical Trial NA study, sponsored by Treace Medical Concepts.
NCT05082012 is a NA study that was terminated before completion, run by Treace Medical Concepts. The registered enrollment target is 123 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05082012, a NA study, was terminated before completion, sponsored by Treace Medical Concepts.
- TERMINATED
- Registry status
- NA
- Development phase
- 123 participants
- Enrollment target
Study Summary
Prospective, multicenter, unblinded study to evaluate outcomes of the Lapiplasty® Procedure using the Lapiplasty® Mini-Incision™ System for patients in need of hallux valgus surgery. Up to 200 subjects will be treated in this study at up to 20 clinical sites. Patients 14 years through 58 years with symptomatic hallux valgus will be eligible to participate based on the inclusion and exclusion criteria defined in the study protocol.
Primary Outcome
Radiographic recurrence of hallux valgus deformity at 24 months for subjects with successful correction (defined as Intermetatarsal Angle (IMA) \<9.0°, Hallux Valgus Angle (HVA)\<15.0° and Tibial Sesamoid Position (TSP) as ≤ 3 at 6 weeks post-Lapiplasty® Procedure). Recurrence is defined by any two of the following three criteria being met at 24 months post-procedure: IMA of ≥12°, HVA ≥20° and TSP ≥4
Interventions
- DEVICE Treatment of Hallux Valgus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2021-09-17 |
| Est. Completion | 2024-05-09 |
| Phase | NA |
Why NCT05082012 stopped before completion
NCT05082012 is an interventional study that assigns participants to a tested intervention. The registered 123 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which Treatment of Hallux Valgus is the first listed.
NCT05082012 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05082012 about?
NCT05082012 is a clinical study titled "Early Weight-Bearing After the Lapiplasty Mini-Incision Procedure (Mini3D)". Prospective, multicenter, unblinded study to evaluate outcomes of the Lapiplasty® Procedure using the Lapiplasty® Mini-Incision™ System for patients in need of hallux valgus surgery. Up to 200 subjects will be treated in this study at up to 20 clinical sites. Patients 14 years through 58 years with...
What is the current status of trial NCT05082012?
This trial is currently terminated. It is a NA study. The enrollment target is 123 participants. The study started on 2021-09-17. Estimated completion is 2024-05-09.
What interventions are being tested in trial NCT05082012?
The interventions under investigation include: Treatment of Hallux Valgus (DEVICE).
Who is sponsoring clinical trial NCT05082012?
This trial is sponsored by Treace Medical Concepts, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05082012's enrollment target sits among peer trials
123 762nd of 2000 higher than 1,239 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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