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Outcomes Following Combined Adductoplasty™ and Lapiplasty® (MTA3D)
NCT05587569 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DEVICE Treatment of metatarsus adductus and hallux valgus with the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure
Study Locations (9)
Ohio
- Ohio Foot and Ankle Center — Canton
- Ohio Foot and Ankle Center — Stow
Colorado
- Foot and Ankle Center of the Rockies — Greeley
Iowa
- Foot and Ankle Center of Iowa — Ankeny
Maine
- Coastal Maine Foot and Ankle — Yarmouth
Missouri
- JCMG - Jefferson City Medical Group — Jefferson City
North Carolina
- Duke Orthopaedics Arringdon — Morrisville
Pennsylvania
- Greater Pittsburgh Foot and Ankle Center — Wexford
Texas
- Foot and Ankle Associates of North Texas - Keller — Keller
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2022-09-28 |
| Est. Completion | 2030-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05587569
The ClinicalTrials.gov registry entry for NCT05587569 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Treace Medical Concepts, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Hallux Valgus appearing as the primary indexed condition, and to 1 intervention — of which Treatment of metatarsus adductus and hallux valgus with the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05587569 reports 9 study locations spanning 8 distinct geographic areas — top geographies include Ohio, Colorado, Iowa. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05587569 about?
NCT05587569 is a clinical study titled "Outcomes Following Combined Adductoplasty™ and Lapiplasty® (MTA3D)". 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...
What is the current status of trial NCT05587569?
This trial is currently recruiting. It is a NA study. The enrollment target is 80 participants. The study started on 2022-09-28. Estimated completion is 2030-12-31.
What conditions does trial NCT05587569 study?
This clinical trial studies the following conditions: Hallux Valgus, Metatarsus Adductus. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05587569?
The interventions under investigation include: Treatment of metatarsus adductus and hallux valgus with the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05587569?
This trial is sponsored by Treace Medical Concepts, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05587569 being conducted?
This trial has 9 study locations across Colorado, Iowa, Maine, Missouri, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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