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NCT05587569 · ClinicalTrials.gov registry record · NA

Outcomes Following Combined Adductoplasty™ and Lapiplasty® (MTA3D)

A NA study of Hallux Valgus and Metatarsus Adductus, sponsored by Treace Medical Concepts.

Recruiting
Registry status
NA
Development phase
80
Enrollment target
9
Study locations

NCT05587569 is a NA study of Hallux Valgus and Metatarsus Adductus that is actively recruiting participants, run by Treace Medical Concepts. The registered enrollment target is 80 participants, above the 64-participant average among 4 other Hallux Valgus trials with a reported enrollment target (25% higher). The trial reports 9 study locations across 8 states.

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The verdict

NCT05587569, a NA study of Hallux Valgus and Metatarsus Adductus, is actively recruiting participants, sponsored by Treace Medical Concepts.

RECRUITING
Registry status
NA
Development phase
80 participants
Enrollment target
9
Study locations

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.

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

FieldValue
Enrollment Target 80 participants
Start Date 2022-09-28
Est. Completion 2030-12-31
Phase NA

Sponsor

Treace Medical Concepts

4 total trials

What the Registry Record Tells You About NCT05587569

The ClinicalTrials.gov registry entry for NCT05587569 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 64-participant average among 4 other Hallux Valgus trials with a reported enrollment target (25% higher). The listed sponsor is Treace Medical Concepts, which has 4 total studies on file at ClinicalTrials.gov.

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.

NCT05587569 reports 9 study locations spanning 8 distinct geographic areas - top geographies include Ohio, Colorado, Iowa.

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.

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).

Who is sponsoring clinical trial NCT05587569?

This trial is sponsored by Treace Medical Concepts, which has 4 total clinical trials registered on ClinicalTrials.gov.

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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