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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: Recruiting NA study of Hallux Valgus and Metatarsus Adductus, sponsored by Treace Medical Concepts.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Successful correction is defined as two of the following three criteria: measured IMA \<9.0°, HVA \<15.0°, and TSP as ≤3 at 6 months post Adductoplasty® Procedure and Lapiplasty® Procedure. Recurrence at 24 months is defined by HVA \>15.0°.
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 |
What NCT05587569 shows while recruiting
NCT05587569 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, above the 64-participant average among 4 other Hallux Valgus trials with a reported enrollment target (25% higher).
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 lists 9 locations in 8 states (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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