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NCT03740282 · ClinicalTrials.gov registry record · NA
Early Weight-Bearing After the Lapiplasty Procedure
A NA study of Bunion and Hallux Valgus, sponsored by Treace Medical Concepts.
- Active
- Registry status
- NA
- Development phase
- 183
- Enrollment target
- 7
- Study locations
NCT03740282: Active NA study of Bunion and Hallux Valgus, sponsored by Treace Medical Concepts.
NCT03740282 is a NA study of Bunion and Hallux Valgus that is active but no longer recruiting, run by Treace Medical Concepts. The registered enrollment target is 183 participants, above the 137-participant average among 4 other Bunion trials with a reported enrollment target (34% higher). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03740282, a NA study of Bunion and Hallux Valgus, is active but no longer recruiting, sponsored by Treace Medical Concepts.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 183 participants
- Enrollment target
- 7
- Study locations
Study Summary
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.
Primary Outcome
Defined as IMA ≥ 12, HVA ≥ 20 and TSP as ≥ 4 at 24 Months post Lapiplasty Procedure
Conditions Studied
Interventions
- DEVICE Lapiplasty
Study Locations (7)
Texas
- UT Southwestern - Dallas
- Stonebriar Foot & Ankle - Frisco
Colorado
- Foot & Ankle Center of Northern Colorado - Greeley
Iowa
- Foot & Ankle Center of Iowa - Ankeny
Missouri
- Jefferson City Medical Group, P.C. - Jefferson City
Nevada
- Desert Orthopaedic Center - Las Vegas
Pennsylvania
- University of Pennsylvania/Penn Medicine - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 183 participants |
| Start Date | 2018-11-06 |
| Est. Completion | 2026-05-31 |
| Phase | NA |
What the registry record for NCT03740282 still lists
NCT03740282 is an interventional study that assigns participants to a tested intervention. The registered 183 participants enrollment target is mid-sized for trials with a published cap, above the 137-participant average among 4 other Bunion trials with a reported enrollment target (34% higher).
The record links to 2 conditions, with Bunion appearing as the primary indexed condition, and to 1 intervention - of which Lapiplasty is the first listed.
NCT03740282 lists 7 locations in 6 states (Texas, Colorado, Iowa).
Frequently Asked Questions
What is clinical trial NCT03740282 about?
NCT03740282 is a clinical study titled "Early Weight-Bearing After the Lapiplasty Procedure". 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® P...
What is the current status of trial NCT03740282?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 183 participants. The study started on 2018-11-06. Estimated completion is 2026-05-31.
What conditions does trial NCT03740282 study?
This clinical trial studies the following conditions: Bunion, Hallux Valgus.
What interventions are being tested in trial NCT03740282?
The interventions under investigation include: Lapiplasty (DEVICE).
Who is sponsoring clinical trial NCT03740282?
This trial is sponsored by Treace Medical Concepts, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03740282 being conducted?
This trial has 7 study locations across Colorado, Iowa, Missouri, Nevada, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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