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Early Weight-Bearing After Lapiplasty for Bunions (Mini3D Trial)

N/A
Waitlist Available
Led By Jody McAleer, DPM, FACFAS
Research Sponsored by Treace Medical Concepts, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Willing and able to adhere to early weight-bearing instructions post-operatively
Female patients must be of non-child bearing potential or have a negative pregnancy test within 7 days prior to index procedure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-2 weeks, 2-3 weeks, 6 weeks, 4 months, 6 months, 12 months, 24 months post lapiplasty® procedure
Awards & highlights

Mini3D Trial Summary

This trial will look at the outcomes of a new surgical procedure for hallux valgus (a bunion) using a mini-incision system. Up to 200 people will be enrolled at 20 different medical sites.

Who is the study for?
This trial is for males and females aged 14-58 with symptomatic bunions, specifically a hallux valgus angle of 16.0˚ - 40.0˚ and an intermetatarsal angle of 10.0˚ - 22.0˚ who can follow post-op instructions and attend follow-ups. Exclusions include previous foot surgeries, severe arthritis in the toe joint, BMI over 40, smokers, uncontrolled diabetes or hypothyroidism, certain infections or conditions affecting healing.Check my eligibility
What is being tested?
The study tests the Lapiplasty Mini-Incision System on patients needing bunion surgery (hallux valgus correction). It's prospective and multicenter involving up to 200 subjects at no more than 20 sites to evaluate early weight-bearing outcomes after surgery.See study design
What are the potential side effects?
While specific side effects are not listed here, typical risks associated with bunion surgery may include infection at the incision site, pain or swelling around the toe area, delayed bone healing or failure to correct the deformity.

Mini3D Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can follow instructions for putting weight on my leg after surgery.
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I am not able to have children or I have a recent negative pregnancy test.
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I can fill out questionnaires by myself.
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I am fit for surgery and can be put under general anesthesia.
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I am between 14 and 58 years old.

Mini3D Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-2 weeks, 2-3 weeks, 6 weeks, 4 months, 6 months, 12 months, 24 months post lapiplasty® procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-2 weeks, 2-3 weeks, 6 weeks, 4 months, 6 months, 12 months, 24 months post lapiplasty® procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Radiographic Recurrence
Secondary outcome measures
Change in Pain
Change in Quality of Life
Change in Radiographic Foot Length
+10 more

Find a Location

Who is running the clinical trial?

Treace Medical Concepts, Inc.Lead Sponsor
2 Previous Clinical Trials
263 Total Patients Enrolled
Jody McAleer, DPM, FACFASPrincipal InvestigatorJCMG - Podiatry

Media Library

Lapiplasty Mini-Incision Procedure (N/A) Clinical Trial Eligibility Overview. Trial Name: NCT05082012 — N/A
Bunions Research Study Groups:
Bunions Clinical Trial 2023: Lapiplasty Mini-Incision Procedure Highlights & Side Effects. Trial Name: NCT05082012 — N/A
Lapiplasty Mini-Incision Procedure (N/A) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05082012 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does my profile meet the stated criteria for enrollment in this medical experiment?

"To be eligible for inclusion in this trial, prospective participants must have bunion and possess an age between 14 and 58. At present, around 200 patients are being recruited."

Answered by AI

Does this study accept participants who are of senior age?

"This trial has a specified age range of 14 to 58, with additional studies available for minors and elderly individuals respectively. In total, there are 3 trials specifically designed for those under 18 years old and 15 dedicated towards seniors who exceed the age of 65."

Answered by AI

What is the extent of participation in this clinical research?

"To commence the trial, 200 suitable participants must be identified. Treace Medical Concepts will spearhead this clinical research from two locations: University of Pennsylvania / Penn Medicine in Philadelphia and Stonebriar Foot and Ankle in Frisco."

Answered by AI

Is the current recruitment phase of this research open to participants?

"Affirmative. Evidence from clinicaltrials.gov suggests that this experiment is currently in the recruitment phase, which began on September 17th 2021 and was most recently updated on September 29th 2022. 200 participants are required to be sourced between 10 separate sites."

Answered by AI

How many institutions are participating in this research endeavor?

"Currently, the trial is enrolling patients at 10 sites throughout Philadelphia, Frisco, Keller and other cities. It would be beneficial to select a clinic close by you in order to reduce the amount of travel needed for your participation."

Answered by AI

Who else is applying?

What site did they apply to?
Foot & Ankle Associates of North Texas - Keller
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

~28 spots leftby Sep 2024