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Early Weight-Bearing After Lapiplasty for Bunions (Mini3D Trial)
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.
Mini3D Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowMini3D Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Find a Location
Who is running the clinical trial?
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- I have had surgery for a bunion on the foot I'm seeking treatment for.You have had an allergic reaction to titanium in the past.I am currently on oral steroids or medications for rheumatoid arthritis.I have used man-made or donor bone graft substitutes.I can follow instructions for putting weight on my leg after surgery.I am scheduled for a same-day bilateral procedure and agree not to have surgery on the other foot for at least 6 months.My thyroid condition is not currently under control.I currently use nicotine products.I have moderate to severe arthritis in my big toe joint confirmed by an X-ray or physical test.I have been diagnosed with fibromyalgia.I have poor bone quality or conditions that slow healing.I have or might have an infection in the area affected by my condition.My foot condition is diagnosed as metatarsus adductus.I have been diagnosed with peripheral neuropathy.I am not able to have children or I have a recent negative pregnancy test.You have a tendency to develop keloid or hypertrophic scars.I can fill out questionnaires by myself.I have had surgery on my foot or ankle that involved fusing bones together, excluding surgeries for hammertoe or lesser toes.I have been diagnosed with CRPS/RSD.I am undergoing other procedures besides the main one.I am currently on medication that suppresses my immune system.I am fit for surgery and can be put under general anesthesia.I have diabetes with high blood sugar or HbA1c levels.I am scheduled for a procedure that will prevent me from putting weight on my feet soon after.My surgery will need an incision larger than 4.0 cm.Your bones have finished growing and you have closed growth plates.I am between 14 and 58 years old.The angle between the bones in your foot is within a range of 10.0˚ to 22.0˚.I have flatfoot with symptoms or my flatfoot is severe based on specific measurements.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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