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Procedure
Early Weight-Bearing After Lapiplasty for Bunions (ALIGN3D Trial)
N/A
Waitlist Available
Led By Dane Wukich, MD
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
Male and females between the ages 14 and 58 years at the time of consent
Acceptable surgical candidate, including use of general anesthesia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-operatively, 6 weeks, 4 months, 6 months, 12 months, 24 months, 36 month, 48 months, 60 months
Awards & highlights
ALIGN3D Trial Summary
This trial will assess the Lapiplasty® Procedure for hallux valgus surgery in terms of recurrence, anatomical alignment, weight-bearing, union rates, and quality of life.
Who is the study for?
This trial is for individuals aged 14-58 with mild to moderate bunions, who can undergo general anesthesia and are able to follow early weight-bearing instructions after surgery. They must not be pregnant or planning pregnancy soon, have closed growth plates in their bones, and be capable of filling out questionnaires.Check my eligibility
What is being tested?
The Lapiplasty Procedure is being tested for its effectiveness in correcting bunions (hallux valgus) on three planes, assessing the impact of early weight-bearing on surgical outcomes like bone healing and alignment maintenance, as well as evaluating quality of life and pain reduction post-surgery.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical risks may include pain at the surgery site, swelling, difficulty with weight-bearing despite instructions, potential misalignment recurrence or failure to correct the bunion properly.
ALIGN3D Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 14 and 58 years old.
Select...
I am fit for surgery and can be put under general anesthesia.
ALIGN3D Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-operatively, 6 weeks, 4 months, 6 months, 12 months, 24 months, 36 month, 48 months, 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-operatively, 6 weeks, 4 months, 6 months, 12 months, 24 months, 36 month, 48 months, 60 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Radiographic recurrence of hallux valgus
Secondary outcome measures
Change in MOxFQ Foot Problems score across multiple time-points
Change in PROMIS-25 score across multiple time-points
Change in PROMIS-29 score across multiple time-points
+8 moreALIGN3D Trial Design
1Treatment groups
Experimental Treatment
Group I: LapiplastyExperimental Treatment1 Intervention
All study participants receiving Lapiplasty procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lapiplasty
2022
N/A
~40
Find a Location
Who is running the clinical trial?
Treace Medical Concepts, Inc.Lead Sponsor
2 Previous Clinical Trials
280 Total Patients Enrolled
Dane Wukich, MDPrincipal InvestigatorUTSW
1 Previous Clinical Trials
75 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have flatfoot with symptoms or severe flatfoot without symptoms.I am currently on medication that suppresses my immune system.I currently use nicotine products.I can fill out questionnaires by myself.My foot condition is diagnosed as metatarsus adductus.I am scheduled for a procedure on both sides of the same body part and agree not to have bunion surgery on the other foot for 6 months.I might have an infection in the area affected by my condition.I have been diagnosed with CRPS/RSD.I am currently on oral steroids or rheumatoid arthritis medication.I can have the main treatment within 3 months and can go to all follow-up visits.I have been diagnosed with fibromyalgia.I have diabetes with high blood sugar or HbA1c levels.I have used synthetic or donor bone graft substitutes.I am between 14 and 58 years old.My thyroid condition is not currently under control.I can follow instructions for putting weight on my leg after surgery.I have moderate to severe arthritis in my big toe joint confirmed by an X-ray or physical test.I have had surgery for a bunion on the foot I'm seeking treatment for.I have poor bone quality or conditions that slow healing.I am not able to become pregnant or I have a recent negative pregnancy test.I have been diagnosed with peripheral neuropathy.I can fill out questionnaires by myself.I am fit for surgery and can be put under general anesthesia.I have had joint fusion surgery in my foot, but not at the first tarsometatarsal joint.I have had surgery on my foot or ankle that involved fusing bones together, excluding surgeries for hammertoe or lesser toes.I am scheduled for a procedure that will prevent me from putting weight on my feet soon after.
Research Study Groups:
This trial has the following groups:- Group 1: Lapiplasty
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can I be enrolled as a participant for this research endeavor?
"This clinical trial will include 183 participants with bunions ranging in ages from 14 to 58. Key requirements are that the candidate must be a viable surgical subject, able to adhere to follow-up visits and early weight bearing post-operation, have intermetatarsal angle between 10.0 ̊ - 22.0 ̊ as well as hallux valgus angle between 16.0 ̊ - 40.0 ̊; additionally all female patients require proof of non-childbearing potential or negative pregnancy test within 7 days prior to index procedure."
Answered by AI
Are there a significant number of medical centers participating in this trial?
"This study is being conducted by Jefferson City Medical Group, P.C., University of Pennsylvania/Penn Medicine, and UT Southwestern in Dallas alongside 7 other medical facilities."
Answered by AI
Are applications currently being accepted for this research project?
"This research is no longer recruiting participants; the trial was first posted on November 6th 2018 and its most recent update occurred April 7th 2022. Nonetheless, 20 other clinical trials are currently searching for volunteers."
Answered by AI
Could octogenarians partake in the research trial?
"The medical trial allows patients between the ages of 14 and 58 to join. Additionally, there are 3 studies for minors, and 15 separate trials for those above 65 years old."
Answered by AI
Who else is applying?
What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Desert Orthopaedic Center
University of Pennsylvania/Penn Medicine
UT Southwestern
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
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