Actively Recruiting
Outcomes Following Combined Adductoplasty™ and Lapiplasty® (MTA3D)
Led by Treace Medical Concepts, Inc. · Updated on 2025-05-25
80
Participants Needed
9
Research Sites
430 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Outcomes Following Combined Adductoplasty™ and Lapiplasty® (MTA3D)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and females 214 years old at the time of consent
- Closed physeal plates at the time of consent
- Intermetatarsal angle is 218.0da; OR True IMA of >10�b0
- Hallux valgus angle is 212.0da
- Metatarsus adductus angle based on Sgarlatos method 215�b0
- Willing and able to adhere to post-op care instructions
- Capable of completing self-administered questionnaires
- Acceptable surgical candidate, including use of general anesthesia
- Female patients must be of non-childbearing potential or have a negative pregnancy test prior to the Index Procedure
- Willing and able to schedule index procedure within 3 months of consent and return for follow-up visits
- Willing and able to provide written informed consent
- Patient agrees to refrain from any reconstructive procedures on contralateral foot for minimum of 6 months post index procedure
You will not qualify if you...
- Previous surgery for hallux valgus on operative side
- Previous surgeries on operative foot involving fusion of foot or ankle joints (except hammertoe, lesser toes/digits, or posterior muscle lengthening)
- Moderate-severe osteoarthritis of foot or ankle outside 1st, 2nd or 3rd tarsometatarsal joints
- Severe osteoarthritis of 1st, 2nd or 3rd tarsometatarsal joints
- Any hindfoot or midfoot deformity affecting tarsometatarsal realignment or requiring surgical correction
- BMI >40 kg/m�b2
- Current nicotine use in any form
- Current diagnosis or treatment of diabetes
- Current diagnosis of peripheral neuropathy
- Current diagnosis of fibromyalgia
- Current diagnosis of Complex Regional Pain Syndrome/Reflex Sympathetic Dystrophy
- Current uncontrolled hypothyroidism
- Current diagnosis of chronic dependent edema
- Previously sensitized to titanium
- Currently taking oral steroids or rheumatoid biologics
- Currently taking immunosuppressant drugs
- Insufficient bone quality or healing conditions
- Active, suspected, or latent infection in affected area
- Use of synthetic or allogenic bone graft substitutes
- Use of non-Treace products for Index Procedure
- Additional bone procedures needed during index procedure (except Weil osteotomies)
- Scheduled same-day bilateral procedure
- Previously enrolled in this study for contralateral procedure
- Scheduled for concomitant procedure affecting weight-bearing post-procedure
- Active workman's compensation case or litigation involvement
- Participation in another clinical study within 30 days prior to consent or planning participation during this study (with some exceptions)
- Any condition that may jeopardize patient well-being or study integrity as judged by Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Foot and Ankle Center of the Rockies
Greeley, Colorado, United States, 80634
Actively Recruiting
2
Foot and Ankle Center of Iowa
Ankeny, Iowa, United States, 50023
Actively Recruiting
3
Coastal Maine Foot and Ankle
Yarmouth, Maine, United States, 04096
Actively Recruiting
4
JCMG - Jefferson City Medical Group
Jefferson City, Missouri, United States, 65019
Actively Recruiting
5
Duke Orthopaedics Arringdon
Morrisville, North Carolina, United States, 27560
Actively Recruiting
6
Ohio Foot and Ankle Center
Canton, Ohio, United States, 44708
Actively Recruiting
7
Ohio Foot and Ankle Center
Stow, Ohio, United States, 44224
Actively Recruiting
8
Greater Pittsburgh Foot and Ankle Center
Wexford, Pennsylvania, United States, 15090
Actively Recruiting
9
Foot and Ankle Associates of North Texas - Keller
Keller, Texas, United States, 76248
Actively Recruiting
Research Team
C
Cara Bethell
CONTACT
S
Shana Zink
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
0
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here