An interventional study of Treatment of metatarsus adductus and hallux valgus with the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure in Metatarsus Adductus and Hallux Valgus, sponsored by Treace Medical Concepts, Inc.. Recruiting at 9 sites in United States. Open to participants aged 14 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-25.
Sponsored by Treace Medical Concepts, Inc. · Not applicable, Interventional, and Treatment
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.
The objectives of this study are to evaluate outcomes of the Adductoplasty™ Procedure combined with the Lapiplasty® Procedure for patients in need of hallux valgus and metatarsus adductus surgery:
157 studies on the registry are indexed under Hallux Valgus; 36 are open to participants now.
This study's planned enrollment of 80 is above the median of 58 across 119 interventional studies indexed under Hallux Valgus.
Browse Hallux Valgus studies →Treace Medical Concepts, Inc. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients 14 years of age or older with symptomatic metatarsus adductus and hallux valgus will be eligible to participate based on the inclusion/exclusion criteria established in the study protocol. Anticipated study duration will be 5 years post index procedure.
Also known as: Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure
Radiographic recurrence of hallux valgus deformity with metatarsus adductus will be evaluated at 24 months for subjects wtih successful correction
Successful correction is defined as two of the following three criteria: measured IMA \<9.0°, HVA \<15.0°, and TSP as ≤3 at 6 months post Adductoplasty® Procedure and Lapiplasty® Procedure. Recurrence at 24 months is defined by HVA \>15.0°.
Time frame: 24 Months
Radiographic Recurrence
Radiographic recurrence of hallux valgus deformity at 24 months defined by HVA \>20°.
Time frame: 24 Months
Union vs non-Union
Evaluate clinical/radiographic healing (union vs non-union). Non-union is defined as pain and lucency at the 1st, 2nd, and/or 3rd TMT joint at 12 months post- Adductoplasty® Procedure and Lapiplasty® Procedure.
Time frame: 12 Months
Clinical Complications
Clinical complications due to system implants the post-op instructions or health conditions that could affect other outcome measures.
Time frame: 60 Months
Weight-Bearing Recovery Time
Assessment of weight-bearing recovery time following the procedures. Weight-bearing will be measured in days and recorded based upon individual surgeon recovery protocol.
Time frame: 12 Months
Time to Weight-Bear in Boot
Time to start of weight-bearing in boot, in days.
Time frame: 6 Weeks
Time to Weight-Bear in Shoes
Time to start of weight-bearing in shoes, in days.
Time frame: 8 Weeks
Time to Return to Unrestricted Activity
Time to return to full unrestricted activity, in days.
Time frame: 6 weeks - 6 months, post Lapiplasty® Procedure
Change in Pain
Change in pain at the base of the big toe (bunion related), as well as the midfoot region for the operative foot only, assessed via the Visual Analog Scale (VAS) with 0-10 minimum and maximum values - with 0 being a better outcome and 10 being a worse outcome.
Time frame: 0-3 weeks, 6 weeks, 4 months, 6 months, 12 months, 24 months, 36 months, 48 months and 60 months post- Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure, in comparison to baseline visit pain.
Change in Quality of Life
Change in Quality of Life, (PROMIS-29/PROMIS-25 and MOxFQ) defined as the total domain score measured.
Time frame: 6 months, 12 months, 24 months, 36 months, 48 months and 60 months post-Adductoplasty™ Procedure and Lapiplasty® Procedure, in comparison to baseline visit
Change in Range of Motion
Change in Range of Motion - 1st MTP dorsiflexion and plantarflexion
Time frame: 12 months, 24 months, 36 months, 48 months and 60 months post- Adductoplasty™ Procedure and Lapiplasty® Procedure, in comparison to baseline visit
Change in Osseous Foot Width
Change in osseous foot width - radiographically
Time frame: 12 months and 24 months post - Adductoplasty™ Procedure and Lapiplasty® Procedure, in comparison to baseline visit
Plan to share: No
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Treace Medical Concepts, Inc.