Outcomes Following Combined Adductoplasty™ and Lapiplasty® (MTA3D)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-65
SponsorTreace Medical Concepts, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
Male and females ≥14 years old at the time of consent
Closed physeal plates at the time of consent
Intermetatarsal angle is ≥8.0˚; OR True IMA of >10°, (IMA+MTA-15=True IMA)
Hallux valgus angle is ≥12.0˚
Disqualifiers
Previous surgery for hallux valgus on operative side
Previous surgeries on operative foot involving fusion of foot or ankle joints (other than hammertoe, lesser toes/digits, or posterior muscle lengthening)
Moderate-severe osteoarthritis of the foot or ankle outside of the 1st, 2nd or 3rd tarsometatarsal joints
Severe osteoarthritis of the 1st, 2nd or 3rd tarsometatarsal joints
Trial design
Treatments tested in this trial
- Treatment of metatarsus adductus and hallux valgus with the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov