Outcomes Following Combined Adductoplasty™ and Lapiplasty® (MTA3D)
Recruiting
N/A
Interventional Study
Metatarsus Adductus
Hallux Valgus
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 14 – 65
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 80 (estimated)
- Sponsor
- Treace Medical Concepts, Inc. · Industry
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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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Male and females ≥14 years old at the time of consent
2. Closed physeal plates at the time of consent
3. Intermetatarsal angle is ≥8.0˚; OR True IMA of \>10°, (IMA+MTA-15=True IMA)
4. Hallux valgus angle is ≥12.0˚
5. Metatarsus adductus angle based on Sgarlatos method ≥15°
6.…
Contacts