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
This trial accepts healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Treatment of metatarsus adductus and hallux valgus with the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure
DevicePatients 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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 MonthsSecondary outcomes
1
Radiographic Recurrence
Radiographic recurrence of hallux valgus deformity at 24 months defined by HVA \>20°.
Time frame
24 Months2
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 Months3
Clinical Complications
Clinical complications due to system implants the post-op instructions or health conditions that could affect other outcome measures.
Time frame
60 Months4
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 MonthsSponsors and contacts
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Source ClinicalTrials.gov