Outcomes Following Combined Adductoplasty™ and Lapiplasty® (MTA3D)

Part of paid clinical trials in Greeley, Colorado.

Sponsor
Treace Medical Concepts, Inc.
Study ID
NCT05587569
Status
Recruiting
Apply to this trial

Conditions

  • Hallux Valgus
  • Metatarsus Adductus

Eligibility Criteria

Sex
ALL
Age
14 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Treatment of metatarsus adductus and hallux valgus with the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Sep 28, 2022
Status verified
May 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2030

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

Radiographic recurrence of hallux valgus deformity with metatarsus adductus will be evaluated at 24 months for subjects wtih successful correction [ Time Frame: 24 Months ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Foot and Ankle Center of the RockiesGreeleyColorado80634
Michael D Vaardahl, DPM
[email protected]
970-351-0900
Lauren Shodrock
[email protected]
(970) 351-0900
Michael D Vaardahl, DPM (PRINCIPAL_INVESTIGATOR)
Foot and Ankle Center of IowaAnkenyIowa50023
Mindi Dayton, DPM
[email protected]
515-639-3775
Paul Dayton, DPM (PRINCIPAL_INVESTIGATOR)
Mindi Dayton, DPM (SUB_INVESTIGATOR)
Jesseka Kaldenberg-Leppert, DPM (SUB_INVESTIGATOR)
Coastal Maine Foot and AnkleYarmouthMaine04096
Barry White, DPM
[email protected]
207-888-3640
Barry White, DPM (PRINCIPAL_INVESTIGATOR)
JCMG - Jefferson City Medical GroupJefferson CityMissouri65019
Jody McAleer, DPM
[email protected]
573-556-7724
Christy Kidwell
[email protected]
(573) 556-7724
Jody McAleer, DPM (PRINCIPAL_INVESTIGATOR)
Duke Orthopaedics ArringdonMorrisvilleNorth Carolina27560
Jacob Carpenter
[email protected]
919-744-8166
Jennifer Friend
[email protected]
(919) 668-4373
Cesar de Cesar Netto, MD (PRINCIPAL_INVESTIGATOR)
Mark Easley, MD (SUB_INVESTIGATOR)
Ohio Foot and Ankle CenterCantonOhio44708
Aaron Chokan, DPM
[email protected]
330-447-4400
Aaron Chokan, DPM (PRINCIPAL_INVESTIGATOR)
Ohio Foot and Ankle CenterStowOhio44224
Aaron Chokan, DPM
[email protected]
330-929-3331
Aaron Chokan, DPM (PRINCIPAL_INVESTIGATOR)
Greater Pittsburgh Foot and Ankle CenterWexfordPennsylvania15090
William DeCarbo, DPM
[email protected]
724-799-8727
Shannon Litton
[email protected]
(724) 799-8727
William DeCarbo, DPM (PRINCIPAL_INVESTIGATOR)
Foot and Ankle Associates of North Texas - KellerKellerTexas76248
Paul Steinke, DPM
[email protected]
817-416-6155
Paul Steinke, DPM (PRINCIPAL_INVESTIGATOR)

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Foot and Ankle Center of the Rockies· Greeley, COFoot and Ankle Center of Iowa· Ankeny, IACoastal Maine Foot and Ankle· Yarmouth, MEJCMG - Jefferson City Medical Group· Jefferson City, MODuke Orthopaedics Arringdon· Morrisville, NCOhio Foot and Ankle Center· Canton, OH

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