NCT05082012

Early Weight-Bearing After the Lapiplasty Mini-Incision Procedure (Mini3D)

Prospective Clinical StuDy of Tri-planar Tarsometatarsal (TMT) ArthroDesis With Early Weight-Bearing After Lapiplasty® ProceDure Through a Mini-Incision™ Approach (Mini3D)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Treace Medical Concepts, Inc. · Industry
• Sex: All
• Age: 14 Years – 58 Years
• Healthy volunteers: Accepted

Summary

Prospective, multicenter, unblinded study to evaluate outcomes of the Lapiplasty® Procedure using the Lapiplasty® Mini-Incision™ System for patients in need of hallux valgus surgery. Up to 200 subjects will be treated in this study at up to 20 clinical sites. Patients 14 years through 58 years with symptomatic hallux valgus will be eligible to participate based on the inclusion and exclusion criteria defined in the study protocol.

Detailed description

Prospective, multicenter, unblinded study to evaluate outcomes of the Lapiplasty® Procedure using the Lapiplasty® Mini-Incision™ System for patients in need of hallux valgus surgery: 1. To determine radiographic recurrence of hallux valgus and the timing of failure following hallux valgus correction with the Lapiplasty® Procedure. 2. To determine whether the Lapiplasty® Procedure effectively corrects anatomical alignment of the 1st metatarsal and sesamoids in all three planes. 3. To assess whether early weight-bearing after the Lapiplasty® Procedure affects the union rates or causes loss of 3-plane correction. 4. To evaluate the quality of life and pain scores following the Lapiplasty® Procedure.

Conditions

• Hallux Valgus
• Bunion

Interventions

Type	Name	Description
DEVICE	Treatment of Hallux Valgus	Patients 14 years through 58 years with symptomatic hallux valgus will be eligible to participate based on the inclusion/exclusion criteria established in the study protocol. Anticipated subject duration will be 2 years post index procedure.

Timeline

• Start date: 2021-09-17
• Primary completion: 2024-05-09
• Completion: 2024-05-09
• First posted: 2021-10-18
• Last updated: 2024-06-10

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated device study