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

Hallux Valgus Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Bunion
• Hallux Valgus

• NCT number: NCT05082012
• Study type: Interventional
• Source: Treace Medical Concepts, Inc.
• Status: Terminated
• Phase: N/A
• Start date: September 17, 2021
• Completion date: May 9, 2024