Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
Study NCT ID:
NCT05082012
Status:
TERMINATED
Last Update Posted:
2024-06-10
First Post:
2021-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early Weight-Bearing After the Lapiplasty Mini-Incision Procedure (Mini3D)
Sponsor:
Treace Medical Concepts, Inc.
Organization:
Study Overview
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
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Corporate decision to early term study to prepare for publication and addition of new studies
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Mini3D
Brief 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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: