Plantar Plate Repair for Treatment of Floating Toe: Must we Associate it to Weil Osteotomy?

Not Applicable

Recruiting

• Conditions: Floating Toe
• Interventions: Procedure: Weil osteotomy; Procedure: Plantar plate repair

• Registration Number: NCT05625282
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary

The aim of this study is to assess if isolated Weil osteotomy for floating toe grade II or III provides results that are not inferior to those obtained with the Weil osteotomy associated with plantar plate repair.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-11
• Study Start: 2022-11-18
• Study First Submitted QC: 2022-11-21
• Study First Posted: 2022-11-22
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-01
• Primary Completion: 2024-06-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• 18 years old, minimum
• ability to understand treatment and recovery
• floating toe

Exclusion Criteria

• age less than 18 years old at the moment of recruiting
• patients who are not able to understand treatment and recovery
• intraoperative diagnosis of plantar plate injury grade 0, I or IV in Nery's classification
• secondary surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention	Weil osteotomy	Weil osteotomy alone
control	Plantar plate repair	Weil osteotomy and plantar plate repair
control	Weil osteotomy	Weil osteotomy and plantar plate repair

Primary Outcome Measures

Name	Time	Method
Manchester-Oxford Foot Questionnaire (MOXFQ) score at the end of follow-up	1 year	Score obtained at Manchester-Oxford Foot and Ankle Questionnaire (0-100, where higher scores mean a worse outcome) one year after surgery.

Secondary Outcome Measures

Name	Time	Method
side	moment of recruiting	left or right foot
age	moment of recruiting
sex	moment of recruiting
rate of recurrence	1 month, 3 months, 6 months, 1 year after surgery
rate of complications	1 month, 3 months, 6 months, 1 year after surgery	related to surgery
Score obtained at Manchester-Oxford Foot and Ankle Questionnaire (0-100, where higher scores mean a worse outcome)	3 months, 6 months after surgery

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain