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

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.

Study Overview

• Status: Recruiting
• Conditions: Floating Toe
• Intervention / Treatment: Procedure: Weil osteotomy; Procedure: Plantar plate repair

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Recruiting
    • Hospital De La Santa Creu I Sant Pau
    • Contact: Sergio López Hervás; Phone Number: 7028 +34932919000; Email: slopezh@santpau.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control; Weil osteotomy and plantar plate repair	Procedure: Weil osteotomy; Open, oblique, distal osteotomy of the metatarsal bone, with screw fixation.; Procedure: Plantar plate repair; Plantar plate reconstruction at metatarsophalangeal area, using sutures.
Experimental: intervention; Weil osteotomy alone	Procedure: Weil osteotomy; Open, oblique, distal osteotomy of the metatarsal bone, with screw fixation.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
age		moment of recruiting
sex		moment of recruiting
side	left or right foot	moment of recruiting
rate of recurrence		1 month, 3 months, 6 months, 1 year after surgery
rate of complications	related to surgery	1 month, 3 months, 6 months, 1 year after 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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: November 11, 2022
• First Submitted That Met QC Criteria: November 21, 2022
• First Posted (Actual): November 22, 2022

Study Record Updates

• Last Update Posted (Estimated): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: IIBSP-FLO-2020-131

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No