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

NCT ID: NCT05625282

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-18

Study Completion Date

2026-09-30

Brief Summary

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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

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Conditions

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Floating Toe

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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control

Weil osteotomy and plantar plate repair

Group Type ACTIVE_COMPARATOR

Weil osteotomy

Intervention Type PROCEDURE

Open, oblique, distal osteotomy of the metatarsal bone, with screw fixation.

Plantar plate repair

Intervention Type PROCEDURE

Plantar plate reconstruction at metatarsophalangeal area, using sutures.

intervention

Weil osteotomy alone

Group Type EXPERIMENTAL

Weil osteotomy

Intervention Type PROCEDURE

Open, oblique, distal osteotomy of the metatarsal bone, with screw fixation.

Interventions

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Weil osteotomy

Open, oblique, distal osteotomy of the metatarsal bone, with screw fixation.

Intervention Type PROCEDURE

Plantar plate repair

Plantar plate reconstruction at metatarsophalangeal area, using sutures.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status RECRUITING

Countries

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Spain

Facility Contacts

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Sergio López Hervás

Role: primary

+34932919000 ext. 7028

Other Identifiers

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IIBSP-FLO-2020-131

Identifier Type: -

Identifier Source: org_study_id

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