NCT05625282

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Nov 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
Nov 2022Sep 2026

First Submitted

Initial submission to the registry

November 11, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

November 18, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 22, 2022

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

November 18, 2025

Status Verified

October 1, 2025

Enrollment Period

3.6 years

First QC Date

November 11, 2022

Last Update Submit

November 14, 2025

Conditions

Floating Toe

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • age

    moment of recruiting

  • sex

    moment of recruiting

  • side

    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

  • +1 more secondary outcomes

Study Arms (2)

control

ACTIVE COMPARATOR

Weil osteotomy and plantar plate repair

Procedure: Weil osteotomyProcedure: Plantar plate repair

intervention

EXPERIMENTAL

Weil osteotomy alone

Procedure: Weil osteotomy

Interventions

Weil osteotomyPROCEDURE

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

controlintervention
Plantar plate repairPROCEDURE

Plantar plate reconstruction at metatarsophalangeal area, using sutures.

control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2022

First Posted

November 22, 2022

Study Start

November 18, 2022

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

November 18, 2025

Record last verified: 2025-10

Locations

ES(1)