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Recruiting NCT05625282

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

No phase Interventional Floating Toe

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Weil osteotomy, Plantar plate repair.
Who it may be relevant to
Registry conditions: Floating Toe. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Manchester-Oxford Foot Questionnaire (MOXFQ) score at the end of follow-up [Time frame: 1 year]
Secondary outcome measures (6)
  • age [Time frame: moment of recruiting]
  • sex [Time frame: moment of recruiting]
  • side [Time frame: moment of recruiting]
  • rate of recurrence [Time frame: 1 month, 3 months, 6 months, 1 year after surgery]
  • rate of complications [Time frame: 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) [Time frame: 3 months, 6 months after surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Hospital de la Santa Creu i Sant Pau — Barcelona

Identifiers

NCT: NCT05625282 · IIBSP-FLO-2020-131

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗