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Functional Orthosis Versus Cast Immobilization for Partially Unstable Weber B Ankle Fractures

NCT05412693 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-08-03

No results posted yet for this study

Summary

Stability dictates treatment choice for trans-syndesmotic fibula fractures. Optimal treatment for partially unstable fractures remains a topic of debate. The purpose of this study is to evaluate possible outcome non-inferior of functional orthosis treatment versus cast immobilization for these fractures.

Conditions

  • Ankle Fractures

Interventions

DEVICE

Functional orthosis

See arm descriptions

DEVICE

Cast immobilization

See arm descriptions

Sponsors & Collaborators

  • Alesund Hospital

    collaborator OTHER

  • Sykehuset Innlandet HF

    collaborator OTHER

  • Ostfold Hospital Trust

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-15
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05412693 on ClinicalTrials.gov