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ACTIVE NOT RECRUITING
NCT05412693
NA

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

Sponsor: Ostfold Hospital Trust

View on ClinicalTrials.gov

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.

Official title: Six Weeks Functional Orthosis Versus Cast Immobilization for Partially Unstable Weber B/SER4a Ankle Fractures - a Multicenter Randomized Non-inferiority Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2022-05-15

Completion Date

2025-12-31

Last Updated

2025-08-03

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Functional orthosis

See arm descriptions

DEVICE

Cast immobilization

See arm descriptions

Locations (3)

Ålesund Hospital

Ålesund, Norway

Sykehuset Innlandet, Gjøvik

Gjøvik, Norway

Østfold Hospital Trust

Sarpsborg, Østfold fylke, Norway