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Weight-bearing Radiographs to Evaluate Stability in Ankles With Isolated Weber Type B Fractures.

NCT03831009 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2023-01-19

No results posted yet for this study

Summary

The investigators will conduct a prospective cohort study on the use of weight-bearing radiographs to evaluate stability in ankles with isolated, trans-syndesmotic (Weber type B) fibular fractures. Stable fractures will be treated conservatively using a functional brace, unstable fractures will undergo surgical fixation.

Conditions

  • Lateral Malleolus Fractures
  • Ankle Fractures

Interventions

PROCEDURE

Open reduction internal fixation (ORIF)

Open fracture reduction followed by internal fixation using a plate and screws. The goal is an osteosynthesis that allow for early range-of-motion exercises, but weightbearing is usually not tolerated until 6 weeks postoperatively.

OTHER

Conservative treatment

Conservative treatment involves ankle protection with a functional brace (AirCast) for 6 weeks. Participants will be instructed to bear weight as tolerated and to actively do standardized range-of-motion exercises.

Sponsors & Collaborators

  • Ostfold Hospital Trust

    lead OTHER

Principal Investigators

  • Marius Molund · Ostfold Hospital Trust

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2022-06-30
Completion
2022-12-31

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 NCT03831009 on ClinicalTrials.gov