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A Noninferiority RCT Comparing Operative vs Nonoperative Treatment for ER-stress Positive Weber-B Unimalleolar Fractures

NCT01758796 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2023-09-14

No results posted yet for this study

Summary

Current gold standard treatment for unstable (those found unstable in external rotation (ER) stress testing Weber B-type, Lauge-Hansen supination-external rotation type IV) ankle fractures is open reduction and internal fixation (ORIF) with semitubular plates and screws. However, there is some preliminary evidence to suggest that these type of fibula fractures can be managed non-operatively with comparable functional outcome. The aim of this randomized, non-inferiority trial is to assess whether non-operative treatment (cast immobilisation) yields a non-inferior functional outcome compared to surgery with no excess harms (primarily, fracture and wound healing problems and infection).

Conditions

  • Lateral Malleolus Fracture

Interventions

PROCEDURE

Non-operative treatment

Below-the-knee cast for six weeks.

PROCEDURE

Surgery

Open reduction and internal fixation with 1/3 semi-tubular plate and screws.

Sponsors & Collaborators

  • University of Oulu

    lead OTHER

Principal Investigators

  • Harri J Pakarinen, MD, PhD · Oulu University Hospital

  • Tero HJ Kortekangas, MD, PhD · Oulu University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2021-07-07
Completion
2024-04-30

Countries

  • Finland

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 NCT01758796 on ClinicalTrials.gov