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Comparing Function, Pain and Return to Work in Conservative Versus Surgical Treated Stable Lateral Malleolar Fractures

NCT03587571 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2023-03-08

No results posted yet for this study

Summary

Ankle fractures are one of the most common fractures in adults resulting in hospital stays and inability to work. Instable or dislocated ankle fractures are mostly treated by surgery. Treatment of stable lateral ankle fractures is still discussed controversial. They can be treated conservatively as well as by surgery.

Furthermore, optimal aftercare is part of on-going discussion in both groups. Goal of any treatment is a fast, good functional outcome with pain free patients at low overall costs. Long-term results in terms of osteoarthritis should be kept in mind.

The investigators seek to compare conservative and operative treatment in stable lateral ankle fractures in a prospective, randomised trial.

The hypothesis is that there is no difference between conservative and surgically treated stable lateral malleolar fractures regarding pain, function, and return to the workplace.

Conditions

  • Malleolus Fracture, Lateral

Interventions

PROCEDURE

Surgical intervention

Open reduction and plate osteosynthesis.

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Fabian Krause, PD Dr. · Dep. of Orthopaedic Surgery, Inselspital, University of Berne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Switzerland

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 NCT03587571 on ClinicalTrials.gov