RecruitingNot ApplicableNCT04429217

A Study to Compare Two Different Managements After Ankle Surgery: Immediate and Delayed Weight-bearing.

Immediate vs Delayed Weight-bearing After Surgical Treatment of Malleolar Fractures: a Randomized Controlled Trial


Sponsor

Ente Ospedaliero Cantonale, Bellinzona

Enrollment

100 participants

Start Date

Apr 28, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

The investigators will compare two types of rehabilitation in patients who undergo a surgery for treatment of malleolar fractures: immediate complete weight-bearing and delayed weight-bearing. The investigators want to evaluate if the immediate complete weight-bearing can improve and hasten the functional outcome of the ankle without increasing the risk of complications.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying delayed weight-bearing for 6 weeks after surgery and immediate post-operative complete weight-bearing after surgery for people with lateral malleolus fracture. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERimmediate post-operative complete weight-bearing after surgery

Patients randomized to the experimental post-operative rehabilitation intervention will undergo to immediate complete weight-bearing starting immediately after surgery. Immediate complete weight-bearing consists in the possibility to undergo all the everyday activities without limiting weight-bearing and without the use of walking aids. During the rehabilitation period, patients will wear an ankle brace (VACOankle® OPED); this will ensure the safety of the early recovery phases, protecting from dangerous movements while allowing the mobilization in the healthy range of movement.

OTHERdelayed weight-bearing for 6 weeks after surgery

Patients randomized to the control post-operative rehabilitation intervention will undergo to delayed weight-bearing starting at 6-weeks post-operatively. Delayed weight-bearing consists in the limitation of the weight-bearing to 20-30% of patient's total weight using crutches for the first 6 weeks after surgery. During the rehabilitation period, patients will wear an ankle brace (VACOankle® OPED).


Locations(1)

Ente Ospedaliero Cantonale

Lugano, Switzerland

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NCT04429217


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