Not Yet RecruitingNot Applicable

Early Protected Full Weight-bearing vs. Partial Weight-bearing After Surgical Fixation of Unstable Ankle Fractures, Monitored With Bio-feedback Insoles.

Switzerland110 participantsStarted 2023-09-01

Plain-language summary

The purpose of this study is to compare the postoperative results after ORIF (Open Reduction Inner Fixation) with a partial weight-bearing protocol versus an early full weight-bearing protocol. But in addition, we will measure every patient's actual load by the means of walker integrated bio-feedback insoles for the first six postoperative weeks to record the adherence to the protocol.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * patients with surgically stabilized unstable ankle fractures * signed informed consent * closed tibial and fibular epiphysis * age 18 or older Exclusion Criteria: * dementia and other known cognitive impairment or incapacity of judgement * polytrauma * bilateral injury of the lower extremities * additional injury of the ipsilateral lower extremity which prevents full weight bearing * associated injury of one or both upper extremities * open fractures grade II° and III° * chronic loss of sensation on plantar aspect of the feet due to known distal neuropathy * open epiphysis * pregnancy

What they're measuring

Manchester Oxford Foot and Ankle Questionnaire

Timeframe: 1 year

Trial details

NCT IDNCT06023979

SponsorCantonal Hospital of St. Gallen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-31

Contact for this trial

Primoz Potocnik, MD

0041714941111 primoz.potocnik@kssg.ch

View on ClinicalTrials.gov More Post Operative Treatment After Unstable Malleolar Fractures trials