About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
patients with surgically stabilized unstable ankle fractures
signed informed consent
closed tibial and fibular epiphysis
age 18 or older
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Full weight bearing
Other interventionFull weight bearing monitored with a bio-feedback insole
Partial weight bearing
Other interventionPartial weight bearing monitored with a bio-feedback insole
Treatment groups
Trial outcomes
Primary outcomes
Manchester Oxford Foot and Ankle Questionnaire
Patient reported Outcome measure
Secondary outcomes
other PROMs (patient reported outcome measures)
Range of Motion
Secondary dislocation of fracture
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: