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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCantonal Hospital of St. Gallen

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Full weight bearing

    Other intervention

    Full weight bearing monitored with a bio-feedback insole

  • Partial weight bearing

    Other intervention

    Partial weight bearing monitored with a bio-feedback insole

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Full weight bearingExperimental treatment 1 intervention
Group B: Partial weight bearingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Manchester Oxford Foot and Ankle Questionnaire

Patient reported Outcome measure

Time frame
1 year

Secondary outcomes

1

other PROMs (patient reported outcome measures)

Time frame
1 year
2

Range of Motion

Time frame
1 year
3

Secondary dislocation of fracture

Time frame
6 weeks

Other outcomes

Sponsors and contacts

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