Early Protected Full Weight-bearing vs. Partial Weight-bearing After Surgical Fixation of Unstable Ankle Fractures, Monitored With Bio-feedback Insoles.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Full weight bearing, Partial weight bearing.
- Who it may be relevant to
- Registry conditions: Post Operative Treatment After Unstable Malleolar Fractures. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Early Protected Full Weight-bearing vs. Partial Weight-bearing After Surgical Fixation of Unstable Ankle Fractures, Monitored With Bio-feedback Insoles. A Single Blinded Randomized Controlled Study
Overview
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.
Detailed description
This study aims to compare the postoperative results after PWB (partial weight bearing) and early FWB (full weight bearing) and to show, that documented early protected weight-bearing after surgical fixation of unstable ankle fractures leads to an improved early clinical outcome and a faster return to work compared to PWB. It also aims to show, that an early FWB is safe in terms of complication rate.
Interventions
- Other Full weight bearing
Full weight bearing monitored with a bio-feedback insole - Other Partial weight bearing
Partial weight bearing monitored with a bio-feedback insole
Primary outcome measures
- Manchester Oxford Foot and Ankle Questionnaire [Time frame: 1 year]
Secondary outcome measures (3)
- other PROMs (patient reported outcome measures) [Time frame: 1 year]
- Range of Motion [Time frame: 1 year]
- Secondary dislocation of fracture [Time frame: 6 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Switzerland · 1 center
- Canton Hospital St. Gallen — Sankt Gallen
Identifiers
NCT: NCT06023979 · BASEC Nr. 2023-01242