Status:
NOT_YET_RECRUITING
Early Protected Full Weight-bearing vs. Partial Weight-bearing After Surgical Fixation of Unstable Ankle Fractures, Monitored With Bio-feedback Insoles.
Lead Sponsor:
Cantonal Hospital of St. Gallen
Conditions:
Post Operative Treatment After Unstable Malleolar Fractures
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
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 f...
Eligibility Criteria
Inclusion
- patients with surgically stabilized unstable ankle fractures
- signed informed consent
- closed tibial and fibular epiphysis
- age 18 or older
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT06023979
Start Date
September 1 2023
End Date
October 31 2026
Last Update
September 5 2023
Active Locations (1)
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1
Canton Hospital St. Gallen
Sankt Gallen, Switzerland, 9007