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
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Manchester Oxford Foot and Ankle Questionnaire
Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Manchester Oxford Foot and Ankle Questionnaire
Time Frame: 1 year
Patient reported Outcome measure
Secondary Outcomes
- Secondary dislocation of fracture(6 weeks)
- other PROMs (patient reported outcome measures)(1 year)
- Range of Motion(1 year)
Investigators
Primoz Potocnik
Dr. med. Primoz Potocnik
Cantonal Hospital of St. Gallen