Status:
SUSPENDED
Evaluation of the Effect of Biofeedback on Osseous Union Using Pedobarography After Mid- and Hindfoot Arthrodesis
Lead Sponsor:
Prof. Dr. med. Arno Frigg
Conditions:
Complication of Surgical or Medical Care
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The current study aims at evaluating the effect of biofeedback of correct partial weight bearing on the rate of osseous non-union compared to conventional patient instruction without biofeedback.
Detailed Description
Post-traumatic situations or instabilities of other aetiology at the level of the foot can lead to painful degenerative arthritis that necessitates surgical arthrodesis for pain relief. Surgical arthr...
Eligibility Criteria
Inclusion
- Indication for hind- or midfoot arthrodesis
- Informed Consent
- Body weight \< 90kg (according to Smartsens manufacturers recommendations)
Exclusion
- Physical or mental inability to follow weight-bearing recommendations (e.g. dementia, neurologic disease, upper extremity pathology)
- Participation in a potentially interfering interventional trial during the last 30 day or before wash-out of any trial medication (e.g. steroids, medications affecting bone metabolism etc.)
- Previous infection at the intended surgical site
- Body weight \> 90kg
- Pregnancy
Key Trial Info
Start Date :
September 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT04732884
Start Date
September 25 2023
End Date
January 1 2027
Last Update
October 22 2024
Active Locations (1)
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1
FussZentrumHirslanen
Zurich, Canton of Zurich, Switzerland, 8032