S82
Conditions
Interventions
Group 1: Treatment with a CAM-splint, which is supplemented by at least twelve physiotherapy sessions two days a week. The subjects are given their own exercises, which take 20 minutes to complete twi
Sponsors
Universitästmedizin der Johannes Gutenberg Universität Mainz
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. fracture of the upper ankle joint (Weber classification B, C) with surgical treatment 2. FAOS-ADL = 80 at baseline 3. age: = 18 years 4. motion- or load-stable treatment (physiotherapy and CAM-splint possible) 5. declaration of consent for participation
Exclusion criteria
Exclusion criteria: 1. concomitant diseases: o Dementia/cognitive limitations for the implementation of physiotherapy and CAM-splint o Osteoporosis o Rheumatic diseases o peripheral arterial occlusive disease o Diseases that clinically limit the ability to walk (amputations, neurological diseases with severe changes in changes in muscle tone, etc.) 2. accident-related comorbidities: o Polytrauma o Craniocerebral trauma (> grade 2) o Combination injuries to the upper ankle joint o Open fractures o Involvement of the medial malleolus 3. pregnancy 4. prerequisites for poor patient compliance with therapy (e.g. Reservations/aversion to physiotherapeutic treatment) 5. insufficient knowledge of German to understand the consent form and study documents to understand the consent form and study documents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the improvement in joint function, as measured by the FAOS activities of daily living subscore, after three months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are the assessment of activities of daily living, symptoms, pain, sports and leisure activities as well as quality of life using the FAOS (Foot and Ankle Outcome Score). The health-related quality of life, the frequency and severity of adverse events, the frequency of surgical interventions or revision procedures, as well as treatment discontinuations due to adverse events and the occupation at the time before the accident and on re-entry are also determined. In relation to this, information is also collected on the time to return to work, the time to unrestricted full weight-bearing - return to sports, pain reduction, changes in the intake of pain medication, adherence to therapy, the extent of movement of the affected side and the unaffected side, and the swelling and wound condition. | — |
Countries
Germany
Contacts
Public ContactClaudia Wolf
Interdisziplinäres Zentrum Klinische Studien (IZKS) der Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Outcome results
None listed