S32.1
Conditions
Interventions
Group 1: **English – Intervention/observational group**
Hospitalized patients with a newly diagnosed fragility fracture of the pelvis / pelvic insufficiency fracture are included if they are admitted
Sponsors
Klinik und Poliklinik für Unfallchirurgie TUM Universitätsklinikum, Klinikum rechts der Isar
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - inpatient admission to the Department of Trauma Surgery at Klinikum rechts der Isar / TUM University Hospital - newly diagnosed and radiologically confirmed fragility fracture of the pelvis / osteoporotic pelvic insufficiency fracture - written informed consent after comprehensive oral and written study information ability to participate in the study-specific assessments and follow-up interviews
Exclusion criteria
Exclusion criteria: Patients with diseases or conditions that prevent or substantially affect the performance or validity of hand dynamometry are excluded. These include in particular: - Dupuytren’s disease - recent fracture of the distal upper extremity within the last 3 months - paraplegia or hemiplegia Further exclusion criteria are severe cognitive impairments that make participation in the study-specific tests and questionnaires impossible, such as advanced dementia or other severe cognitive disorders. A Mini-Mental State Examination score < 10 points is used as an indicative threshold.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of the study is functional outcome 6 months after fragility fracture of the pelvis. It is assessed using the Barthel Index and the EQ-5D-5L questionnaire and compared between patients with and without sarcopenia at baseline. A clinically relevant worse functional outcome is defined as a decrease in the Barthel Index of at least 10 points compared with baseline and/or a relevant deterioration in the EQ-5D-5L. This is defined as a decrease in the EQ-5D-5L index value of at least 0.1 points or a deterioration by at least one level in at least two dimensions of the EQ-5D-5L. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are rehospitalizations and recurrent fractures within 6 months after fragility fracture of the pelvis, changes in mobility, walking distance, use of mobility aids, care dependency, and living situation, as well as the occurrence of complications, particularly wound-healing disorders, infections, and thromboembolic events. In addition, changes in quality of life, assessed using the SarQoL and EQ-5D-5L questionnaires, and changes in nutritional status, assessed using the Mini Nutritional Assessment, are recorded during the course of the study. The course of muscle strength during hospitalization is evaluated using repeated handgrip strength measurements with a hand dynamometer. Secondary outcomes are documented during the hospital stay and during telephone follow-up assessments after 6 weeks, 3 months, and 6 months, and are exploratorily compared between patients with and without sarcopenia at baseline. | — |
Countries
Germany
Contacts
Public ContactOlivia Bohe
Klinik und Poliklinik für Unfallchirurgie des TUM Universitätsklinikums
Outcome results
None listed