Osteosynthesis or Conservative Treatment, Proximal Humeral Fracture
Conditions
Keywords
Proximal Humerus Fracture in elderly
Brief summary
1. Do a standardized surgical treatment of unstable displaced proximal humerus fracture in patients aged over 60 compared to a standardized conservative treatment gain a better functional outcome after one year? 2. Do surgical treatment gain more QALY than conservative treatment after one year?
Interventions
PROCEDURESurgical treatment with LCP
Sponsors
University of Oslo
University Hospital, Aker
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* proximal humerus fracture of AO group B2 or C2 (displaced fracture of extra-articular or articular, bifocal type) admitted in hospital
Exclusion criteria
* aged less than 60 year * patients of non-Scandinavian ethnicity * previous history of injury or illness of the injured or contralateral shoulder * injury of other part of the humerus or the contralateral upper extremity, * alcohol- or drug abuse * dementia or neurological diseases * severe cardiovascular disease that would contraindicate surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional shoulder score according to Constant (Original described Differences between the injured and uninjured shoulder as well as Adjusted according to age and gender). | 12 and 24 months |
Secondary
| Measure | Time frame |
|---|---|
| QALY (HRQoL score according to Harri Sintonen 15D and Costs) | 12 and 24 months |
| ASES score (modified self assessment) C) Radiographic score | 12 and 24 months |
| Radiographic score | 12 and 24 months |
Countries
Norway
Outcome results
None listed