Proximal Humeral Fracture
Conditions
Keywords
Humerus, Fractures, Locking Plates, Nail System
Brief summary
The aim of the study is to compare the results regarding fracture healing and functional outcome after the treatment of proximal humeral fractures with the four different treatment methods after 12w./6months and 12 months based on radiological evaluation as well as the constant score and the neer score.
Detailed description
Evaluation of proximal humeral fractures using a new stable-angled implant.
Interventions
DEVICELocking proximal humerus plate
DEVICEProximal Humerus Internal Locking System
DEVICEProximal Humerus Nail
Sponsors
Synthes Inc.
AO Research Fund
AO Clinical Investigation and Publishing Documentation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* fractures of proximal humerus * age over 18 years * completed skeletal development * fracture less than 5 days old
Exclusion criteria
* open fractures * pseudoarthrosis, pathological or refractures * ipsilateral fractures of distal humerus or elbow * polytraumatic conditions * pregnancy * subject with known history of diseases that influence the healing process * alcohol, drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiological comparison of the fracture healing | — |
| Functional outcome based on constant and neer score after 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Analysis of occured complications | — |
| Radiological evaluation of possible misallocation | — |
| Subjective patient judgement of before and after treatment according to DASH-questionnaire | — |
Countries
Germany
Outcome results
None listed