LPHP-Philos-PHN Conservative Treatment
Phase 4
Completed
- Conditions
- Proximal Humeral Fracture
- Registration Number
- NCT00205959
- Lead Sponsor
- AO Clinical Investigation and Publishing Documentation
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 640
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Functional outcome based on "constant and neer score" after 12 months Radiological comparison of the fracture healing
- Secondary Outcome Measures
Name Time Method Analysis of occured complications Subjective patient judgement of before and after treatment according to DASH-questionnaire Radiological evaluation of possible misallocation
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie proximal humeral fracture healing with angled implants compared to traditional methods?
How does the LPHP-Philos-PHN conservative treatment compare to standard-of-care surgical interventions for proximal humeral fractures in terms of functional outcomes?
Are there specific biomarkers that correlate with improved radiological healing and Constant/Neer scores in proximal humeral fracture patients treated with angled implants?
What are the potential adverse events associated with the use of stable-angled implants in proximal humeral fracture treatment and how are they managed?
What combination therapies or alternative implants have been evaluated for proximal humeral fractures in phase 4 trials and how do they compare to the LPHP-Philos-PHN approach?
Trial Locations
- Locations (1)
Universitaestklinik Freiburg, Klinik für Traumatologie
🇩🇪Freiburg, Germany
Universitaestklinik Freiburg, Klinik für Traumatologie🇩🇪Freiburg, Germany