Comminuted Proximal Humeral Fractures. A Randomised Study of Surgical Versus Conservative Treatment
Phase 2
Completed
- Conditions
- Proximal Humeral FractureOsteosynthesis or Conservative Treatment
- Registration Number
- NCT00863473
- Lead Sponsor
- University Hospital, Aker
- 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?
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Radiographic score 12 and 24 months 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
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 pathways influence bone healing outcomes in LCP-treated comminuted proximal humeral fractures versus conservative management?
How does interlocking plate surgery (LCP) compare to standard conservative care in long-term functional recovery for displaced proximal humeral fractures in elderly patients?
Which biomarkers correlate with improved QALY outcomes in surgical versus conservative treatment of comminuted proximal humeral fractures in patients over 60?
What are the most common adverse events associated with LCP fixation for displaced proximal humeral fractures in geriatric populations, and how are they managed?
Are there adjunctive pharmacological agents or biologics that synergize with LCP surgery to enhance functional outcomes in comminuted proximal humeral fractures?
Trial Locations
- Locations (1)
Tore Fjalestad, Ortopeadic Dept, Oslo University Hospital
🇳🇴Oslo, Norway
Tore Fjalestad, Ortopeadic Dept, Oslo University Hospital🇳🇴Oslo, Norway