Primary hemiarthroplasty versus conservative treatment for comminuted fractures of the proximal humerus in the elderly (ProCon) - A Multicenter Randomized trial.
Suspended
- Conditions
- ederlands:proximale humerusfractuurschouderfractuurschouderprotheseEngels:proximal humeral fractureshoulder fractureshoulder prosthesis
- Registration Number
- NL-OMON24819
- Lead Sponsor
- Erasmus MC, University Medical Center Rotterdam, Department of Surgery-TraumatologyErasmus MC, Medical Ethical Committee (METC)
- Brief Summary
Den Hartog D, Van Lieshout EMM, Tuinebreijer WE, Polinder S, Van Beeck EF, Breederveld RS, Bronkhorst MWGA, Eerenberg JP, Rhemrev S, Roerdink WH, Schraa G, Van der Vis HM, Van Thiel TPH, Patka P, Nijs S, Schep NWL. Primary hemiarthroplasty versus conservative treatment for comminuted fractures of the proximal humerus in the elderly (ProCon): A Multicenter Randomized Controlled trial. BMC Musculoskelet Disord 2010;11(1):97.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
1. Adult men or women aged 65 years and older (with no upper age limit);
2. Fracture of the humeral head;
Exclusion Criteria
1. Polytraumatized patients;
2. Patients with an additional traumatic injury of the affected arm;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Constant Score.
- Secondary Outcome Measures
Name Time Method 1. Disabilities of the Arm, Shoulder and Hand (DASH) score, including optional module for sports/music performance; <br /><br>2. Pain level (Visual Analog Scale, VAS); <br /><br>3. Radiographic healing; <br /><br>4. Rate of secondary interventions; <br /><br>5. Complication rates; <br /><br>6. Mortality rate; <br /><br>7. Health-related quality of life (Short-Form 36 (SF-36) and EuroQol-5D (EQ-5D)); <br /><br>8. Costs; <br /><br>9. Cost-effectiveness.