Status:
COMPLETED
Influence of Local Bone Status on Complications After Surgical Treatment of Proximal Humerus Fractures
Lead Sponsor:
AO Clinical Investigation and Publishing Documentation
Conditions:
Proximal Humeral Fractures
Poor Bone Quality
Eligibility:
All Genders
50-90 years
Brief Summary
The purpose of this study is to evaluate if poor bone quality increases the risk of specific types of treatment complications in patients with proximal humerus fractures treated with open reduction an...
Detailed Description
More than 70% of patients with a proximal humerus fracture are older than 60 years, up to three quarters are women and the incidence of low-energy fractures increases exponentially with age. The stand...
Eligibility Criteria
Inclusion
- Radiologically confirmed closed fracture (within 10 days) of the proximal humerus
- All dislocated (mod. Neer) proximal humerus fractures except dislocated fractures of the greater and lesser tuberosity
- Primary fracture treatment with a PHILOS-plate
- Age equal greater than 50 and equal younger than 90 years
- Normal function of both shoulders (pre-trauma) according to age
- Monotrauma
- Willing and able to give written informed consent to participate in the study
- Willing and able to participate in the study follow-ups according to the CIP
- Willing and able to comply with the postoperative management program
- Able to understand and read country national language
Exclusion
- Open proximal humerus fractures
- Concomitant contralateral proximal humerus fracture
- Previous proximal humerus fracture on either side after the age of 25
- Time to operation \> 10 days
- Polytrauma
- Cuff-arthropathy of the contralateral proximal humerus
- Associated nerve or vessel injury
- Regular systemic therapy with corticosteroids due to chronic disease
- Legal incompetence
- Patient received radio- or chemotherapy prior to, during or within the last year
- Currently active cancer
- Recent history of substance abuse (i.e. recreational drugs, alcohol)
- Prisoner
- Currently involved in a pharmaceutical clinical study§
- Has a disease process that would preclude accurate evaluation (e.g. neuromuscular or rheumatic disease, significant psychiatric or metabolic disorders)
- Simultaneous participation in another orthopedic/surgical study with the same or another fracture has to be approved by the AOCID.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT01143675
Start Date
March 1 2007
End Date
April 1 2010
Last Update
August 12 2020
Active Locations (10)
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1
Medizinische Uni Innsbruck
Innsbruck, Tyrol, Austria, 6020
2
Queen Mary Hospital
Hong Kong, China
3
Klinikum rechts der Isar der TU München
Munich, Bavaria, Germany, 81675
4
Ev. Diakoniewerk Friederikenstift
Hanover, Lower Saxony, Germany, 30169