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 and angle-stable plates (Proximal Humeral Internal Locking System - PHILOS).
Who can participate
Age range50 Years – 90 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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 metaboli…
What they're measuring
1
Local bone quality-related complication
Timeframe: From enrollment to 12 months postoperative
Trial details
NCT IDNCT01143675
SponsorAO Clinical Investigation and Publishing Documentation