Operative Treatment of 2-fragment-fractures (AO 11-A3) of the Proximal Humerus in the Elderly: Cement Augmented Locking Plate Philos vs. Proximal Humerus Nail MultiLoc

Launched by LMU KLINIKUM · Nov 19, 2015

Keywords

ClinConnect Summary

Because of the lack of clinical studies which compare cement augmented locking plates with multiplanar humeral nail systems after 2-part proximal humeral fractures, the decision of surgical method currently depends only on surgeons favour. Because only a randomized clinical trial (RCT) can sufficiently answer the question if one treatment option provides advantages compared to the other method we are planning to perform a RCT.

Investigators hypothesis: The cement augmented angle stable plate fixation system PhilosTM with augmentation (Depuy-Synthes) achieves significant differences concern...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age: ≤60 years or younger postmenopausal woman
• • 2-fragment-fracture according to AO-classification AO 11-A3
• • Signed informed consent
• • Patient can read and understand German
• Exclusion Criteria:
• • Refusal to participate in the study
• • Not Independent
• • Dementia and/or institutionalized
• • Does not understand written and spoken guidance German
• • Pathologic fracture or a previous fracture of the same proximal humerus
• • Alcoholism or drug addiction, e.g., in the emergency department, breathalyzer indicates blood alcohol concentration of more than 2%
• • Other injury to the same upper limb requiring surgery
• • Major nerve injury (e.g., complete radial- or axillary nerve palsy)
• • Rotator cuff tear arthropathy
• • Open fracture
• • Multi-trauma or -fractured patient
• • Fracture dislocation or head-splitting fracture
• • Non-displaced fracture
• • Isolated fracture of the major or minor tubercle
• • Gross displacement of the fracture fragments (no bony contact between fracture parts or the humeral shaft is in contact with the articular surface)
• • Any medical condition that excludes surgical treatment
• • Pregnancy