Open reduction internal fixation vs non-operative management in proximal humerus fractures: a prospective, randomized controlled trial protocol

• DOI: 10.1186/s12891-018-2223-3
• Publication Date: 2018-08-18T15:32:28Z
• Authors: Lisa Howard; Randa Berdusco; Franco Momoli; J. Pollock; Allan Liew; Steve Papp; Karl-Andre Lalonde; Wade Gofton; Sara Ruggiero; Peter Lapner
• Keywords: Sports medicine

Proximal humerus fractures are the third most common fracture in elderly population and expected to increase due aging population. Surgical fixation with locking plate technology has increased over last decade despite a lack of proven superiority literature. Three previous randomized controlled trials have not shown difference patient-centered outcomes when comparing non-operative treatment open reduction internal fixation. Low patient enrollment other methodological concerns however limit generalizability these conclusions as result, management remains controversy. By functional locked surgical versus displaced three four-part proximal large scale, prospective, multi-centered trial, optimal strategy for this injury may be determined. We will conduct single blind parallel arm trial compare using plating technology. One-hundred sixty patients > age 60 acute 3- or 4- part either arms. The primary outcome measure is Constant Score at 24 months post-operative. Secondary measures include American Shoulder Elbow Surgeon's (ASES), EuroQol EQ-5D-5 L Health Questionnaire Score, short form PROMIS upper extremity score IPAQ score. Further assessment initial classification, displacement angulation quality via standard computed tomography (CT) scan; rates non-union, malunion, arthrosis, osteopenia complications including infection, nerve injury, intra-articular screw penetration, reoperation hospital re-admission rates. results provide Level 1 evidence guide decision-making ClinicalTrials.gov NCT02362100 . Registered 5 Feb 2015.