Abstract
BackgroundProximal humerus fractures are the third most common fracture in the elderly population and are expected to increase due to the aging population. Surgical fixation with locking plate technology has increased over the last decade despite a lack of proven superiority in the literature. Three previous randomized controlled trials have not shown a difference in patient-centered outcomes when comparing non-operative treatment with open reduction and internal fixation. Low patient enrollment and other methodological concerns however limit the generalizability of these conclusions and as a result, management of these fractures remains a controversy. By comparing the functional outcomes of locked plate surgical fixation versus non-operative treatment of displaced three and four-part proximal humerus fractures in the elderly population with a large scale, prospective, multi-centered randomized controlled trial, the optimal management strategy for this common injury may be determined.MethodsWe will conduct a prospective, single blind randomized controlled parallel arm trial to compare non-operative management of proximal humerus fractures with open reduction and internal fixation using locked plating technology. One-hundred and sixty patients > age 60 with acute 3- or 4- part proximal humerus fractures will be randomized to either open reduction and internal fixation with locked plating technology or non-operative management treatment arms. The primary outcome measure is the Constant Score at 24 months post-operative. Secondary outcome measures include the American Shoulder and Elbow Surgeon’s Score (ASES), EuroQol EQ-5D-5 L Health Questionnaire Score, short form PROMIS upper extremity score and IPAQ for the elderly score. Further outcome measures include assessment of the initial classification, displacement and angulation and the quality of surgical reduction via a standard computed tomography (CT) scan; rates of non-union, malunion, arthrosis, osteopenia or other complications including infection, nerve injury, intra-articular screw penetration, reoperation rates and hospital re-admission rates.DiscussionThe results of this trial will provide Level 1 evidence to guide decision-making in the treatment of proximal humerus fractures in the elderly population.Trial registrationClinicalTrials.gov NCT02362100. Registered 5 Feb 2015.
Highlights
Proximal humerus fractures are the third most common fracture in the elderly population and are expected to increase due to the aging population
Our primary objective is to determine if there is a difference in the functional outcome between non-operative management and locking plate surgical fixation of low-energy displaced threeand four-part proximal humerus fractures in the elderly population based on the Constant functional outcome score [46] over a 2-year follow-up period
Is there a difference between non-operative management and locking plate surgical fixation of low-energy displaced three- and four-part proximal humerus fractures in the elderly population based on the ASES functional outcome score [47], the short form Patient Reported Outcomes Measurement Information System (PROMIS) upper extremity score [48], the International Physical Activity Questionnaire (IPAQ) for the elderly [49], and the EuroQol EQ-5D-5 L Health Questionnaire Quality of Life (QoL) functional outcome score [50] over a 2-year follow-up period? What is the incidence of complications of non-operative management and locking plate surgical fixation of low-energy displaced three- and four-part proximal humerus fractures in the elderly population based on infection, nerve injury, intra-articular screw penetration and bleeding, reoperation rate, or hospital readmission over a 2-year follow-up period
Summary
Proximal humerus fractures are the third most common fracture in the elderly population and are expected to increase due to the aging population. By comparing the functional outcomes of locked plate surgical fixation versus non-operative treatment of displaced three and four-part proximal humerus fractures in the elderly population with a large scale, prospective, multi-centered randomized controlled trial, the optimal management strategy for this common injury may be determined. With a large focus on undisplaced fractures, these studies highlight that non-operative management of proximal humerus fractures can lead to satisfactory functional outcomes with modest complication rates. In a report of non-operative management of displaced proximal humerus fractures, Yuksel et al reported a mean Constant score of 61.3 (n = 18, eight 3-part and ten 4-part; mean age of 68.2 years; mean follow-up of 3.3 years), with nonunion and osteonecrosis detected in 27.8% (n = 5) [23]
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