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

BMC Musculoskelet Disord. 2018 Aug 18;19(1):299. doi: 10.1186/s12891-018-2223-3.

Abstract

Background: Proximal 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.

Methods: We 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.

Discussion: The 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 registration: ClinicalTrials.gov NCT02362100 . Registered 5 Feb 2015.

Keywords: Locked plating; Open reduction internal fixation (ORIF); Proximal humeral fracture; Randomized controlled trial; Shoulder; Shoulder joint.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Bone Plates
  • Clinical Protocols
  • Disability Evaluation
  • Female
  • Fracture Fixation, Internal* / adverse effects
  • Fracture Fixation, Internal* / instrumentation
  • Fracture Healing*
  • Humans
  • Male
  • Middle Aged
  • Ontario
  • Open Fracture Reduction* / adverse effects
  • Open Fracture Reduction* / instrumentation
  • Patient Readmission
  • Patient Reported Outcome Measures
  • Postoperative Complications / etiology
  • Prospective Studies
  • Recovery of Function
  • Research Design
  • Shoulder Fractures / diagnostic imaging
  • Shoulder Fractures / physiopathology
  • Shoulder Fractures / therapy*
  • Single-Blind Method
  • Time Factors
  • Tomography, X-Ray Computed
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT02362100