Minimally invasive treatment of proximal humerus fractures with locking compression plate improves shoulder function in older patients: study protocol for a prospective randomized controlled trial

Abstract

Background: Manual reduction or traditional steel plate fixation is commonly used for repair of proximal humerus factures in older patients, making these injuries prone to fracture malunion because of poor stability. While open reduction with steel plate fixation has a better outcome than closed reduction, the stability of internal fixation is still less than satisfactory. Therefore, we hypothesize that use of a locking compression plate will provide better stability and that biocompatibility will potentiate fracture healing and shoulder function recovery in older patients with proximal humerus fractures. This hypothesis is based on the fact that minimally invasive treatment with locking compression plates has presented good clinical results in terms of fixation stability, bone healing, and functional recovery. Methods/Design: This prospective, single-center, randomized controlled clinical trial will be completed at the Department of Joint Surgery, Affiliated Hospital of Qinghai University in China. Eighty-two older patients with proximal humerus fractures will be enrolled and equivalently assigned to two groups. In the test group, patients will undergo closed reduction via a lateral approach to the shoulder followed by locking compression plate fixation using a minimally invasive technique, and those in the control group will be subjected to closed reduction via a lateral approach to the shoulder followed by conventional steel plate fixation using a minimally invasive technique. All patients will be followed up for 6 months. The primary outcome will be recovery of shoulder function as indicated by clinical outcome scores according to the Neer classification system for proximal humeral fractures 6 months after surgery. The secondary outcomes will include the operation time; intraoperative blood loss; postoperative hospital stay; fracture healing time; clinical outcome scores according to the Neer classification system 0.5, 1, and 3 months after surgery; Visual Analogue Scale scores 1 and 3 days and 1 and 2 weeks after surgery to assess pain; scores of the Medical Outcomes Study 36-item Short Form Health Survey 0.5, 1, 3, and 6 months after surgery to assess quality of life; and X-ray examinations 0.5, 1, 3, and 6 months after surgery to assess fracture healing. Discussion: This study protocol represents an attempt to objectively choose appropriate methods for internal fixation of proximal humerus fractures in older patients by comparing locking compression plate with conventional steel plate fixation to improve shoulder function. Trial registration: ClinicalTrial.gov identifier: NCT02784522. Ethics: This study acquired written approval from the Ethics Committee of the Affiliated Hospital of Qinghai University in China (approval No. QHY1005D); this study will be performed in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: Written informed consent will be obtained prior to involvement in the clinical trial.