BackgroundProximal humerus fracture is the third most common fracture type after hip and distal radius fracture in elderly patients. A comprehensive study by Palvanen et al. demonstrated an increase in the annual fracture rate of 13.7% per year over the past 33 years. Should this trend continue, the fracture rate would triple over the next three decades. The increasing incidence of low-energy fractures raises questions about the optimal treatment in terms of functional outcome, pain, and rehabilitation time, as well as the economical impact. Despite the high incidence and costs of proximal humerus fractures, there is currently no valid scientific evidence for the best treatment method. Several publications, including a Cochrane review outline the need for high-quality, well-designed randomized controlled trials.Methods/DesignThe study is a prospective, randomized, national multi-center trial. The hypothesis of the trial is that surgical treatment of displaced proximal humerus fractures achieves better functional outcome, pain relief, and patient satisfaction compared to conservative treatment. The trial is designed to compare conservative and surgical treatment of proximal humerus fractures in patients 60 years and older. The trial includes two strata. Stratum I compares surgical treatment with locking plates to conservative treatment for two-part fractures. Stratum II compares multi-fragmented fractures, including three- and four-part fractures. The aim of Stratum II is to compare conservative treatment, surgical treatment with the Philos locking plate, and hemiarthroplasty with an Epoca prosthesis. The primary outcome measure will be the Disabilities of the Arm, Shoulder and Hand (DASH) score and the secondary outcome measures will be the EuroQol-5D (EQ-5D) value, OSS, Constant-Murley Score, VAS, and 15D.Recruiting time will be 3 years. The results will be analyzed after the 2-year follow-up period.DiscussionThis publication presents a prospective, randomized, national multi-center trial. It gives details of patient flow, randomization, aftercare and also ways of analysis of the material and ways to present and publish the results.Trial registrationClinicalTrials.gov identifier: NCT01246167
Background and Aims: Both cemented and uncemented hemiarthroplasties are acceptable methods for treating displaced femoral neck fractures. Cemented hemiarthroplasty has traditionally been recommended as being more safe and reliable. However, the cementing process carries a risk of fat embolism and cardiovascular problems. This study attempted to determine whether these complications can be avoided when using a modern uncemented stem. Material and Methods:We retrospectively compared 222 hip fracture patients treated with hemiarthroplasty in our hospital. A total of 100 of these patients were treated with a hydroxyapatite-coated uncemented hemiendoprosthesis (Bi-Metric BFx) and 122 patients with a cemented hemiendoprosthesis (Lubinus SPII). Information on mortality and complications during the first 18.7 months was retrieved from patient files.Results and Conclusions: Nine perioperative fat-embolic events were found in the cemented group and none in the uncemented group. During the initial hospital treatment, there were five deaths (4.1%) in the cemented group and one death (1%) in the uncemented group. There were significantly more perioperative fractures in the uncemented versus cemented group (7% versus 0.8%). We conclude that uncemented hemiarthroplasty is associated with more perioperative fractures than cemented hemiarthroplasty. However, perioperative cardiovascular disturbances may be less frequent with uncemented hemiarthroplasty, and early mortality may be lower with uncemented hemiarthroplasty.
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