Conservative treatment, plate fixation, or prosthesis for proximal humeral fracture. A prospective randomized study

Abstract

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

Economic and social impact of upper extremity fragility fractures in elderly patients

“…The number of upper extremity fragility fractures will continue to increase as the US population continues to age, and the impact these fractures have on our health care system and patient quality of life will become a greater burden. Distal radius and proximal humerus fractures (PHF) are common among the elderly population as they are the second and third most common fractures in adults over the age of 65 [8]. It is estimated that proximal humerus fractures account for 20 % of all osteoporotic fractures, and it has been reported that more than 70 % of proximal humeral fractures occur in patients over 60 years old [9][10][11].…”

The ProFHER (PROximal Fracture of the Humerus: Evaluation by Randomisation) trial – a pragmatic multicentre randomised controlled trial evaluating the clinical effectiveness and cost-effectiveness of surgical compared with non-surgical treatment for proximal fracture of the humerus in adults

“…In total, HH identified one new single-centre RCT, 95 which compared hemiarthroplasty with non-surgical treatment in 50 patients, and a published protocol for an ongoing trial [Treatment of Proximal Humeral Fractures (TPHF)]. 96 Brief details of the eight RCTs now available on this topic are provided in Table 89. …”

Reliability, agreement and validity of the 1988 version of the Rowe Score

“…The strategy reduces the risk of influence of subjective expectations, which may influence the results [44]. By the same reason, the statistician and the researchers evaluating the study will be blinded for which treatment the three group of patients have received until the results are interpreted and consensus is reached.…”

“…Therefore, a prospective study without control group is in general considered to represent a low level of evidence [44]. The inclusion of a control group will improve the evidence, but groups may be different and bias results.…”

“…The use of EQ-5D cannot be recommended for use in costeffectiveness studies in the present patient population. It may be better suited for shoulder patients who are expected to be more disabled, by example patients with comminute fractures of the humeral head [44].…”