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

ABSTRACT: Proximal 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.The 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.This 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.ClinicalTrials.gov identifier: NCT01246167.

SUBMITTER: Launonen AP

PROVIDER: S-EPMC3520878 | biostudies-literature | 2012 Sep

REPOSITORIES: biostudies-literature

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

Launonen Antti P AP Lepola Vesa V Flinkkilä Tapio T Strandberg Niko N Ojanperä Johanna J Rissanen Pekka P Malmivaara Antti A Mattila Ville M VM Elo Petra P Viljakka Timo T Laitinen Minna M

BMC musculoskeletal disorders 20120907

<h4>Background</h4>Proximal 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, an ...[more]

PMID: 22954329

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Project description:BackgroundAlmost one-third of patients with proximal humeral fractures are treated surgically, and the number is increasing. When surgical treatment is chosen, there is sparse evidence on the optimum method. The DelPhi (Delta prosthesis-PHILOS plate) trial is a clinical trial comparing 2 surgical treatments. Our hypothesis was that reverse total shoulder arthroplasty (TSA) yields better clinical results compared with open reduction and internal fixation (ORIF) using an angular stable plate.MethodsThe DelPhi trial is a randomized controlled trial comparing reverse TSA with ORIF for displaced proximal humeral fractures (OTA/AO types 11-B2 and 11-C2) in elderly patients (65 to 85 years of age). The primary outcome measure was the Constant score at a 2-year follow-up. The secondary outcome measures included the Oxford Shoulder Score and radiographic evaluation. Results were reported as the mean difference with 95% confidence interval (CI). The intention-to-treat principle was applied for crossover patients.ResultsThere were 124 patients included in the study. At 2 years, the mean Constant score was 68.0 points (95% CI, 63.7 to 72.4 points) for the reverse TSA group compared with 54.6 points (95% CI, 48.5 to 60.7 points) for the ORIF group, resulting in a significant mean difference of 13.4 points (95% CI, 6.2 to 20.6 points; p < 0.001) in favor of reverse TSA. When stratified for fracture classification, the mean score was 69.3 points (95% CI, 63.9 to 74.7 points) for the reverse TSA group and 50.6 points (95% CI, 41.9 to 59.2 points) for the ORIF group for type-C2 fractures, which yielded a significant mean difference of 18.7 points (95% CI, 9.3 to 28.2 points; p < 0.001). In the type-B2 fracture group, the mean score was 66.2 points (95% CI, 58.6 to 73.8 points) for the reverse TSA group and 58.5 points (95% CI, 49.6 to 67.4 points) for the ORIF group, resulting in a nonsignificant mean difference of 7.6 points (95% CI, -3.8 to 19.1 points; p = 0.19).ConclusionsAt a 2-year follow-up, the data suggested an advantage of reverse TSA over ORIF in the treatment of displaced OTA/AO type-B2 and C2 proximal humeral fractures in elderly patients.Level of evidenceTherapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Project description:BACKGROUND:Treating proximal humerus fractures can be challenging because of large metaphyseal defects that conceal anatomical landmarks. In such cases, medial cortical support with, for example, calcar screws, is mandatory. Nevertheless, varus dislocations and implant failures in patients with impaired bone quality persist. Thus, the need for effective treatment of these patients exists. Hybrid double plate osteosynthesis was introduced as an alternative, yielding similar results as calcar screws. However, a biomechanical comparison of the stability of these two techniques is pending. METHODS:Cadaveric humeral specimens were treated with plate osteosynthesis and calcar screws (group 1, n = 9) or hybrid double plate osteosynthesis (group 2, n = 9) using a proximal humerus fracture model with a two-part fracture. Displacement, stiffness, failure mode, and ultimate load were examined biomechanically in a cyclic compressive-loading scenario. RESULTS:Although the hybrid double plate osteosynthesis (group 2) tended to confer higher stiffnesses than the medial support screws at higher cycles (group 1), this trend was below the level of significance. The displacement revealed non-significantly lower values for group 1 as compared with group 2 for cycles 50 and 2000, but at 5000 cycles, group 2 offered non-significantly lower displacement values than group 1. The ultimate load tended to be non-significantly higher in the hybrid double plate osteosynthesis group (group 2: 1342±369 N, group 1: 855±408 N). Both groups yielded similar failure rates, with the majority of failures in group 2 being gap closures (n = 8), whereas those in group 1 being plate dislocations (n = 4). CONCLUSIONS:The use of an additive plate osteosynthesis in the region of the bicipital groove may be a potential alternative to the previously-established method of using calcar screws. The biomechanical data obtained in this study suggests that hybrid double plate osteosynthesis is as rigid and robust as calcar screws.

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

Publications

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

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