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Clinical investigation for displaced proximal humeral fractures in the elderly: a randomized study of two surgical treatments: reverse total prosthetic replacement versus angular stable plate Philos (The DELPHI-trial).

ABSTRACT: Treatment for displaced proximal humeral fractures is still under debate. Few studies exist at the highest level of evidence. Although reversed total shoulder prosthesis has gained popularity and showed promising results in the treatment for proximal humeral fractures in the elderly patients, no randomized controlled trials exist to the authors' knowledge.This study is a randomized semi-blinded controlled multicenter trial designed according to the Consort statement and the recommendations given by the Cochrane reviewers for proximal humeral fractures. The study will investigate whether a reversed total shoulder prosthetic replacement gain better functional outcome compared to open reduction and internal fixation using an angular stable plate in displaced three- and four parts proximal humeral fractures after two and five years follow-up.Participants are aged 65-85 admitted in seven different hospitals with a displaced proximal humeral fracture according to AO-OTA type 11-B2 or 11-C2. The intervention group is surgical treatment using a reversed total shoulder prosthesis (Delta X-tend) compared to open reduction and internal fixation with an angular stable plate (Philos) and thread cerclage in the control group. 60 patients will be randomized to each group.The primary outcome is shoulder function (Constant score). Secondary outcomes will be patient self-assessment form (Oxford shoulder score), a quality of life questionnaire (15D score) and resource implications (cost-effectiveness). Follow-ups take place at 3, 6, 12 and 24 months, and five years. The trial design is semi-blinded with blinded physiotherapists performing the functional testing of patients at all follow-ups.Randomization to treatment groups is electronic online, by independent supervisor (web-CRF). The recruitment of patients started at January 1.st 2013. Inclusion of 120 patients during three years is expected.This semiblinded trial include a high number of patients compared to existing randomized trials in this field. To our knowledge and according to ClinicalTrials.gov, this is the first study that compare these two treatments for a displaced proximal humeral fracture in elderly patients. This may provide important information to help the surgeon to decide the best treatment in the future.ClinicalTrials.gov Identifier: NCT01737060.

SUBMITTER: Fjalestad T

PROVIDER: S-EPMC4247153 | biostudies-literature | 2014 Sep

REPOSITORIES: biostudies-literature

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Clinical investigation for displaced proximal humeral fractures in the elderly: a randomized study of two surgical treatments: reverse total prosthetic replacement versus angular stable plate Philos (The DELPHI-trial).

Fjalestad Tore T Iversen Petter P Hole Margrethe Øye MØ Smedsrud Morten M Madsen Jan Erik JE

BMC musculoskeletal disorders 20140928

<h4>Background</h4>Treatment for displaced proximal humeral fractures is still under debate. Few studies exist at the highest level of evidence. Although reversed total shoulder prosthesis has gained popularity and showed promising results in the treatment for proximal humeral fractures in the elderly patients, no randomized controlled trials exist to the authors' knowledge.<h4>Methods/design</h4>This study is a randomized semi-blinded controlled multicenter trial designed according to the Conso ...[more]

PMID: 25261913

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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:BackgroundRandomized controlled trials (RCT) are regarded as the gold standard for effect evaluation in clinical interventions. However, RCTs may not produce relevant results to all patient groups. We aimed to assess the external validity of a multicenter RCT (DelPhi trial).MethodsThe DelPhi RCT investigated whether elderly patients with displaced proximal humeral fractures (PHFs) receiving reversed total shoulder prosthetic replacement (RTSA) gained better functional outcomes compared to open reduction and internal fixation (ORIF) using an proximal humerus locking plate (PHILOS). Eligible patients were between 65 and 85 years old with severely displaced 11-B2 or 11-C2 fractures (AO/OTA-classification, 2007). We compared baseline and follow-up data of patients for two of the seven hospitals that were included in the DelPhi trial (n = 54) with non-included patients (n = 69). Comparisons were made based on reviewing medical records regarding demographic, health and fracture parameters.ResultsForty-four percent of the eligible patients were included in the DelPhi trial. Comparing included and non-included patients indicated higher incidences of serious heart disease (P = 0.044) and a tendency toward higher tobacco intake (P = 0.067) in non-included patients. Furthermore, non-included patients were older (P = 0.040) and had higher ASA classification (P < 0.001) and were in more need for resident aid (in-home assistance) (P = 0.022) than included patients. The cause of PHF was more frequently related to fall indoors in non-included vs. included patients (P = 0.018) and non-included patients were more prone to other concomitant fractures (P = 0.004). Having concomitant fractures was associated with osteoporosis (P = 0.014). We observed no significant differences in rates of complications or deaths between included and non-included patients within 3 months after treatment. In descending order, non-included patients were treated conservatively, with PHILOS, RTSA, anatomic hemi-prothesis or an alternative type of ORIF. RTSA was the preferred treatment choice for C2-type fractures (P < 0.001).ConclusionsResults from the DelPhi RCT may not directly apply to older PHFs patients with lower health status or concomitant fractures.Level of evidenceLevel 4.

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.

Dataset Information

Clinical investigation for displaced proximal humeral fractures in the elderly: a randomized study of two surgical treatments: reverse total prosthetic replacement versus angular stable plate Philos (The DELPHI-trial).

Publications

Clinical investigation for displaced proximal humeral fractures in the elderly: a randomized study of two surgical treatments: reverse total prosthetic replacement versus angular stable plate Philos (The DELPHI-trial).

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