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Open reduction internal fixation vs non-operative management in proximal humerus fractures: a prospective, randomized controlled trial protocol.

ABSTRACT: BACKGROUND:Proximal humerus fractures are the third most common fracture in the elderly population and are expected to increase due to the aging population. Surgical fixation with locking plate technology has increased over the last decade despite a lack of proven superiority in the literature. Three previous randomized controlled trials have not shown a difference in patient-centered outcomes when comparing non-operative treatment with open reduction and internal fixation. Low patient enrollment and other methodological concerns however limit the generalizability of these conclusions and as a result, management of these fractures remains a controversy. By comparing the functional outcomes of locked plate surgical fixation versus non-operative treatment of displaced three and four-part proximal humerus fractures in the elderly population with a large scale, prospective, multi-centered randomized controlled trial, the optimal management strategy for this common injury may be determined. METHODS:We will conduct a prospective, single blind randomized controlled parallel arm trial to compare non-operative management of proximal humerus fractures with open reduction and internal fixation using locked plating technology. One-hundred and sixty patients > age 60 with acute 3- or 4- part proximal humerus fractures will be randomized to either open reduction and internal fixation with locked plating technology or non-operative management treatment arms. The primary outcome measure is the Constant Score at 24 months post-operative. Secondary outcome measures include the American Shoulder and Elbow Surgeon's Score (ASES), EuroQol EQ-5D-5 L Health Questionnaire Score, short form PROMIS upper extremity score and IPAQ for the elderly score. Further outcome measures include assessment of the initial classification, displacement and angulation and the quality of surgical reduction via a standard computed tomography (CT) scan; rates of non-union, malunion, arthrosis, osteopenia or other complications including infection, nerve injury, intra-articular screw penetration, reoperation rates and hospital re-admission rates. DISCUSSION:The results of this trial will provide Level 1 evidence to guide decision-making in the treatment of proximal humerus fractures in the elderly population. TRIAL REGISTRATION:ClinicalTrials.gov NCT02362100 . Registered 5 Feb 2015.

SUBMITTER: Howard L

PROVIDER: S-EPMC6098830 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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Open reduction internal fixation vs non-operative management in proximal humerus fractures: a prospective, randomized controlled trial protocol.

Howard Lisa L Berdusco Randa R Momoli Franco F Pollock J J Liew Allan A Papp Steve S Lalonde Karl-Andre KA Gofton Wade W Ruggiero Sara S Lapner Peter P

BMC musculoskeletal disorders 20180818 1

<h4>Background</h4>Proximal humerus fractures are the third most common fracture in the elderly population and are expected to increase due to the aging population. Surgical fixation with locking plate technology has increased over the last decade despite a lack of proven superiority in the literature. Three previous randomized controlled trials have not shown a difference in patient-centered outcomes when comparing non-operative treatment with open reduction and internal fixation. Low patient e ...[more]

PMID: 30121091

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Project description:BackgroundOpen reduction and plate fixation are the preferred treatment options for most distal humerus fractures in adults. However, it is often challenging for orthopedic surgeons because of the complex anatomy and the difficulty in achieving stable fixation. This multicenter study aimed to analyze the complication types and rates of patients with distal humerus fractures treated with open reduction and plate fixation, and compare the results with those found in the literature. In addition, we describe the clinical outcomes.MethodsThis retrospective multicenter study was conducted between September 2001 and March 2021 and included data from four hospitals. In total, 349 elbows underwent surgical treatment at these hospitals during the study period. Patients > 17 years of age who were treated by plate fixation were included, and patients who were treated by other fixation methods were excluded. A total of 170 patients were included in the study. The following types of complications were investigated: (1) nerve related; (2) fixation and instrument related; (3) osteosynthesis related; (4) infection; and (5) others.ResultsThe following complications were found: (1) 26 (15.3%) cases of postoperative ulnar nerve symptoms; 4 (2.4%) of postoperative radial nerve symptoms; (2) one (0.6%) case of screw joint penetration and screw loosening; and eight (4.7%) cases of hardware removal due to instrument skin irritation; (3) seven (4.1%) cases of nonunion; (4) two (1.2%) and four (2.2%) cases of superficial and deep infection, respectively, and seven (3.9%) cases of wound complication; and (5) 37 (21.8%) cases of heterotrophic ossification, 79 (46.5%) cases of elbow stiffness (did not achieve functional range of motion [ROM]), and 41 (24.1%) cases of osteoarthritis over Broberg and Morrey Grade I. Paradoxically, the postoperative ulnar nerve symptoms were more frequent in the prophylactic ulnar nerve anterior transposition group. However, this difference was not statistically significant (p = 0.086). The mean ROM was 123.5° flexion to 9.5° extension. The average Disabilities of the Arm, Shoulder and Hand (DASH) score was 14.5 ± 15.6.ConclusionsOpen reduction and plate fixation for distal humeral fractures is a reasonable treatment option with acceptable complication rates and favorable clinical outcomes. Surgeons must be vigilant about ulnar nerve complications. Level of Evidence Therapeutic Level III.

Project description:BackgroundProximal humerus fractures treated in the face of ipsilateral injuries to the shoulder girdle may be predisposed to worse clinical outcomes.Questions/purposesThe purpose of this investigation was to examine outcomes of proximal humerus fractures treated with open reduction internal fixation (ORIF) using an endosteal augment in the presence of a concomitant shoulder girdle injury in comparison to isolated proximal humerus fractures treated with ORIF and endosteal augment.MethodsA prospective database was used to identify proximal humerus fractures with ipsilateral shoulder girdle injuries (glenohumeral and acromioclavicular dislocation, fractures of the acromion, clavicle, scapula, or humeral diaphysis). These were compared to isolated proximal humerus fractures treated in the same fashion (ORIF with endosteal augment). Minimum of 1 year follow-up was required for inclusion. Outcomes assessed included range of motion (ROM), development of avascular necrosis (AVN), hardware-related complications, reoperation, and subjective outcome assessments including the Disabilities of Arm Shoulder and Hand questionnaire (DASH), Constant score, UCLA rating scale, and the Short Form-36 (SF-36).ResultsFifteen ipsilateral injuries were seen in 14 patients. Seventy-seven isolated proximal humerus fractures were available for comparison. The ipsilateral injury group had significantly worse forward flexion (141 vs 156°, p = 0.02), external rotation (56 vs 64°, p = 0.03), higher rates of avascular necrosis (4 of 14, 28.6% vs 1 of 77, 1.3%, p = 0.002), and inferior SF-36 physical health scores (48.5 vs 63.5; p = .04). Despite these differences, no significant differences were seen with hardware-related complications or DASH, Constant score, or UCLA rating scale results. No patients required secondary reconstructive procedures.ConclusionDespite a statistically higher rate of AVN and decreased ROM, patient-based outcomes of proximal humerus fractures with ipsilateral shoulder injuries approached those seen in isolated proximal humerus fractures. This suggests that these injuries can achieve similarly good clinical results provided any associated shoulder pathology is identified and treated appropriately.

Project description:BackgroundDistal humerus fracture open reduction and internal fixation (ORIF) represents a substantial cost burden to the health care system. The purpose of this study was to describe surgical encounter cost variation for distal humerus ORIF, and to determine demographic-, injury-, and treatment-specific factors that influence cost.MethodsWe retrospectively identified adult patients (≥18 years) treated for isolated distal humerus fractures between July 2014 and July 2019 at a single tertiary academic referral center. For each case, surgical encounter total direct costs (SETDCs) were obtained via our institution's information technology value tools, which prospectively record granular direct cost data for every health care encounter. Costs were converted to 2019 dollars using the personal consumption expenditure indices for health and summarized with descriptive statistics. Univariate and multivariate linear regression models were used to identify factors influencing SETDC.ResultsSurgical costs varied widely for the 47 included patients, with a standard deviation (SD) of 33% and interquartile range of 76%-124% relative to the mean SETDC. Implant and facility costs were responsible for 46.2% and 32.6% of the SETDC, respectively. Implant costs also varied considerably, with an SD of 21% and range from 13%-36% relative to the mean SETDC. Multivariate analysis demonstrated that SETDC increased 24% (P < .001) on performing an olecranon osteotomy, and by 15% for each additional 1 hour of surgical time (P < .001). These findings were independent of age, sex, body mass index, open fracture, need for an additional small plate construct as a reduction aid, and fracture pattern (all insignificant in the multivariate analysis, with P >.05 for each factor).ConclusionSubstantial variations in surgical encounter total direct costs for distal humerus ORIF exist, as do wide variations in associated implant costs that comprise nearly half of the entire surgical cost. Performing an olecranon osteotomy, and increased surgical time, significantly increased surgical costs. Although use of an olecranon osteotomy may not be a completely controllable factor as it is confounded by fracture severity and operative time, this may suggest that surgeons should try to use an olecranon osteotomy judiciously. Although complexity of the fracture pattern was statistically insignificant, it is confounded by the need for an olecranon osteotomy and increased surgical time and likely is a clinically relevant and nonmodifiable driver of surgical cost. These findings highlight opportunities to reduce cost variation, and potentially improve the value of care, for distal humerus ORIF patients.

Project description:BackgroundThis study aimed to identify the threshold for success in supracondylar humeral fracture surgery by describing the learning curve for beginners and exploring the relationship between the learning curve and the prognosis of supracondylar fractures of the humerus.MethodsSurgical information was collected of the first 100 humeral fractures treated by four pediatric orthopedic surgeons. The relationship between operation time, wire placement success rate, and surgical experience was determined using the restricted cubic strip (RCS). The inflection point in the curve and other risk factors that may affect fracture prognosis were collected and subjected to multiple logistic regression to clarify the relationship between the learning curve and prognosis of supracondylar fractures of the humerus. After the training, the four fresh surgeons were interviewed in the form of questionnaires to get feedback from the trainees.ResultsA total of 400 supracondylar fractures of the humerus from four pediatric orthopedists were included in the study. On an RCS analysis, 65 surgical experiences were the inflection point of the learning curve. Before and after these 65 surgical experiences, there were significant differences in the patients' anatomical reduction (186 vs. 122, P < 0.001), conversion to incision (33 vs. 6, P = 0.008), and supervising physician guidance (28 vs. 2, P < 0.001). In the multiple logistic regression analysis, functional recovery after supracondylar fractures of the humerus was significantly associated with surgical experience, intraoperative conversion to incision, and post-operative infection. Four surgeons and a supervisor were interviewed. They believed that self-confidence establishment requires the experience accumulation of about 30 operations. The most critical surgical technique is the reduction of fractures.ConclusionsAlthough the accumulated experience of 30 operations can establish the self-confidence of trainers, fresh surgeons must accumulate experience with 65 operations to master closed reduction and internal fixation for supracondylar fractures. Surgical experience significantly impacts the post-operative recovery of patients with fractures.Level of evidenceLevel III.

Project description:BackgroundOpen reduction internal fixation (ORIF) has long been the conventional procedure for managing displaced patella fracture. This surgical approach has certain drawbacks, which might affect clinical outcomes and patient prognosis. Minimally invasive percutaneous fixation (MIPF) was proposed to overcome these disadvantages. Few in-depth investigations have been performed to determine the superiority of MIPF over ORIF. The aim of this study was to compare the efficacies of MIPF and ORIF for patella fractures.MethodsThe PubMed, Cochrane Library, Embase, and Scopus databases were searched for relevant studies from November 26 to December 17, 2020. Non-English publications and pediatric orthopedic articles were excluded. Statistical analysis was performed using Review Manager, version 5.4, with mean differences (MDs), standardized mean differences (SMDs), odds ratios (ORs), and respective 95% confidence intervals (CIs) calculated using a random effects model. The primary outcomes were the pain score, knee range of motion, and joint functionality. The secondary outcomes were the surgical time, complications, and implant removal rate.ResultsSix articles with a total of 304 patients were included in the meta-analysis. Pooled analysis revealed that patients with MIPF had a significantly reduced pain score (MD = - 1.30, 95% CI = - 1.77 to -0.82; p < 0.00001) and increased knee extension angles (MD = 0.72, 95% CI = 0.18 to 1.25; p = 0.009) at 3-month follow-up. Furthermore, knee flexion angles (MD = 8.96, 95% CI = 5.81 to 12.1; p < 0.00001) and joint functionality (SMD = 0.54, 95% CI = 0.21 to 0.86; p = 0.001) had statistically improved at 2 years. However, no difference was observed between MIPF and ORIF with regard to the surgical time. The risk of complications (OR = 0.10, 95% CI = 0.05 to 0.18; p < 0.00001) and implant removal rate (OR = 0.20, 95% CI = 0.07 to 0.57; p = 0.003) were significantly lower with MIPF than with ORIF.ConclusionsMIPF is more favorable than ORIF in terms of the pain score, knee range of motion, joint functionality, complications, and implant removal rate. Thus, it can be adopted as an alternative to ORIF.

Dataset Information

Open reduction internal fixation vs non-operative management in proximal humerus fractures: a prospective, randomized controlled trial protocol.

Publications

Open reduction internal fixation vs non-operative management in proximal humerus fractures: a prospective, randomized controlled trial protocol.

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