Explore the vast range of titles available.

Although increasingly used, the benefit of surgical treatment of displaced 2-part proximal humerus fractures has not been proven. This trial evaluates the clinical effectiveness of surgery with locking plate compared with non-operative treatment for these fractures. The NITEP group conducted a superiority, assessor-blinded, multicenter randomized trial in 6 hospitals in Finland, Estonia, Sweden, and Denmark. Eighty-eight patients aged 60 years or older with displaced (more than 1 cm or 45 degrees) 2-part surgical or anatomical neck proximal humerus fracture were randomly assigned in a 1:1 ratio to undergo either operative treatment with a locking plate or non-operative treatment. The mean age of patients was 72 years in the non-operative group and 73 years in the operative group, with a female sex distribution of 95% and 87%, respectively. Patients were recruited between February 2011 and April 2016. The primary outcome measure was Disabilities of Arm, Shoulder, and Hand (DASH) score at 2-year follow-up. Secondary outcomes included Constant-Murley score, the visual analogue scale for pain, the quality of life questionnaire 15D, EuroQol Group's 5-dimension self-reported questionnaire EQ-5D, the Oxford Shoulder Score, and complications. The mean DASH score (0 best, 100 worst) at 2 years was 18.5 points for the operative treatment group and 17.4 points for the non-operative group (mean difference 1.1 [95% CI -7.8 to 9.4], p = 0.81). At 2 years, there were no statistically or clinically significant between-group differences in any of the outcome measures. All 3 complications resulting in secondary surgery occurred in the operative group. The lack of blinding in patient-reported outcome assessment is a limitation of the study. Our assessor physiotherapists were, however, blinded. This trial found no significant difference in clinical outcomes at 2 years between surgery and non-operative treatment in patients 60 years of age or older with displaced 2-part fractures of the proximal humerus. These results suggest that the current practice of performing surgery on the majority of displaced proximal 2-part fractures of the humerus in older adults may not be beneficial. ClinicalTrials.gov NCT01246167.

Background This study was performed to compare the operative clinical outcomes of helical plating, intramedullary nailing (IMN), and long straight lateral plating in the treatment of humeral shaft fractures extending into the proximal humerus, as well as to identify the optimal fixation strategy for managing such injuries. Methods In total, 81 patients with humeral shaft fractures extending into the proximal humerus were divided into three groups based on treatment strategy: helical plating (Group A, n  = 16), IMN (Group B, n  = 12), and long straight lateral plating (Group C, n  = 53). Preoperative demographic data and imaging were collected from the medical records. Operative time, blood transfusion, bone reduction quality, bone healing rate, and incidence of complications were recorded. Clinical evaluation included the Constant–Murley score for shoulder function, the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire for upper limb function, the visual analogue scale (VAS) for pain, and assessments of shoulder stiffness or instability and patient satisfaction. Results Compared with Groups A and C, patients in Group B had a longer operative time and lower blood transfusion requirements. More than 80% of patients in each group achieved bone reduction quality rated as “better than good.” There were no significant differences among the three groups in operative time, blood transfusion, or shaft angulation. Bone healing rates were 100%, 91.7%, and 94.3% in Groups A, B, and C, respectively. Mean shoulder flexion was 155.0°, 130.0°, and 150.0°, respectively. Functional outcomes, including the Constant–Murley score, DASH score, VAS score, and patient satisfaction, were significantly better in Group A than in Groups B and C. No complications occurred in Group A. One patient in Group B developed nonunion. In Group C, complications were observed in five patients (9.4%). Conclusion In the treatment of humeral shaft fractures extending into the proximal humerus, helical plating was associated with a higher bone union rate, better functional outcomes, and a lower postoperative complication rate compared with IMN or long straight lateral locking plates. Outcomes after nailing and long straight lateral plating were similar.

Background Proximal humerus fractures (PHF) are common in adults above 50 years, often following low-energy trauma and underlying osteoporosis. Randomized trials in patients 60 years and older have found no clinically important difference in 1- and 2-year outcomes between surgical and non-surgical treatments. There is limited evidence for the 50–65 age group, who may have different functional demands and even a different overall health status. There is limited knowledge to guide treatment decisions for this age group. Method A multicenter, parallel-group, randomized, superiority trial comparing osteosynthesis with non-surgical treatment in patients aged 50–65 years with displaced PHF. A total of 60 patients will be randomized equally to surgical treatment (primary osteosynthesis) or non-surgical treatment. Follow-up visits are arranged at 6 weeks and 6 months for all patients, with an additional 12-week visit mandatory for the surgical group and optional for the non-surgical group. The primary outcome is the between-group difference in Oxford Shoulder Score at 12 months. Sample size was calculated assuming a clinically relevant difference of 9.6 points on the OSS (SD 12), corresponding to 80% power at a 5% significance level. In case of treatment failure (persistent pain or a failed osteosynthesis), a salvage procedure will be offered. Patients not consenting to randomization will be asked to participate in a non-randomized cohort. They will have baseline data and preferences recorded, and they will receive the same follow-up and outcome assessments. Discussion Young shoulder CARE trial aims to provide insights into the treatment of displaced proximal humerus fractures in patients aged 50–65 years, and to understand the benefits and harms of both surgical and non-surgical treatment options. The trial results will be published in an open-access peer-reviewed journal. Trial registration Clinicaltrials.gov, NCT06416618, registered 14 May 2024.

Background Proximal humeral fractures are common injuries in the elderly population, with their incidence expected to rise due to increased life expectancy. A small subset of these fractures may be associated with dislocating forces that can result in shoulder dislocation concurrent with the fracture. For the elderly patients, proximal humeral fracture dislocation can be treated by open reduction and internal locking plate (LP) fixation or reverse shoulder arthroplasty (RSA). By now, no high-quality trials have compared the two. Methods This study is a prospective, single-center, superiority randomized controlled trial (RCT) comparing RSA and LP fixation in elderly patients (aged 65 to 85 years) with a proximal humeral fracture dislocation. Eligible participants will be randomly assigned to either the RSA or LP group (1:1 ratio). Postoperative follow-up will be conducted at 1 day (in the ward), 1 month, 3 months, 6 months, 12 months, and 24 months after surgery. Primary outcome is the Constant-Murley Score at 1-year postoperatively. Secondary outcomes include short version of Disabilities of the Arm Shoulder and Hand questionnaire score, American Shoulder and Elbow Surgeons score, Visual Analog Scale score, EuroQol-5 Dimension score, range of motion, strength and postoperative complications. Discussion This trial is the first RCT comparing RSA with LP fixation for proximal humeral fracture dislocations in elderly patients. The results of this study will provide high-quality evidence to guide clinical practice. Trial registration China Clinical Trials Registry No. ChiCTR2400088249.

BackgroundFollowing blunt trauma, diagnosis of shoulder dislocation based on physical examination alone is difficult due to possible concurrent proximal humeral fractures. X-rays are therefore used to confirm diagnosis. Results from recent observational studies comparing diagnostic accuracy of point-of-care ultrasound (PoCUS) with X-rays for shoulder dislocation have been encouraging. The aim of this study was to determine whether PoCUS improves diagnostic accuracy when used with physical examination for the diagnosis of shoulder dislocation, proximal humeral fracture and ascertaining successful reduction in the ED.MethodsA prospective, single-centre, open, parallel randomised control study over a 6-month period was used to answer the research question and test the null hypothesis. Consecutive eligible adult patients attending the ED of Mater Dei Hospital in Malta were randomised to either the control (C) (physical examination only) or experimental group (E) (physical examination and a two-point PoCUS scan). The study objectives were to measure diagnostic accuracy for both examinations for detecting shoulder dislocation, any associated proximal humeral fractures and confirming reduction. X-rays were used as reference standard for both groups.Results1206 patients were enrolled in this study (C n=600, E n=606). 290 dislocations (C n=132 and E n=158), 332 proximal humeral fractures (C n=154 and E n=178) and 278 reductions (C n=130 and E n=148) were analysed. A statistically significant difference (p<0.001) was found between the two groups for diagnostic accuracy in shoulder dislocation (C=65%, likelihood ratio (LR)+=2.03 and LR−=0.35 and E=100%, LR+=∞ and LR−=0), proximal humeral fractures (C=45.7%, LR+=1.23 and LR−=0.52 and E=98.3%, LR+=103.9 and LR−=0.03) and reduction (C=68.7%, E=100%). The null hypothesis for this study was thus rejected.ConclusionsThe addition of PoCUS to a physical examination significantly improves diagnostic accuracy for dislocations, proximal humeral fractures and reduction confirmation.Trial registration numberInternational Standard Randomised Controlled Trials Number Registry (ISRCTN17048126).

IntroductionWe compared the angle of the humerus and plate and to assess compatibility of a plate to the proximal humerus using three-dimensional (3D) printed models.Materials and methodsA total of 120 cases were included, who underwent anteroposterior shoulder radiographs. From these, 30 cases with 3D shoulder computed tomography scans were randomly selected to print 3D model. The lateral angle between the lateral cortex of the humeral shaft and lateral border of the greater tuberosity (GT), neck-shaft angle, and height from the most proximal point of the GT to the angular point were measured. When the plates were applied on the 3D models, the gap from the most proximal point of the GT to the proximal rim of the plate was measured.ResultsThe mean lateral angle in plain radiographs was 12.9 ± 2.2° and height from the most proximal point of the GT to the angular point was 44.4 ± 4.7 mm. The bending angles of the three plates were 8° and 10°. Height from the proximal rim of the plate to the bending point was 42.4, 42.0 and 43.8 mm. In 98% of cases, the lateral angle of the humerus was larger than all three plates. In 43% of cases, height of the GT was smaller than height of plates. When plates were applied to the 3D model, the mean gap from GT to plate was 4.8 ± 2.8 mm.ConclusionsThere was large variation in the lateral angle of the proximal humerus, which was not correlated with the neck-shaft angle. The lateral angle of the humerus was larger than the plates and prone to varus reduction and medial collapse.Level of evidence or clinical relevanceBasic science study.

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.

BackgroundProximal humeral fractures (PHFs) are still controversial with regards to treatment and are difficult to classify. The study’s objective is to show that preoperative planning performed while handling a three-dimensional (3D) printed anatomical model of the fracture can ensure a better understanding of trauma for both surgeons and patients.Materials and methodsTwenty patients (group A, cases) with complex PHF were evaluated preoperatively by reproducing life-size, full-touch 3D anatomical models. Intraoperative blood loss, radiographic controls, duration of surgery, and clinical outcomes of patients in group A were compared with 20 patients (group B, controls) who underwent standard preoperative evaluation. Additionally, senior surgeons and residents, as well as group A patients, answered a questionnaire to evaluate innovative preoperative planning and patient compliance. Cost analysis was evaluated.ResultsIntraoperative radiography controls and length of operation were significantly shorter in group A. There were no differences in clinical outcomes or blood loss. Patients claim a better understanding of the trauma suffered and the proposed treatment. Surgeons assert that the planning of the definitive operation with 3D models has had a good impact. The development of this tool has been well received by the residents. The surgery was reduced in length by 15%, resulting in savings of about EUR 400 for each intervention.ConclusionsFewer intraoperative radiography checks, shorter surgeries, and better patient compliance reduce radiation exposure for patients and healthcare staff, enhance surgical outcomes while reducing expenses, and lower the risk of medicolegal claims.Level of evidenceLevel I, prospective randomized case–control study.

Background Local implantation of ex vivo concentrated, washed and filtrated human bone marrow-derived mononuclear cells (BMC) seeded onto β-tricalciumphosphate (TCP) significantly enhanced bone healing in a preclinical segmental defect model. Based on these results, we evaluated in a first clinical phase-I trial safety and feasibility of augmentation with preoperatively isolated autologous BMC seeded onto β-TCP in combination with angle stable plate fixation for the therapy of proximal humeral fractures as a potential alternative to autologous bone graft from the iliac crest. Methods 10 patients were enrolled to assess whether cell therapy with 1.3 × 10 6 autologous BMC/ml/ml β-TCP, collected on the day preceding the definitive surgery, is safe and feasible when seeded onto β-TCP in patients with a proximal humeral fracture. 5 follow-up visits for clinical and radiological controls up to 12 weeks were performed. Results β-tricalciumphosphate fortification with BMC was feasible and safe; specifically, neither morbidity at the harvest site nor at the surgical wound site were observed. Neither local nor systemic inflammation was noted. All fractures healed within the observation time without secondary dislocation. Three adverse events were reported: one case each of abdominal wall shingles, tendon loosening and initial screw perforation, none of which presumed related to the IND. Conclusions Cell therapy with autologous BMC for bone regeneration appeared to be safe and feasible with no drug-related adverse reactions being described to date. The impression of efficacy was given, although the study was not powered nor controlled to detect such. A clinical trial phase-II will be forthcoming in order to formally test the clinical benefit of BMC-laden β-TCP for PHF patients. Trial registration The study was registered in the European Clinical Trial Register as EudraCT No. 2012-004037-17. Date of registration 30th of August 2012. Informed consent was signed from all patients enrolled.

Objective To compare and analyze the clinical outcomes of the proximal humeral internal locking system (PHILOS) alone and the PHILOS combined with fibular allograft in the treatment of Neer three‐ and four‐part proximal humerus fractures (PHF) in the elderly. Methods From January 2014 to January 2018, a total of 42 elderly patients with Neer three‐ or four‐part PHF admitted to our hospital were randomly divided into observation group and control group, with 21 patients in each group. The observation group was treated with the PHILOS combined with fibular allograft. The control group was treated with the PHILOS alone. Perioperative parameters and fracture classification were recorded in the two groups. Function results were assessed by Visual Analog Scale (VAS), Constant‐Murley score (CMS), American Shoulder and Elbow Surgeons (ASES) score, and the Disability of Arm‐Shoulder‐Hand (DASH) score. Radiological results were evaluated using the neck‐shaft angle (NSA) and humeral head height (HHH), and complications were also recorded in each group. Results There were no significant differences between the two groups in terms of preoperative status, age, gender, cause of trauma, fracture site, and fracture classification. The average follow‐up time was 12 months. At the last follow‐up, the VAS and DASH observation groups were lower than the control group, and there was significant difference between the two groups (P < 0.05). The CMS and ASES were higher in the observation group than the control group, and there was significant difference between the two groups (P < 0.05). The mean difference in the NSA and HHH were lower in the observation group than the control group, and there was a significant difference between the two groups (P < 0.05). There was one postoperative complication in the observation group, which was humeral head avascular necrosis (AVN). There were seven postoperative complications in the control group, including three cases of humeral head collapse and three cases of screw cutout and one case of humeral head AVN. The incidence of postoperative complications in the observation group was significantly lower than the control group (P < 0.05), there was a significant difference between the two groups. Conclusions For Neer three‐ or four‐part PHF in the elderly patients, PHILOS fixation with fibular allograft shows satisfactory short‐term results with respect to humeral head support and maintenance of reduction, and may reduce the incidence of complications associated with fixation using a PHILOS alone.