scholarly journals External validity in a multicenter randomized clinical trial of proximal humeral fractures: the DelPhi trial

Author(s):  
Elias Tallay ◽  
Sondre K. Lindberg ◽  
Sindre Lee-Ødegård ◽  
Jonas Bjordal ◽  
Alexander N. Fraser ◽  
...  

Abstract Background Randomized 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). Methods The 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. Results Forty-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). Conclusions Results from the DelPhi RCT may not directly apply to older PHFs patients with lower health status or concomitant fractures. Level of evidence Level 4.

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
J. Miquel ◽  
R. Martínez ◽  
F. Santana ◽  
P. Marimon ◽  
C. Torrens

Abstract Background The surgical treatment of displaced proximal humeral fractures is commonly affected by implant-related complications. We evaluated the functional and radiographic results of transosseous suture fixation in a series of displaced proximal humeral fractures (PHF). Methods Sixty-four patients were retrospectively classified by age, sex, and the Neer fracture classification. Two-part greater tuberosity (2pGT) displaced fractures and 3-part (varus and valgus) and 4-part valgus impacted fractures were managed with fragment reduction and transosseous suture fixation. Patients with minimum follow-up of 24 months and assessed with the Constant-Murley score (CMS) were included. Radiological and medical complications, as well as reinterventions were also recorded. Results Forty-six patients with a mean follow-up of 58 (24–132) and a mean age of 58 years old were analyzed. Patients with 2pGT (n = 10) fractures had a CMS of 76 points (59–89); patients with 3-part fractures (n = 22) had a score of 67 points (13–91); and those with 4-part fractures (n = 14) had a score of 64 (24–76) points. The overall complication rate was 6 out of 46, and 4 patients required reintervention for different reasons. Patients presenting with 3-part varus fractures had significantly lower functional outcomes scores (p = 0.007). Humeral head osteonecrosis was present in 9 patients and significantly affected the functional outcomes (p < 0.05). However, only three out of nine patients with osteonecrosis required subsequent surgery at the indicated follow-up. Conclusions The fracture reduction and transosseous fixation technique represents a safe technique with low complication and reintervention rates. The presence of humeral head necrosis did not lead to subsequent surgical intervention because no hardware had protruded. Level of evidence Level IV, retrospective study


Children ◽  
2021 ◽  
Vol 8 (8) ◽  
pp. 635
Author(s):  
Florian Freislederer ◽  
Susanne Bensler ◽  
Thomas Specht ◽  
Olaf Magerkurth ◽  
Karim Eid

Background: Recommended treatment for severely displaced proximal humeral fractures in children is the closed reduction and percutaneous fixation by K-wires or intramedullary nailing. Methods: From January 2016 to January 2017 6, 21 children/adolescents (range 8 to 16 years) with proximal humeral fractures were treated surgically for severe displacement. In these six patients, several attempts of closed reduction were unsuccessful, and an open reduction was performed. The humeral head was fixed with a 3.5 mm T-plate without affecting the growth plate. Plate removal was performed at a mean interval of 132 days after initial surgery. Two years after initial surgery, the clinical outcome was assessed by the Constant–Murley score and QuickDASH score (including sport/music and work) and the shoulder joint was evaluated with a standardized sonographic examination for the rotator cuff and the conjoint tendon. Results: In all six patients, dorsal displacement of the fracture was irreducible due to the interposition of tendinous or osseous structures. Intraoperatively, the interposed structures were the long biceps tendon in two, periosteal tissue in two, a bony fragment in one, and the long biceps tendon together with the conjoint tendon in one case. At mean follow-up of 26 months (range 22 months to 29 months), patients showed very good clinical results with an excellent mean Constant–Murley score of 97.5 (range 91 to 100) and mean QuickDASH score (including sport/music and work) of 5.5 (range 0–20.8). An X-ray follow-up 6 weeks after surgery demonstrated early consolidation and correct alignment in all patients. A sonographic evaluation at 2 years post injury showed that the biceps and the conjoined tendon were intact in all patients. Conclusions: If a proximal humeral fracture is not reducible by closed means, a tissue entrapment (most likely biceps tendon) should be considered. Treatment with an open reduction and plate fixation yields very good clinical and radiological results and preserves interposed structures as the biceps and conjoint tendon.


BMC Surgery ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jiantao Li ◽  
Yuan Gao ◽  
Caixia Yin ◽  
Hao Zhang ◽  
Shaobo Nie ◽  
...  

Abstract Background The treatment of a displaced proximal humeral fracture is still a matter of controversy. The purpose of this study was to report outcomes at a long-term follow-up after fixation augmentation using peek (polyether-ether-ketone) cage and locking compression plate (LCP). Methods A total of 27 patients (average age 53.8 years, range 19–86 years) were treated with peek cage and LCP. All of them had a minimum radiographic and clinical follow-up of 1 years. Outcomes were assessed using the Constant-Murley score (CMS), disability of the arm, shoulder and hand (DASH) score. Complications were also recorded during follow-up. Results The average follow-up was 28 months (range 12–48 months). The mean functional outcomes were as follows: CMS, 73.3 (range 61–86); DASH, 45.9 (range 27–68). A total of 4 patients had complications: osteonecrosis developed in one patient, loss of reduction was observed in 1 patient and stiffness was occurred in two patients. Conclusion The use of peek cage and LCP has been a valuable option in the treatment of proximal humeral fractures. The complication rate was acceptable. Suitable void filler in the proximal humerus for reconstructing the medial column integrity attains mechanical stability in reducing the incidence of the complications.


2021 ◽  
Vol 103-B (6) ◽  
pp. 1063-1069
Author(s):  
Alexander Amundsen ◽  
Stig Brorson ◽  
Bo S. Olsen ◽  
Jeppe V. Rasmussen

Aims There is no consensus on the treatment of proximal humeral fractures. Hemiarthroplasty has been widely used in patients when non-surgical treatment is not possible. There is, despite extensive use, limited information about the long-term outcome. Our primary aim was to report ten-year patient-reported outcome after hemiarthroplasty for acute proximal humeral fractures. The secondary aims were to report the cumulative revision rate and risk factors for an inferior patient-reported outcome. Methods We obtained data on 1,371 hemiarthroplasties for acute proximal humeral fractures from the Danish Shoulder Arthroplasty Registry between 2006 and 2010. Of these, 549 patients (40%) were alive and available for follow-up. The Western Ontario Osteoarthritis of the Shoulder (WOOS) questionnaire was sent to all patients at nine to 14 years after primary surgery. Revision rates were calculated using the Kaplan-Meier method. Risk factors for an inferior WOOS score were analyzed using the linear regression model. Results Mean age at surgery was 67 years (24 to 90) and 445 (81%) patients were female. A complete questionnaire was returned by 364 (66%) patients at a mean follow-up of 10.6 years (8.8 to 13.8). Mean WOOS score was 64 (4.3 to 100.0). There was no correlation between WOOS scores and age, sex, arthroplasty brand, or year of surgery. The 14-year cumulative revision rate was 5.7% (confidence interval 4.1 to 7.2). Patients aged younger than 55 years and patients aged between 55 to 74 years had 5.6-times (2.0 to 9.3) and 4.3-times (1.9 to 16.7) higher risk of revision than patients aged older than 75 years, respectively. Conclusion This is the largest long-term follow-up study of acute proximal humeral fractures treated with hemiarthroplasty. We found a low revision rate and an acceptable ten-year patient-reported outcome. The patient-reported outcome should be interpreted with caution as we have no information about the patients who died or did not return a complete WOOS score. The long-term outcome and revision rate suggest that hemiarthroplasty offers a valid alternative when non-surgical treatment is not possible. Cite this article: Bone Joint J 2021;103-B(6):1063–1069.


Joints ◽  
2017 ◽  
Vol 05 (01) ◽  
pp. 021-026 ◽  
Author(s):  
Cosimo Tudisco ◽  
Salvatore Bisicchia ◽  
Sandro Tormenta ◽  
Amedeo Taglieri ◽  
Ezio Fanucci

Purpose The purpose of this study was to evaluate the effect of correction of abnormal radiographic parameters on postoperative pain in a group of patients treated arthroscopically for femoracetabular impingement (FAI). Methods A retrospective study was performed on 23 patients affected by mixed-type FAI and treated arthroscopically. There were 11 males and 12 females with a mean age of 46.5 (range: 28–67) years. Center-edge (CE) and α angles were measured on preoperative and postoperative radiographic and magnetic resonance imaging (MRI) studies and were correlated with persistent pain at follow-up. Results The mean preoperative CE and α angles were 38.6 ± 5.2 and 67.3 ± 7.2 degrees, respectively. At follow-up, in the 17 pain-free patients, the mean pre- and postoperative CE angle were 38.1 ± 5.6 and 32.6 ± 4.8 degrees, respectively, whereas the mean pre- and postoperative α angles at MRI were 66.3 ± 7.9 and 47.9 ± 8.9 degrees, respectively. In six patients with persistent hip pain, the mean pre- and postoperative CE angles were 39.8 ± 3.6 and 35.8 ± 3.1 degrees, respectively, whereas the mean pre- and postoperative α angles were 70.0 ± 3.9 and 58.8 ± 2.6 degrees, respectively. Mean values of all the analyzed radiological parameters, except CE angle in patients with pain, improved significantly after surgery. On comparing patient groups, significantly lower postoperative α angles and lower CE angle were observed in patients without pain. Conclusion In case of persistent pain after arthroscopic treatment of FAI, a new set of imaging studies must be performed because pain may be related to an insufficient correction of preoperative radiographic abnormalities. Level of Evidence Level IV, retrospective case series.


2020 ◽  
Vol 48 (12) ◽  
pp. 030006052097921
Author(s):  
Zhaofeng Jia ◽  
Chuangli Li ◽  
Jiandong Lin ◽  
Qisong Liu ◽  
Guangheng Li ◽  
...  

Objective This study was performed to evaluate the clinical effect of MultiLoc® nails (DePuy Synthes, Raynham, MA, USA) on the treatment of four-part proximal humeral fractures (PHFs). Methods From January 2014 to January 2018, 32 patients with four-part PHFs were treated with intramedullary MultiLoc® nails in our hospital. The operation time, bleeding volume, postoperative X-ray findings, and fracture healing status were recorded and analyzed. At the end of follow-up, the clinical outcome was evaluated based on the visual analog scale (VAS) score, American Shoulder and Elbow Surgeons (ASES) shoulder score, Constant–Murley score (CMS), and occurrence of any complications. Results Among all patients, the average operation time was 124.5 minutes (range, 91–152 minutes), the average amount of bleeding was 90 mL (range, 55–150 mL), and the fracture healing rate was 100%. At the end of follow-up, the mean VAS score was 1.6 ± 0.4, mean ASES score was 84.4 ± 6.3, and mean CMS was 70.3 ± 6.1; no serious complications had occurred; and the patients exhibited good recovery of shoulder function. Conclusions MultiLoc nails® can be applied to the treatment of four-part PHFs. This surgical fixation method has no obvious complications and helps to restore shoulder function.


2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Dominique I. Dabija ◽  
Hongshu Guan ◽  
Andrew Neviaser ◽  
Nitin B. Jain

Abstract Background Proximal humeral fractures can be treated non-operatively or operatively with open reduction and internal fixation (ORIF) and arthroplasty. Our objective was to assess practice patterns for operative and non-operative treatment of proximal humeral fractures. We also report on complications, readmissions, in-hospital mortality, and need for surgery after initial treatment of proximal humeral fractures in California, Florida, and New York. Methods The State Inpatient Databases and State Emergency Department Databases from the Healthcare Cost and Utilization Project, sponsored by the Agency for Healthcare Research and Quality, were used for the states of California (2005–2011), Florida (2005–2014), and New York (2008–2014). Data on patients with proximal humeral fractures was extracted. Patients underwent non-operative or operative (ORIF or arthroplasty) treatment at baseline and were followed for at least 4 years from the index presentation. If the patient needed subsequent surgery, time to event was calculated in days, and Kaplan-Meier survival curves were plotted. Results At the index visit, 90.3% of patients with proximal humeral fractures had non-operative treatment, 6.7% had ORIF, and 3.0% had arthroplasty. 7.6% of patients initially treated non-operatively, 6.6% initially treated with ORIF, and 7.2% initially treated with arthroplasty needed surgery during follow-up. Device complications were the primary reason for readmission in 5.3% of ORIF patients and 6.7% of arthroplasty patients (p < 0.0001). All-cause in-hospital mortality was 9.8% for patients managed non-operatively, 8.8% for ORIF, and 10.0% for arthroplasty (p = 0.003). Conclusions A majority of patients with proximal humeral fractures underwent non-operative treatment. There was a relatively high all-cause in-hospital mortality irrespective of treatment. Given the recent debate on operative versus non-operative treatment for proximal humeral fractures, our study provides valuable information on the need for revision surgery after initial treatment. The differences in rates of revision surgery between patients treated non-operatively, with ORIF, and with arthroplasty were small in magnitude. At nine years of follow-up, ORIF had the lowest probability of needing follow-up surgery, and arthroplasty had the highest.


2019 ◽  
Vol 101 (18) ◽  
pp. 1654-1661
Author(s):  
Davide Blonna ◽  
Marco Assom ◽  
Enrico Bellato ◽  
Gabriele Pisanu ◽  
Valentina Greco ◽  
...  

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