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In this multicenter, randomized trial comparing cemented with modern uncemented hemiarthroplasty in persons 60 years of age or older with an intracapsular hip fracture, cemented hemiarthroplasty resulted in a modestly but significantly better quality of life and a lower risk of periprosthetic fracture than uncemented hemiarthroplasty.

Patients who were 50 years of age or older and had a displaced femoral neck fracture were randomly assigned to total hip arthroplasty or hemiarthroplasty. Total hip arthroplasty did not differ significantly from hemiarthroplasty with regard to the incidence of secondary procedures and led to clinically unimportant improvement over hemiarthroplasty in function over 24 months.

Background Displaced femoral neck fractures usually are treated with hemiarthroplasty. However, the degree to which the design of the implant used (cemented or uncemented) affects the outcome is not known and may be therapeutically important. Questions/purposes In this randomized controlled trial, we sought to compare cemented with cementless fixation in bipolar hemiarthroplasties at 5 years in terms of (1) Harris hip scores; (2) femoral fractures; (3) overall health outcomes using the Barthel Index and EQ-5D scores; and (4) complications, reoperations, and mortality since our earlier report on this cohort at 1-year followup. Methods We present followup at a median of 5 years after surgery (range, 56–65 months) from a randomized trial comparing a cemented hemiarthroplasty (112 hips) with an uncemented, hydroxyapatite-coated hemiarthroplasty (108 hips), both with a bipolar head. Results were previously reported at 1-year followup. Harris hip scores, Barthel Index, and EQ-5D scores were assessed by one research nurse and one orthopaedic surgeon. Complications and reoperations were determined by chart review and radiographs examined by three orthopaedic surgeons. Sixty patients (56%) had died in the cemented group and 63 (60%) in the uncemented group. Respectively, three and two patients (2.7% and 1.9%) were completely lost to followup. Results Harris hip scores at 5 years were higher in the uncemented group than in the cemented group (86.2 versus 76.3; mean difference 9.9; 95% confidence interval [CI], 1.9–17.9). The prevalence of postoperative periprosthetic femoral fractures was 7.4% in the uncemented group and 0.9% in the cemented group (hazard ratio [HR], 9.3; 95% CI, 1.16–74.5). Barthel Index and EQ-5D scores were not different between the groups. Between 1 and 5 years, we found no additional infections or dislocations. The mortality rate was not different between the groups (HR, 1.2; 95% CI, 0.82–1.7). Conclusions Both arthroplasties may be used with good medium-term results after displaced femoral neck fractures. The uncemented hemiarthroplasty may result in higher hip scores but appears to carry an unacceptably high risk of later femoral fractures. Level of Evidence Level I, therapeutic study. See the Guidelines for Authors for a complete description of levels of evidence.

Proximal humerus fractures (PHFs) are common fractures, especially in older female patients. These fractures are commonly treated surgically, but the consensus on the best treatment is still lacking. The primary aim of this multicenter, randomized 3-arm superiority, open-label trial was to assess the results of nonoperative treatment and operative treatment either with locking plate (LP) or hemiarthroplasty (HA) of 3- and 4-part PHF with the primary outcome of Disabilities of the Arm, Shoulder, and Hand (DASH) at 2-year follow-up. Between February 2011 and December 2019, 160 patients 60 years and older with 3- and 4-part PHFs were randomly assigned in 1:1:1 fashion in block size of 10 to undergo nonoperative treatment (control) or operative intervention with LP or HA. In total, 54 patients were assigned to the nonoperative group, 52 to the LP group, and 54 to the HA group. Five patients assigned to the LP group were reassigned to the HA group perioperatively due to high comminution, and all of these patients had 4-part fractures. In the intention-to-treat analysis, there were 42 patients in the nonoperative group, 44 in the LP group, and 37 in the HA group. The outcome assessors were blinded to the study group. The mean DASH score at 2-year follow-up was 30.4 (standard error (SE) 3.25), 31.4 (SE 3.11), and 26.6 (SE 3.23) points for the nonoperative, LP, and HA groups, respectively. At 2 years, the between-group differences were 1.07 points (95% CI [-9.5,11.7]; p = 0.97) between nonoperative and LP, 3.78 points (95% CI [-7.0,14.6]; p = 0.69) between nonoperative and HA, and 4.84 points (95% CI [-5.7,15.4]; p = 0.53) between LP and HA. No significant differences in primary or secondary outcomes were seen in stratified age groups (60 to 70 years and 71 years and over). At 2 years, we found 30 complications (3/52, 5.8% in nonoperative; 22/49, 45% in LP; and 5/49, 10% in HA group, p = 0.0004) and 16 severe pain-related adverse events. There was a revision rate of 22% in the LP group. The limitation of the trial was that the recruitment period was longer than expected due to a high number of exclusions after the assessment of eligibility and a larger exclusion rate than anticipated toward the end of the trial. Therefore, the trial was ended prematurely. In this study, no benefit was observed between operative treatment with LP or HA and nonoperative treatment in displaced 3- and 4-part PHFs in patients aged 60 years and older. Further, we observed a high rate of complications related to operative treatments. ClinicalTrials.gov NCT01246167.

Background Four-part fractures of the proximal humerus account for 3% of all humeral fractures and are regarded as the most difficult fractures to treat in the elderly. Various authors recommend nonoperative treatment or hemiarthroplasty, but the literature is unclear regarding which provides better quality of life and function. Questions/purposes We therefore performed a randomized controlled trial to compare (1) function, (2) strength, and (3) pain and disability in patients 65 years and older with four-part humeral fractures treated either nonoperatively or with hemiarthroplasty. Methods We randomly allocated 50 patients to one of the two approaches. There were no differences in patient demographics between the two groups. The Constant-Murley score was the primary outcome measure. Secondary outcome measures were the Simple Shoulder Test, abduction strength test as measured by a myometer, and VAS scores for pain and disability. All patients were assessed at 12 months. Results We found no between-group differences in Constant-Murley and Simple Shoulder Test scores at 3- and 12-months followup. Abduction strength was better at 3 and 12 months in the nonoperatively treated group although the nonoperatively treated patients experienced more pain at 3 months; this difference could not be detected after 12 months. Conclusions We observed no clear benefits in treating patients 65 years or older with four-part fractures of the proximal humerus with either hemiarthroplasty or nonoperative treatment. Level of Evidence Level I, therapeutic study. See Instructions for Authors for a complete description of levels of evidence.

Background Intravenous tranexamic acid (TA) has proven efficacy in reducing blood loss and incidence of transfusion of blood products in elective total joint arthroplasty. However, evidence of efficacy in the setting of intracapsular hip fractures needing hip hemiarthroplasty (HA) or total hip arthroplasty (THA) are scarce. This study aimed to assess post-operative transfusion incidence in this clinical setting. Methods Over a five-year period 250 patients with intracapsular neck of femur fractures requiring arthroplasty were randomised to two groups. The treatment group received three-dose intravenous TA protocol and the control group received usual treatment without administration of TA. Blood loss was estimated from the change in Hb levels on day 1, 3 and 5 after surgery compared to preoperative levels. Transfusions of blood products were recorded when they were triggered by an a priori protocol. Post-operative complications were recorded during patient hospital admission. Results The intervention group showed significantly lower transfusion incidence of packed red blood cells (PRBC) (6 vs. 15, p  = 0.04, OR = 0.37, 95%CI OR = 0.14 to 0.99) and in the group of patients who received a blood transfusion, a trend was observed for patients who received TA to have lesser number of units of PRBC (mean = 1.3 vs. 1.6, p  = 0.51). A significant difference was noted in post-operative Hb levels of day 1,3 and 5. Backward stepwise multivariable regression analysis showed the use of TA was the most significant factor for reduction in postoperative blood transfusion ( p  = 0.047, OR = 0.37, 95% CI OR = 0.14 to 0.99). Assessment of the strength of the correlation showed modest correlation (Pearson correlation − 0.13 p  = 0.04, 95% CI correlation= -0.25 to -0.01). There was no increase in adverse events in patients who received TA. Conclusion The use of TA in setting of intracapsular hip fractures requiring arthroplasty reduces blood loss, the need for transfusion of blood products and may reduce surgical site complications without increasing the risk of VTE.

Background Proximal humerus fractures (PHF) are common and painful injuries, with the majority resulting from falls from a standing height. As with other fragility fractures, its age-specific incidence is increasing. Surgical treatment with hemiarthroplasty (HA) and reverse shoulder arthroplasty (RSA) have been increasingly used for displaced 3- and 4-part fractures despite a lack of good quality evidence as to whether one type of arthroplasty is superior to the other, and whether surgery is better than non-surgical management. The PROFHER-2 trial has been designed as a pragmatic, multicentre randomised trial to compare the clinical and cost-effectiveness of RSA vs HA vs Non-Surgical (NS) treatment in patients with 3- and 4-part PHF. Methods Adults over 65 years of age presenting with acute radiographically confirmed 3- or 4-part fractures, with or without associated glenohumeral joint dislocation, who consent for trial participation will be recruited from around 40 National Health Service (NHS) Hospitals in the UK. Patients with polytrauma, open fractures, presence of axillary nerve palsy, pathological (other than osteoporotic) fractures, and those who are unable to adhere to trial procedures will be excluded. We will aim to recruit 380 participants (152 RSA, 152 HA, 76 NS) using 2:2:1 (HA:RSA:NS) randomisation for 3- or 4-part fractures without joint dislocation, and 1:1 (HA:RSA) randomisation for 3- or 4-part fracture dislocations. The primary outcome is the Oxford Shoulder Score at 24 months. Secondary outcomes include quality of life (EQ-5D-5L), pain, range of shoulder motion, fracture healing and implant position on X-rays, further procedures, and complications. Independent Trial Steering Committee and Data Monitoring Committee will oversee the trial conduct, including the reporting of adverse events and harms. Discussion The PROFHER-2 trial is designed to provide a robust answer to guide the treatment of patients aged 65 years or over who sustain 3- and 4-part proximal humeral fractures. The pragmatic design and recruitment from around 40 UK NHS hospitals will ensure immediate applicability and generalisability of the trial findings. The full trial results will be made available in a relevant open-access peer-reviewed journal. Trial registration ISRCTN76296703. Prospectively registered on 5th April 2018

IntroductionThere were higher rates of revision, complication, non-union, delayed union, and poorer functional outcomes reported in super-aged patients of undisplaced femoral neck fractures treated with internal fixation. Therefore, we designed this randomized comparative study aiming to compare the effectiveness and long-term follow-up results of hemiarthroplasty (HA) with that of multiple cannulated screws (MCS).Materials and methodsEligible participants were randomly assigned into two groups for different methods of operation (hemiarthroplasty group and internal fixation group). The related indexes and data of two groups were collected for comparative analysis during the average follow-up period of 38.68 ± 28.24 months.ResultsThere were only two patients performed reoperation in HA group, and the reoperation rate of HA group (5.41%, 2/37) was significantly lower than that of IF group (21.4%, 9/41) (P value = 0.000). The comparison of survival curves for reoperation showed significant differences between two groups (P value = 0.031).The results of Cox proportional hazards model suggested that only operation method significantly affected the occurrence of reoperation (P value = 0.049). The results of survival analysis showed that there was no significant difference in survival time between two groups (P value = 0.682). And in the Cox proportional hazards model, only age significantly affected the occurrence of death (P value = 0.000). The average Harris scores of two groups were all above 75 points, and there was no significant difference in Harris scores between the two groups (P value greater than 0.05). But in the early term follow-up, the excellent and good rate of hip joint function in HA group was significantly higher than that in IF group (P value less than 0.05).ConclusionsHemiarthroplasty with less postoperative complications, low reoperation rate and better function recovery in early stage provide a good choice for the treatment of super-aged patients with nondisplaced femoral neck fracture.

Background The HemiSPAIRE trial is being conducted to determine whether a modified muscle sparing technique (SPAIRE-“Save Piriformis and Internus, Repairing Externus”) in hip hemiarthroplasty brings clinical benefits compared to the standard lateral technique in adults aged 60 years or older, with a displaced intracapsular hip fracture. This article describes the detailed statistical analysis plan for the trial.  Methods and design HemiSPAIRE is a definitive, pragmatic, superiority, multicentre, randomised controlled trial (with internal pilot) with two parallel groups. Participants, ward staff and all research staff involved in post-operative assessments are blinded to allocation. This article describes in detail (1) the primary and secondary outcomes; (2) the statistical analysis principles, including a survivor average causal effect (SACE) method chosen specifically to address the issue of potential bias from differential survival between trial arms, which was seen from data review by the Trial Steering Committee, the participants that will be included in each analysis, the covariates that will be included in each analysis, and how the results will be presented; (3) planned main analysis of the primary outcome; (4) planned analyses of the secondary outcomes; and (5) planned additional analyses of the primary and secondary outcomes. Trial registration ClinicalTrials.gov NCT04095611. Registered on 19 September 2019.

Background One of the most common complications of hip arthroplasty is excessive blood loss that could necessitate allogenic blood transfusion, which is further associated with other complications, such as infections, transfusion reactions or immunomodulation. In gynecology, 4DryField®PH, an absorbable polysaccharide-based formulation, is used for hemostasis and adhesion prophylaxis. In this study, we evaluated its hemostatic effect in patients undergoing hip bipolar hemiarthroplasty following intracapsular femoral neck fracture. Methods We studied 40 patients with intracapsular femoral neck fractures (Garden III or IV) admitted at our institution between July 2016 and November 2017. We included patients above 60 years with simple fracture and without pathologic fractures. Patients were randomized into intervention and control groups. The intervention group received 5 g of 4DryField® PH (subfascially and subcutaneously) during wound closure. Three drainages were inserted in a standardized manner (submuscular, subfascial, and subcutaneous) and drainage volume was measured immediately before extraction. Total blood loss was calculated using Mercuriali’s formula and standard hemograms upon admission and five days after surgery. Volume of postoperative hematoma was measured using point-of-care ultrasound seven days after surgery. Results Volume of the postoperative hematoma was reduced by 43.0 mL. However, significant reduction of total blood loss and drainage volume was not observed. Conclusions We observed that 4DryField® PH had a local hemostatic effect, thereby reducing volume of the postoperative hematoma. However, this reduction was small and had no effect on the total blood loss. Further studies are warranted to improve the application algorithm. Trial registration DRKS, DRKS00017452 , Registered 11 June 2019 – Retrospectively registered.