Primary hemiarthroplasty versus conservative treatment for comminuted fractures of the proximal humerus in the elderly (ProCon): A Multicenter Randomized Controlled trial

Background. Fractures of the proximal humerus are associated with a profound temporary and sometimes permanent, impairment of function and quality of life. The treatment of comminuted fractures of the proximal humerus like selected three-or four-part fractures and split fractures of the humeral head is a demanding and unresolved problem, especially in the elderly. Locking plates appear to offer improved fixation; however, screw cut-out rates ranges due to fracture collapse are high. As this may lead to higher rates of revision surgery, it may be preferable to treat comminuted fractures in the elderly primarily with a prosthesis or non-operatively. Results from case series and a small-sample randomized controlled trial (RCT) suggest improved function and less pain after primary hemiarthroplasty (HA); however these studies had some limitations and a RCT is needed. The primary aim of this study is to compare the Constant scores (reflecting functional outcome and pain) at one year after primary HA versus non-operative treatment in elderly patients who sustained a comminuted proximal humeral fracture. Secondary aims include effects on functional outcome, pain, complications, quality of life, and cost-effectiveness. Methods/Design. A prospective, multi-center RCT will be conducted in nine centers in the Netherlands and Belgium. Eighty patients over 65 years of age, who have sustained a three-or four part, or split head proximal humeral fracture will be randomized between primary hemiarthroplasty and conservative treatment. The primary outcome is the Constant score, which indicates pain and function. Secondary outcomes include the Disability of the Arm and Shoulder (DASH) score, Visual Analogue Scale (VAS) for pain, radiographic healing, health-related quality of life (Short-form-36, EuroQol-5D) and healthcare consumption. Cost-effectiveness ratios wi

Update to a randomized controlled trial of lutetium-177-PSMA in Oligo-metastatic hormone-sensitive prostate cancer:the BULLSEYE trial

Background: The BULLSEYE trial is a multicenter, open-label, randomized controlled trial to test the hypothesis if 177Lu-PSMA is an effective treatment in oligometastatic hormone-sensitive prostate cancer (oHSPC) to prolong the progression-free survival (PFS) and postpone the need for androgen deprivation therapy (ADT). The original study protocol was published in 2020. Here, we report amendments that have been made to the study protocol since the commencement of the trial. Changes in methods and materials: Two important changes were made to the original protocol: (1) the study will now use 177Lu-PSMA-617 instead of 177Lu-PSMA-I&T and (2) responding patients with residual disease on 18F-PSMA PET after the first two cycles are eligible to receive additional two cycles of 7.4 GBq 177Lu-PSMA in weeks 12 and 18, summing up to a maximum of 4 cycles if indicated. Therefore, patients receiving 177Lu-PSMA-617 will also receive an interim 18F-PSMA PET scan in week 4 after cycle 2. The title of this study was modified to; “Lutetium-177-PSMA in Oligo-metastatic Hormone Sensitive Prostate Cancer” and is now partly supported by Advanced Accelerator Applications, a Novartis Company. Conclusions: We present an update of the original study protocol prior to the completion of the study. Treatment arm patients that were included and received 177Lu-PSMA-I&T under the previous protocol will be replaced. Trial registration: ClinicalTrials.gov NCT04443062. First posted: June 23, 2020

Small Stem Total Hip Arthroplasty in Hypoplasia of the Femur

Total hip arthroplasty in hypoplastic femurs is technically difficult and the incidence of complications and aseptic loosening is relatively high. Cemented, uncemented, off-the-shelf, and custom-made stems all have been advocated in these cases. From 1978 to 1997, we performed 86 total hip arthroplasties in 77 patients with a hypoplastic femur using a cemented, off-the-shelf, small, curved, cobalt-chromium stem. We hypothesized results equaled those of the identical but larger-sized stems in normal-sized femora which were used as comparisons. Clinical and radiographic evaluations were performed. Minimum followup was 4.2 years (mean, 12 years; range, 4.2–20.3 years); mean Harris hip score was 88, and mean hip flexion was 104°. Six stems were revised: four because of aseptic loosening, one after a femoral fracture, and one because of malpositioning. Complications included one perforation and one fracture of the femur, one fracture, one nonunion of the greater trochanter, and one deep infection. Implant survivorship for all hips at 15 years with aseptic revision of the stem as the end point was 90% (confidence interval, 82–99) which equaled results of the larger stems. The small off-the-shelf cemented Weber stem has a high long-term survival and a low complication rate. Survival compares favorably with other small-sized total hip systems

Obesity in total hip arthroplasty—does it really matter?: A meta-analysis

Discussion persists as to whether obesity negatively influences the outcome of hip arthroplasty. We performed a meta-analysis with the primary research question of whether obesity has a negative effect on short- and long-term outcome of total hip arthroplasty. We searched the literature and included studies comparing the outcome of hip arthroplasty in different weight groups. The methodology of the studies included was scored according to the Cochrane guidelines. We extracted and pooled the data. For continuous data, we calculated a weighted mean difference and for dichotomous variables we calculated a weighted odds ratio (OR). Heterogeneity was calculated using I(2) statistics. 15 studies were eligible for data extraction. In obese patients, dislocation of the hip (OR = 0.54, 95% CI: 0.38-0.75) (10 studies, n = 8,634), aseptic loosening (OR = 0.64, CI: 0.43-0.96) (6 studies, n = 5,137), infection (OR = 0.3, CI: 0.19-0.49) (10 studies, n = 7,500), and venous thromboembolism (OR = 0.56, CI: 0.32-0.98) (7 studies, n = 3,716) occurred more often. Concerning septic loosening and intraoperative fractures, no statistically significant differences were found, possibly due to low power. Subjective outcome measurements did not allow pooling because of high heterogeneity (I(2) = 68%). Obesity appears to have a negative influence on the outcome of total hip replacemen

Factors Associated with Revision Surgery after Internal Fixation of Hip Fractures

Background: Femoral neck fractures are associated with high rates of revision surgery after management with internal fixation. Using data from the Fixation using Alternative Implants for the Treatment of Hip fractures (FAITH) trial evaluating methods of internal fixation in patients with femoral neck fractures, we investigated associations between baseline and surgical factors and the need for revision surgery to promote healing, relieve pain, treat infection or improve function over 24 months postsurgery. Additionally, we investigated factors associated with (1) hardware removal and (2) implant exchange from cancellous screws (CS) or sliding hip screw (SHS) to total hip arthroplasty, hemiarthroplasty, or another internal fixation device. Methods: We identified 15 potential factors a priori that may be associated with revision surgery, 7 with hardware removal, and 14 with implant exchange. We used multivariable Cox proportional hazards analyses in our investigation. Results: Factors associated with increased risk of revision surgery included: female sex, [hazard ratio (HR) 1.79, 95% confidence interval (CI) 1.25-2.50; P = 0.001], higher body mass index (fo

Polyethylene wear particles do not induce inflammation or gelatinase (MMP-2 and MMP-9) activity in fibrous tissue interfaces of loosening total hip arthroplasties

In vitro and in vivo studies have suggested that polyethylene wear particles are the main cause for osteolysis in prosthetic loosening. Elevated amounts of proteases including gelatinases (or matrix metalloproteinases MMP-2 and MMP-9) have been found in fibrous tissue interfaces of loosened total hip arthroplasties suggesting that proteolysis plays a role in osteolysis. The presence of proteases does not mean that they are active, because activity of proteases is highly regulated at the post-translational level. We investigated whether the activity of two major proteases that are active extracellularly and have been associated with loosening, MMP-2 and MMP-9, is involved in loosening of non-cemented hip implants with polyethylene acetabular components. Eight interface tissues retrieved during revision were studied with light and electron microscopy and by in situ zymography to localize MMP-2 and MMP-9 activity in combination with immunohistochemistry to localize MMP-2 and MMP-9 proteins. All interface tissues contained large amounts of polyethylene wear particles, either in large accumulations or dispersed in the extracellular matrix or intracellularly in fibroblasts. Particles were not encountered in association with MMP-2 or MMP-9 activity or leukocytes. Inflammation was never found. MMP-9 activity was restricted to macrophages and MMP-2 activity was restricted to microvascular endothelial cells mainly outside areas where particles were present. Our data indicate that wear particles do not induce activation of leukocytes or MMP-2 or MMP-9 activity. Therefore, aseptic loosening may not be particle induced but initiated by other mechanisms such as mechanical stress. (C) 2010 Elsevier GmbH. All rights reserve

Early complications after high tibial osteotomy: a comparison of two techniques

This prospective cohort study compared opening wedge high tibial osteotomy with use of the Puddu plate and the Vitoss synthetic cancellous bone versus closing wedge high tibial osteotomy with use of the AO/ASIF L-plate, focusing on complications (nonunions, infections, loss of correction, reoperations) and patient satisfaction (visual linear analog scale). During a 10-month period, we performed high tibial osteotomy for 40 patients experiencing medial knee osteoarthritis and a varus deformity. The average follow-up was 11 months. The complication rate in patients treated with the opening wedge technique was significantly higher regarding tibial nonunion, loss of correction, and material failure. Patients in the closing wedge group were more satisfied with the postoperative result. This study found that the Puddu plate, despite 6 weeks of non-weight bearing facilitating the osseous consolidation with Vitoss cement, was not able to maintain the correction during the time required for bone healin

Ceramic-on-ceramic vs ceramic-on-polyethylene, a comparative study with 10-year follow-up

BACKGROUND In press-fit total hip arthroplasty (THA) ceramic-on-ceramic (CoC) bearings are a potential for overcoming the wear that is seen in ceramic-on-polyethylene (CoPE) bearings, and can lead to wear-induced osteolysis, resulting in loosening of the implant. However, CoC bearings show disadvantages as well, such as squeaking sounds and being more fragile, which can cause ceramic head or liner fracture. Because comparative long-term studies are limited, the objective of this study was to determine the long-term difference in wear, identify potential predictive factors for wear, investigate radiological findings such as osteolysis, and evaluate clinical functioning and complications between these bearings. AIM To determine 10-year differences in wear, predictive factors for wear, and investigate radiological findings and clinical functioning between CoC and CoPE. METHODS This observational prospective single-center cohort study with a 10-year followup includes a documented series of elective THAs. Primary outcome was wear measured by anteroposterior (AP) radiographs. Secondary outcomes were potential predictive factors for wear, complications during follow-up, Harris hip score (HHS), and radiological findings such as presence of radiolucency, osteolysis, atrophy, and hypertrophy around the cup. Due to the absence of wear in the CoC group, stratified analysis to identify risk factors for wear was only performed in the CoPE group by use of univariate linear regression analysis. HHS was expressed as a change from baseline and the association with bearing type was assessed by use of multivariate linear regression analysis, adjusted for potential confounders. RESULTS A total of 17 CoPE (63.0%) and 25 CoC (73.5%) cases were available for follow-up and showed a linear wear of respectively 0.130 mm/year (range 0.010; 0.350) and 0.000 mm/year (range 0.000; 0.005), which was significant (P < 0.001) between both groups. Wear always occurred in the cranial direction. Cup inclination was the only predictive factor for polyethylene (PE) wear. No dislocations, ceramic head, or liner fractures were seen. The HHS showed a mean change from baseline of 37.1 points (SD 18.5) in the CoPE group and 43.9 (SD 17.0) in the CoC group. This crude difference of 6.8 (range -5.2; 18.7) in favor of the CoC group was not significant (P = 0.26) and was not significant when adjusted for age, gender, and diagnosis either (P = 0.99). No significant differences in complications and radiological findings were seen between groups. CONCLUSION CoC bearing shows lower wear rates compared to CoPE at 10-year follow-up with cup inclination as a predictive factor for wear and no differences in complications, HHS, and radiological findings

Does hydroxyapatite coating enhance ingrowth and improve longevity of a Zweymuller type stem? A double-blinded randomised RSA trial

Introduction: An ongoing discussion is whether using a hydroxyapatite coating enhances the ingrowth and longevity of a femoral stem in total hip arthroplasty. The best way to predict speed of ingrowth and long-term outcome is by evaluating micromotion by radiostereometric analysis. To study the effect of hydroxyapatite (HA) coating on the migration of the SL-PLUS hip stem, we performed a prospective double blind randomised controlled trial comparing the early migration of the hydroxyapatite (HA)-coated SL-PLUS stem compared to the Standard (non-coated) SL-PLUS stem. Patients and methods: 51 patients were randomly assigned to receive either an uncoated or a HA-coated femoral component during total hip replacement. RSA images were obtained direct postoperatively and at 6 weeks, 12 weeks, 6 months, 12 months and 24 months. HOOS scores were obtained preoperative and at final follow-up. Results: RSA evaluation demonstrated significant migration up to 3 months postoperatively in both groups. After initial setting no significant migration was observed. There was no significant difference in migration between the HA-coated group and the uncoated group. Both Harris Hip Score (HHS) and HOOS domain scores (pain and ADL) significantly improved compared to baseline at 24 months after surgery in both treatment groups (p<0.001 for all comparisons). Improvement did not differ significantly between the 2 groups. Conclusions: At 2 years follow-up, the HA-coated and uncoated Zweymuller type, distal fitting stem do not show different migration patterns