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Synopsis: The PREPARE Trial was a cluster-randomized, crossover trial part of the PREP-IT program, which compared alcohol-based anti-septic solutions of iodine povacrylex vs.chlorhexidine gluconate in operative fracture patients.THE PREPARE Trial included a total of 8485 patients who underwent fracture fixation: 1700 patients with open limb fractures and 6785 with closed lower-limb or pelvic fractures.Randomization occurred at the hospital level.The primary outcome of interest was the incidence of surgical-site infection, which included superficial incisional infections within 30 days and deep incisional or organ-space infections within 60 days post-surgery.Secondary outcomes included unplanned fracture-related reoperations and serious adverse events.The iodone povacrylex group (77/3205; 2.4%) had a lower incidence of surgical site infections compared to chlorhexidine (108/3272; 3.3%) in closed-fracture patients [OR, 0.74; 95% CI, 0.55 to 1.00; p=0.049].The rates were similar in open-fracture patients between the iodine (54/3272; 6.5%) and chlorhexidine (60/3272; 7.3%) [OR, 0.86; 95% CI, 0.58 to 1.27; p=0.45].In the closed-fracture group, 5.5% in the iodine group and 5.9% in the chlorhexidine group underwent unplanned reoperations [OR, 0.96; 95% CI, 0.77 to 1.20].In the open-fracture group, the figures were 16.1% for iodine and 14.5% for chlorhexidine [OR, 1.16; 95% CI, 0.87 to 1.54]. The results of... Read More »
Level 1 RCT
6%
Synopsis: 12,211 patients from 21 trauma centers in the United States and Canada were included in this non-inferiority randomized trial comparing aspirin (n=6,101) and low molecular-weight heparin (n=6110).The primary outcome of interest was death by any cause at 90 days.Secondary outcomes of interest included the risk of thromboembolic events (pulmonary embolism; deep-vein thrombosis), cause-specific death, bleeding & wound complications, and the rate of infection.Aspirin was found to be non-inferior to low molecular-weight heparin with respect to the primary outcome of death by any cause. No differences in... Read More »
Level 1 RCT
4%
Synopsis: Sixteen randomized controlled studies containing a total of 3084 patients were included in this meta-analysis including patients with displaced femoral neck fractures undergoing total hip arthroplasty (THA; n=1521) or hemiarthroplasty (HA; n=1563).Pooled outcomes of interest included the following: incidence of revision, functional outcomes (evaluated using the Harris hip score), incidence of mortality, health-related quality of life (QoL; evaluated using the EuroQol-5 Dimensions [EQ-5D] Index), incidence of periprosthetic fracture, incidence of dislocation, and operative time.Subgroup analyses was conducted by level of risk of bias.Revision surgery, incidence of mortality and dislocation were all analyzed at 12-60 months follow-up, where as the rest of the outcomes were assessed at 12-36 months.Pooled results revealed that health-related quality of life, evaluated using EQ-5D Index, was statistically significantly in favour of the THA group vs.HA (p=0.001).However, pooled operative time was statistically significantly shorter in the HA group vs THA (p=0.001). All other pooled... Read More »
Author verified Level 1 Meta Analysis
4%
Synopsis: Sixty patients undergoing unilateral primary TKA were randomized to receive surgery with a handheld semi-active robot (n=32) or a control group without robotic assistance (n=28).The primary outcomes of interest were postoperative mechanical alignment, joint line deviation and prosthesis rotation.The robotic group demonstrated improved overall mechanical alignment and reduced joint line deviation compared to the control group. No differences in... Read More »
Level 1 RCT
4%
Synopsis: 170/321 (53%) patients with distal tibial fractures from the FixDT trial consented to participate in the 5-year follow-up study comparing intramedullary nailing (n=83) and locking plate fixation (n=87).The primary outcome of interest was the Disability Rating Index (DRI).The secondary outcomes included health-related quality of life, measured with the EQ-5D-3L and EQ-VAS scales, as well as the incidence of complications.Follow-up was conducted up to 5 years post-operation.No significant differences between the two groups were observed in all outcomes, suggesting comparable efficacy and safety between the two treatment methods over 5 years. However, the significant... Read More »
Author verified Level 1 RCT
4%
Synopsis: 16 randomized controlled trials (1813 patients) that compared unipolar hemiarthroplasty against bipolar hemiarthroplasty in patients with displaced femoral neck fractures were included in this systematic review and meta-analysis.Outcomes of interest included the incidence of acetabular erosion, Harris Hip Score (HHS), Normalized Pain Scale (NPS), range of motion (ROM), incidence of mortality, dislocation, reoperation, and infection, 6-minute walk-test, and quality of life measured using the EuroQol 5D (EQ-5D) questionnaire.Acetabular erosion at 6 and 12 months, HHS scores at 12 and 24 months, postoperative pain at 12, 24, and 48 months, and the EQ-5D scores at 48 months all favored the bipolar group compared to the unipolar group. All other outcomes... Read More »
Level 1 Meta Analysis
2%
Synopsis: 186 patients with a severe lateral ankle sprain (type III) were randomized to treatment to 3 weeks of rigid immobilization with a walking boot followed by 3 weeks of immobilization with a functional brace, or to a functional brace for 6 weeks.The purpose was to compare these two conservative treatment methods for outcomes in pain, function, and ankle stability up to 12 weeks after the injury.AOFAS scores were better for the first 6 weeks in patients receiving the functional brace, and pain and comfort outcomes also benefited within the first few weeks from using a functional brace. By 12 weeks,... Read More »
Author verified Level 2 RCT
2%
Synopsis: 814 patients scheduled for surgical fixation of open or closed fractures of the ankle or foot were randomized to 14-day thromboprophylaxis with subcutaneous low molecular weight heparin, or to placebo with subcutaneous saline.The purpose of this study was to determine if routine low molecular weight heparin significantly reduced the incidence of venous thromboembolic (VTE) complications.Results demonstrated an overall low incidence of VTE in both groups, with no significant difference between groups.All VTE complications were cases of asymptomatic deep vein thrombosis; no cases of pulmonary embolism were documented. It should be... Read More »
Level 2 RCT
2%
Synopsis: 1000 patients with an AO type A1-3 trochanteric fracture were randomized to fixation with either an intramedullary nail or a sliding hip screw.Patients were assessed for postoperative pain, mobility, and the incidence of complications over 1-year follow-up, as well as surgical outcomes during the perioperative stay.Subgroup analyses were performed for outcomes based on fracture type.No significant differences between IMN and SHS devices were found in either primary analyses or subgroup analyses when compared for the rates of implant cutout, device failure, nonunion, superficial infection, and deep infection.The only significant difference observed for clinical measures was lower pain among patients with an AO type 3 fracture treated with an IMN versus a SHS. No significant difference... Read More »
RCT
2%
Synopsis: Fifty-two patients with distal fibula fractures scheduled to undergo an open reduction and internal fixation surgery were randomized to receive a non-locking, one-third semitubular plate with delayed weight-bearing or a polyaxial locking plate plus an early weight-bearing protocol.A total of 45 patients completed follow-up including 25 patients in the semitubular plate group and 20 patients in the polyaxial locking plate group.Primary outcomes of interest included ankle function which was assessed by the the Olerud and Molander ankle score (OMAS), Foot and Ankle outcome score (FAOS), and Karlsson and Peterson Scoring System (KPSS).The secondary outcome of interest included the incidence of complications.Additional outcomes of interest included pain measured on the Visual Analogue Scale (VAS) and range of motion (ROM) (dorsiflexion and flexion).All outcomes were evaluated at 6 weeks and at 3, 6, and 12 months post-surgery, except for ROM which was evaluated at 6 weeks,12 weeks, 6 months, and 12 months.Results of this study demonstrated that OMAS and FAOS scores were statistically significantly improved at both 6 and 12 weeks follow-up in the polyaxial locking plate group vs non-locking plate (p<0.05 for all).Furthermore, KPSS scores were also statistically significantly improved in the polyaxial plate compared to the non-locking plate at 6 weeks (p<0.04) and 6 months (p<0.03) follow-up, but not at the other timepoints.For the incidence of minor complications, 4 cases and 2 cases were observed in the non-locking plate and polyaxial plate groups, respectively.For the incidence of major complications, 2 cases and 1 case were observed in the non-locking plate and polyaxial locking plate groups, respectively. Moreover, no statistical... Read More »
Level 1 RCT