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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
7%
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
6%
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
5%
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: 124 patients undergoing total hip arthroplasty for osteonecrosis or femoral head or hip osteoarthritis were randomized to receive either a calcium alginate dressing system (n=62) or a traditional gauze (n=62).Outcomes of interest included the number of dressing changes, length of stay, Stony Brook Scar Evaluation Scale (SBSES), ASEPSIS wound score, pain on a Visual Analog Scale (VAS), Harris Hip Score (HHS), patient satisfaction, and incidence of subcutaneous hematoma.The calcium alginate dressing system showed significantly better results in all outcomes, compared to the traditional gauze group except ASEPSIS scores, VAS pain, and HHS. Two patients in... Read More »
Level 1 RCT
3%
Synopsis: 61 patients with idiopathic frozen shoulder were randomized to receive either watchful waiting (WW; n=31) or physical therapy (PT; n=30).The primary outcome of interest was the American Shoulder and Elbow Surgeons score (ASES) questionnaire.Secondary outcomes of interest included pain scores on a Visual Analog Scale (VAS), the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, direct patient healthcare costs, and patient value (defined as the 12-month ASES score divided by healthcare costs).Outcomes were assessed at baseline, 6 weeks, and 3, 6, and 12 months.Both cohorts improved at each time point for all primary outcomes, but no significant differences in patient-reported outcomes (PROMs) between treatment modalities were found at any time point.WW patients incurred significantly lower direct costs than PT patients, with a normalized mean difference was of 1,635.67.Patients in the WW group also achieved greater patient value, with a normalized mean difference of -146.97. Both of these... Read More »
Conference Report
3%
Synopsis: Ten randomized controlled trials including 3,968 elderly hip fracture patients were included in this systematic review and meta-analysis comparing neuraxial anesthesia and general anesthesia.The outcomes of interest included post-operative delirium incidence, mini-mental state examination, neuropsychological tests, post-operative pain, length of stay and discharge location, and mortality (in-hospital, 30-day, 90-day).The results of the meta-analysis found no differences between general anesthesia and neuraxial anesthesia in all outcomes.Sub-group analyses by the inclusion of patients with pre-existing delirium yielded similar results for post-operative delirium incidence and length of stay. The results of... Read More »
Level 1 Meta Analysis
3%
Synopsis: One hundred and sixty-four patients with severe knee osteoarthritis scheduled for a total knee arthroplasty were randomized to receive pre-operative cryoneurolysis plus standard of care pain management (n=62) or standard of care pain management only (n=62).The primary endpoint was cumulative opioid consumption.Secondary endpoints included improvement in Numeric Rating Scale (NRS) pain scores and functional outcomes (Knee Injury and Osteoarthritis Outcomes Score [KOOS]; timed up and go test; range of motion).Results revealed significantly less opioid consumption in the cryoneurolysis group compared to the control group in the per-protocol analysis, however, no differences in opioid consumption were observed in the intent-to-treat analysis. Improvements from baseline... Read More »
Level 1 RCT
2%
Synopsis: This abstract presents the 5-year follow-up results of a previously published prospective randomized controlled trial.30 patients with an International Cartilage Repair Society (ICRS) grade 3 to 4 chondral defect in the knee were randomized to receive costal chondrocyte–derived pellet-type autologous chondrocyte implantation (CCP-ACI; n=20) or microfracture (MFx; n=10).25 of these patients were followed-up at 5 years.Outcomes of interest included the Lysholm score, International Knee Documentation Committee (IKDC) score, Knee Injury and Osteoarthritis Outcome Score (KOOS), Visual Analog Scale (VAS) pain score, Magnetic resonance Observation of Cartilage Repair Tissue (MOCART) score, and treatment failure, all assessed at 5 years.In the CCP-ACI group, MOCART, Lysholm and KOOS scores improved significantly from baseline compared the the MFx group. One treatment failure... Read More »
Conference Report
2%
Synopsis: One hundred and seventy-seven patients with chronic knee pain from knee osteoarthritis (OA) were randomized to receive cooled radiofrequency ablation (CRFA; n=89) of the genicular nerves or a single intra-articular hyaluronic acid (HA; n=88).The primary outcome of interest was the number of patients who reported a =>50% reduction in pain scores from baseline after 6 months.Additional outcomes of interest included pain scores on a Numeric Rating Scale (NRS), the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, WOMAC pain scores, WOMAC physical function scores, WOMAC stiffness scores, patient perception of treatment effect as reflected by the Global Perceived Effect (GPE) score, the Euro-Qol-5 Dimensions-5 Level (EQ-5D-5L) quality of life questionnaire, and the incidence of treatment-related and non-treatment related adverse events.Outcomes were assessed at 1, 3, and 6 months post-treatment.Results revealed a statistically significantly higher proportion of patients in the CRFA group who reported =>50% improvement in pain scores from baseline compared to the HA group (71% vs.38%, p<0.0001).NRS pain scores, WOMAC total scores, WOMAC pain scores WOMAC physical function scores, GPE scores, and EQ-5D-5L scores were statistically significantly in favour of the CRFA group at all time points compared to the HA group (p<0.05 for all).WOMAC stiffness scores were statistically significantly in favour of the CRFA group at 3 months (p=0.0022) and 6 months (p<0.0001) post-treatment. The incidence of... Read More »
Author verified Level 1 RCT