The importance of laminar airflow systems in operating rooms as protection from surgical site infections has been questioned. The aim of our study was to explore the differences in air contamination rates between displacement ventilation and laminar airflow systems during planned and acute orthopedic implant surgery. A second aim was to compare the influence of the number of people present, the reasons for traffic flow, and the door-opening rates between the 2 systems.
Active air sampling and observations were made during 63 orthopedic implant operations.
The laminar airflow system resulted in a reduction of 89% in colony forming units in comparison with the displacement system (P
Lundberg Laboratory of Orthopaedic Research, Department of Orthopaedics, Göteborg University, Sahlgrenska University Hospital, Gröna Stråket 12, 413 45 Göteborg, Sweden. email@example.com
Achilles tendinopathy is a common overuse injury, especially among athletes involved in activities that include running and jumping. Often an initial period of rest from the pain-provoking activity is recommended.
To prospectively evaluate if continued running and jumping during treatment with an Achilles tendon-loading strengthening program has an effect on the outcome.
Randomized clinical control trial; Level of evidence, 1.
Thirty-eight patients with Achilles tendinopathy were randomly allocated to 2 different treatment groups. The exercise training group (n = 19) was allowed, with the use of a pain-monitoring model, to continue Achilles tendon-loading activity, such as running and jumping, whereas the active rest group (n = 19) had to stop such activities during the first 6 weeks. All patients were rehabilitated according to an identical rehabilitation program. The primary outcome measures were the Swedish version of the Victorian Institute of Sports Assessment-Achilles questionnaire (VISA-A-S) and the pain level during tendon-loading activity.
No significant differences in the rate of improvements were found between the groups. Both groups showed, however, significant (P
This multicentre dose-finding study compared TAK-442, an oral factor Xa inhibitor, with enoxaparin for thromboprophylaxis after knee arthroplasty. In this parallel group study, patients were randomised to oral TAK-442 (40 or 80 mg once-daily [QD] or 10, 20, 40, or 80 mg twice-daily [BID] started 6-8 hours postoperatively), which was blinded as to dose, or to open-label subcutaneous enoxaparin (30 mg BID starting 12-24 hours postoperatively) for 10 days. Treatments were continued until bilateral venography was performed (maximum of 14 days). The primary efficacy endpoint was the composite of any deep-vein thrombosis, non-fatal pulmonary embolism or all-cause mortality, while the primary safety endpoint was major bleeding. Of 1,038 patients randomised who received at least one dose of study drug, 949 completed the study and 730 (76.9%) were evaluable for the primary efficacy analysis. Recruitment into the 10 and 20 mg BID dose groups was stopped early because the incidences of the primary efficacy endpoint were significantly higher than that with enoxaparin. The primary efficacy endpoint occurred in 22.0% of patients given enoxaparin and in 39.0%, 38.4%, 23.5%, 21.4%, 26.8%, and 14.3% of those receiving TAK-442 10 mg BID, 20 mg BID, 40 mg QD, 40 mg BID, 80 mg QD, and 80 mg BID, respectively. The incidences of major and clinically relevant non-major bleeding with TAK-442 were not dose-dependent or different from that with enoxaparin. All TAK-442 doses except 10 and 20 mg BID displayed similar efficacy and safety profiles to enoxaparin.
A dose-ranging study of the oral direct thrombin inhibitor, ximelagatran, and its subcutaneous form, melagatran, compared with dalteparin in the prophylaxis of thromboembolism after hip or knee replacement: METHRO I. MElagatran for THRombin inhibition in Orthopaedic surgery.
The novel, oral direct thrombin inhibitor, ximelagatran (formerly H 376/95), represents an advance in antithrombotic therapy through its oral availability. After oral administration, ximelagatran is converted to its active form, melagatran. Melagatran can also be administered subcutaneously (s.c.). The results from the first clinical study with ximelagatran are reported. In this randomized, parallel-group, controlled study, 103 patients scheduled for elective total hip or total knee replacement received s.c. melagatran (1, 2 or 4 mg bid) for 2 days commencing immediately before surgery, followed by oral ximelagatran (6, 12 or 24 mg bid) for 6-9 days. Another 33 patients received dalteparin 5000 IU s.c. once daily, started the evening before surgery, for 8-11 days. At bilateral venography, deep vein thrombosis was found in 20.5% (16/78) of patients who had received s.c. melagatran and oral ximelagatran and in 18.5% (5/27) of patients in the dalteparin group. The study did not evaluate a dose-response for efficacy, and no differences between the three dose levels of melagatran and ximelagatran were shown. No pulmonary embolism was diagnosed during treatment. Total bleeding in the s.c. melagatran plus oral ximelagatran groups showed no dose-response and was similar to that seen in the dalteparin group. The pharmacokinetic properties of melagatran in the surgery patients were consistent with those observed for healthy subjects, and the APTT ratio, which increased non-linearly with plasma melagatran concentration, showed a consistent concentration-effect relationship during the treatment period. Ximelagatran and melagatran were well tolerated. In conclusion, ximelagatran and its active form melagatran appear to be promising agents for the prevention of venous thromboembolism following orthopaedic surgery.
Edoxaban is a new oral direct factor Xa inhibitor. The purpose of this study was to evaluate the efficacy and safety of different doses of edoxaban for the prevention of venous thromboembolism (VTE) in patients undergoing elective total hip replacement. A total of 903 patients were randomised to oral edoxaban 15, 30, 60 or 90 mg once daily or subcutaneous dalteparin once daily (initial dose 2,500 IU, subsequent doses 5,000 IU). Both drugs were begun 6-8 hours postoperatively and continued for 7-10 days, when bilateral venography was performed. The primary efficacy endpoint was the incidence of total VTE, which included proximal and/or distal deep-vein thrombosis (DVT) by venography or symptomatic, objectively confirmed DVT or pulmonary embolism during the treatment period. The primary safety outcome was the incidence of the composite of major and clinically relevant non-major bleeding. All venograms and bleeding events were reviewed by a central independent adjudication committee blinded as to treatment allocation. Of the 903 patients randomised, 776 were evaluable for the primary efficacy analysis. The incidences of VTE were 28.2%, 21.2%, 15.2%, and 10.6% in patients receiving edoxaban 15, 30, 60 and 90 mg, respectively, compared with 43.8% in the dalteparin group (p
Ximelagatran, an oral direct thrombin inhibitor, is rapidly bioconverted to melagatran, its active form. The objective of this population analysis was to characterise the pharmacokinetics of melagatran and its effect on activated partial thromboplastin time (APTT), an ex vivo measure of coagulation time, in orthopaedic surgery patients sequentially receiving subcutaneous melagatran and oral ximelagatran as prophylaxis for venous thromboembolism. To support the design of a pivotal dose-finding study, the impact of individualised dosage based on bodyweight and calculated creatinine clearance was examined.
Pooled data obtained in three small dose-guiding studies were analysed. The patients received twice-daily administration, with either subcutaneous melagatran alone or a sequential regimen of subcutaneous melagatran followed by oral ximelagatran, for 8-11 days starting just before initiation of surgery. Nonlinear mixed-effects modelling was used to evaluate rich data of melagatran pharmacokinetics (3326 observations) and the pharmacodynamic effect on APTT (2319 observations) in samples from 216 patients collected in the three dose-guiding trials. The pharmacokinetic and pharmacodynamic models were validated using sparse data collected in a subgroup of 319 patients enrolled in the pivotal dose-finding trial. The impact of individualised dosage on pharmacokinetic and pharmacodynamic variability was evaluated by simulations of the pharmacokinetic-pharmacodynamic model.
The pharmacokinetics of melagatran were well described by a one-compartment model with first-order absorption after both subcutaneous melagatran and oral ximelagatran. Melagatran clearance was correlated with renal function, assessed as calculated creatinine clearance. The median population clearance (creatinine clearance 70 mL/min) was 5.3 and 22.9 L/h for the subcutaneous and oral formulations, respectively. The bioavailability of melagatran after oral ximelagatran relative to subcutaneous melagatran was 23%. The volume of distribution was influenced by bodyweight. For a patient with a bodyweight of 75kg, the median population estimates were 15.5 and 159L for the subcutaneous and oral formulations, respectively. The relationship between APTT and melagatran plasma concentration was well described by a power function, with a steeper slope during and early after surgery but no influence by any covariates. Simulations demonstrated that individualised dosage based on creatinine clearance or bodyweight had no clinically relevant impact on the variability in melagatran pharmacokinetics or on the effect on APTT.
The relatively low impact of individualised dosage on the pharmacokinetic and pharmacodynamic variability of melagatran supported the use of a fixed-dose regimen in the studied population of orthopaedic surgery patients, including those with mild to moderate renal impairment.
CONTEXT: The Knee Self-Efficacy Scale (K-SES) has good reliability, validity, and responsiveness for patients' perceived knee-function self-efficacy during rehabilitation after an anterior cruciate ligament (ACL) injury. Preoperative knee-function self-efficacy has also been shown to have a predictive ability in terms of outcome 1 y after ACL reconstruction. OBJECTIVE: To evaluate a new clinical rehabilitation model containing strategies to enhance knee-function self-efficacy. DESIGN: A randomized, controlled study. SETTING: Rehabilitation clinic and laboratory. PATIENTS: 40 patients with ACL injuries. INTERVENTION: All patients followed a standardized rehabilitation protocol. Patients in the experimental group were treated by 1 of 3 physiotherapists who had received specific training in a clinical rehabilitation model. These physiotherapists were also given their patients' self-efficacy scores after the initial and 4-, 6-, and 12-mo follow-ups, whereas the 5 physiotherapists treating the patients in the control group were not given their patients' self-efficacy scores. MAIN OUTCOME MEASURES: The K-SES, the Tegner Activity Scale, the Physical Activity Scale, the Knee Injury and Osteoarthritis Outcome Score, and the Multidimensional Health Locus of Control. RESULTS: Twenty-four patients (12 in each group) completed all follow-ups. Current knee-function self-efficacy, knee symptoms in sports, and knee quality of life improved significantly (P = .05) in both groups during rehabilitation. Both groups had a significantly (P = .05) lower physical activity level at 12 mo than preinjury. No significant differences were found between groups. CONCLUSION: In this study there was no evidence that the clinical rehabilitation model with strategies to enhance self-efficacy resulted in a better outcome than the rehabilitation protocol used for the control group.
An important objective of anterior cruciate ligament (ACL) registries is to detect and report early graft failure and revision surgery after ACL reconstruction.
To investigate surgical variables and identify predictors of revision surgery after ACL reconstruction.
Prospective cohort study; Level of evidence, 2.
This prospective cohort study was based on data from the Swedish National Knee Ligament Register during the years 2005 through 2011. Eight surgical variables were investigated: graft selection, graft width, single-bundle or double-bundle techniques, femoral graft fixation, tibial graft fixation, injury-to-surgery interval, injuries to menisci, and injuries to cartilage. The primary endpoint was the 2-year incidence of revision surgery. Relative risks (RRs) and 95% confidence intervals (CIs) were calculated and adjusted for confounders by use of multivariate statistics.
A total of 13,102 patients were included (5541 women [42%] and 7561 men [58%]; P
Understanding the protective potential of operating room (OR) ventilation under different conditions is crucial to optimizing the surgical environment. This study investigated the air quality, expressed as colony-forming units (CFU)/m(3), during orthopedic trauma surgery in a displacement-ventilated OR; explored how traffic flow and the number of persons present in the OR affects the air contamination rate in the vicinity of surgical wounds; and identified reasons for door openings in the OR.
Data collection, consisting of active air sampling and observations, was performed during 30 orthopedic procedures.
In 52 of the 91 air samples collected (57%), the CFU/m(3) values exceeded the recommended level of