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PubMed2006

Hyperbaric oxygen therapy in orthopedic conditions: an evaluation of safety.

BACKGROUND: Because of the documented cellular and biochemical benefits of hyperbaric oxygen (HBO), HBO therapy is applied now with increasing frequency to various orthopedic conditions. Many traumatologists and orthopedic surgeons might refer their patients for adjuvant HBO therapy. However, the potential risks and risk-benefit ratio have often been underemphasized in therapeutic trials. METHODS: From October 2002 to September 2004, 240 patients with a total of 4,638 treatments received HBO therapy at the hyperbaric medicine center of our institution on an identical treatment protocol. HBO therapy patient treatment logs were reviewed to analyze the incidence of complications during HBO treatment. RESULTS: The overall incidence of complications was 1.83%. Over 94% of treatment complications were mild to moderate and designated as minor complications; fewer than 6% were severe or life threatening and designated as major complications. The incidence of major complications (central nervous system [CNS] oxygen toxicity in this series) was 0.109%. There was no mortality. Two patients with unusual presentation of CNS oxygen toxicity were observed during the study period. CONCLUSIONS: HBO therapy in orthopedic conditions is considered as a safe treatment because of a very low complication rate; however, analysis of patients with CNS oxygen toxicity revealed its unpredictability and inevitability. Although it is common sense that patients who develop a seizure in the hospital need help from the medical staff, it cannot be done in a monoplace hyperbaric chamber because of pressure unequalization. Therefore, a multiplace chamber equipped with an antechamber for medical contingency is possibly the better facility in consideration of safety.

Adult↗
PubMed1984

Genetic study of an orthopedic referral center.

A prospective study of patients seen at the Shriners Hospital for Crippled Children, Houston Unit, showed that there is a substantial genetic component to orthopedic disorders. A mean of 25% of new patients and 46% of specialty clinic patients had orthopedic diseases of genetic etiology. The respective single gene component was 7.2% and 12.9%. Rare disorders were observed, and some of these are discussed. The results indicate that genetic counseling should be an integral part of orthopedic care.

Adolescent↗
PubMed1999

CRIGOS: a compact robot for image-guided orthopedic surgery.

The CRIGOS (compact robot for image-guided orthopedic surgery) project was set up for the development of a compact surgical robot system for image-guided orthopedic surgery based on user requirements. The modular system comprises a compact parallel robot and a software system for planning of the surgical interventions and for supervision of the robotic device. Because it is not sufficient to consider only technical aspects in order to improve in clinical routine the therapeutic outcome of conventional interventions, a user-centered and task-oriented design process has been developed which also takes human factors into account. The design process for the CRIGOS system was started from requirement analysis of various orthopedic interventions using information gathered from literature, questionnaires, and workshops with domain experts. This resulted in identification of conventional interventions for which the robotic system would improve the medical and procedural quality. A system design concept has been elaborated which includes definitions of components, functionalities, and interfaces. Approaches to the acquisition of calibrated X-rays will be presented in the paper together with design and evaluation of a first human-computer interface. Finally, the first labtype parallel robot based on low-cost standard components is presented together with the first evaluation results concerning positioning accuracy.

Humans↗
PubMed1995

A simple model for predicting postoperative delirium in older patients undergoing elective orthopedic surgery.

OBJECTIVE: To determine the incidence, and severity of postoperative delirium (POD) in older patients undergoing elective orthopedic procedures and to identify potential preoperative risk factors. DESIGN: A prospectively studied cohort of elective orthopedic surgery patients. SETTING: A University teaching hospital. PATIENTS: Eighty patients who attended a preadmission clinic and, subsequently, underwent elective orthopedic surgery. All patients were aged 60 years or older, and all spoke English. MEASUREMENTS: Patients underwent preoperative medical, cognitive, and activities of daily living assessment with standardized instruments and were followed postoperatively with daily visits, telephone interviews with attending nurses using a modified confusion assessment model (CAM), and repeated cognitive testing. Suspected delirium was verified by direct physician assessment. RESULTS: The elective group had 14 (17.5%) cases of POD, of which six (7.5%) were severe. These incidences are low compared with those of nonelective surgery groups reported elsewhere in the literature. Stepwise multiple logistic regression identified two POD risk factors: clock-drawing scores < or = 6 (OR = 9.0, CI, 2.8 to 45.6) and male gender (OR = 5.6, CI 1.9 to 33.8). CONCLUSION: A simple model using clock-drawing scores and male gender for preoperative identification of elective patients at greatest risk for POD appears sensitive, predictive, and practical for the preadmission clinic setting, but it should be validated in a prospective trial.

Aged↗
PubMedDate not supplied

Analgesic comparison of meloxicam or ketoprofen for orthopedic surgery in dogs.

OBJECTIVE: To compare the safety and efficacy of 2 analgesic protocols (preoperative meloxicam or intraoperative ketoprofen administration) during the first 24 hours after orthopedic surgery in dogs. STUDY DESIGN: Double-blind, prospective randomized clinical trial. ANIMALS: Sixty client-owned dogs. METHODS: Dogs with surgical orthopedic disorders were randomly separated into 2 groups: 30 dogs were administered 0.2 mg/kg meloxicam intravenously (IV) immediately before induction and 30 dogs were administered 2 mg/kg ketoprofen IV, 30 minutes before the end of surgery. Pain was assessed with a visual analog scale (VAS) and a cumulative pain score (CPS) preoperatively and at 30 minutes, 1, 2, 3, 4, 6, 8, and 24 hours after extubation. Selected serum biochemical variables were measured before and 24 hours after surgery and, buccal mucosal bleeding time (BMBT) and whole blood clotting time (WBCT) were measured before and 8 hours after surgery. Dogs were anesthetized with propofol and maintained on halothane in oxygen. Any complications were documented for 7 days after surgery. Results were compared between the 2 groups for significant differences in VAS scores (2-sample t-test) and in CPS (Wilcoxon's 2-sample test). Moreover, results were analyzed for significant differences in area under the curve (AUC) for VAS (2-sample t-test) and CPS (Wilcoxon's 2-sample test) among groups. To assess the effects of treatments on biochemical and coagulation functions, pre- and postoperative mean values of BMBT and WBCT were compared within both treatment groups (paired t-tests) and between both groups (2-sample t-test). RESULTS: No significant differences in pain response or coagulation were found between meloxicam- and ketoprofen-treated dogs. In both groups, alkaline phosphatase and alanine aminotransferase concentrations were significantly increased compared with baseline. No serious complications occurred. CONCLUSIONS: Preoperative administration of meloxicam is a safe and effective method of controlling postoperative pain for up to 24 hours in dogs undergoing orthopedic surgery. CLINICAL RELEVANCE: Analgesia after administration of preoperative meloxicam was comparable with administration of ketoprofen at the end of the surgery.

Analgesia↗
PubMed2004

Prevention of venous thromboembolism in orthopedic surgery with vitamin K antagonists: a meta-analysis.

BACKGROUND: The benefit-to-risk ratio of vitamin K antagonists (VKA), relative to active comparators, especially low-molecular-weight heparins (LMWH), for preventing venous thromboembolism in patients undergoing major orthopedic surgery is debated. OBJECTIVES: We performed a meta-analysis of all randomized trials in orthopedic surgery comparing adjusted doses of VKA to control treatments. PATIENTS AND METHODS: An exhaustive literature search, both manual and computer-assisted, was performed. Studies were selected on the basis of randomization procedure (VKA vs. a control group). At least one of the following outcome measures was to be evaluated: deep vein thrombosis (DVT), pulmonary embolism (PE), death, major hemorrhage or wound hematoma. Four reviewers assessed each article to determine eligibility for inclusion and outcome measures. RESULTS: VKAs were more effective than placebo or no treatment in reducing DVT [567 patients, relative risk (RR) = 0.56, 95% confidence interval (CI) 0.37, 0.84, P < 0.01] and clinical PE (651 patients, RR = 0.23, 95% CI 0.09, 0.59, P < 0.01). These results were obtained at the cost of a higher rate of wound hematoma (162 patients, RR = 2.91, 95% CI 1.09, 7.75, P = 0.03). VKAs were also more effective than intermittent pneumatic compression (534 patients, RR = 0.46, 95% CI 0.25, 0.82, P = 0.009) in preventing proximal DVT. In contrast, VKAs were less effective than LMWH in preventing total DVT and proximal DVT (9822 patients, RR = 1.51, 95% CI 1.27, 1.79, P < 0.001; and 6131 patients, RR = 1.51, 95% CI 1.04, 2.17, P = 0.028, respectively). The differences between VKA and LMWH in major hemorrhage and wound hematoma were not significant. CONCLUSIONS: In patients undergoing major orthopedic surgery, VKAs are less effective than LMWH, without any significant difference in the bleeding risk.

Fibrinolytic Agents↗
PubMed2003

Effect of antibiotics on cell surface hydrophobicity of bacteria causing orthopedic wound infections.

BACKGROUND: Despite antibiotic prophylaxis and treatment, the incidence of wound infections in orthopedic surgery is significant. Postoperative wound infection is a multifactorial process, which can be modified by several bacterial factors. Cell surface hydrophobicity of bacteria is a very important physicochemical feature, which has a great influence on the ability of bacteria to adhere to the surface of host cells or medical implants. METHODS: In this study, the hydrophobic properties of thirteen bacterial strains (coagulase-negative staphylococci, Staphylococcus aureus and Pseudomonas aeruginosa) isolated from patients with postoperative deep wound infections following orthopedic procedures were determined by the salt aggregation test. Results were compared to the hydrophobicity of three Hungarian standard bacterial strains. The modifying effect of four antibiotics (cefuroxime, cefotaxime, amoxicillin combined with clavulanic acid and amikacin)--applied most often in our Department for prophylaxis and treatment of patients--were analyzed. RESULTS: The cell surface hydrophobicity of certain strains showed considerable changes after antibiotic treatment. These alterations indicated the decrease in hydrophobicity. Supra-inhibitory concentrations (2x minimum inhibitory concentrations, MIC) of the antibiotics were able to induce more frequent alterations in hydrophobicity than sub-inhibitory (0.5x MIC) levels. CONCLUSIONS: Alterations in cell surface hydrophobicity caused by antibiotics can modify the adhesion process and thus the pathogenicity of bacterial strains. These changes should be taken into consideration in the management of proper antibiotic prophylaxis and in the treatment of orthopedic patients.

Anti-Bacterial Agents↗
PubMed2005

Etiology of implant orthopedic infections: a survey on 1027 clinical isolates.

In spite of the recent achievements derived from modern protocols of prophylaxis, orthopedic surgical infections still remain unacceptably frequent, especially in light of the often devastating outcomes of septic complications. The spectrum and the prevalence of the bacteria most frequently involved in orthopedic infections are here explored, with particular reference to those infections associated to implant biomaterials, which were grouped based on device typology. During a 30 months period (from September 2000 to April 2003), 1027 microbial strains were consecutively isolated from 699 patients undergoing revision surgery at the Rizzoli Orthopedic Institute. 775 (75.5%) of all these microorganisms were identified as belonging to the Staphylococcus genus, 82 (8%) to the Enterobacteriaceae family, 75 (7.3%) to the Pseudomonas genus, 54 (5.3%) to the Enterococcus genus and 20 (1.9%) to the Streptococcus genus. While confirming the importance of staphylococci as the most diffuse cause of infection, our data indicate an unexpectedly high prevalence of S. epidermidis on infected hip and knee arthroprostheses, respectively of 42% and 44%. The spectrum of bacteria infecting either internal or external fracture fixation devices appears to differ from that of hip and knee arthroprostheses and more closely resembles that of infections non-associated to medical devices, being characterized by a relatively higher prevalence of Staphylococcus aureus (over 40%) and Pseudomonas aeruginosa. Enterobacteriaceae and members of the Streptococcus and Corynebacterium genera are frequently associated with implants in which surgical incisions were made near the perineum, determining a completely altered spectrum.

Bacterial Infections↗
PubMed2000

Plasma tissue factor pathway inhibitor levels as a marker for postoperative bleeding after enoxaparin use in deep vein thrombosis prophylaxis in orthopedics and general surgery.

Low-molecular-weight heparins (LMWH) are widely used as antithrombotic prophylactic pharmaceutical agents in orthopedic and general surgery. Their antithrombotic characteristics are expressed by plasma mediators such as anti-Xa, anti-IIa, and increased release of tissue factor pathway inhibitor (TFPI) from vascular endothelium. The purpose of this clinical research is to study the relation between plasma levels of these mediators and postoperative bleeding. Forty-one consecutive patients undergoing hip or knee arthroplasty (n = 36) and colectomy (n = 5) received the standard enoxaparin (a LMWH) dose preoperatively (general surgery) or immediately postoperatively (orthopedic surgery). Major bleeding was defined as a postoperative drop of > or = 5 g/dL) of hemoglobin. The authors observed that there was a linear relationship between an increase in free/total TFPI ratio levels and postoperative bleeding. When that ratio increased by > 60%, the hemoglobin dropped to > 5 g/dL (n = 17). This relationship between free/total TFPI ratio increase and postoperative bleeding was statistically significant (P < 0.001). Those who did not bleed (hemoglobin drop was less than 5 g/dL) (n = 24) had a ratio increase (if any) of less than 50%. However, the authors did not observe any statistical relationship between anti-Xa, anti-IIa, or prothrombin time and postoperative bleeding in patients receiving LMWH for deep vein thrombosis prophylaxis in orthopedic and general surgery patients. The authors recommend a pre- and postoperative ratio level measurement whenever major bleeding is anticipated, as adjustments of LMWH dose or frequency might be necessary.

Biomarkers↗
PubMed2001

Plasma tissue factor pathway inhibitor levels as a marker for postoperative bleeding after enoxaparin use in deep vein thrombosis prophylaxis in orthopedics and general surgery.

Low-molecular-weight heparins (LMWH) are widely used as antithrombotic prophylactic pharmaceutical agents in orthopedic and general surgery. Their antithrombotic characteristics are expressed by plasma mediators such as anti-Xa. anti-IIa, and increased release of tissue factor pathway inhibitor (TFPI) from vascular endothelium. The purpose of this clinical research is to study the relation between plasma levels of these mediators and postoperative bleeding. Forty-one consecutive patients undergoing hip or knee arthroplasty (n = 36) and colectomy (n = 5) received the standard enoxaparin (a LMWH) dose preoperatively (general surgery) or immediately postoperatively (orthopedic surgery). Major bleeding was defined as a postoperative drop of > or = 5 g/dL) of hemoglobin. The authors observed that there was a linear relationship between an increase in free/total TFPI ratio levels and postoperative bleeding. When that ratio increased by >60%, the hemoglobin dropped to >5 g/dL (n = 13). This relationship between free/total TFPI ratio increase and postoperative bleeding was statistically significant (P < 0.001). Those who did not bleed (hemoglobin drop was less than 5 g/dL) (n = 28) had a ratio increase (if any) of less than 50%. However, the authors did not observe any statistical relationship between anti-Xa, anti-IIa, or prothrombin time and postoperative bleeding in patients receiving LMWH for deep vein thrombosis prophylaxis in orthopedic and general surgery patients. The authors recommend a pre- and postoperative ratio level measurement whenever major bleeding is anticipated, as adjustments of LMWH dose or frequency might be necessary.

Anticoagulants↗
PubMed2006

Analysis of patient flows for orthopedic procedures using small area analysis in Switzerland.

BACKGROUND: In general cantons regulate and control the Swiss health service system; patient flows within and between cantons are thereby partially disregarded. This paper develops an alternative spatial model, based upon the construction of orthopedic hospital service areas (HSAOs), and introduces indices for the analysis of patient streams in order to identify areas, irrespective of canton, with diverse characteristics, importance, needs, or demands. METHODS: HSAOs were constructed using orthopedic discharge data. Patient streams between the HSAOs were analysed by calculating three indices: the localization index (% local residents discharged locally), the netindex (the ratio of discharges of nonlocal incoming residents to outgoing local residents), and the market share index (% of local resident discharges of all discharges in local hospitals). RESULTS: The 85 orthopedic HSAOs show a median localization index of 60.8%, a market share index of 75.1%, and 30% of HSAOs have a positive netindex. Insurance class of bed, admission type, and patient age are partially but significantly associated with those indicators. A trend to more centrally provided health services can be observed not only in large urban HSAOs such as Geneva, Bern, Basel, and Zurich, but also in HSAOs in mountain sport areas such as Sion, Davos, or St.Moritz. Furthermore, elderly and emergency patients are more frequently treated locally than younger people or those having elective procedures. CONCLUSION: The division of Switzerland into HSAOs provides an alternative spatial model for analysing and describing patient streams for health service utilization. Because this small area model allows more in-depth analysis of patient streams both within and between cantons, it may improve support and planning of resource allocation of in-patient care in the Swiss healthcare system.

Adolescent↗
PubMed2006

Seasonal variation in orthopedic health services utilization in Switzerland: the impact of winter sport tourism.

BACKGROUND: Climate- or holiday-related seasonality in hospital admission rates is well known for many diseases. However, little research has addressed the impact of tourism on seasonality in admission rates. We therefore investigated the influence of tourism on emergency admission rates in Switzerland, where winter and summer leisure sport activities in large mountain regions can generate orthopedic injuries. METHODS: Using small area analysis, orthopedic hospital service areas (HSAo) were evaluated for seasonality in emergency admission rates. Winter sport areas were defined using guest bed accommodation rate patterns of guest houses and hotels located above 1000 meters altitude that show clear winter and summer peak seasons. Emergency admissions (years 2000-2002, n = 135'460) of local and nonlocal HSAo residents were evaluated. HSAo were grouped according to their area type (regular or winter sport area) and monthly analyses of admission rates were performed. RESULTS: Of HSAo within the defined winter sport areas 70.8% show a seasonal, summer-winter peak hospital admission rate pattern and only 1 HSAo outside the defined winter sport areas shows such a pattern. Seasonal hospital admission rates in HSAo in winter sport areas can be up to 4 times higher in winter than the intermediate seasons, and they are almost entirely due to admissions of nonlocal residents. These nonlocal residents are in general -and especially in winter- younger than local residents, and nonlocal residents have a shorter length of stay in winter sport than in regular areas. The overall geographic distribution of nonlocal residents admitted for emergencies shows highest rates during the winter as well as the summer in the winter sport areas. CONCLUSION: Small area analysis using orthopedic hospital service areas is a reliable method for the evaluation of seasonality in hospital admission rates. In Switzerland, HSAo defined as winter sport areas show a clear seasonal fluctuation in admission rates of only nonlocal residents, whereas HSAo defined as regular, non-winter sport areas do not show such seasonality. We conclude that leisure sport, and especially ski/snowboard tourism demands great flexibility in hospital beds, staff and resource planning in these areas.

Adult↗
PubMed2004

A survey of orthopedic surgeons' attitudes and knowledge regarding regional anesthesia.

UNLABELLED: We conducted a survey to explore the surgical attitudes and preferences regarding regional anesthesia among Canadian orthopedic surgeons. Surveys were returned by 468 (61%) of 768 surgeons. Forty-eight percent of respondents directed their patients' choice of anesthetic. Forty percent of surgeons directed their patients to choose regional anesthesia. The principal reasons for favoring regional anesthesia were less postoperative pain (32%), decreased nausea and vomiting (12%), and safety (14%). Reasons for not favoring regional anesthesia were delays in the induction of anesthesia (43%) and an unpredictable success rate (12%). This survey suggests that orthopedic surgeons are supportive of regional anesthesia. Barriers to increased popularity include perceived delays and unreliability. IMPLICATIONS: Orthopedic surgeons understand the benefits of and are supportive of the use of regional anesthesia in their practices. Barriers to increased popularity include perceived operating room delays and lack of reliability.

Adult↗
PubMed2006

The analgesic efficacy of acetaminophen, ketoprofen, or their combination for pediatric surgical patients having soft tissue or orthopedic procedures.

The combined use of acetaminophen and a nonsteroidal antiinflammatory drug has been shown to provide better postoperative analgesia than either drug alone in several adult studies. However, there are no pediatric studies analyzing similar effects when the currently recommended doses of acetaminophen are used. In a double-blind, placebo-controlled design we randomized 120 children, aged 1-9 yr, undergoing orthopedic or soft tissue surgery, into 3 groups to receive either acetaminophen 60 mg/kg rectally and 40 mg/kg orally, ketoprofen 2 mg/kg IV twice, or the combination of the active drugs. The first drug doses were given at anesthetic induction and the second doses 8 h thereafter. During anesthesia all children received sevoflurane and a continuous infusion of remifentanil. Postoperative pain was evaluated by the behavioral objective pain scale (0-9) for 24 h. The rescue medication was morphine 0.05 mg/kg IV. The primary outcome variable was morphine consumption. For statistical analysis, analysis of variance, chi2 test and Kaplan-Meier survival analysis were used. Morphine requirement was less in the combination than in the acetaminophen group both in the postanesthesia care unit (2.5 +/- 1.7 versus 3.9 +/- 2.1 morphine doses) and during the 24-h postoperative follow-up (4.1 +/- 2.5 versus 5.9 +/- 2.9 morphine doses) (P < 0.05). No differences existed between the ketoprofen and the acetaminophen groups. The objective pain scale scores were lowest in the combination group both in the postanesthesia care unit and in the postoperative ward (P < 0.05). When children were divided based on their surgery, opioid requirement and pain scores were less in the combination than in the parent drug groups only after orthopedic surgery. The combination of acetaminophen 100 mg/kg and ketoprofen 4 mg/kg in a day provided better analgesia and lower pain scores after orthopedic, but not soft tissue, surgery in children.

Acetaminophen↗
PubMed2003

[The analysis of prescription frequency and the factors on adverse reactions of NSAIDs for post-operative pain in orthopedic patients].

Recently, adverse reaction of non-steroidal anti-inflammatory drugs (NSAIDs) is the critical problem, although NSAIDs are one of the most commonly used classes of medications worldwide. Therefore, it is worthwhile to investigate the prescription frequency and the factors on adverse reactions of NSAIDs for post-operative pain in orthopedic patients of our hospital. In orthopedic field, loxoprofen was most prescribed in various kinds of NSAIDs. Logistic regression analysis strongly indicated that previous adverse reaction or allergy caused by drugs (not NSAIDs) or food is the important role in the adverse reaction of NSAIDs. In addition, significant correlation was observed between previous illness of gastrointestinal ulcer and gastrointestinal complication of NSAIDs. Moreover, the present study point out that pharmacist clinical intervention against the adverse reaction of NSAIDs may be saved on medical costs. Although further investigation may be needed, these present studies provide the good information for our medication management and instruction tasks (i.e. pharmaceutical care and counseling for inpatients) for post-operative pain of orthopedic patients.

Adult↗
PubMed2005

Toxicology screening in orthopedic trauma patients predicting duration of prescription opioid use.

Following hospitalization for orthopedic trauma, some patients continue to use opioids following fracture healing. This retrospective cohort study of 50 patients with high-energy fractures was conducted to determine if toxicology screening tests upon admission can predict subsequent opioid use. Data were collected from clinical records and a statewide electronic database of prescription records. Six months following hospital discharge, those with positive toxicology used more Following hospitalization for orthopedic trauma, some patients continue to use opioids following fracture healing. This retrospective cohort study of 50 patients with high-energy fractures was conducted to determine if toxicology screening tests upon admission can predict subsequent opioid use. Data were collected from clinical records and a statewide electronic database of prescription records. Six months following hospital discharge, those with positive toxicology used more. Following hospitalization for orthopedic trauma, some patients continue to use opioids following fracture healing. This retrospective cohort study of 50 patients with high-energy fractures was conducted to determine if toxicology screening tests upon admission can predict subsequent opioid use. Data were collected from clinical records and a statewide electronic database of prescription records. Six months following hospital discharge, those with positive toxicology used more opioids (730 mg vs. 364 mg; P = .04) expressed as morphine equivalents than those with negative toxicology and were more likely to continue using opiates at the end of the 3rd, 4th, 5th, and 6th month after discharge. Patients hospitalized for high-energy fractures with positive admission toxicology are at risk for prolonged opiate use during the initial six months following discharge.

Adult↗
PubMed2003

Venous thromboembolism prevention with LMWHs in medical and orthopedic surgery patients.

OBJECTIVE: To discuss the role of low-molecular-weight heparins (LMWHs) in the prevention of venous thromboembolism (VTE) in medical and orthopedic surgery patients. VTE prophylaxis trials in these practice settings establishing the current use of LMWHs marketed in the US are included. An overview is also provided of VTE incidence, risk factors, and prophylaxis consensus guidelines. DATA SOURCES AND STUDY SELECTION: Clinical trials, review articles, and meta-analyses for Food and Drug Administration-approved LMWHs were identified from a MEDLINE search (1980-March 2002). Search terms included dalteparin, enoxaparin, internal medicine, low-molecular-weight heparin, orthopedic surgery, risk factors, tinzaparin, and venous thromboembolism. DATA SYNTHESIS: Consensus guidelines are useful as an initial guide to appropriate VTE prophylaxis; however, a review of the primary literature is needed to identify optimal agents, regimens, or interventions. LMWHs have demonstrated sound efficacy in VTE prevention; however, the quantity and quality of literature are not always comparable for the available agents. CONCLUSIONS: Enoxaparin has demonstrated efficacy and safety in VTE prevention in medical patients, whereas information is limited or lacking for dalteparin and tinzaparin. Total hip replacement (THR) trials have been conducted with all US-marketed LMWHs and have demonstrated the efficacy and safety of each agent. Trials specifically establishing the efficacy of an LMWH in total knee replacement surgery (TKR) have been published for enoxaparin. One combination THR and TKR trial has been published for tinzaparin. These trial outcomes have positioned the LMWHs as key alternatives to adjusted-dose warfarin for VTE prophylaxis in orthopedic surgery. Inherent differences between LMWHs prevent the extrapolation of clinical outcomes from 1 trial to another.

Anticoagulants↗
PubMed2004

Superiority of fondaparinux over enoxaparin in preventing venous thromboembolism in major orthopedic surgery using different efficacy end points.

STUDY OBJECTIVES: To assess the relevance of various efficacy end points established for thromboprophylaxis trials, we compared the results of the fondaparinux phase III program in major orthopedic surgery using the original primary efficacy end point with those obtained when the efficacy end points recently suggested by the American College of Chest Physicians (ACCP) Consensus Conference on Antithrombotic Therapy and the European Committee for Proprietary Medicinal Products (CPMP) were used. SETTING AND PATIENTS: Fondaparinux was compared with enoxaparin in four multicenter, randomized, double-blind trials of major orthopedic surgery. The original primary efficacy end point consisted of a composite of deep-vein thrombosis detected by mandatory bilateral venography, documented symptomatic deep-vein thrombosis, or pulmonary embolism up to day 11. The efficacy end point established by the ACCP Consensus Conference on Antithrombotic Therapy comprises any proximal deep-vein thrombosis, symptomatic proven deep-vein thrombosis or pulmonary embolism, or fatal pulmonary embolism, and that established by the European CPMP comprises any proximal deep-vein thrombosis, symptomatic proven pulmonary embolism, or death from any cause. INTERVENTIONS: Patients were randomized to receive either subcutaneous fondaparinux (2.5 mg once daily) starting postoperatively or approved enoxaparin regimens. RESULTS: Using the original end point of the fondaparinux studies, the incidence of venous thromboembolism was 13.7% (371 of 2,703 patients) in the enoxaparin group compared with 6.8% (182 of 2,682 patients) in the fondaparinux group, with a common odds reduction of 55.2% (p = 10(-17); 95% confidence interval, 45.8% to 63.1%) in favor of fondaparinux. The respective incidences of efficacy end points with enoxaparin and fondaparinux were 3.3% and 1.7%, respectively, according to the ACCP definition, and 3.9% and 2.1%, respectively, according to the CPMP definition. The common odds reduction in favor of fondaparinux was 49.6% (p < 0.001) and 48.0% (p < 0.001), respectively. CONCLUSIONS: Fondaparinux was consistently more effective than enoxaparin in preventing venous thromboembolism in patients undergoing major orthopedic surgery, irrespective of the established composite outcomes used.

Adolescent↗