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Prevention of thromboembolism with low-molecular-weight heparin in orthopedic surgery: a 5-year experience.

A regimen of prophylaxis of thromboembolism with low molecular weight heparin (LMWH) and unfractionated heparin (UFH) in orthopedic surgery is presented. Over a 5-year period, 11,905 patients have been operated in all fields of orthopedic surgery in a big trauma center. In 498 cases, deep vein thrombosis (DVT) was clinically suspected and phlebography was performed: 122 patients had confirmed DVT (rate 0.98%); 59.8% of the DVT were limited to the calf. Nineteen pulmonary embolisms (rate 0.16%) were diagnosed (3 lethal). Heparin-induced thrombocytopenia type II was diagnosed in 12 of 122 patients. Only one of these had received LMWH. The related rates of DVT were highest for tibial head fractures (12.4%), total knee replacement (6.7%), and multiple trauma (6.4%). The extent of DVT was most severe in multiple trauma. The results proved the regimen to be of good clinical use and showed that more attention has to be paid to fractures, especially of the knee; and to patients with multiple injuries.

Adolescent↗

Clostridial orthopedic infections: case reports and review of the literature.

Clostridia are anaerobic Gram-positive bacilli that can be isolated from the soil and the intestinal tract of humans. These microorganisms are recognized as the cause of devastating soft tissue infections, such as cellulitis, myositis, and gas gangrene. However, such bacteria may also be involved in various postoperative orthopedic infections, including prosthetic joint infection. We present three clinical cases of clostridial orthopedic infection and review the related medical literature.

Adult↗

Continuous psoas compartment blocks after major orthopedic surgery in children: a prospective computed tomographic scan and clinical studies.

UNLABELLED: Femoral shaft or hip surgeries are very painful for children. We conducted both computed tomographic (CT) and clinical prospective studies to define new landmarks in children and to evaluate the effectiveness of continuous psoas compartment blocks (CPCBs) using disposable elastomeric pumps. In a preliminary CT scan study of 20 patients, the plexus depth was correlated to patient age and the optimal point of puncture for CPCB was three-quarters of the distance from the spinous process of L4 to a line parallel to the spinal column passing through the posterior superior iliac spine. In a subsequent prospective series, a CPCB was administered before surgery to 15 children for pain relief after femoral and hip osteotomies. After general anesthesia, a 0.5 mL/kg bolus of a mixture of 1% lidocaine with epinephrine (1/200.000) and 0.5% ropivacaine was injected through the CPCB catheter. After contrast media assessment of the catheter location, a disposable pump (Infusor LV); Baxter, Paris, France) with 0.2% ropivacaine was connected and pump flow was adjusted to the patient's weight (0.2 mg x kg(-1) x h(-1)). Postoperative pain was evaluated using a visual analog scale or the Children and Infants Postoperative Pain Score at hour H1, H6, H12, H18, H24, H36, and H48, and in terms of rescue analgesia, adverse events, and motor blocks. All blocks were effective during surgery. Postoperative analgesia was excellent. The median pain scores were 1 for H1 and 0 beginning H6. The motor blockade was minimal before 24 h and absent thereafter. No major adverse event was noted. Parents of 93% of the children were satisfied. We conclude that postoperative analgesia with CPCB is a very effective technique in children after major proximal lower limb orthopedic surgery. The CT scan landmarks described in this study were more medial than the conventional landmarks used in the literature. IMPLICATIONS: Continuous psoas compartment blocks provide optimal pain relief in children after major orthopedic surgery without major adverse events. The landmarks used, defined in a preliminary computed tomographic scan study, were more medial than conventional landmarks.

Adolescent↗

The effects of paracetamol and parecoxib on kidney function in elderly patients undergoing orthopedic surgery.

The common adverse effects of traditional nonsteroidal antiinflammatory drugs on renal function include reductions in renal blood flow, glomerular filtration rate, and sodium and potassium excretion, mainly via inhibition of renal cyclooxygenase. We designed the present study to determine the effects of IV paracetamol or parecoxib on renal function in elderly patients undergoing orthopedic surgery. Seventy-five patients (76 +/- 8 yr, mean +/- sd) undergoing hip replacement or surgery of the femoral shaft completed this randomized and placebo-controlled study. After their arrival in the postanesthesia care unit, patients received an initial dose of the study medication, paracetamol 1000 mg IV (n = 25), parecoxib 40 mg IV (n = 25), or saline IV (n = 25); subsequent doses were administered for the next 3 days. Opioids were provided as rescue medication. Blood and urine samples were collected before and after surgery, and markers of renal function were determined. During the first 2 h after the initial dose of parecoxib, creatinine clearance was slightly diminished (125 +/- 83 to 86 +/- 45 mL/min, P < 0.05), whereas no significant decrease of creatinine clearance was observed in the placebo and paracetamol groups. After all treatments, sodium and potassium excretion as well as urine albumin and alpha-1-microglobulin were transiently increased (group differences: not signicifant). In conclusion, glomerular and tubular functions were transiently affected in all patients after orthopedic surgery; however, the differences between the treatment groups were small and not clinically relevant. Further studies are warranted to determine adverse renal effects of longer-lasting therapy with these drugs, especially in patients with renal impairment or concomitant diseases.

Acetaminophen↗

Fondaparinux for prevention of venous thromboembolism in major orthopedic surgery.

OBJECTIVE: To review clinical information related to fondaparinux, a synthetic pentasaccharide recently approved for the prevention of deep-vein thrombosis (DVT) in patients undergoing major orthopedic surgeries and for extended DVT prophylaxis after hip fracture surgery. DATA SOURCES: Primary and review articles were identified by MEDLINE (1983-June 2003) using the key words pentasaccharide, Org31540, SR90107A, DVT prophylaxis, and fondaparinux. Additional sources were found listed in articles, abstracts, and unpublished data on file from the manufacturer. Articles selected were based on their coverage of the pharmacology, pharmacokinetics, safety, and efficacy of fondaparinux. STUDY SELECTION AND DATA EXTRACTION: All of the articles identified were evaluated and all information deemed relevant was included. DATA SYNTHESIS: Fondaparinux is a selective antithrombin-dependent, indirect inhibitor of activated factor Xa. It has a favorable and predictable pharmacokinetic profile when administered subcutaneously, and has a long half-life, allowing once-daily dosing. Fondaparinux lacks in vitro cross-reactivity with heparin-induced antibodies. Major Phase III studies have demonstrated that subcutaneous fondaparinux sodium 2.5 mg given at least 6 hours postoperatively resulted in a 55% reduction in the risk of venous thromboembolism (VTE) in patients undergoing hip fracture surgery, total hip replacement surgery, or knee replacement surgery compared with standard enoxaparin therapy. It has a safety profile similar to that of enoxaparin with respect to clinically relevant major bleeding, including fatal bleeding, nonfatal bleeding, and bleeding requiring repeat surgery. The use of fondaparinux for prolonged prophylaxis after hip fracture has demonstrated further reduction in VTE events without increasing the risk of bleeding. CONCLUSIONS: Fondaparinux is the first of a new class of synthetic factor Xa inhibitors that demonstrated greater efficacy compared with enoxaparin for the prevention of VTE in major orthopedic surgery without an increase in clinically relevant bleeding. Given the favorable cost-effectiveness analysis and improved efficacy profile, fondaparinux should be considered for formulary addition for DVT prophylaxis in patients undergoing hip and knee replacement surgery. In patients undergoing hip fracture surgery, fondaparinux should be considered the DVT prophylaxis of choice. Extended thromboprophylaxis up to 28 days resulted in additional reduction in VTE (both symptomatic and venography-proven DVT) in patients with hip fracture surgery.

Adult↗

Recent advances in the design of titanium alloys for orthopedic applications.

To increase an orthopedic implant's lifetime, research trends have included the development of new titanium alloys made of nontoxic elements with suitable mechanical properties (low Young's modulus - high fatigue strength), good workability and corrosion resistance. In accordance with the background on titanium and metallic biomaterials, recent interesting developments in titanium-based biomaterials are reported in this review, with a special emphasis on the design of new metastable beta-titanium alloys for orthopedic applications. In addition, as the concept of titanium alloys can now be regarded as relatively old, having emerged at the beginning of the 1980s, the author suggests some future directions that would permit the emergence of a new generation of titanium implants.

Alloys↗

Selective factor Xa inhibition improves efficacy of venous thromboembolism prophylaxis in orthopedic surgery.

Venous thromboembolism is a serious, frequent, and potentially fatal complication of major orthopedic surgery. Currently available pharmacologic agents for the prevention of venous thromboembolism in this high-risk population consist of the oral anticoagulants and the heparin family of antithrombotic agents (unfractionated heparin, low-molecular-weight heparin, heparinoids). These classes of agents interfere with the activity of both thrombin and factor Xa (or their respective zymogens) to varying degrees. Newer antithrombotic agents in various stages of development exert their antithrombotic effect through a more targeted mechanism of action. Direct factor Xa inhibitors and the newest class of antithrombotic agents, the indirect factor Xa inhibitors, the prototype of which is the synthetic pentasaccharide fondaparinux sodium, limit fibrin formation through their exclusive inactivation of factor Xa. Clinical data from venous thromboembolism prophylaxis trials in hip and knee replacement and hip fracture surgeries, including the recently completed fondaparinux phase II and phase III trials, indicate that selective antifactor Xa activity may improve the efficacy:safety ratio of antithrombotic therapies for the prevention of venous thromboembolism in high-risk major orthopedic surgery.

Factor Xa Inhibitors↗

Emerging options for thromboprophylaxis after orthopedic surgery: a review of clinical data.

In four randomized, controlled studies of patients undergoing orthopedic surgery, the antithrombotic efficacy and safety of subcutaneous fondaparinux 2.5 mg once/day were compared with those of subcutaneous enoxaparin regimens that were approved by the United States Food and Drug Administration. In patients undergoing elective hip replacement surgery, fondaparinux significantly reduced the frequency of venous thromboembolism (VTE). However, in a second trial that compared fondaparinux with enoxaparin 30 mg twice/day beginning 12-24 hours after surgery, a 26% risk reduction in favor of fondaparinux was not statistically significant. In patients undergoing elective knee replacement surgery, fondaparinux significantly reduced the risk of VTE compared with enoxaparin without increasing the risk of clinically relevant bleeding, although the risk of major bleeding defined by the bleeding index was significantly higher with fondaparinux. Fondaparinux was superior to enoxaparin 40 mg once/day in the setting of hip fracture surgery, with no increased risk of major bleeding. Meta-analysis of the four studies confirms the superior antithrombotic efficacy of fondaparinux over enoxaparin in orthopedic surgery and suggests that the risk of major bleeding is similar to that of enoxaparin when the first dose of fondaparinux is given at least 6 hours after surgery.

Anticoagulants↗

Evidence for extended prophylaxis in the setting of orthopedic surgery.

Patients undergoing orthopedic surgery represent one of the highest risk groups for the development of venous thromboembolism (VTE). Evidence shows that this risk extends beyond the period in which the patient is hospitalized, especially for patients undergoing hip surgery. Clinical trials have shown that extended prophylaxis with the low-molecular-weight heparins is effective in reducing the rate of total VTE, and a meta-analysis demonstrated a reduction in symptomatic VTE with extended prophylaxis after total hip replacement surgery. Based on these results, the American College of Chest Physicians gives a grade 2A recommendation for the use of extended prophylaxis after orthopedic surgery. Until recently, data evaluating the role of prophylaxis in patients undergoing hip fracture surgery were limited. Subsequently, a novel anticoagulant, fondaparinux, demonstrated significant benefit in these patients and has become the first and only agent approved by the United States Food and Drug Administration (FDA) for use in patients undergoing hip fracture surgery Despite the limitations of the older trials, their findings supported the need to evaluate extended prophylaxis in patients undergoing hip fracture surgery. In the first well-conducted trial of extended prophylaxis for hip fracture surgery, fondaparinux provided impressive results in reducing total and symptomatic VTE. The results of this trial have once again led to fondaparinux being the first and only agent to be granted FDA approval for the indication of extended prophylaxis in patients undergoing hip fracture surgery.

Anticoagulants↗

Changes produced by presurgical orthopedic treatment before cheiloplasty in cleft lip and palate patients.

OBJECTIVE: The purpose of this study was to test the hypothesis that, with the use of preoperative treatment, the dimensions of the upper part of the oral cavity of an infant with unilateral cleft lip and palate (UCLP) become more similar to those of a noncleft infant. DESIGN: This was a retrospective study of upper dental casts taken at birth and prior to lip repair at 6 months of age. A treated group, an untreated group, and a group of noncleft contemporaries were compared cross-sectionally and longitudinally. Models were analyzed by the trigonometric method. SETTING: The study was performed at a maxillofacial center servicing a population of two million. PARTICIPANTS: The treated group consisted of 24 babies born after 1990 with UCLP that started presurgical treatment within 20 days of life. The untreated group consisted of 25 randomly selected UCLP casts taken at birth and 25 casts taken just before lip surgery. The noncleft group consisted of 25 full-term infants whose mothers participated in the longitudinal growth study. All participants belonged to the same ethnic group. INTERVENTIONS: Presurgical treatment consisted of the babies constantly wearing a thin, passive acrylic plate mimicking the normal palate and a slim adhesive tape fixed to the lip segments to bring them slightly together. RESULTS: The upper oral cavity in a newborn with UCLP was significantly larger than in a noncleft infant, the only exception being in the sagittal dimension. After presurgical treatment, the upper oral cavity was remodeled and slightly enlarged; there was a lesser difference from the noncleft at 6 months than at birth. The cleft in the alveolus reduced significantly, and the position of the incisive point improved. The group without presurgical treatment had no remodeling, and the growth dynamics were similar to the noncleft so that the dimensional differences from the normal remained the same as at birth. CONCLUSION: The morphological characteristics of the upper part of the mouth change if the functional conditions in the oral cavity are changed. Infants with presurgical orthopedics become more similar to noncleft contemporaries than those without presurgical orthopedics.

Cleft Lip↗

MDCT versus digital radiography in the evaluation of bone healing in orthopedic patients.

OBJECTIVE: Assessment of bone healing in orthopedic patients is usually monitored by radiographs in two views. The purpose of our study was to compare multiplanar reconstructions from MDCT data sets with digital radiographs for assessing the extent of bone healing. MATERIALS AND METHODS: Forty-three orthopedic patients (19 women, 24 men) who underwent MDCT and radiography after arthrodesis, fractures, or spinal fusions were included in our study. MDCT was performed on an MX 8000IDT scanner and served as the gold standard. The technical parameters were adapted to the anatomic region. A bone algorithm for reconstruction was used (3,500/600 H). Multiplanar reconstructions were calculated in two orthogonal planes. All patients underwent digital radiography on a Multix FD system in two views according to standard procedures. Multiplanar reconstructions and radiographs were analyzed by two musculoskeletal radiologists in a consensus interpretation to determine bone healing using a semiquantitative approach. RESULTS: In 27 patients (63%), MDCT and digital radiography were concordant with regard to the extent of bone healing, whereas in 16 patients (37%) the results were not concordant. In eight patients (19%) digital radiographs underestimated the extent of bone healing, whereas in another eight patients (19%) they overestimated the degree of fusion. CONCLUSION: MDCT using high-quality 2D reformatting is recommended as the primary imaging technique for the evaluation of bone healing.

Female↗

[Nosocomial infections in the departments of orthopedics and traumatology].

AIM: To determine the incidence and the localization of nosocomial infections (NI) in the departments of orthopedics and traumatology. METHODS: A prospective cohort study carried out between February 1 and July 31, 2002 included all of the surgical patients who were hospitalized longer than 48 hours, as well as 30 days after the discharge. The patients were examined and their diagnoses made according to the definition of NI, that was based on the clinical and/or laboratory findings. RESULTS: Out of 277 hospitalized patients, 78 had a total of 91 NIs. Sixty-seven (85.8%) of the patients had 1 registered NI each, 9 (11.6%) of the patient had 2 NIs each, while only the 2 (2.6%) were with 3 NIs. The incidence of the patients with HAI was 28.2% (95% IP = 22.9-33.5), while the incidence of HAI was 32.8%. The patients who developed a NI were hospitalized almost twice as long as the patients who did not (t test = 6.0, DF = 275, p < 0.001). In regard to the duration of hospitalization, the incidence of NI was 12.3 per 1000 patient-hospital days. The patients operated on most frequently had the surgical-site infections (69.2%). Of 63 infections of the surgical site, 3 patients (4.8%) were diagnosed as having the NI at that localization following the discharge, and then the urinary tract infections, 25.3% (23/91), and sepsis, 5.5% (5/91). CONCLUSION: Epidemiological surveillance was the first step towards the prevention and the eradication of NI. The results of this study could be of use in planning of the adequate measures for the prevention of NI in the departments of orthopedic surgery.

Adolescent↗

A prospective study of fertility and outcome of pregnancy after discontinuation of oral contraception in relation to elective orthopedic surgery.

OBJECTIVE: To evaluate the risk of unwanted pregnancies, their outcome and the rate of resuming contraception after discontinuation of oral contraception (OC) prior to elective surgery. DESIGN: A six months prospective follow-up study. SETTING: Orthopedic unit, operating on a total of 897 women during a period of 24 months. SUBJECTS: Seventy-eight healthy women in whom OC was stopped prior to elective orthopedic surgery. OUTCOME: Pregnancy rate, pregnancy outcome and reinstitution rate of OC. RESULTS: Complete outcome data are available for 73 (93.5%) of 78 women who were asked to participate in the study. Five pregnancies were reported, giving a cumulated six month pregnancy rate of 6.8%. Three pregnancies were completed to term, one was ectopic and one terminated by induced abortion. Within six months after the operation the cumulative user rate of oral contraceptives was 74.2%. None of the women were readmitted to hospitals for severe illness during the study period. CONCLUSIONS: The women resumed oral contraceptives relatively soon after their first post-operative menstrual cycle. This may explain why the pregnancy rate during the first six postoperative months appears low.

Abortion, Induced↗

Early bone grafting in complete cleft lip and palate cases following maxillofacial orthopedics. III. A study of the dental occlusion.

The dental occlusion of children born with complete cleft lip and palate was studied in deciduous and mixed dentition. The children were divided in two unilateral groups: one group of 39 children operated on between 1960-1965 without preoperative orthopedics and another group of 46 children operated on between 1965-1972 after preoperative orthopedics ("T-traction"). One group of 19 children with bilateral clefts operated on 1960-1972 after premaxillary retropositioning pressure, if necessary combined with outward rotation of the lateral maxillary segments was also studied. All children were bone grafted with the "four flap" technique. Comparisons were made with cleft children bone grafted with a different surgical method, with non-grafted U.S. cleft children, with cleft children operated on with infant periosteoplasty and with nonclefts. Crossbites were more frequent in clefts bone grafted with a different surgical method. The results of this study corresponded more to those operated on with infant periosteoplasty or to the non-grafted cases. However, all cleft groups differed significantly from nonclefts with a reduced overjet and overbite and narrower and shorter upper dental arches.

Bone Transplantation↗

Early bone grafting in complete cleft lip and palate cases following maxillofacial orthopedics. IV. A radiographic study of the incorporation of the bone grafts.

The development of bone grafts in complete alveolar clefts was studied with standard radiographic methods. The patients were divided into three groups: one unilateral group of 39 children operated on between 1960-1965 without preoperative orthopedics, another unilateral group of 46 children operated on between 1965-1972 after preoperative orthopedics ("T-traction") and one group of bilateral clefts with 19 children operated on 1960-1972 after premaxillary retropositioning pressure if necessary combined with outward rotation of the lateral segments. All children had bone grafts inserted with "a four-flap" technique. The results were compared with those operated on with early bone grafting by a different method. The results were similar with good healing and incorporation of the transplanted bone. The group bone grafted after preoperative "T-traction", which facilitates the surgical procedure, showed the highest alveolar bone level. The amount of bone seemed to increase with increasing age of the patient and migration of teeth into the grafted region.

Alveolar Process↗

Early bone grafting in complete cleft lip and palate cases following maxillofacial orthopedics. V. A postoperative evaluation of nasal patency.

The nasal patency of children born with complete unilateral or bilateral cleft lip and palate was studied with rhinomanometry. The children had all been early bone grafted with a "four-flap" technique. The unilateral deformities were composed of two groups. One group of 39 children (mean age 17.6 years) primarily operated without preoperative orthopedics and another group of 46 children (mean age 10.8 years), where preoperative orthopedics ("T-traction") was performed before the operation. In the bilateral group, 19 children (mean age 15.1 years), preoperative retropositioning pressure and if necessary outward rotation of the lateral maxillary segments was performed before the operation. No difference of total nasal patency was found between unilateral and bilateral cleft children. The nasal cavity of the cleft side of unilateral clefts had, however, a more pronounced nasal stenosis than each cavity of bilateral clefts. In unilateral groups a significant difference in nasal patency was found between the cleft and the noncleft side. This difference was not changed by decongestion indicating a skeletal anatomical stenosis. Nasal patency did not differ between the unilateral groups. However, considering the age difference between the two groups a further improvement of nasal patency with increasing age may possibly occur in the younger "T-traction" group.

Adolescent↗

Prophylactic mupirocin could reduce orthopedic wound infections. 1,044 patients treated with mupirocin compared with 1,260 historical controls.

We analyzed the effect of perioperative elimination of nasal carriage of Staphylococcus aureus using mupirocin nasal ointment on the reduction of the postoperative wound infection rate in orthopedics. In an unblinded intervention trial, we compared 1,044 patients treated with mupirocin (intervention group) with 1,260 historical controls (control group). From each group a random sample of 50 patients was taken. Risk factors were analyzed in these random samples and we found it unlikely that different distributions of risk factors might have influenced the results. The wound infection rates were 14/1,044 in the intervention group and 34/1,260 in the control group (p = 0.02). The rates of wound infections caused by S. aureus were subsequently 7/1,044 and 14/1,260 (p = 0.3). On checking the data we found that prophylaxis had unintentionally not been given to 172 patients in the intervention group. Correction of the data gave a comparable total infection rate, but a further reduced infection rate by S. aureus. Our findings suggest that prophylactic treatment with mupirocin in orthopedic surgery can reduce the infection rate.

Administration, Intranasal↗