Front Matter - The Journal of Bone & Joint Surgery

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Three of the major bleeding events that occurred by Day 21 were fatal, all due to gastrointestinal hemorrhage (two patients in the group treated with FRAGMIN and one in the group receiving placebo). Two deaths occurred after Day 21: one patient in the placebo group died from a subarachnoid hemorrhage that started on Day 55, and one patient died on day 71 (two months after receiving the last dose of FRAGMIN) from a subdural hematoma. Patients with Cancer and Acute Symptomatic Venous Thromboembolism Table 12 summarizes the number of patients with bleeding events that occurred in the clinical trial of patients with cancer and acute symptomatic venous thromboembolism. A bleeding event was considered major if it: 1) was accompanied by a decrease in hemoglobin of >2 g/dL in connection with clinical symptoms; 2) occurred at a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial bleeding); 3) required transfusion of >2 units of blood products; or 4) led to death. Minor bleeding was classified as clinically overt bleeding that did not meet criteria for major bleeding. At the end of the six-month study, a total of 46 (13.6%) patients in the FRAGMIN arm and 62 (18.5%) patients in the OAC arm experienced any bleeding event. One bleeding event (hemoptysis in a patient in the FRAGMIN arm at Day 71) was fatal. Table 12: Bleeding Events (Major and Any) (As treated population) 1 Study period FRAGMIN OAC 200 IU/kg (max. 18,000 IU) s.c. FRAGMIN 200 IU/kg (max 18,000 IU) s.c. once daily x 1 month, then 150 IU/kg once daily x 5-7 days and OAC (max 18,000 IU) s.c. once daily x 5 months for 6 months (target INR 2-3) Number Patients with Patients with Number Patients with Patients with at risk Major Bleeding Any Bleeding at Risk Major Bleeding Any Bleeding n(%) n(%) n(%) n(%) Total during study 338 19 (5.6) 46 (13.6) 335 12 (3.6) 62 (18.5) Week 1 338 4 (1.2) 15 (4.4) 335 4 (1.2) 12 (3.6) Weeks 2-4 332 9 (2.7) 17 (5.1) 321 1 (0.3) 12 (3.7) Weeks 5-28 297 9 (3.0) 26 (8.8) 267 8 (3.0) 40 (15.0) 1Patients with multiple bleeding episodes within any time interval were counted only once in that interval. However, patients with multiple bleeding episodes that occurred at different time intervals were counted once in each interval in which the event occurred. Thrombocytopenia: See WARNINGS: Thrombocytopenia. Other: Allergic Reactions: Allergic reactions (i.e., pruritus, rash, fever, injection site reaction, bulleous eruption) have occurred rarely. A few cases of anaphylactoid reactions have been reported. Local Reactions: Pain at the injection site, the only non-bleeding event determined to be possibly or probably related to treatment with FRAGMIN and reported at a rate of at least 2% in the group treated with FRAGMIN, was reported in 4.5% of patients treated with FRAGMIN 5000 IU once daily vs 11.8% of patients treated with heparin 5000 U twice daily in the abdominal surgery trials. In the hip replacement trials, pain at injection site was reported in 12% of patients treated with FRAGMIN 5000 IU once daily vs 13% of patients treated with heparin 5000 U three times a day. Ongoing Safety Surveillance: Since first international market introduction in 1985, there have been more than 15 reports of epidural or spinal hematoma formation with concurrent use of dalteparin sodium and spinal/epidural anesthesia or spinal puncture. The majority of patients had postoperative indwelling epidural catheters placed for analgesia or received additional drugs affecting hemostasis. In some cases the hematoma resulted in long-term or permanent paralysis (partial or complete). Because these events were reported voluntarily from a population of unknown size, estimates of frequency cannot be made. Post-Marketing Experience: Skin necrosis has occurred rarely. There have been isolated cases of alopecia reported that improved on drug discontinuation. OVERDOSAGE Symptoms/Treatment: An excessive dosage of FRAGMIN Injection may lead to hemorrhagic complications. These may generally be stopped by the slow intravenous injection of protamine sulfate (1% solution), at a dose of 1 mg protamine for every 100 anti-Xa IU of FRAGMIN given. A second infusion of 0.5 mg protamine sulfate per 100 anti-Xa IU of FRAGMIN may be administered if the APTT measured 2 to 4 hours after the first infusion remains prolonged. Even with these additional doses of protamine, the APTT may remain more prolonged than would usually be found following administration of conventional heparin. In all cases, the anti-Factor Xa activity is never completely neutralized (maximum about 60 to 75%). Particular care should be taken to avoid overdosage with protamine sulfate. Administration of protamine sulfate can cause severe hypotensive and anaphylactoid reactions. Because fatal reactions, often resembling anaphylaxis, have been reported with protamine sulfate, it should be given only when resuscitation techniques and treatment of anaphylactic shock are readily available. For additional information, consult the labeling of Protamine Sulfate Injection, USP, products. A single subcutaneous dose of 100,000 IU/kg of FRAGMIN to mice caused a mortality of 8% (1/12) whereas 50,000 IU/kg was a non-lethal dose. The observed sign was hematoma at the site of injection. Rx only U.S. Patent 4,303,651 April 2007 FR080231 © 2007 Pfizer Inc. 818 312 112 All rights reserved. Printed in USA/July 2007 Downloaded From: http://jbjs.org/ on 01/27/2014
Adv 64 JBJS [Br] Abstracts Now Available Trauma Fractures of the distal third of the humerus with palsy of the radial nerve MANAGEMENT USING MINIMALLY-INVASIVE PERCUTANEOUS PLATE OSTEOSYNTHESIS A. Livani, W. D. Belangero, and R. Castro de Medeiros From the State University of Campinas, Sao Paulo, Brazil J Bone Joint Surg (Br) 2006;88-B:1625-28 Fractures of the distal third of the humerus may be complicated by complete lesions of the radial nerve which may be entrapped or compressed by bone fragments. Indirect reduction and internal fixation may result in a permanent nerve lesion. We describe the treatment of these lesions by insertion of a bridge plate using the minimally-invasive percutaneous technique. Six patients were operated on and showed complete functional recovery. Healing of the fractures occurred at a mean of 2.7 months (2 to 3) and complete neurological recovery by a mean of 2.3 months (1 to 5). In one patient infection occurred which resolved after removal of the implant. gen 1 (sca-1+) and stem cell factor receptor, CD117 (c-kit+) in order to identify the endothelial precursor cell population. Immunomagnetically-enriched sca-1+ mononuclear cell (MNCsca-1+) populations were then cultured and examined for functional vascular endothelial differentiation. Bone marrow MNCsca-1+,c-kit+ counts increased almost twofold within 48 hours of the event, compared with baseline levels, before decreasing by 72 hours. Sca-1+ mononuclear cell populations in culture from samples of bone marrow at 48 hours bound together Ulex Europus-1, and incorporated fluorescent 1,1'-dioctadecyl- 3,3,3,’3'-tetramethylindocarbocyanine perchlorate-labelled acetylated low-density lipoprotein intracellularily, both characteristics of mature endothelium. Our findings suggest that a systemic provascular response of bone marrow is initiated by musculoskeletal trauma. Its therapeutic manipulation may have implications for the potential enhancement of neovascularisation and the healing of fractures. Upper Limb Research A systemic provascular response in bone marrow to musculoskeletal trauma in mice A. J. Laing, J. P. Dillon, E.T. Condon, J. C. Coffey, J. T. Street, J. H. Wang, A. J. McGuinness, and H. P. Redmond J Bone Joint Surg Br 2007 89-B: 116-120 Post-natal vasculogenesis, the process by which vascular committed bone marrow stem cells or endothelial precursor cells migrate, differentiate and incorporate into the nacent endothelium and thereby contribute to physiological and pathological neurovascularisation, has stimulated much interest. Its contribution to neovascularisation of tumours, wound healing and revascularisation associated with ischaemia of skeletal and cardiac muscles is well established. We evaluated the responses of endothelial precursor cells in bone marrow to musculoskeletal trauma in mice. Bone marrow from six C57 Black 6 mice subjected to a standardised, closed fracture of the femur, was analysed for the combined expression of cell-surface markers stem cell anti- The outcome of peri-operative humeral condylar fractures after total elbow replacement in patients with rheumatoid arthritis H. Ito, T. Matsumoto, H. Yoshitomi, R. Kakinoki, and T. Nakamura J Bone Joint Surg Br 2007 89-B: 62-65 We compared the outcome of peri-operative humeral condylar fractures in patients undergoing a Coonrad-Morrey semiconstrained total elbow replacement with that of patients with rheumatoid arthritis undergoing the same procedure without fractures. In a consecutive series of 40 elbows in 33 patients, 13 elbows had a fracture in either condyle peri-operatively, and 27 elbows were intact. The fractured condyle was either fixed internally or excised. We found no statistical difference in the patients’ background, such as age, length of follow-up, immobilisation period, Larsen’s radiological grade, or Steinbrocker’s stage and functional class. There was also no statistical difference between the groups in relation to the Mayo Elbow Performance Score, muscle strength, range of movement, or radiolucency around the implants at a mean of 4.8 years (1.1 to 8.0) followup. We conclude that fractured condyles can be successfully treated with either internal fixation or excision, and cause no harmful effect. Downloaded From: http://jbjs.org/ on 01/27/2014 THE JOURNAL OF BONE AND JOINT SURGERY www.jbjs.org.uk
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