Carsten Tørholm

Efficacy and Safety of Prolonged Thromboprophylaxis with a Low Molecular Weight Heparin (Dalteparin) after Total Hip Arthroplasty— The Danish Prolonged Prophylaxis (DaPP) Study☆☆☆★

The aim of this study was to compare the efficacy and safety of prolonged (35 days) thromboprophylaxis with a standard length (7 days) regimen of a low molecular weight heparin in patients undergoing total hip arthroplasty. The study was multicentre, randomised, double-blind, and prospective with two groups. Following seven days on a standard length regimen of dalteparin (5000 antifactor Xa units subcutaneously once daily starting 12 h before surgery), patients were randomized to continue the prophylaxis with either subcutaneous injections of dalteparin or placebo injections for a further 28 days. Efficacy was evaluated at the end of the study (day 35) in all patients with bilateral ascending phlebography to detect deep vein thrombosis. Bleeding complications and other adverse events were registered throughout the study period. Three hundred consecutive patients agreed to participate before the operation: 281 were finally randomised and 215 completed the study; two patients died before randomisation; 17 developed deep vein thrombosis; none developed pulmonary embolism; and five of 113 patients (4.4%, 95% CI 1-10%) developed deep vein thrombosis in the dalteparin group, compared with 12 of 102 (11.8%; 95% CI 6-20%) in the placebo group (p=0.039). Deep vein thrombosis in the proximal veins was diagnosed in one patient (0.9%; 95% CI 0-5%) in the dalteparin group, and in five (5.0%; 95% CI 2-11%) in the placebo group (p=0.076). Major bleeding was observed in one patient in the placebo group; minor bleeding complications and adverse events were equally distributed between the groups. We concluded that prolonged (35 days) thrombo prophylaxis with dalteparin is more effective than a standard length (7 days) regimen without increased risk of bleeding complications or other adverse events.

Low molecular weight heparin (Innohep) as thromboprophylaxis in outpatients with a plaster cast: a venografic controlled study.

INTRODUCTION The aim of this study was to investigate the incidence of deep vein thrombosis (DVT) in patients immobilized in plaster cast and the possible efficacy of prophylaxis with low molecular weight heparin (LMWH). MATERIAL AND METHODS The study was a randomized, assessor-blinded, open multicenter (three centers) study. All patients over 18 years of age with planned plaster cast on a lower extremity of at least 3 weeks were eligible for participation. Written informed consent was obtained from 300 patients and they were randomized to either 3.500 IU anti-Xa of tinzaparin (Innohep) subcutaneously once daily or no prophylaxis. On the day the cast was removed, ascending unilateral venography was performed. Two experienced radiologists, unaware of treatment, assessed the pictures independently. The radiologist had to obtain consensus as to whether DVT was present or not. RESULTS 300 patients were included (148 in the treatment group and 152 in the control group). Ninety-five were subsequently withdrawn. DVT was diagnosed in 10/99 patients in the treatment group and in 18/106 patients in the control group. This difference is not significant (P=.15, chi(2) test) and the odds ratio was 0.55 (95% confidence interval=0.34-1.26). CONCLUSION DVT in legs after plaster casting is a big problem, with an incidence of almost 20%. An effective prophylactic regime is required. Once-daily dose of 3.500 IU anti-Xa of tinzaparin was not sufficient.

Removal of Internal Fixation—The Effect on Patients’ Complaints: A Study of 66 Cases of Removal of Internal Fixation after Malleolar Fractures

To estimate the effect of removal of internal fixation after treatment of malleolar fractures on postoperatively presented complaints, we retrospectively evaluated 66 patients by their records and by personal questionnaires. Of all the patients, 89.4% had one or more complaints. These were typically soreness over implant and cicatrix, reduced movement of the ankle joint, and strain-related pain. About 75% of these patients reported improvement after removal. The AO mode of fixation, i.e., typically by lateral semitubular plating and transsyndesmotic screw and a medial screw or pins, and the Wiberg-Cedell mode, i.e., typically consisting of lateral single or double cerclage and staple and medial pinning, constituted the principal groupings of the patients. The two groups were comparable. In this series, we found significantly more complaints associated with the AO mode in the postoperative period. We conclude that removal of internal fixation after malleolar fractures is indicated when common types of complaints are presented.

Early Preoperative Thromboprophylaxis with Klexane® in Hip Fracture Surgery: A Placebo-Controlled Study

The aim of this study was to evaluate any possible benefits of early thromboprophylactic treatment in the preven tion of deep vein thrombosis (DVT) in high-risk hip fracture patients. Within 30 months, 239 patients were included in a double-blind placebo-controlled study. With the diagnosis of hip fracture confirmed, patients received either 40-mg Enoxa parin s.c. or placebo once daily until operation. Postoperatively, all patients received 40-mg Enoxaparin s.c. once daily until phlebography. Phlebography was first performed on the oper ated leg, and with no thrombosis detected, the other leg was investigated as well. The two groups did not differ demograph ically. Eighty-five patients were excluded. Eight patients died during the study period. The remaining 146 patients had as cending phlebography performed and 24 patients (16.4%) de veloped DVT. Nine (12%) of 75 patients in the Klexane® and 15 (21 %) of 72 patients in the placebo group developed DVT. The risk ratio was 0.58 (95% confidence limits 0.27-1.25) and p = .15 (X2 test). There was no difference in perioperative bleeding or transfusion requirements. We conclude that Klex ane® is an effective and safe thromboprophylactic agent in hip fracture patients. Key Words: Hip fracture—Thrombopro phylaxis—Low—molecular heparin.

External Fixation with the Orthofix System in Dislocated Fractures of the Lower Extremities in Children

Eighteen children with dislocated fractures of the lower extremities were operated on with a dynamic axial unilateral external fixator, the Orthofix system. Telescopic facility allows easy conversion from rigid to dynamic fixation. Seven girls and 11 boys with an average age of 11¾ years were treated. The material comprised 10 femoral and nine tibial fractures (one girl had both fracture types). Average follow-up of these children was 19 months. Closed reduction was possible in 11 cases, and eight fractures were treated by open reduction. Physiotherapy for the adjacent joints was started on the second postoperative day. In 14 of the 18 patients, partial weight-bearing crutches was also started at this time. Average hospital stay was 13 days. At the first radiographic indication of periosteal callus, dynamic loading was started. Removal offered as an outpatient procedure, was performed after an average time of 9 weeks. In one case, pin-tract-infection developed, requiring deep soft tissue revision. No pin hole loosening, chronic infection, nonunion, and or malalignment occurred. For all patients, we achieved an overall success rate of < 10° angular deviation, <1.5 cm leg length discrepancy and full range of associated joint movements.

Resection arthroplasty of the forefoot in rheumatoid arthritis cases

Resection arthroplasty of the forefoot was performed in 30 patients (48 feet) with rheumatoid arthritis. A Keller/Clayton procedure yielded good results, whereas a less radical operation (Hybbinette) created poor results. Reoperation following failed Hybbinette operations was possible.

External compression of forearm nonunion: A report on 6 cases

We treated 6 patients with 7 cases of aseptic nonunion of the forearm with external fixation and compression (Orthofix) without open reduction and bone grafting. By turning a screw on the side of the bar, compression was carried out until the nonunion gap with radiographically obliterated, usually within 2 weeks. After compression had stopped, the external fixator was retained during the following period of healing and bone remodeling. Healing of the nonunions was seen after 7 (4-11) weeks. 5 patients obtained normal mobility, while 1 had slightly restricted supination and pronation.

The use of a personal computer program for monitoring wound infections and other complications in orthopedics

A personal computer program to monitor wound infections and other complications after orthopedic operations was developed, adopting international criteria and definitions.The program offers fixed data entry screens, and a free text editor, and produces user-specified variations of seven screen pages comprising most of the epidemiological data needed for surveillance and complciation control. Furthermore a number of special lists can be generated for use in the daily work.For all reports and lists it is possible to generate subpopulations with up to twelve criteria.The program was tested in four danish orthopedic departments and serves well as a simple local tool for the operating staff, offering fast information on complication rates. Results consisting 2,583 operations are presented. The overall rates of complications were 1.8% superficial wound infections, 0.6% deep wound infections, 2.6% other infections and 3.8 other complications.The system is lowcost and an effective method of providing a widespread uniform surveillance of surgical wound infections and other complications in the orthopedic wards.

The Use of Dextran 70 as a Plasma Expander Increases the Intraoperative Bleeding in Total Hip Replacement

In total hip replacement (THR) dextran 70 is widely used as a plasma expander and as a thromboprophylactic agent. In a rec-hirudin multicenter dose-finding study approximately one third of the patients in our center received dextran 70 as a plasma expander at the beginning of the operation, the remainder received Haemaccel preoperatively. The average intraoperative bleeding was 1,572 ml (770-3,950 ml) in group 1 (dextran) and 1,160 ml (500-2,400 ml) in group 2. This difference is statistically significant (p = 0.002). The average postoperative bleeding was in group 1,273 ml (50-675 ml) and in group 2, 229 ml (0-870 ml), the difference is not significant. Total bleeding was in average 1,846 ml (850-4,250 ml) in group 1 and 1,451 ml (620-2,810 ml) in group 2; this difference is statistically significant (p = 0.012). Regarding the transfusion requirement measured in units; a median of 2, 5 units (0-8 units) were used in group 1 as opposed to 1.7 units (0-7 units) in group 2 (p = 0.055). The use of dextran 70 as a plasma expander led to significantly increased intraoperative bleeding. Key Words: Bleeding—Dextran—Hiparthroplasty.

Interest and possibilities of performing post-operative registration of wound infections in Danish orthopaedic departments. A study survey.

Surgical wound infections, like other nosocomial infections, represent a considerable burden on both the individual patient and society. As the direct result of the operation is less than optimal, and there is a considerable economic wastage. A questionnaire survey including all 69 surgical departments in Denmark was implemented. The present study indicates interest in continuous post-operative infection surveillance in 81% of the 52 answering Danish surgical departments, where orthopaedic surgery is carried out. Only about the half of the wards had financial possibilities to buy computer hardware and software for continuous registration. In Denmark only between one third and one half of the wards had prior experience with registration systems. None of the wards used the same system, and in a very few cases the registration was continuous, definitions were different and the amount of data registered varied considerably. The survey indicates the importance of establishment of uniform registration criteria and the Danish chief surgeons will accept criteria defined by a working group within the Danish Orthopedic Society. An expanded registration system developed by this working party was preferred over a ‘simple’ minimum data base system. Most departments wanted local registration only, and doctors and secretaries in unison should perform the daily registration.