The incidence of DVT and need for thrombo-prophylaxis following isolated distal lower extremity fractures is unknown. The purpose of this study was to determine whether or not thrombo-prophylaxis with low molecular weight heparin was needed in this trauma population. A Multicentered Prospective Randomised Double Blind Placebo Controlled Trial was designed to define the incidence of DVT and need for thrombo-prophylaxis in this population. A sample size of two hundred and ninety-nine patients ensured a one tailed type one error of alpha = 0.05 and power of 80% as confirmed from previous studies. Males and female patients between the ages of eighteen and seventy-five years with isolated distal lower extremity fractures (excluding the foot) were eligible. All patients had surgery within forty-eight hours after injury. Patients excluded from the trial were polytrauma patients, those medically unfit for the operating room, patients with foot fractures, those receiving anticoagulation, inability to provide consent, platelets 200 umol /L. Randomization was carried out via computer generation to receive either placebo or Fragmin for fourteen days. At fourteen days, all patients underwent bilateral venograms interpreted by three independent radiologists. Equivocal venograms were interpreted by consensus. Routine follow-up was carried out for all patients at two, six, eight and twelve weeks. A total of two hundred and ninety-nine patients were enrolled in the study. One hundred thirty-six patients in the Fragmin group and one hundred and twentyfive in the placebo group completed the intervention. There were one hundred and twenty-five males and one hundred and thirty-six females in total. There was no statistically significant difference in DVT incidence between those patients treated with Fragmin or Placebo (p = 0.41). Gender, medical issues, pre-operative level of activity and body mass index had no effect on the incidence of DVT. The incidence of DVT in fragmin treated and placebo treated patients is 8.1% and 11.2%, respectively (p = 0.41). This study suggests that DVT thrombo-prophylaxis is not indicated in this patient population. To our knowledge, this is the first Randomised Controlled Trial utilizing venograms (gold standard) for DVT identification.
The incidence of deep-vein thrombosis and the need for thromboprophylaxis following isolated trauma below the knee is uncertain. We have investigated this with a prospective randomised double-blind controlled trial using low molecular weight heparin with saline injection as placebo in patients aged between 18 and 75 years who had sustained an isolated fracture below the knee which required operative fixation. All patients had surgery within 48 hours of injury and were randomised to receive either the placebo or low molecular weight heparin for 14 days, after which they underwent bilateral lower limb venography, interpreted by three independent radiologists. Further follow-up was undertaken at two, six, eight and 12 weeks. A total of 238 patients fulfilled all the inclusion criteria, with 127 in the low molecular weight heparin group and 111 in the placebo group, all of whom underwent bilateral venography. There was no statistically significant difference in the incidence of deep-vein thrombosis between those patients treated with low molecular weight heparin or the placebo (p = 0.22). The number of deep-vein thromboses in the two groups was 11 (8.7%) and 14 (12.6%), respectively. Age and the type of fracture were significantly associated with the rate of deep-vein thrombosis (p = 0.001 and p = 0.009, respectively) but gender, comorbidities and the body mass index were not. The overall incidence of deep-vein thrombosis in this series was 11%. There was no clinical or statistical significant reduction in the incidence of deep-vein thrombosis with the use of thromboprophylaxis. However, we accept that owing to a cessation of funding, recruitment to this trial had to be ended prior to establishing the necessary sample size. Our results cannot, therefore, categorically exclude the possibility that low molecular weight heparin treatment could be beneficial. We recommend a further multicentre trial be undertaken to resolve this matter.
Testing of cadaver ankle specimens was conducted to investigate the changes in kinematics with lateral ligament reconstructions. Testing included an intact condition, after injury at the ATFL and CFL sites, and separately a Brostrom repair and an anatomical gracil-lis graft reconstruction. Calcaneal range of motion was determined about the axis of applied moment in plantarflexion-dorsiflexion and in inversion-eversion directions. The injury and reconstructions were most sensitive during IE applied moment. Both reconstructions appeared to behave similar to intact motion. Failure of some Brostrom repairs however, suggest that the gracillis-graft reconstruction is initially a stronger repair. Limited research has biomechanically investigated lateral ankle ligament reconstruction procedures. The objective of this study was to determine the changes in ankle kinematics with a dual ligament Brostrom repair and an anatomical gracillis graft reconstruction. Seven cadaveric ankle specimens were tested independently in an intact condition, after an ATFL/CFL injury model, and two reconstructions. The anatomical graft reconstruction wove a gracillis tendon through the calcaneus and fibula to dually reconstruct the ATFL and CFL, and anchored to the talus. Moments were applied to the calcaneus for three cycles in plantarflexion-dorsiflexion (PD) and inversion-eversion (IE) while allowing unconstrained motion. Three dimensional motions of the calcaneus and tibia were optoelectronically tracked. Range of motion (ROM) was calculated about the axis of applied moment for the calcaneus with respect to the tibia. The ROM increase from the intact condition with the injury model was only significant for IE (p=0.001). No significant differences were found between intact and any treatments in the PD configuration. In IE, both the graft reconstruction and the Brostrom repair were significantly different from the injury model (p=0.002 and p=0.015 respectively), where the gracillis reconstruction appears more similar to the intact condition. For two specimens the Brostrom repaired ATFL failed during applied inversion moment. The injury and reconstructions were most sensitive during IE applied moment. Both reconstructions appeared to behave similar to the intact condition. Failure of some Brostrom repairs however, suggest that the gracillis-graft reconstruction is initially a stronger repair. Funding: Workers Compensation Board of British Columbia
The cost effective management of diabetic foot infections is a challenge to the Canadian health system. The objective of this study was to predict preoperatively diabetic foot patients who will fail a transmetatarsal amputation (TMA) and end in a costly and disabling below knee amputation (BKA) and hence perform a primary BKA in select patients. Twenty-one patients failing TMA and revised to BKA within the first year were compared with a matched cohort of twenty-one successful TMA’s. The factors that were selected for comparison were: age at amputation, sex, smoking, type of DM, use of osetoset, presence of charcot fractures, previous contralateral surgery, previous debridement before TMA, debridement after TMA, dialysis, duration of ulcer prior to TMA, hemoglobin level at time of TMA, HbA1C, presence of heel ulcer, prior ipsilateral toe amputation, pulse status prior to TMA, vascular reconstruction and presence of unre-constructable vascular problem. Chi-square was done for group data, and ANOVA for numeric data. Long-term control of blood glucose level (HbA1C) was found to be significant in predicting the success of TMA. Need of debridement after TMA was found to be a significant predictor of failure of TMA. There was a trend towards duration of ulcer prior to TMA and smoking being significant. All other variables, including vascular status or renal failure were not significantly different between the two groups. As we have previously achieved a 75% success rate with TMAs in diabetics, we recommend a TMA as the first procedure in all diabetics with major forefoot infection or ulceration instead of a BKA. Obtaining good diabetic control in patients at risk for or requiring amputation for foot infection may prevent the TMA from failing and the subsequent need for BKA.
Patients were randomized between surgeon chosen pressure (control) and an automatically determined tourniquet pressure(study) group. Of the study group 94/106 (88.7%) had good to excellent fields compared to the control group where 100/132 (75.8%) had good to excellent fields (p<
0.05). In the study group, 5% failed to obtain an automatic pressure. Of the remainder, the average tourniquet pressure was 198 +/− 20.2 mHg compared to 259.6 +/− 4.4 mmHg for the control group (p<
0.0001). The automatic measurement of limb occlusion pressure resulted in better operative fields at a lower pressure. To compare the quality of the operative field that results from using an automatic limb occlusion pressure measurement (study group) versus the tourniquet cuff pressure chosen by the surgeon (control group). A module allowing rapid determination of tourniquet pressure from limb occlusion pressure was attached to a Zimmer ATS tourniquet machine. Using a coin toss, patients were randomized to the study or control groups. All patients underwent elective foot and ankle operations using a wide contoured tourniquet cuff. Of two hundred and forty-three patients, one hundred and twelve were assigned to the study (automatic) group and one hundred and thirty-two to the control (surgeon selected) group. Six patients (5.4%) failed to obtain a limb occlusion pressure measurement due to anatomical constraints (toe or thigh shape) or equipment problems, leaving one hundred and six in the study group. The average measurement time to determine limb occlusion pressure was 20 +/− 6 seconds. The mean tourniquet pressure for the study group was 198.5 +/−20.2 mmHg, and 259.6 +/−4.4 mmHg for the control group (p<
0.0001). Of the study group 94 (88.7%) had good to excellent fields compared to the control group where one hundred (75.8%) had good to excellent fields (p<
0.05). An automatically determined tourniquet pressure reduced the tourniquet pressure and improved the incidence of good to excellent operative fields compared to surgeon chosen pressures. The distribution curve of automatically determined tourniquet pressure indicates that 16% of patients will have a failed field if a standard pre-selected pressure of 250 mmHg is always chosen, in part explaining why pre-selected pressure may cause a poorer operative field.
