Fracture surgery of the extremities with the intra-operative use of 3D-RX: a randomized multicenter trial (EF3X-trial).

BACKGROUND: Posttraumatic osteoarthritis can develop after an intra-articular extremity fracture, leading to pain and loss of function. According to international guidelines, anatomical reduction and fixation are the basis for an optimal functional result. In order to achieve this during fracture surgery, an optimal view on the position of the bone fragments and fixation material is a necessity. The currently used 2D-fluoroscopy does not provide sufficient insight, in particular in cases with complex anatomy or subtle injury, and even an 18-26% suboptimal fracture reduction is reported for the ankle and foot. More intra-operative information is therefore needed.Recently the 3D-RX-system was developed, which provides conventional 2D-fluoroscopic images as well as a 3D-reconstruction of bony structures. This modality provides more information, which consequently leads to extra corrections in 18-30% of the fracture operations. However, the effect of the extra corrections on the quality of the anatomical fracture reduction and fixation as well as on patient relevant outcomes has never been investigated.The objective of this study protocol is to investigate the effectiveness of the intra-operative use of the 3D-RX-system as compared to the conventional 2D-fluoroscopy in patients with traumatic intra-articular fractures of the wrist, ankle and calcaneus. The effectiveness will be assessed in two different areas: 1) the quality of fracture reduction and fixation, based on the current golden standard, Computed Tomography. 2) The patient-relevant outcomes like functional outcome range of motion and pain. In addition, the diagnostic accuracy of the 3D-RX-scan will be determined in a clinical setting and a cost-effectiveness as well as a cost-utility analysis will be performed. METHODS/DESIGN: In this protocol for an international multicenter randomized clinical trial, adult patients (age > 17 years) with a traumatic intra-articular fracture of the wrist, ankle or calcaneus eligible for surgery will be subjected to additional intra-operative 3D-RX. In half of the patients the surgeon will be blinded to these results, in the other half the surgeon may use the 3D-RX results to further optimize fracture reduction. In both randomization groups a CT-scan will be performed postoperatively. Based on these CT-scans the quality of fracture reduction and fixation will be determined. During the follow-up visits after hospital discharge at 6 and 12 weeks and 1 year postoperatively the patient relevant outcomes will be determined by joint specific, health economic and quality of life questionnaires. In addition a follow up study will be performed to determine the patient relevant outcomes and prevalence of posttraumatic osteoarthritis at 2 and 5 years postoperatively. DISCUSSION: The results of the study will provide more information on the effectiveness of the intra-operative use of 3D-imaging during surgical treatment of intra-articular fractures of the wrist, ankle and calcaneus. A randomized design in which patients will be allocated to a treatment arm during surgery will be used because of its high methodological quality and the ability to detect incongruences in the reduction and/or fixation that occur intra-operatively in the blinded arm of the 3D-RX. An alternative, pragmatic design could be to randomize before the start of the surgery, then two surgical strategies would be compared. This resembles clinical practice better, but introduces more bias and does not allow the assessment of incongruences that would have been detected by 3D-RX in the blinded arm. TRIAL REGISTRATION: Dutch Trial Register NTR 1902.

[Perioperative 3D fluoroscopy of intra-articular fractures of the extremities]. / Peroperatieve 3D-doorlichting bij intra-articulaire fracturen aan de extremiteiten.

During operative treatment of intra-articular fractures of the extremities, 2D fluoroscopy is often used for assessing the quality of fracture reduction and fixation and for making any necessary corrections. Post-operative radiographs or CT scans, however, frequently reveal suboptimal reduction or fixation of the fracture. To help prevent this, a 3D-fluoroscopy technique that can be used during surgery has been developed. The radiation exposure from intra-operative 3D fluoroscopy is higher than that from 2D fluoroscopy, but significantly lower than exposure resulting from CT scanning. The diagnostic value of 3D fluoroscopy is comparable to that of CT scanning. Extra corrections were performed during a considerably high percentage of operations (11-39%) using 3D fluoroscopy; it is unknown, however, whether corrections are required of all the defects detected. In a randomised clinical trial, we are currently investigating the added value of 3D fluoroscopy in terms of the quality of procedures involving the reduction and fixation, as well as patient-relevant outcomes such as pain and joint function in the long term.

[Choosing between different treatment options: how should I inform my patients?]. / Kiezen tussen verschillende behandelopties; hoe informeer ik mijn patiënt?

Evidence-based medicine promotes the use of best available evidence to improve the transparency and quality of health care. The physician's clinical expertise and patient preferences are also important. Clear communication with the patient, based on available evidence from scientific research, is pivotal to making a balanced treatment choice, particularly when several equivalent treatment options are available. Although cure is obviously the aim of any medical intervention a certain risk of damage is always involved. Several verbal, numerical and graphical methods are available to inform the patient, with the aim of enabling the patient to make an informed choice when taking part in decisions on available treatment options. The aim should be to explain both beneficial and harmful effects of medical interventions in a straightforward manner. However, the amount and content of this information should be tailored to the patient's wishes.

[Antiseptics to prevent or treat wound infections; myths and evidence]. / Antiseptica ter preventie of behandeling van wondinfecties: mythes en evidence.

Antiseptics are commonly applied to prevent or treat wound infections. Many common opinions about antiseptics appear not to be supported by convincing evidence. The aim of this review is to compare such traditional beliefs with currently available evidence. While antiseptics obviously reduce the number of pathogens, their value as a supplement to or as replacement of wound cleansing remains unclear.Some antiseptics encourage wound healing, others may even delay it. Many of the adverse effects ascribed to antiseptics are not supported by evidence; nevertheless this has resulted in a reduction of their use.If used as part of a multifaceted approach to wound care, antiseptics are to be preferred over locally applied antibiotics as they are safer, have a broader spectrum of activity (particularly against antibiotic-resistant bacteria), and rarely lead to resistance.

Comparison of homecare costs of local wound care in surgical patients randomized between occlusive and gauze dressings.

AIMS AND OBJECTIVES: To study the material and nursing costs and outcome of wound care at home comparing two dressing groups (occlusive vs. gauze-based) in surgical patients after hospital dismissal. BACKGROUND: The large variety in dressing materials and lack of convincing evidence make the choice for optimum local wound care at home cumbersome. Occlusive wound dressings require a lower change frequency than gauze-based dressings, which appears especially useful for homecare patients and could save costs. METHODS: We investigated a consecutive series of 76 patients with wounds, included in a randomized trial comparing occlusive vs. gauze dressings. Daily dressing change frequency, consumption of dressing materials and need for district nursing visits were recorded until wound closure by means of diaries and at outpatient visits. Costs were expressed as means and 95% confidence intervals (CI) after calculation using non-parametric bootstrapping. RESULTS: Patient groups were similar regarding age, wound size and aetiology. Dressing change frequency in the occlusive group (median: 0.6/day) was significantly (p = 0.008) lower than in the gauze group (1.1/day). Mean daily material costs of modern dressings were euro5.31 vs. euro0.71 in the gauze group. Mean difference; euro4.60 (95% CI, euro2.68-euro6.83) while daily total (material plus nursing) costs showed no difference between the groups; mean euro2.86 (95% CI, euro-6.50-euro10.25). Wound healing in the gauze-treated group tended to be quicker than in the occlusive dressing group (medians: 30 vs. 48 days, respectively; log-rank p = 0.060). CONCLUSIONS: The use of occlusive dressings does not lead to a reduction in costs and wound healing time as compared with gauze dressings for surgical patients receiving wound care at home. RELEVANCE TO CLINICAL PRACTICE: District nurses should reconsider using gauze-based dressings, particularly in surgical patients with exudating wounds.

External validation of the Glasgow Aneurysm Score to predict outcome in elective open abdominal aortic aneurysm repair.

OBJECTIVES: Selecting patients based on their risk profiles could improve the outcome after elective surgery of an abdominal aortic aneurysm (AAA). The Glasgow Aneurysm Score (GAS) is a scoring system developed to determine such risk profiles. In other settings, the GAS has proved to have a predictive value for the postoperative outcome. The aim of this study was to investigate whether the GAS was also valid for the patients in our hospital and to examine risk factors with a possible predictive value for postoperative mortality and morbidity. METHODS: We performed a retrospective cohort study in a university hospital. The medical records of 229 patients who underwent open elective repair for an AAA in the period 1994 to 2003 were retrospectively analyzed to assess the GAS and to determine which of the examined risk factors had a predictive value for the prognosis. RESULTS: Five patients (2.2%) died after surgery and 30 (13.1%) had a major complication. The GAS was predictive for postoperative death (P = .021; sensitivity, 1.00; 95% confidence interval [CI], 0.52 to 1.00; specificity, 0.67; 95% CI, 0.61 to 0.73) and also for major morbidity (P = .029; sensitivity, 0.63; 95% CI, 0.46 to 0.78; specificity, 0.70; 95% CI, 0.64 to 0.76). The positive predictive value (mortality, 0.06; morbidity, 0.24) and the positive likelihood ratio (mortality, 3.07; morbidity, 2.14) were low, however. The best cutoff value for the GAS was determined at 77. All the deceased patients (100%) and 63.3% of those who had a major complication had a risk score of >or=77. Of all examined risk factors, suprarenal clamping during surgery was predictive of in-hospital mortality (8.3%, P = .017). For major morbidity, three risk factors, all of which are components of the GAS, were predictive: age (P = .046), cardiac disease (P = .032), and renal disease (P = .041). CONCLUSIONS: The Glasgow Aneurysm Score has a predictive value for outcome after open elective AAA repair. Because of its relatively low positive predictive value for death and major morbidity, the GAS is of limited value in clinical decision-making for the individual high-risk patient. In some particular cases, however, the GAS can be a useful tool, especially for low-risk patients because it has good negative predictive value for this group. Suprarenal clamping was found to be a risk factor for postoperative death.

Spinal cord stimulation for critical leg ischemia: a review of effectiveness and optimal patient selection.

Patients suffering from inoperable critical leg ischemia (CLI) ultimately face a major amputation. Spinal cord stimulation (SCS) has been introduced as a possible treatment option. This paper presents the best available evidence from a systematic review on the effectiveness of SCS in these patients and discusses the indications for SCS therapy. A meta-analysis of six controlled trials, including 444 patients, showed 11% (95% confidence interval: -0.02 to -0.20) lower amputation rate after 12 months compared to those treated with optimum medical treatment. In addition, SCS patients required significantly fewer analgesics and showed a significant clinical improvement. These positive effects have to be weighed against the higher costs and (generally minor) complications of SCS. TcpO(2) measurements were found to be useful in selecting the most respondent patients, yielding a 12-month limb salvage up to 83%. Hence, SCS should be considered as a possible treatment option in patients with CLI, particularly if their foot TcpO(2) is between 10 and 30 mmHg.

The diagnostic randomized clinical trial is the best solution for management issues in critical limb ischemia.

OBJECTIVE: The value of a new diagnostic test is usually established by analyzing its accuracy in relation to a reference standard. Here we describe a potentially better model of diagnostic research, namely, a diagnostic randomized clinical trial (D-RCT), and discuss its pros and cons using management of critical limb ischemia as an example. STUDY DESIGN AND SETTING: Patients clinically suspected of critical limb ischemia are randomized either for the conventional management strategy (treating physician determines the diagnostic and therapeutic strategy on clinical judgment and ankle pressure) or new strategy (transcutaneous oxygen and toe pressure determine the diagnostic and therapeutic strategy). The effect of the diagnostic work-up on the diagnostic and therapeutic process and clinical outcome will be evaluated. RESULTS: A D-RCT is suited when a true reference standard is lacking. It is the best available research method to control for confounding and bias, and it also incorporates the total effect (interpretation and side effects) on clinical outcome. The D-RCT has some disadvantages, however, as to the power and size of the trial and the influence of treatment on the outcome parameter. CONCLUSIONS: A D-RCT can provide valuable information as to the evaluation of diagnostic tests.

Contrast-enhanced duplex scanning of crural arteries by means of continuous infusion of Levovist.

OBJECTIVES: To estimate the dosage needed for continuous infusion and to investigate whether continuous infusion of the ultrasound contrast-enhancing agent Levovist (SH U 508A) can improve duplex scanning of crural arteries in patients with peripheral arterial obstructive disease (PAOD) eligible for distal bypass graft surgery. DESIGN, PATIENTS, AND METHODS: The study design consisted of two parts. Part 1 investigated the color and spectral Doppler scan enhancement of three different Levovist dosages (200, 300, and 400 mg/mL) in one arterial segment of a patent lumen of a crural artery in seven patients with PAOD. Part 2 investigated the value of the optimum Levovist dosage in the assessment of 10 crural arteries in 10 consecutive patients with PAOD. Angiography was the reference standard. RESULTS: Part 1: Levovist significantly enhanced color and spectral Doppler scan as compared with baseline ultrasound scan, but no differences were found between the Levovist dosages. Thus, the lowest Levovist dosage sufficed for application in part 2, because of its infusion volume and prolonged enhancement time. Part 2: The agreement between contrast-enhanced duplex scanning and angiography was moderate (kappa = 0.50; 95% confidence interval [CI], 0.03-0.97). Five (50%) of 10 crural arteries that could not adequately be visualized with routine duplex scanning could be visualized with contrast-enhanced duplex scanning. CONCLUSION: Contrast-enhanced duplex scanning by means of continuous infusion of Levovist in patients with PAOD improves the ultrasound scan investigation of crural arteries in case routine duplex scanning is inconclusive and might reduce the need for angiography.

Influence of peripheral arterial disease on capillary pressure in the foot.

BACKGROUND: Capillary perfusion and transmural pressure are delicately regulated by microvascular constriction mechanisms, which are activated upon a change in posture. Capillary flow is known to be disturbed in patients with severe peripheral arterial disease. To date, however, the influence of this disease on capillary pressure is unknown. METHODS: Capillary pressure in the nail fold of the hallux, ankle, and toe blood pressures were measured in the sitting and supine positions in 8 patients with intermittent claudication (F2), in 7 patients with rest pain and/or ischemic ulcers (F3-4), and in 12 age-matched healthy controls (F0). Red blood cell velocity, laser Doppler flux, and continuous blood pressure of the second toe were measured simultaneously. Toe, ankle, and brachial pressure were measured after the experiment in both positions. RESULTS: Capillary pressure did not increase significantly with increasing disease severity (F0, F2, and F3-4) in supine (P =.37; medians, 17, 21, and 14 mm Hg, respectively) and sitting (P =.96; medians, 59, 60, and 60 mg Hg, respectively) positions, whereas toe systolic pressure did, both in supine (P <.001; medians, 91, 49, and 14 mm Hg, respectively) and sitting (140, 104, and 64 mm Hg, respectively) positions. Nutritive skin perfusion (red blood cell velocity) decreased with increasing disease severity (F0, F2, and F3-4) while supine (P =.005; medians,.19,.20, and.04 mm/s, respectively) and while sitting (P =.06; medians,.22,.15, and.04 mm/s, respectively). CONCLUSIONS: An increase in orthostatic pressure increases both toe and capillary pressures. Arterial insufficiency of the leg seems to leave the capillary pressure unscathed. Apparently, arteriolar vasodilation compensates for the lower arterial pressure in both positions, even in patients with rest pain and low nutritive perfusion.

Evaluation of toe pressure and transcutaneous oxygen measurements in management of chronic critical leg ischemia: a diagnostic randomized clinical trial.

OBJECTIVE: The definition of critical limb ischemia (CLI) requiring vascular intervention is still under debate. The clinical eye of the physician and ankle blood pressure measurements used so far may fall short in appreciation of the severity of disease, which makes decision-making for a vascular intervention subjective. In previous studies two simple functional tests, ie, transcutaneous oxygen pressure (tcPo(2)) and toe blood pressure (TP) measurements, provided reliable information about the need for vascular intervention. Therefore we evaluated the diagnostic value of tcPo(2) and TP in management of clinically suspected critical leg ischemia. Study design This was a diagnostic randomized controlled clinical trial. Subjects were ambulatory and hospitalized patients in a referral university hospital. METHODS: Ninety-six patients (128 legs) with clinically suspected critical limb ischemia were referred to the vascular laboratory for routine investigation. Two diagnostic management strategies were compared: conventional strategy, ie, clinical judgment and ankle pressure determined the diagnostic and therapeutic approach, and a new strategy in which tcPo(2) and TP determined the diagnostic and therapeutic approach. Main outcome measures included clinical outcome, defined as pain relief, wound healing, and limb survival. RESULTS: At 18-month follow-up, 26 of 62 legs treated with the conventional approach and 28 of 66 legs treated with the new approach were treated conservatively. The new method did not score significantly different from the conventional method insofar as clinical outcome: pain score, 50 versus 48; number of amputations, 8 versus 10; and number of deaths, 11 versus 8 deaths, respectively. CONCLUSION: Two simple objective diagnostic tests, TP and tcPo(2), did not improve clinical outcome when incorporated into routine management of suspected critical limb ischemia. Nevertheless, these techniques might still be helpful for physicians less experienced with treating critical limb ischemia and who are in doubt regarding the need for vascular intervention.

Effect of beta-blockers on peripheral skin microcirculation in hypertension and peripheral vascular disease.

OBJECTIVE: This study was undertaken to investigate the possible negative effect of beta-blockers on skin microcirculation in patients with intermittent claudication and hypertension. Methods and materials In this clinical crossover study, 20 patients with mild to moderate hypertension, treated with long-term beta-blockade, and intermittent claudication or ischemic rest pain, underwent assessment of peripheral circulation before and after 2-week withdrawal of beta-blocking therapy and again 2 weeks after restarting therapy. Replacement therapy (calcium antagonist) was given if considered necessary to control hypertension. Skin microcirculation was assessed with three noninvasive techniques: capillary microscopy of the hallux nailfold, transcutaneous oximetry of the forefoot, and laser Doppler fluxmetry of the great toe. RESULTS: Mean initial blood pressure was 163/81 mm Hg. Mean heart rate significantly increased with withdrawal of beta-blocker, from 65 bpm to 85 bpm. No significant differences in skin microcirculation and blood pressure were found between measurements obtained before, during, and after withdrawal of beta-blocking therapy. Patients experienced no change in symptoms during the study. CONCLUSION: beta-Blockers do not appear to have a negative effect on peripheral skin microcirculation and are therefore not contraindicated to treat hypertension when intermittent claudication or ischemic rest pain is also present.

Improved assessment of the hemodynamic significance of borderline iliac stenoses with use of hyperemic duplex scanning.

OBJECTIVE: To improve the assessment of the hemodynamic significance of borderline iliac stenoses (stenosis with a peak systolic velocity [PSV] ratio between 1.5 and 3.5) by means of hyperemic duplex scanning. The duplex ultrasound parameter-absolute increase in PSV across the stenosis after exercise (Delta PSV(e))-was studied prospectively. PATIENTS AND METHODS: Fifty-eight legs in 53 consecutive patients with symptomatic arterial obstructive disease with borderline iliac stenosis were studied prospectively. Ultrasound velocity data collected after exercise on a bicycle ergometer at 2 W/kg during 2 minutes were judged against the assessment of the hemodynamic significance by means of intraarterial pressure measurement, before and after the administration of 50 mg papaverine. RESULTS: On the basis of receiver operating characteristic curves traced for 43 iliac stenoses in 39 patients who finished the exercise, Delta PSV(e) > or = 1.4 m/s had optimal sensitivity of 93% (95% confidence interval [CI],.77-.99), specificity of 87% (95% CI,.60-.98), positive predictive value of 93% (95% CI,.77-.99) and negative predictive value of 87% (95% CI,.60-.98). CONCLUSIONS: The results of this study show that Delta PSV(e) with a cutoff value of 1.4 m/s in combination with the PSV ratio improves the assessment of the hemodynamic significance of borderline iliac artery stenoses if the patient can accomplish the workload.

The impact of peripheral and coronary artery disease on health-related quality of life.

Vascular diseases, like peripheral arterial diseases (PAD) and coronary artery disease (CAD), are common diseases with a high morbidity. We investigated and compared the impact of these diseases on daily life using health-related quality of life (HRQOL) analysis. In 89 patients with PAD and 89 patients with multivessel CAD, the SF-36 was assessed before diagnostic staging and compared with an age-matched reference population. Both groups of patients had a significantly impaired HRQOL as compared to a reference population. Patients with PAD scored significantly (p < 0.001) lower than those with CAD on the domains general health perception, change in health, physical functioning, social functioning, and pain. Patients with PAD have a reduced HRQOL in comparison with patients with CAD. Each disease has an impact on a specific domain of the HRQOL. Vascular disease mainly influences physical health.

The feasibility and reliability of capillary blood pressure measurements in the fingernail fold.

Capillary blood pressure is an essential parameter in the study of the (patho-)physiology of microvascular perfusion. Currently, capillary pressure measurements in humans are performed using a servo-nulling micropressure system containing an oil-water interface, which suffers some drawbacks. In addition, the effect of the preparation of the skin and the presence of the tip of the pipette in the capillary during the measurement on microcirculatory perfusion has never been described. Therefore, we assessed the feasibility of capillary pressure measurements using an alternative micropressure system using an air-water interface (900 A, WPI) and examined the effect of the measurement on local microcirculation. In 19 healthy male volunteers the apex of capillaries in the eponychium of the fourth finger was punctured, after skin peeling, by a micropipette connected to a servo-nulling micropressure system. Red blood cell velocity (RBCV) was assessed after peeling during the measurement and at an adjacent area. Mean capillary pressure (in 16/19 volunteers) was 20.5 +/- 3.7 mm Hg (systolic 26.2 +/- 5.6 mm Hg, diastolic 17.6 +/- 3.9 mm Hg). RBCV was not significantly different before (0.52 mm/s) and during the measurement (0.51 mm/s) and at an adjacent area (0.51 mm/s). Capillary pressure can be measured well with the alternative setup used without hampering capillary flow, while the pressures obtained are in agreement with the results reported previously by other investigators.

Color-flow duplex scanning of the leg arteries by use of a new echo-enhancing agent.

OBJECTIVE: This was a dose-finding and effectiveness study of a newly developed contrast-enhancing agent, sulphur hexafluoride (SF(6)), in patients with peripheral arterial disease in whom the therapeutic policy could not be established on the basis of standard color-flow duplex scanning of the leg arteries. METHODS: In this open-label, randomized, dose-ranging, crossover design, 14 patients in whom the assessment of vessel patency was difficult because of poor visibility (low-flow state) or extensive wall calcifications were studied. Contrast-enhanced duplex scanning was performed on the upper leg (n = 4), lower leg (n = 6), or pedal (n = 4) arteries after intravenous injection of four different dosages of SF(6). The results were compared with those from selective angiography of the vessel of interest. Contrast duration and agreement about the diagnosis and the confidence in the diagnosis were obtained before and after administration of the contrast agent. RESULTS: No adverse effects of the contrast agent were seen. Overall agreement was reasonable with regard to vessel patency between contrast-enhanced duplex scanning and angiography (71%). Nine of 14 vessels (64%) appeared open when contrast was applied. In four cases this could not be confirmed by angiography; in two of these cases this was due to the presence of collateral vessels. All vessels that appeared occluded with the contrast agent were also occluded on the angiogram. The confidence in the diagnosis increased from 56% to 91% after contrast administration (P <.0001). CONCLUSION: SF(6)-enhanced color-flow duplex scanning is a safe method that may improve the assessment of the patency of leg arteries, particularly in low-flow states. The visualization of collateral vessles during (enhanced) duplex scanning may be misleading because they may be regarded as the vessel of interest.