Insufficient evidence for routine use of thromboprophylaxis in ambulatory patients with an isolated lower leg injury requiring immobilization: Results of a meta-analysis

Background: : There are no generally accepted guidelines for the prevention of venous thromboembolism (VTE) in ambulatory patients requiring immobilization after an isolated lower leg injury. Our objective was to evaluate the effectiveness and safety of pharmacological interventions for preventing VTE in these patients. Study Design: : Meta-analysis of randomized controlled trials. Materials and Methods: : We searched PubMed/Medline, EMBASE and the Cochrane Central Register of Controlled Trials for trials with random allocation of thromboprophylaxis, notably low molecular weight heparin (LMWH) versus no prophylaxis or placebo, in ambulatory patients with below-knee or lower leg (including the knee joint) immobilization. Outcome was analyzed using MIX to calculate the pooled risk ratio/relative risk (RR) for each outcome, along with its 95% confidence interval (CI). Results: : The RR of asymptomatic deep vein thrombosis (DVT) was 0.66 (95% CI 0.44; 1.02) for below-knee immobilization and 0.51 (95% CI 0.37; 0.70) for lower leg immobilization. Low molecular weight heparin versus no prophylaxis or placebo was evaluated. The incidence of symptomatic DVT and PE was too low to show any statistically significant difference between thromboprophylaxis and controls in both groups. Although only one adverse bleeding event was considered to bemajor, the RR for any adverse bleeding event was 1.94 (95% CI 1.03; 3.67). Conclusion: : There is insufficient evidence to warrant routine use of thromboprophylaxis in ambulatory patients with below-knee or lower leg immobilization after an isolated lower leg injury. The incidence of symptomatic VTE is too low to show a relevant clinical benefit from thromboprophylaxis

Acute Achilles tendon rupture: minimally invasive surgery versus non operative treatment, with immediate full weight bearing. Design of a randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>We present the design of an open randomized multi-centre study on surgical versus conservative treatment of acute Achilles tendon ruptures. The study is designed to evaluate the effectiveness of conservative treatment in reducing complications when treating acute Achilles tendon rupture.</p> <p>Methods/Design</p> <p>At least 72 patients with acute Achilles tendon rupture will be randomized to minimally invasive surgical repair followed by functional rehabilitation using tape bandage or conservative treatment followed by functional rehabilitation with use of a functional bracing system. Both treatment arms use a 7 weeks post-rupture rehabilitation protocol. Four hospitals in the Netherlands will participate. Primary end-point will be reduction in complications other than re-rupture. Secondary end-point will be re-rupturing, time off work, sporting activity post rupture, functional outcome by Leppilahti score and patient satisfaction. Patient follow-up will be 12 month.</p> <p>Discussion</p> <p>By making this design study we wish to contribute to more profound research on AT rupture treatment and prevent publication bias for this open-labelled randomized trial.</p> <p>Trial registration</p> <p>ISRCTN50141196</p