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

Will the Playstation generation become better endoscopic surgeons?

A frequently heard comment is that the current "Playstation generation" will have superior baseline psychomotor skills. However, research has provided inconsistent results on this matter. The purpose of this study was to investigate whether the "Playstation generation" shows superior baseline psychomotor skills for endoscopic surgery on a virtual reality simulator. The 46 study participants were interns (mean age 24 years) of the department of surgery and schoolchildren (mean age 12.5 years) of the first year of a secondary school. Participants were divided into four groups: 10 interns with videogame experience and 10 without, 13 schoolchildren with videogame experience and 13 without. They performed four tasks twice on a virtual reality simulator for basic endoscopic skills. The one-way analysis of variance (ANOVA) with post hoc test Tukey-Bonferroni and the independent Student's t test were used to determine differences in mean scores. Interns with videogame experience scored significantly higher on total score (93 vs. 74.5; p=0.014) compared with interns without this experience. There was a nonsignificant difference in mean total scores between the group of schoolchildren with and those without videogame experience (61.69 vs. 55.46; p=0.411). The same accounts for interns with regard to mean scores on efficiency (50.7 vs. 38.9; p=0.011) and speed (18.8 vs. 14.3; p=0.023). In the group of schoolchildren, there was no statistical difference for efficiency (32.69 vs. 27.31; p=0.218) or speed (13.92 vs. 13.15; p=0.54). The scores concerning precision parameters did not differ for interns (23.5 vs. 21.3; p=0.79) or for schoolchildren (mean 15.08 vs. 15; p=0.979). Our study results did not predict an advantage of videogame experience in children with regard to superior psychomotor skills for endoscopic surgery. However, at adult age, a difference in favor of gaming is present. The next generation of surgeons might benefit from videogame experience during their childhoo

Early mobilisation versus plaster immobilisation of simple elbow dislocations: Results of the FuncSiE multicentre randomised clinical trial

Background/aim To compare outcome of early mobilisation and plaster immobilisation in patients with a simple elbow dislocation. We hypothesised that early mobilisation would result in earlier functional recovery. Methods From August 2009 to September 2012, 100 adult patients with a simple elbow dislocation were enrolled in this multicentre randomised controlled trial. Patients were randomised to early mobilisation (n=48) or 3 weeks plaster immobilisation (n=52). Primary outcome measure was the Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) score. Secondary outcomes were the Oxford Elbow Score, Mayo Elbow Performance Index, pain, range of motion, complications and activity resumption. Patients were followed for 1 year. Results Quick-DASH scores at 1 year were 4.0 (95% CI 0.9 to 7.1) points in the early mobilisation group versus 4.2 (95% CI 1.2 to 7.2) in the plaster immobilisation group. At 6 weeks, early mobilised patients reported less disability (Quick-DASH 12 (95% CI 9 to 15) points vs 19 (95% CI 16 to 22); p<0.05) and had a larger arc of flexion and extension (121° (95% CI 115° to 127°) vs 102° (95% CI 96° to 108°); p<0.05). Patients returned to work sooner after early mobilisation (10 vs 18 days; p=0.020). Complications occurred in 12 patients; this was unrelated to treatment. No recurrent dislocations occurred. Conclusions Early active mobilisation is a safe and effective treatment for simple elbow dislocations. Patients recovered faster and returned to work earlier without increasing the complication rate. No evidence was found supporting treatment benefit at 1 year

A hinged external fixator for complex elbow dislocations: A multicenter prospective cohort study

Background: Elbow dislocations can be classified as simple or complex. Simple dislocations are characterized by the absence of fractures, while complex dislocations are associated with fractures of the radial head, olecranon, or coronoid process. The majority of patients with these complex dislocations are treated with open reduction and internal fixation (ORIF), or arthroplasty in case of a non-reconstructable radial head fracture. If the elbow joint remains unstable after fracture fixation, a hinged elbow fixator can be applied. The fixator provides stability to the elbow joint, and allows for early mobilization. The latter may be important for preventing stiffness of the joint. The aim of this study is to determine the effect of early mobilization with a hinged external elbow fixator on clinical outcome in patients with complex elbow dislocations with residual instability following fracture fixation. Methods/Design. The design of the study will be a multicenter prospective cohort study of 30 patients who have sustained a complex elbow dislocation and are treated with a hinged elbow fixator following fracture fixation because of residual instability. Early active motion exercises within the limits of pain will be started immediately after surgery under supervision of a physical therapist. Outcome will be evaluated at regular intervals over the subsequent 12 months. The primary outcome is the Quick Disabilities of the Arm, Shoulder, and Hand score. The secondary outcome measures are the Mayo Elbow Performance Index, Oxford Elbow Score, pain level at both sides, range of motion of the elbow joint at both sides, radiographic healing of the fractures and formation of periarticular ossifications, rate of secondary interventions and complications, and health-related quality of life (Short-Form 36). Discussion. The outcome of this study will yield quantitative data on the functional outcome in patients with a complex elbow dislocation and who are treated with ORIF and additional stabilization with a hinged elbow fixator. Trial Registration. The trial is registered at the Netherlands Trial Register (NTR1996)

HUMeral Shaft Fractures: MEasuring Recovery after Operative versus Non-operative Treatment (HUMMER): A multicenter comparative observational study

Background: Fractures of the humeral shaft are associated with a profound temporary (and in the elderly sometimes even permanent) impairment of independence and quality of life. These fractures can be treated operatively or non-operatively, but the optimal tailored treatment is an unresolved problem. As no high-quality comparative randomized or observational studies are available, a recent Cochrane review concluded there is no evidence of sufficient scientific quality available to inform the decision to operate or not. Since randomized controlled trials for this injury have shown feasibility issues, this study is designed to provide the best achievable evidence to answer this unresolved problem. The primary aim of this study is to evaluate functional recovery after operative versus non-operative treatment in adult patients who sustained a humeral shaft fracture. Secondary aims include the effect of treatment on pain, complications, generic health-related quality of life, time to resumption of activities of daily living and work, and cost-effectiveness. The main hypothesis is that operative treatment will result in faster recovery. Methods/design. The design of the study will be a multicenter prospective observational study of 400 patients who have sustained a humeral shaft fracture, AO type 12A or 12B. Treatment decision (i.e., operative or non-operative) will be left to the discretion of the treating surgeon. Critical elements of treatment will be registered and outcome will be monitored at regular intervals over the subsequent 12 months. The primary outcome measure is the Disabilities of the Arm, Shoulder, and Hand score. Secondary outcome measures are the Constant score, pain level at both sides, range of motion of the elbow and shoulder joint at both sides, radiographic healing, rate of complications and (secondary) interventions, health-related quality of life (Short-Form 36 and EuroQol-5D), time to resumption of ADL/work, and cost-effectiveness. Data will be analyzed using univariate and multivariable analyses (including mixed effects regression analysis). The cost-effectiveness analysis will be performed from a societal perspective. Discussion. Successful completion of this trial will provide evidence on the effectiveness of operative versus non-operative treatment of patients with a humeral shaft fracture. Trial registration. The trial is registered at the Netherlands Trial Register (NTR3617)

Functional treatment versus plaster for simple elbow dislocations (FuncSiE): a randomized trial

Background. Elbow dislocations can be classified as simple or complex. Simple dislocations are characterized by the absence of fractures, while complex dislocations are associated with fractures. After reduction of a simple dislocation, treatment options include immobilization in a static plaster for different periods of time or so-called functional treatment. Functional treatment is characterized by early active motion within the limits of pain with or without the use of a sling or hinged brace. Theoretically, functional treatment should prevent stiffness without introducing increased joint instability. The primary aim of this randomized controlled trial is to compare early functional treatment versus plaster immobilization following simple dislocations of the elbow. Methods/Design. The design of the study will be a multicenter randomized controlled trial of 100 patients who have sustained a simple elbow dislocation. After reduction of the dislocation, patients are randomized between a pressure bandage for 5-7 days and early functional treatment or a plaster in 90 degrees flexion, neutral position for pro-supination for a period of three weeks. In the functional group, treatment is started with early active motion within the limits of pain. Function, pain, and radiographic recovery will be evaluated at regular intervals over the subsequent 12 months. The primary outcome measure is the Quick Disabilities of the Arm, Shoulder, and Hand score. The secondary outcome measures are the Mayo Elbow Performance Index, Oxford elbow score, pain level at both sides, range of motion of the elbow joint at both sides, rate of secondary interventions and complication rates in both groups (secondary dislocation, instability, relaxation), health-related quality of life (Short-Form 36 and EuroQol-5D), radiographic appearance of the elbow joint (degenerative changes and heterotopic ossifications), costs, and cost-effectiveness. Discussion. The successful completion of this trial will provide evidence on the effectiveness of a functional treatment for the management of simple elbow dislocations. Trial Registration. The trial is registered at the Netherlands Trial Register (NTR2025)

End cap versus no end cap in intramedullary nailing for displaced midshaft clavicle fractures : influence on implant-related irritation

Purpose: Implant-related irritation at the entry site is a known disadvantage of intramedullary nailing for clavicle fractures. The purpose of this study was to compare implant-related irritation rates of intramedullary nailing with or without an end cap for displaced midshaft clavicle fractures. Methods: Two cohorts of patients treated with intramedullary nailing with or without an end cap were matched and compared. Primary outcome was patient-reported implant-related irritation. Secondary outcome parameters were complications. Results: A total of 34 patients with an end cap were matched with 68 patients without an end cap. There was no difference in implant-related irritation (41 versus 53%, P = 0.26). Significantly more minor revisions were observed in the group without an end cap (15 versus 0%, P = 0.03). For complications requiring major revision surgery, significantly more implant failures were observed in the end cap group (12 versus 2%, P = 0.04). Regardless of their treatment, patients with complex fractures (AO/OTA B2–B3) reported significantly more medial irritation compared to patients with simple fractures (AO/OTA B1)(P = 0.02). Conclusion: The use of an end cap after intramedullary nailing for displaced midshaft clavicle fractures did not result in lower patient-reported irritation rates. Although less minor revisions were observed, more major revisions were reported in the end cap group. Based on the results of this study, no end caps should be used after intramedullary nailing for displaced midshaft clavicle fractures. However, careful selection of simple fractures might be effective in reducing implant-related problems after intramedullary nailing