Validity and responsiveness of the Clubfoot Assessment Protocol (CAP). A methodological study

BACKGROUND: The Clubfoot Assessment Protocol (CAP) is a multi dimensional instrument designed for longitudinal follow up of the clubfoot deformity during growth. Item reliability has shown to be sufficient. In this article the CAP's validity and responsiveness is studied using the Dimeglio classification scoring as a gold standard. METHODS: Thirty-two children with 45 congenital clubfeet were assessed prospectively and consecutively at ages of new-born, one, two, four months and two years of age. For convergent/divergent construct validity the Spearman's correlation coefficients were calculated. Discriminate validity was evaluated by studying the scores in bilateral clubfeet. The floor-ceiling effects at baseline (untreated clubfeet) and at two years of age (treated clubfeet) were evaluated. Responsiveness was evaluated by using effect sizes (ES) and by calculating if significant changes (Wilcoxons signed test) had occurred between the different measurement occasions. RESULTS: High to moderate significant correlation were found between CAP mobility I and morphology and the Dimeglio scores (r(s )= 0.77 and 0.44 respectively). Low correlation was found between CAP muscle function, mobility II and motion quality and the Dimeglio scoring system (r(s )= 0.20, 0.09 and 0.06 respectively). Of 13 children with bilateral clubfeet, 11 showed different CAP mobility I scores between right and left foot at baseline (untreated) compared with 5 with the Dimeglio score. At the other assessment occasions the CAP mobility I continued to show higher discrimination ability than the Dimeglio. No floor effects and low ceiling effects were found in the untreated clubfeet for both instruments. High ceiling effects were found in the CAP for the treated children and low for the Dimeglio. Responsiveness was good. ES from untreated to treated ranged from 0.80 to 4.35 for the CAP subgroups and was 4.68 for the Dimeglio. The first four treatment months, the CAP mobility I had generally higher ES compared with the Dimeglio. CONCLUSION: The Clubfoot Assessment Protocol shows in this study good validity and responsiveness. The CAP is more responsive when severity ranges between mild – moderate to severe, while the Dimeglio focuses more on the extremes. The ability to discriminate between different mobility status of the right and left foot in bilaterally affected children in this population was higher compared with the Dimeglio score implicating a better sensitivity for the CAP

Preclinical experience using a new robotic system created for microsurgery

\u3cp\u3eBACKGROUND: Robotic assistance in microsurgery could enhance human precision and dexterity to improve clinical outcomes. Because no robotic device has been designed primarily for microsurgery, the authors developed a dedicated microsurgical robotic system. This preclinical study investigates whether microsurgical anastomosis can be successfully completed on silicone vessels using a prototype of this new robotic system, and compares outcomes of robot-assisted versus conventional microsurgery. METHODS: Three participants at different levels of microsurgical training completed 10 anastomoses by hand and 10 anastomoses with robotic assistance. Four blinded, experienced microsurgeons evaluated the quality of the microsurgical skills using a modified version of the Structured Assessment of Microsurgical Skills. Time to perform the anastomosis and adverse events were recorded. RESULTS: The total time to perform the anastomoses with and without robotic assistance decreased to 35.1 minutes and 12.5 minutes, respectively, during the study. The overall performance and indicative skill of the Structured Assessment of Microsurgical Skills improved with the conventional method (from 2.8 to 3.6 and from 2.6 to 3.7, respectively) and the robot-assisted method (from 2.3 to 3.0 and from 2.3 to 3.1, respectively). CONCLUSIONS: It is feasible to complete anastomotic microsurgery on silicone vessels using the MicroSure robotic system. In comparison with the conventional method, time to perform the anastomosis was longer and quality of microsurgical skills was lower in the robot-assisted group. However, the robot-assisted performance showed steeper learning curves for both surgical time and domains of microsurgical skills. The encouraging results indicate further development of the system and (pre)clinical trials.\u3c/p\u3

Robotic (super) microsurgery:feasibility of a new master-slave platform in an in vivo animal model and future directions

\u3cp\u3eAdvanced microsurgical procedures are currently limited by human precision and manual dexterity. The potential of robotics in microsurgery is highlighted, including a general overview of applications of robotic assistance in microsurgery and its introduction in different surgical specialties. A new robotic platform especially designed for (super) microsurgery is presented. Results of an in vivo animal study underline its feasibility and encourage further development toward clinical studies. Future directions of robotic microsurgery are proposed.\u3c/p\u3

Fixation using alternative implants for the treatment of hip fractures (FAITH): design and rationale for a multi-centre randomized trial comparing sliding hip screws and cancellous screws on revision surgery rates and quality of life in the treatment of femoral neck fractures

BACKGROUND: Hip fractures are a common type of fragility fracture that afflict 293,000 Americans (over 5,000 per week) and 35,000 Canadians (over 670 per week) annually. Despite the large population impact the optimal fixation technique for low energy femoral neck fractures remains controversial. The primary objective of the FAITH study is to assess the impact of cancellous screw fixation versus sliding hip screws on rates of revision surgery at 24 months in individuals with femoral neck fractures. The secondary objective is to determine the impact on health-related quality of life, functional outcomes, health state utilities, fracture healing, mortality and fracture-related adverse events. METHODS/DESIGN: FAITH is a multi-centre, multi-national randomized controlled trial utilizing minimization to determine patient allocation. Surgeons in North America, Europe, Australia, and Asia will recruit a total of at least 1,000 patients with low-energy femoral neck fractures. Using central randomization, patients will be allocated to receive surgical treatment with cancellous screws or a sliding hip screw. Patient outcomes will be assessed at one week (baseline), 10 weeks, 6, 12, 18, and 24 months post initial fixation. We will independently adjudicate revision surgery and complications within 24 months of the initial fixation. Outcome analysis will be performed using a Cox proportional hazards model and likelihood ratio test. DISCUSSION: This study represents major international efforts to definitively resolve the treatment of low-energy femoral neck fractures. This trial will not only change current Orthopaedic practice, but will also set a benchmark for the conduct of future Orthopaedic trials. TRIAL REGISTRATION: The FAITH trial is registered at ClinicalTrials.gov (Identifier NCT00761813)