Randomized controlled trial of vacuum therapy for intermittent claudication

OBJECTIVE: The "gold standard" treatment of intermittent claudication (IC) is supervised exercise therapy (SET). Intermittent vacuum therapy (IVT) has recently been promoted as an additional treatment of IC. During IVT, negative pressure and atmospheric pressure are alternatingly applied to the lower extremities, possibly resulting in improved circulation. The aim of this study was to determine a potential additional effect of IVT in IC patients undergoing a standardized SET program. METHODS: IC patients were recruited from three Dutch general hospitals between December 2015 and July 2017. They received a standardized SET program but were also randomly assigned to an intervention group receiving an IVT treatment (-50 mBar negative pressure) or a control group receiving a sham treatment (-5 mBar negative pressure). IVT was provided in a dedicated clinic during 12 sessions of 30 minutes during a 6-week period. The primary outcome measure was a change in maximal treadmill walking distance. Secondary outcome measures were a change in functional treadmill walking distance, 6-minute walk test, ambulatory ability, and quality of life. RESULTS: A total of 78 patients were randomized, of whom 70 were available for intention-to-treat analysis (control, n = 34; intervention, n = 36). At 6 and 12 weeks, increases in walking distance were of equal magnitude. Median (interquartile range) change in maximal treadmill walking distance during 12 weeks was +335 (205-756) meters in control patients and +250 (77-466) meters in intervention patients (P = .109), whereas functional treadmill walking distance increased +230 (135-480) meters and +188 (83-389) meters (P = .233), respectively. Mean ± standard deviation change in the 6-minute walk test was +36 ± 48 meters and +55 ± 63 meters (P = .823), respectively. Ambulatory ability and quality of life improved equally in both groups. CONCLUSIONS: IVT does not confer any additional beneficial effects in IC patients undergoing a standardized SET program

Accuracy of the Precision Saw versus the Sagittal Saw during total knee arthroplasty: A randomised clinical trial

Background The aim of this study was to compare the accuracy of the oscillating tip saw system (Precision Saw = PS) with the more conventional fully oscillating blade system (Sagittal Saw = SS) during computer-assisted total knee arthroplasty (CAS-TKA). Methods A prospective, randomised, controlled trial included 58 consecutive patients who underwent primary CAS-TKA and were randomly assigned in the PS group or the SS group to compare the accuracy of both blades. The primary outcome was the difference between the intended cutting planes and the actual cutting planes in degrees (°) in two planes of both the femur and the tibia. The secondary outcome was total surgery time. Results Tibia: In the VV-plane no significant differences were registered for the mean absolute deviation (p = 0.28). The PS was more accurate in the AP-plane (p = 0.03). Femur: The PS showed significantly fewer mean absolute deviations in the VV-plane (p = 0.03); however, the SS revealed better accuracy in the FE-plane (p = 0.04). The difference in the surgery time between the groups was not statistically significant (p = 0.45). Two outliers were measured using the SS, while seven outliers were detected using the PS. Conclusion The Precision Saw is not proven to be overall more accurate than the Sagittal Saw. Significantly better accuracy was shown with the PS in the two cutting planes, with the exception of one cutting plane that favoured the SS. Greater number of outliers were found using the PS. Level of evidence: I

Randomized controlled trial of vacuum therapy for intermittent claudication

OBJECTIVE: The "gold standard" treatment of intermittent claudication (IC) is supervised exercise therapy (SET). Intermittent vacuum therapy (IVT) has recently been promoted as an additional treatment of IC. During IVT, negative pressure and atmospheric pressure are alternatingly applied to the lower extremities, possibly resulting in improved circulation. The aim of this study was to determine a potential additional effect of IVT in IC patients undergoing a standardized SET program. METHODS: IC patients were recruited from three Dutch general hospitals between December 2015 and July 2017. They received a standardized SET program but were also randomly assigned to an intervention group receiving an IVT treatment (-50 mBar negative pressure) or a control group receiving a sham treatment (-5 mBar negative pressure). IVT was provided in a dedicated clinic during 12 sessions of 30 minutes during a 6-week period. The primary outcome measure was a change in maximal treadmill walking distance. Secondary outcome measures were a change in functional treadmill walking distance, 6-minute walk test, ambulatory ability, and quality of life. RESULTS: A total of 78 patients were randomized, of whom 70 were available for intention-to-treat analysis (control, n = 34; intervention, n = 36). At 6 and 12 weeks, increases in walking distance were of equal magnitude. Median (interquartile range) change in maximal treadmill walking distance during 12 weeks was +335 (205-756) meters in control patients and +250 (77-466) meters in intervention patients (P = .109), whereas functional treadmill walking distance increased +230 (135-480) meters and +188 (83-389) meters (P = .233), respectively. Mean ± standard deviation change in the 6-minute walk test was +36 ± 48 meters and +55 ± 63 meters (P = .823), respectively. Ambulatory ability and quality of life improved equally in both groups. CONCLUSIONS: IVT does not confer any additional beneficial effects in IC patients undergoing a standardized SET program