Methods
bony elbow dislocations, upper limb injuries, pulmonary artery embolism, necrosis, injuries, trauma, thrombosis, phlebitis, fracture, infections, decompensated heart failure, fractures, stress blisters, swelling, soft-tissue swelling, pain, distal humerus fractures, lower extremity fractures, oedema, Operability
THROMBOSIS, DECOMPENSATED HEART FAILURE, COMPARTMENT SYNDROME, PHLEBITIS, INFECTIONS, PULMONARY ARTERY EMBOLISM, SECONDARY, OEDEMA, NECROSIS, COMPLICATIONS
This prospective, randomized, controlled, monocentric study included a total of 68 patients with upper (n = 36) and lower limb (n = 32) fractures from 2016 to 2019. These were enrolled and randomized upon admission in permuted blocks of equal length to the intervention (n = 35) and control (n = 33) groups in a 1:1 ratio using the “Randoulette” program from the University of Munich (After informed consent, patients aged between 18 and 80 years with complex fractures of the lower leg shaft (n = 4), tibial plateau (n = 28), proximal (n = 13) and distal (n = 5) humerus, with ligamentous and bony elbow dislocations (n = 7) and distal radius fractures (n = 11) who could not be definitively treated by ORIF on the day of admission were included. Since patients with upper limb injuries were mostly managed as outpatients preoperatively, patients were also included from inpatient admission to surgery after decongestion (n = 5) due to the small number of cases.Exclusion criteria were met if patients were younger than 18 or older than 80 years, had not signed an informed consent, had concomitant injuries to the contralateral side, or had open fractures with pre-existing soft-tissue complications, such as infections, stress blisters, necrosis or compartment syndrome. Patients with decompensated heart failure, thrombosis or pulmonary artery embolism, or acute phlebitis were not included. Participants in other studies, pregnant women, prison inmates, and drug or alcohol abusers were not included either.Figure Flowchart of the VIT study.The time from hospital admission to operability in days was defined as the study’s primary endpoint. Operability was evaluated by an independent observer (one of two senior physicians in trauma surgery who were not involved in the study) during the daily ward round. As practiced in preliminary studies, this was evaluated as soon as the normal skin wrinkling became apparent againThe secondary endpoints (1) length of stay (days), (2) pain intensity (VAS), (3) pain medication (according to WHO step scheme), (4) soft-tissue swelling (cm) to calculate oedema reduction (%/d), (5) complications (n), and (6) revisions (n) were collected during a daily study visit. Swelling of the soft tissues was measured in cm circumference and, derived from this, reduction in swelling was evaluated as a percentage per day. For the evaluation of soft-tissue swelling in lower extremity fractures, the standardized measurement points at the level of the medial knee joint space and at the smallest tibial circumference were used. For proximal and distal humerus fractures, these points were 15 cm proximal and at the elbow level, and for elbow and distal radius fractures at the elbow level and 10 cm distally. These were the sites of greatest swelling and the measurement points closest to the fracture, thus the most clinically relevant. The mean percentage swelling at these points was assessed and further evaluated. Girth measurements were used since volumetric measurement was not suitable. This was because the unstable fractures included were reduced using an external fixator and measurements were obtained during daily work on the surgical ward.In a previously conducted study, sample size calculation led to a group size of 17 patients per group to detect a clinically relevant and statistically significant difference of 2 ± 2 days induced by VIT therapy