Ion, could limit pain and joint swelling immediately after TKA andIon, could limit pain and

Ion, could limit pain and joint swelling immediately after TKA and
Ion, could limit pain and joint swelling immediately after TKA and shorten the time to functional recovery. MethodsPatients and design of studyfavor functional recovery in patients undergoing TKA. The study was designed without placebo devices, following Local Ethical Committee indications that did not consider appropriate to ask patients to devote four hours per day for 60 days to using a placebo device, knowing the anti-inflammatory activity of the treatment. The study was approved by the Local Ethical Committee, and patients signed informed consent for recruitment. The inclusion criteria were the following: patients aged between 60 and 85 years, presenting with an advanced state of knee OA and scheduled for TKA, with varus or valgus deformity not exceeding 20?or 15? respectively, and with a flexion contracture of less than 15? Exclusion criteria were: previous surgery to the same knee, omolateral hip prosthesis, Body Mass Index (BMI; Kg/m2) >30, rheumatoid arthritis, autoimmune diseases, systemic diseases, cancer and the use of steroids.Biophysical stimulationThirty patients were randomly assigned to the experimental and control groups. At selection, the clinician informed the patient regarding the chance to be recruited in a trial with two arms. At enrollment, the patient accepted to be addressed to one of the two groups for the entire duration of the study and the patient PubMed ID: signed informed consent for recruitment. The assignment of the patient to experimental or control group was performed using a web-based computer program ( built on the randomization criteria: sex (M/F), age (60-75 years; 75-85 years) and smoking status (yes/no). Patients in the experimental group were instructed to use PEMFs (I-ONE therapy) four hours per day for 60 days by an independent, unblinded research assistant, who will not be involved in patient care or assessment. Physicians, as well as medical assessors, were blinded to the allocation of patients in the study groups. All devices were provided by the manufacturer at no cost. Treatment began HMPL-013 web within seven days from TKA, and continued at the rehabilitation centre or at the patient’s home. The battery-operated device (I-ONE, IGEA, Carpi, Italy) generated a peak magnetic field of 1.5 mT at a frequency of 75 Hz (Figure 1); the coil was placed on the operated knee, but not in direct contact with the skin. The apparatus had a timer to record the hours of therapy, allowing patient compliance to be monitored. Patients were instructed to interrupt the treatment if there were adverse events such as a burning sensation or skin irritation. Both groups underwent the same rehabilitation protocol.Surgical procedureIn the period between 2008 and 2010, at the Orthopedic and Traumatology Operative Unit of University of Bari in Italy, a prospective, randomized, controlled study was performed to test whether treatment with PEMFs couldFor all patients, TKA was performed by the same surgeon and the same anesthesiologist. Anesthesia was obtainedMoretti et al. BMC Musculoskeletal Disorders 2012, 13:88 3 ofFigure 1 I-ONE therapy. Left: waveform of magnetic field 1.5 mT peak value (top); waveform PubMed ID: of induced electrical field 0.051 mV/cm peak value, as detected using a standard coil probe (50 turns, 0.5 cm internal diameter of the coil probe, 0.2 mm copper diameter) (bottom). Right: I-ONE PEMF generator.using diazepam and selective subarachnoid injection in the spac.