Clinical Trials Logo

Clinical Trial Summary

Arthroplasty operations are very frequent and their number is constantly increasing. The success of prosthetic surgery is linked to surgical factors (prosthesis type, prosthesis design, prosthesis material, surgical hand) and 'biological' factors (inflammation, pain, oedema, impingement). It is well known that important functional limitations may result mainly from an overreaction involving the peri-articular tissues. This is particularly true after total knee arthroplasty (TKA) surgery, during which a large part of the bone tissue and part of the peri-articular tissues (joint capsule, ligaments, synovium) are dislodged or removed. In the days following arthroplasty operations, the presence of a strong local inflammatory component is associated with pain and functional limitation, which usually resolves within a few months; however, it can sometimes take longer, and sometimes result in a chronic, albeit modest, inflammatory condition that lasts for years. There is still a percentage of 11-25% of patients who remain not completely satisfied with the result achieved with prosthetic surgery . Baker et al. state that 19.8% of patients experience pain one year after arthroplasty . Beswick et al. report that many patients (10-34%) continue to experience significant pain and functional limitation after arthroplasty even years later.


Clinical Trial Description

The inflammatory response is mainly due to the presence of pro-inflammatory cytokines in the synovium; in fact, it has been shown that there is an inverse relationship between the amount of the pro-inflammatory cytokine IL-6 in the joint in patients undergoing TKA and the patient's functional recovery one month after surgery. It has also been shown that a high concentration in synovial fluid of catabolic factors, such as TNF-α, MMP-13 and IL-6, is predictive of a lower resolution of pain 2 years after prosthesis surgery. Sellam and Berenbaum emphasise the importance of considering the synovial membrane as a promising target for new therapeutic strategies to control inflammation and thus prevent joint problems or resolve clinical symptoms . There is an increasing need to find a local anti-inflammatory treatment to be implemented in the immediate post-surgery period to avoid chronic pain. Not only the pain condition, but also the functional condition, although better than the starting condition, cannot be considered completely satisfactory; 37% of patients one year after surgery have not achieved a complete functional recovery. Extensive translational research has shown that biophysical stimulation with I-ONE® therapy (Pulsed Electromagnetic Field by IGEA SpA, Carpi, Italy) is able to modulate cartilage metabolism by increasing the reduction of the release of inflammation mediators involved in cartilage degeneration, such as inflammatory cytokines (IL-6 and IL-8) and lipid mediators of inflammation (prostaglandins E2), enhances the anti-inflammatory effect of individual adenosine agonists A2A and A3 by increasing the release of the anti-inflammatory cytokine IL-10. In the clinic, I-ONE® therapy is able to prevent and/or slow down the degenerative phenomena that accompany surgery in patients with cartilage lesions treated with microfractures under arthroscopy in the knee or ankle, both in patients undergoing autologous chondrocyte transplantation in the presence of scaffolds at the knee , and in patients with osteochondral lesions of the talus, treated by graft transplantation, with addition of bone marrow concentrate. I-ONE® therapy has also proven effective in patients undergoing total knee replacement with or without patella prosthesis and after reverse shoulder replacement surgery. Postoperative noninvasive therapy with the use of PEMF in patients with painful TKA resulted in significant improvement in pain and functional recovery, as demonstrated by the preliminary results of this prospective cohort study. The study plans to recruit patients with painful TKA whose pain occurred from at least 30 days after surgery to a maximum of 180 days after surgery. All patients will be instructed to use local non invasive biophysical therapy with I-ONE® therapy (1.5 mT, 75 Hz) for 4 hours a day for 60 days. Clinical evaluations such as Visual Analog Score (VAS), SF-12 Health Survey (SF-12), EuroQol (EQ-5D) are scheduled at 1 month, 2, 6, 12 and 24 months after PEMF treatment; Knee Society Score (KSS) is scheduled at 3 months of follow-up. The use of nonsteroidal anti-inflammatory drugs (NSAIDs) is also recorded. Patients will be analyzed into three different groups based on the time elapsed between surgery and the beginning of PEMF therapy: Group 1 (30-90 days), Group 2 (91-150 days) and Group 3 (151-180 days). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06330454
Study type Observational
Source University Hospital of Ferrara
Contact Leo Massari, MD
Phone +390532239797
Email msl@unife.it
Status Recruiting
Phase
Start date October 22, 2020
Completion date October 21, 2025

See also
  Status Clinical Trial Phase
Completed NCT04580069 - Role of Two Rehabilitative Treatments and Diet in the Modulation of Inflammation in Patients With Knee Prosthesis. N/A
Not yet recruiting NCT06466330 - Efficacy of Microparticle Geniculate Artery Embolization in Total Knee Prosthesis Patients With Pain Resistant to Medical Treatment. A Prospective Randomized Controlled Trial N/A
Completed NCT04118023 - 7T MRI to Evaluate Cartilage Defects in the Knee
Completed NCT05975879 - A Study of the Feasibility of Using the Dietary Supplement "ARTNEO" in Patients With Osteoathritis N/A
Recruiting NCT05261360 - Clinical Efficacy of Exosome in Degenerative Meniscal Injury Phase 2
Completed NCT02037204 - IMPACT: Safety and Feasibility of a Single-stage Procedure for Focal Cartilage Lesions of the Knee. Phase 1/Phase 2
Recruiting NCT06447129 - Effect of NMES as an Add-On to Exercise Program in Degenerative Meniscus Tears N/A
Recruiting NCT06447142 - The Open Kinetic Chain and Closed Kinetic Chain Strengthening Exercises in Degenerative Meniscus Tears N/A
Recruiting NCT04472091 - Genicular Artery Embolization (GAE) for Osteoarthritic Knee Pain N/A
Recruiting NCT04321629 - Knee Arthritis Treatment With Autologous Fragmented Adipose Tissue and PRP - Comparison of Two Treatment Methods Phase 2
Completed NCT02096562 - Knee Swelling Under Use of Compression Stockings After Outpatient Surgery N/A
Recruiting NCT04234282 - Rate of Torque Development and Voluntary Quadriceps Activation in Patients With Knee Osteoarthritis: A Quantitative Analysis Before and After a Single Session of Manual Physical Therapy N/A
Completed NCT05886608 - Evaluation of the Effect of the AI500™ SINGLE-DOSE GEL Medical Device in Patients With Reduced Knee Function N/A
Completed NCT05347602 - Gold Factor on Knee Joint Health and Function N/A
Enrolling by invitation NCT05266365 - The Video-Based Exercise Programs in Degenerative Meniscus Tears N/A