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Modern Methods of Treatment and Diagnosis of Patients With Injuries and Diseases of the Musculoskeletal System

Zaporizhzhiya State Medical University · 2023
ClinicalTrials.gov · Datasets · License: Public Domain · 2023
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arthroplastybone-regenerationfractureskneeknee-osteoarthritisosteoarthritisreplacementtotal-knee-arthroplasty
Brief Summary This clinical study investigates the safety and effectiveness of combining advanced regenerative therapies with personalized surgical technology for patients with delayed fracture healing (non-unions), knee osteoarthritis, and those requiring total knee replacement. Scientific rationale Bone fractures sometimes heal slowly or fail to unite despite standard treatment, and knee osteoarthritis causes progressive cartilage loss, pain, and disability. Mesenchymal stromal cells (MSCs) are multipotent cells with well-documented ability to promote bone formation, modulate inflammation, and support tissue repair. Platelet-rich plasma (PRP), prepared from the patient's own blood, delivers concentrated growth factors that accelerate healing and reduce inflammation. Both therapies are supported by multiple clinical studies showing their potential to improve fracture union rates and relieve osteoarthritis symptoms. For patients undergoing knee replacement, the study uses patient-specific 3D-printed surgical instruments (cutting guides) created from the individual's CT or MRI scans. These custom tools have been shown in scientific literature to improve implant positioning accuracy compared with conventional methods. Safety All three technologies have favorable safety profiles. MSCs and PRP are autologous (derived from the patient), which greatly reduces the risk of immune reactions or disease transmission. Clinical trials have reported no serious treatment-related adverse events, such as tumor formation or systemic complications, with these regenerative approaches. The 3D-printed instruments are biocompatible and designed specifically for each patient, with studies confirming they do not increase perioperative risks. Study procedures (high-level overview) Participants with delayed fracture healing receive a single minimally invasive injection of MSCs combined with PRP directly at the fracture site under local anesthesia or light sedation. Patients with knee osteo
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