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

This clinical study evaluates an integrated approach combining regenerative medicine technologies and personalized surgical navigation for the treatment of two major orthopedic conditions: delayed fracture healing (including non-unions) and knee osteoarthritis, including cases requiring total knee arthroplasty.

Background and Scientific Rationale Delayed fracture healing and non-unions remain significant clinical challenges despite advances in surgical fixation. Similarly, knee osteoarthritis is a leading cause of pain, disability, and reduced quality of life due to progressive cartilage degeneration and subchondral bone changes. Conventional treatments often provide only symptomatic relief or require invasive surgery with variable long-term outcomes.

Mesenchymal stromal cells (MSCs) are multipotent adult stem cells capable of differentiating into osteoblasts and chondrocytes, secreting paracrine factors that promote angiogenesis, modulate inflammation, and stimulate endogenous repair mechanisms. Platelet-rich plasma (PRP), an autologous concentrate of platelets and growth factors (including PDGF, TGF-β, VEGF, and IGF-1), enhances MSC activity and accelerates tissue regeneration. Extensive preclinical and clinical evidence supports the combined use of MSCs and PRP for bone regeneration in delayed unions and for intra-articular cartilage protection and pain relief in osteoarthritis.

For patients indicated for total knee replacement, the study incorporates patient-specific 3D-printed surgical instruments (custom cutting guides and navigation templates) fabricated from the individual's preoperative CT or MRI scans. These instruments enable highly accurate bone resections and implant positioning, which has been shown in peer-reviewed literature to reduce outliers in alignment, decrease operative time, lower blood loss, and potentially improve functional recovery compared with standard instrumentation.

The rationale for this integrated strategy is to harness the biological regenerative potential of autologous MSC-PRP therapy while optimizing mechanical precision through 3D-printed patient-specific tools, thereby addressing both biological and technical aspects of orthopedic repair in a single patient-centered protocol.

Safety Profile MSCs and PRP are autologous products, minimizing immunogenicity and the risk of disease transmission. Published clinical trials have consistently demonstrated a favorable safety profile with no reports of serious adverse events such as tumorigenesis, ectopic bone formation, or systemic complications attributable to the therapy. The 3D-printed instruments are manufactured from biocompatible medical-grade materials and undergo sterilization according to standard hospital protocols. No increased perioperative risks have been associated with their use in prior studies.

Study Procedures

For delayed fracture healing: Participants receive a single ultrasound- or fluoroscopy-guided percutaneous injection of autologous MSCs combined with PRP directly into the fracture site under local anesthesia or light sedation.

For knee osteoarthritis: Participants undergo one or more intra-articular injections of the MSC-PRP combination into the affected knee joint, performed in an outpatient setting under local anesthesia.

For total knee arthroplasty: Surgery is conducted using patient-specific 3D-printed navigation guides placed on the femoral and tibial surfaces to guide precise bone cuts and ensure optimal implant alignment. Standard surgical approaches and implant systems are used in combination with the custom guides.

All interventions are performed by board-certified orthopedic surgeons in accordance with Good Clinical Practice and institutional sterile techniques. Follow-up assessments include clinical evaluation, radiographic imaging, and patient-reported outcome measures to monitor healing, pain, function, and safety.

Potential Advantages This combined regenerative and personalized surgical approach offers several theoretical and practical benefits: accelerated and more reliable bone consolidation in delayed fractures, symptomatic relief and possible disease modification in knee osteoarthritis, and enhanced precision in knee replacement surgery leading to better implant longevity, reduced complications, shorter hospital stays, and faster return to daily activities.

By integrating biological augmentation with state-of-the-art 3D-printed navigation, the study aims to provide a modern, minimally invasive, and highly individualized treatment pathway that may improve clinical outcomes while maintaining an excellent safety profile.