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

Summary

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 osteoarthritis undergo intra-articular injections of the same MSC-PRP combination into the affected joint, usually performed in an outpatient setting. For those scheduled for total knee arthroplasty, the surgery is performed using patient-specific 3D-printed navigation guides that are placed on the bone surfaces to ensure precise bone cuts and optimal implant positioning. All procedures are carried out by experienced orthopedic surgeons following standard sterile techniques.

Advantages The combination aims to offer several potential benefits: faster and more reliable bone healing in delayed fractures, reduced pain and improved joint function in osteoarthritis, and greater precision during knee replacement surgery, which may lead to better long-term implant stability, shorter operation time, less blood loss, and faster recovery. By integrating regenerative biology with personalized surgical navigation, this study evaluates a modern, patient-centered approach that may improve outcomes while minimizing complications.

The primary goal is to assess whether this integrated strategy enhances healing rates, reduces pain, improves mobility, and raises quality of life for patients with these challenging orthopedic conditions.

Conditions

• Osteoarthritis, Knee
• Fractures, Ununited
• Arthroplasty, Replacement, Knee

Interventions

PROCEDURE

Autologous Mesenchymal Stromal Cells Combined with Platelet-Rich Plasma

Autologous mesenchymal stromal cells (MSCs) are isolated from the patient's own bone marrow or adipose tissue and expanded ex vivo. These MSCs are then combined with autologous platelet-rich plasma (PRP) prepared from the patient's peripheral blood on the day of administration. The MSC-PRP combination is used as a regenerative biological intervention to promote tissue repair and reduce inflammation. Administration: For delayed fracture healing: single percutaneous injection directly into the fracture site under imaging guidance (ultrasound or fluoroscopy). For knee osteoarthritis: intra-articular injection into the affected knee joint, performed in an outpatient setting under local anesthesia. For patients undergoing total knee arthroplasty: the MSC-PRP combination is administered intra-articularly or at the surgical site in conjunction with the procedure. This intervention is autologous, minimally invasive where possible, and represents an integrated regenerative approach distinct f

DEVICE

Patient-Specific 3D-Printed Surgical Instruments

Patient-specific 3D-printed surgical instruments (custom cutting guides and navigation templates) are manufactured individually for each participant using their preoperative CT or MRI scans of the knee. These biocompatible, single-use devices are designed to fit precisely onto the patient's bone surfaces during total knee arthroplasty. The instruments guide the surgeon in performing accurate bone resections and achieving optimal implant alignment and positioning. They are used in combination with standard surgical techniques and implants. This intervention represents a personalized surgical navigation approach that aims to improve precision, reduce outliers in component alignment, and potentially decrease operative time and blood loss compared with conventional instrumentation.

Sponsors & Collaborators

• Zaporizhzhiya State Medical University

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-01-13

Primary Completion

2025-11-28

Completion

2027-12-01

Countries

• Ukraine

Study Locations