Active — Not RecruitingNot Applicable

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

Ukraine100 participantsStarted 2023-01-13

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Male or female patients aged 18 to 80 years inclusive Diagnosis of one of the following orthopedic conditions: Delayed fracture healing or established non-union of a long bone fracture (at least 6 months after initial injury, confirmed radiographically) Symptomatic knee osteoarthritis (Kellgren-Lawrence grade 2-4) Indication for primary unilateral total knee arthroplasty due to osteoarthritis Willing and able to provide written informed consent Able to comply with the study protocol, follow-up visits, and required examinations Exclusion Criteria: Active infection at the injection or surgical site, systemic infection, or history of recurrent infections Known malignancy or history of malignancy within the past 5 years (except basal cell carcinoma) Autoimmune or inflammatory rheumatic disease requiring systemic immunosuppressive therapy Uncontrolled diabetes mellitus (HbA1c \> 9.0%) Severe cardiovascular, renal, hepatic, or pulmonary disease that, in the investigator's opinion, makes the patient unsuitable for participation Pregnancy, breastfeeding, or unwillingness to use effective contraception during the study period Previous knee surgery (except diagnostic arthroscopy) in the target knee (for osteoarthritis and TKA groups) Contraindications to bone marrow aspiration or blood draw for PRP preparation Participation in another clinical trial within 30 days prior to screening Any medical condition that, in the investigator's judgment, would interfere wi…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is no longer recruiting new patients — does that mean there's any chance I could still be considered, or should we focus entirely on other options for my knee condition?
2Since this study is measuring treatment-related adverse events as its main outcome, what does that tell us about how much is still unknown regarding the safety of the methods being studied here?
3The trial covers a range of conditions including osteoarthritis, non-healing fractures, and knee replacement — given my specific diagnosis, do you think the treatments being evaluated in this study would even be relevant to my situation?
4Because this trial is listed as Phase NA, which often applies to device or procedure studies rather than drug trials, can you help me understand what type of treatment or diagnostic approach is actually being tested and whether it differs from what I'd receive as standard care?
5Are there other active trials or proven standard treatments for my knee condition that might be worth comparing against what this study was investigating, especially since enrollment is already closed?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Treatment-Related Adverse Events

Timeframe: Baseline and 6, 12, 24 months.

Trial details

NCT IDNCT07628010

SponsorZaporizhzhiya State Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-28

View on ClinicalTrials.gov More Osteoarthritis, Knee trials