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Abstract
Aim: To assess the efficacy of a bioregenerative scaffold derived from bone marrow aspirate, cancellous bone autograft, platelet-rich plasma and autologous fibrin in treating supracondylar femur nonunions. Methods & materials: Three patients with nonunions following multiple surgical failures underwent bone stabilization and the application of a novel bioregenerative scaffold. x-rays and subjective scales were collected before surgery and at 6, 12 and 24 months post-surgery. Results: All nonunions exhibited healing with sufficient callus formation, as confirmed radiologically. After 6 months, all patients resumed full weight-bearing walking without pain. Statistical analysis showed improvements in all scales compared with pre-surgical values. Conclusion: This method presents itself as an option for treating supracondylar femur nonunions following multiple surgical failures.
Plain language summary
What is this summary about?
The objective of this case series study was to evaluate the effectiveness of a new biological autologous scaffold, comprised of stem and blood cells along with blood derivatives, in treating challenging cases of supracondylar femur nonunions.
What were the results?
Three participants underwent the application of this surgical method and were monitored for a period of 2 years. The therapy was well tolerated and deemed safe. Notably, all three patients experienced significant reductions in pain and improvements in functionality. Within a few months, they were able to walk with full weightbearing without pain, and clear indications of progressing toward bone union were evident by the 6 months.
What do the results mean?
This study demonstrates that the surgical application of autologous blood, cancellous bone and bone marrow, following the described concept and method, is an effective, safe and enduring treatment for femur nonunions. It markedly diminishes pain, enhances leg function and yields statistically significant improvements in quality of life.
Nonunions in the distal femur pose a substantial challenge within the realm of orthopedics.
The limited biological capacity following multiple surgeries complicates efforts to attain the ultimate objective: healing nonunions and establishing a robust callus and bone continuity essential for pain-free full weight-bearing walking.
A novel scaffold, composed of bone marrow aspirate, autologous cancellous bone graft and blood derivatives, in conjunction with fracture stabilization, presents a promising solution for addressing supracondylar femur nonunions.
Acknowledgments
The authors wish to express their gratitude to the entire medical team at the University Clinical Center of Vojvodina for their comprehensive support in the preparation, execution and care of our patients.
Author contributions
O Dulic selected patients, devised the surgical technique, conducted the surgeries, followed up with patients and composed the text. Dz Abazovic produced the bioregenerative scaffold under his own patent. G Gavrilovic and D Maric contributed to the development of a surgical technique. P Rasovic, M Obradovic, S Ninkovic, M Tosic, B Baljak and M Milinkov assisted with the surgeries and provided vital insights into the technique as well as postoperative management. I Lalic and N Janjic analyzed the data and meticulously reviewed the scientific objectives.
Financial disclosure
The authors have no financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
Competing interests disclosure
The authors have no competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, stock ownership or options and expert testimony.
Writing disclosure
No writing assistance was utilized in the production of this manuscript.
Ethical conduct of research
The authors state that they have obtained appropriate institutional review board approval (EC KCV 321-322/16)) and/or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.