Osseointegration of new percutaneous Press-fit implants coated with zinc-containing calcium phosphate in the limb stump: experimental study
A. A. Emanov,
V. P. Kuznetsov,
M. V. Stogov,
E. N. Gorbach,
N. V. Tushina,
E. G. Komarova,
T. V. Tolkacheva,
Yu. P. Sharkeev https://doi.org/10.18019/1028-4427-2026-32-4-529-539
Abstract
Introduction The use of transcutaneous implants for the attachment of limb prostheses is a rapidly developing modern technology for restoring function of lost limbs, particularly relevant for lower limb prosthesis applications. The primary challenge in developing this technology is the need to significantly improve implant survival, which depends on its design and the presence of biocoatings.
The purpose of the work is to experimentally evaluate the survival rate of original Press-Fit-type percutaneous implants produced without coating the surface of the osseointegrated part and with an applied zinc-containing calcium phosphate coating during one-stage osseointegration.
Materials and Methods The study was performed on 10 mongrel male dogs aged 1.5 to 2 years and weighing 19.2 ± 1.3 kg. Animals in Group 1 (n = 5) received an uncoated implant, while animals in Group 2 (n = 5) received an implant coated with a zinc-containing calcium phosphate. Osseointegration was assessed using a combination of clinical, radiographic, and laboratory studies. Quantitative analysis of the results was performed using statistical methods.
Results Twenty-six weeks after implantation, all animals had implant stability. A single bone-implantation unit with a continuous and sufficiently dense compact plate was formed. Animals in Group 1 demonstrated organotypic bone remodeling and compaction of periosteal layers. By that time, animals in Group 2 featured completion of organotypic remodeling around the implant that indicated signs of more pronounced osteogenesis in the implant-bone system. The zinc-containing calcium phosphate coating promoted the formation of denser and more mineralized structures on the implant surface and prevented calcium efflux from the compact plate of the bone stump.
Discussion The studies conducted and clinical observations demonstrated the absence of significant local or systemic disorders in the experimental animals during the implant osseointegration period, indicating good tolerability. The zinc-containing calcium phosphate coating provided excellent biocompatibility and stimulated osteogenesis. The obtained results are consistent with data presented in the domestic and international scientific literature and expand the evidence base of the effectiveness of Press-Fit titanium SLM implants with zinc-containing calcium phosphate coating for osseointegration prosthetics.
Conclusion The data obtained during the experiment show fairly good results of osseointegration of Press-Fit implants without coating the surface of the osseointegrated part and with an applied zinc-containing calcium phosphate coating. They did not show pronounced restrictions on their use. However, from the point of view of minimizing the the risks, preference should be given to product with a zinc-containing calcium phosphate coating of the osseointegrated part.
Supporting agencies: This work was conducted as part of the state assignment to the Ilizarov National Medical Research Center of Traumatology and Orthopedics "Development of new Press-Fit implants that ensure the formation and activation of bone matrix particles to improve the survival rate and reliability of prosthetics". The production of coatings on medical devices and the study of their characteristics were carried out within the framework of the state assignment of the Institute of Strength Physics and Materials Science SB RAS (project No FWRW-2026-0004)
About the Authors
A. A. Emanov
Ilizarov National Medical Research Centre for Traumatology and Orthopedics
Russian Federation
Russian Federation
Andrey A. Emanov — Candidate of Veterinary Sciences, Leading Researcher.
Kurgan
V. P. Kuznetsov
Ilizarov National Medical Research Centre for Traumatology and Orthopedics; Ural Federal University named after the first President of Russia B.N. Yeltsin
Russian Federation
Russian Federation
Viktor P. Kuznetsov — Doctor of Technical Sciences, Professor, Head of the Laboratory, Professor of the Department.
Kurgan, Ekaterinburg
M. V. Stogov
Ilizarov National Medical Research Centre for Traumatology and Orthopedics
Russian Federation
Russian Federation
Maksim V. Stogov — Doctor of Biological Sciences, Associate Professor, Head of the Department.
Kurgan
E. N. Gorbach
Ilizarov National Medical Research Centre for Traumatology and Orthopedics
Russian Federation
Russian Federation
Elena N. Gorbach — Candidate of Biological Sciences, Leading Researcher.
Kurgan
N. V. Tushina
Ilizarov National Medical Research Centre for Traumatology and Orthopedics
Russian Federation
Russian Federation
Natalya V. Tushina — Candidate of Biological Sciences, Senior Researcher.
Kurgan
E. G. Komarova
Institute of Strength Physics and Materials Science, Siberian Branch of the Russian Academy of Sciences
Russian Federation
Russian Federation
Ekaterina G. Komarova — Candidate of Technical Sciences, Researcher.
Tomsk
T. V. Tolkacheva
Institute of Strength Physics and Materials Science, Siberian Branch of the Russian Academy of Sciences
Russian Federation
Russian Federation
Tatiana V. Tolkacheva — Leading Technologist.
Tomsk
Yu. P. Sharkeev
Institute of Strength Physics and Materials Science, Siberian Branch of the Russian Academy of Sciences
Russian Federation
Russian Federation
Yurii P. Sharkeev — Doctor of Physical and Mathematical Sciences, Professor, Chief Researcher.
Tomsk
References
1. Evans AR, Tetsworth K, Quinnan S, Wixted JJ. Transcutaneous osseointegration for amputees. OTA Int. 2024;7(2 Suppl):e326. doi: 10.1097/OI9.0000000000000326.
2. Wnuk-Scardaccione A, Bilski J. Breaking Barriers-The Promise and Challenges of Limb Osseointegration Surgery. Medicina (Kaunas). 2025;61(3):542. doi: 10.3390/medicina61030542.
3. Hoellwarth JS, Tetsworth K, Akhtar MA, Al Muderis M. Transcutaneous osseointegration for amputees : lessons from the past of relevance to the future. Bone Joint Res. 2021;10(10):690-692. doi: 10.1302/2046-3758.1010.BJR-2021-0235.R2.
4. Saleib RM, Pekbay B, Verhofstad MHJ, et al. Analyzing research trends and developments in osseointegration in patients with extremity amputations: Systematic bibliometric analysis and research recommendations. Prosthet Orthot Int. 2025;49(5):596-606. doi: 10.1097/PXR.0000000000000410.
5. Atallah R, Leijendekkers RA, Hoogeboom TJ, Frölke JP. Complications of bone-anchored prostheses for individuals with an extremity amputation: A systematic review. PLoS One. 2018;13(8):e0201821. doi: 10.1371/journal.pone.0201821.
6. Haidary A, Hoellwarth JS, Tetsworth K, et al. Transcutaneous osseointegration for amputees with burn trauma. Burns. 2023;49(5):1052-1061. doi: 10.1016/j.burns.2023.02.006.
7. Kafedzic H, Rozbruch SR, Reif TJ, Hoellwarth JS. Constructing an Osseointegrated Prosthetic Leg. JBJS Essent Surg Tech. 2024;14(1):e22.00064. doi: 10.2106/JBJS.ST.22.00064.
8. Rehani M, Stafinski T, Round J, et al. Bone-anchored prostheses for transfemoral amputation: a systematic review of outcomes, complications, patient experiences, and cost-effectiveness. Front Rehabil Sci. 2024;5:1336042. doi: 10.3389/fresc.2024.1336042.
9. Aschoff HH, Örgel M, Sass M, et al. Transcutaneous Osseointegrated Prosthesis Systems (TOPS) for Rehabilitation After Lower Limb Loss: Surgical Pearls. JBJS Essent Surg Tech. 2024;14(1):e23.00010. doi: 10.2106/JBJS.ST.23.00010.
10. Huo D, Wang F, Yang F, et al. Medical titanium surface-modified coatings with antibacterial and anti-adhesive properties for the prevention of implant-associated infections. J Materi Sci Technol. 2024;179:208-223. doi: 10.1016/j.jmst.2023.09.016.
11. Velmurugan SN, Jayakumar S, Raman M, Senthamilarasi N. Multidimensional calcium phosphate coatings for bio activation of titanium implant surfaces using methodological approach. J Ind Eng Chem. 2024;133:228-245. doi: 10.1016/j.jiec.2023.11.061.
12. Wang S, Zhao X, Hsu Y, et al. Surface modification of titanium implants with Mg-containing coatings to promote osseointegration. Acta Biomater. 2023;169:19-44. doi: 10.1016/j.actbio.2023.07.048.
13. Hu S, Shou Z, Xu C, et al. The de novo strategy for bifunctional peptides coating to enhance osteointegration capacity of the implant. Colloids Surf B Biointerfaces. 2025;252:114642. doi: 10.1016/j.colsurfb.2025.114642.
14. Frölke JP, Atallah R, Leijendekkers R. Press-Fit Bone-Anchored Prosthesis for Patients with Short Transfemoral Amputation. JBJS Essent Surg Tech. 2025;15(1):e23.00007. doi: 10.2106/JBJS.ST.23.00007.
15. Hoellwarth JS, Tetsworth K, Al Muderis M. Single-Stage Press-Fit Osseointegration of the Radius and Ulna for Rehabilitation After Trans-Forearm Amputation. JBJS Essent Surg Tech. 2024;14(3):e23.00015. doi: 10.2106/JBJS.ST.23.00015.
16. Cooperman C, Wiznia D, Kunsel K, et al. Personalizing Revision Tibial Baseplate Position and Stem Trajectory With Custom Implants Using 3D Modeling to Optimize Press-fit Stem Placement. Arthroplast Today. 2022;18:45-51. doi: 10.1016/j.artd.2022.08.011.
17. Christensen JC, Smith J, Darter BJ, et al. Physical Recovery After Transfemoral Amputation Using Press-Fit Percutaneous Osseointegrated Prosthesis. Arch Phys Med Rehabil. 2026:S0003-9993(26)00574-5. doi: 10.1016/j.apmr.2026.02.494.
18. Ong G, Hoellwarth JS, Testworth K, Al Muderis M. Techniques to Remove Press-Fit Osseointegration Implants. JBJS Essent Surg Tech. 2024;14(1):e23.00017. doi: 10.2106/JBJS.ST.23.00017.
19. Hoellwarth JS, Reif TJ, Rozbruch SR. Revision Amputation with Press-Fit Osseointegration for Transfemoral Amputees. JBJS Essent Surg Tech. 2022;12(2):e21.00068. doi: 10.2106/JBJS.ST.21.00068.
20. Еmanov AA, Gorbach EN, Stogov MV, et al. Survival of percutaneous implants under various mechanical loading to the bone. Genij ortopedii. 2018;24(4):500-506. doi: 10.18019/1028-4427-2018-24-4-500-506.
21. Stogov MV, Emanov AA., Kuznetsov VP, et al. The effect of zinc-containing calcium phosphate coating on the osseointegraton of transcutaneous implants for limb prosthetics. Genij ortopedii. 2024;30(5):677-686. doi: 10.18019/1028-4427-2024-30-5-677-686.
22. Van den Borre CE, Zigterman BGR, Mommaerts MY, Braem A. How surface coatings on titanium implants affect keratinized tissue: A systematic review. J Biomed Mater Res B Appl Biomater. 2022;110(7):1713-1723. doi: 10.1002/jbm.b.35025.
23. Kuznetsov VP, Gorgots VG, Anikeev AV, et al. Tubular bone stump implant. Patent RF, no. 194912. 2019. Available from: https://www1.fips.ru/registers-doc-view/fips_servlet?DB=RUPM&DocNumber=194912&TypeFile=html. Accessed May 06, 2026. (In Russ.)
24. Kuznetsov VP, Gorgots VG, Emanov AA, et al. Tubular bone stump implant. Patent RF, no. 207637. 2021. Available from: https://www1.fips.ru/registers-doc-view/fips_servlet?DB=RUPM&DocNumber=207637&TypeFile=html. Accessed May 06, 2026. (In Russ.)
25. Komarova EG, Kazantseva EA, Chaikina MV, et al. Morphological and structural features of micro-arc Zn-Si-containing calcium phosphate coatings. Materials Today: Proceedings. 2020;25(3):439-442. doi: 10.1016/j.matpr.2019.12.157.
26. Komarova EG, Sedelnikova MB, Kazantseva EA, et al. Relationship between the porous structure hierarchy and the physical and mechanical properties of calcium phosphate drug carriers. Russ Phys J. 2020;63(7):1249-1256. doi: 10.1007/s11182-020-02151-y.
27. Bulina NV, Khvostov MV, Borodulina IA, et al. Substituted hydroxyapatite and β-tricalcium phosphate as osteogenesis enhancers. Ceram Int. 2024;50(18):33258-33269. doi: 10.1016/j.ceramint.2024.06.136.
28. Komarova EG, Sharkeev YP, Sedelnikova MB, et al. Znor Cu-Containing CaP-Based Coatings Formed by Micro-arc Oxidation on Titanium and Ti-40Nb Alloy: Part I-Microstructure, Composition and Properties. Materials (Basel). 2020;13(18):4116. doi: 10.3390/ma13184116.
29. Komarova EG, Sharkeev YP, Sedelnikova MB, et al. Znor Cu-containing CaP-Based Coatings Formed by MicroArc Oxidation on Titanium and Ti-40Nb Alloy: Part II-Wettability and Biological Performance. Materials (Basel). 2020;13(19):4366. doi: 10.3390/ma13194366.
30. Kuznetsov VP, Gubin AV, Gorgots VG, et al. Device for osseointegration of an implant into the bone of a lower limb stump. Patent RF, no. 185647. 2018. Available from: https://www1.fips.ru/registers-doc-view/fips_servlet?DB=RUPM&DocNumber=185647&TypeFile=html. Accessed May 06, 2026. (In Russ.)
31. Banducci E, Al Muderis M, Lu W, Bested SR. The safety of one-stage versus two-stage approach to osseointegrated prosthesis for limb amputation. Bone Jt Open. 2023;4(7):539-550. doi: 10.1302/2633-1462.47.BJO-2022-0117.R1.
32. Burns DM, LoPolito AG, Glassband Z, et al. Single-Stage Press-Fit Femoral Osseointegrated Limb Replacement: A Prospective Cohort Study. J Am Acad Orthop Surg. 2026;34(8):e1144-e1153. doi: 10.5435/JAAOS-D-24-00718.
33. Atallah R, Rutjes E, Frölke JPM, Leijendekkers RA. Safety and performance of contemporary press-fit titanium osseointegration implants in lower extremity amputation : a five-year follow-up study. Bone Joint J. 2025;107-B(4):486-494. doi: 10.1302/0301-620X.107B4.BJJ-2024-0754.R1.
34. Emanov AA, Kuznetsov VP, Gorbach EN, et al. Osseointegration of Titanium and Steel Additive Manufactured Implant in Rabbit Tibia under External Fixation: Comparative Study. Traumatology and Orthopedics of Russia. 2020;26(2):98-108. doi: 10.21823/2311-2905-2020-26-2-98-108.
35. Barootchi E, Jirofti N, Daliri M, Moradi A. Lower limb osseointegrated prosthetics: are we standing on the edge of a new era? J Orthop Surg Res. 2026;21(1):255. doi: 10.1186/s13018-026-06675-w.
36. Galteri G, Betti V, Alesi D, et al. Improved primary stability and load transfer of a customized osseointegrated transfemoral prosthesis compared to a commercial one. J Orthop Surg Res. 2025;20(1):102. doi: 10.1186/s13018-025-05476-x.
37. Sánchez E, de Vries E, Matthews D, et al. The effect of coating characteristics on implant-bone interface mechanics. J Biomech. 2024;163:111949. doi: 10.1016/j.jbiomech.2024.111949.
38. Ghalayani Esfahani A, Sartori M, Bregoli C, et al. Bactericidal Activity of Silver-Doped Chitosan Coatings via Electrophoretic Deposition on Ti6Al4V Additively Manufactured Substrates. Polymers (Basel). 2023;15(20):4130. doi: 10.3390/polym15204130.
39. Wen Z, Lei L, Zhang H, et al. Magnesium-containing implants enhance bone healing: A mechanobiological perspective. Mechanobiol Med. 2025;3(4):100161. doi: 10.1016/j.mbm.2025.100161.
40. Frossard L, Laux S, Geada M, et al. Evidence-based recommendation of a powered knee for transfemoral bone-anchored prostheses: A cross-sectional study. Can Prosthet Orthot J. 2025;8(2):45790. doi: 10.33137/cpoj.v8i2.45790.
41. Leung ES, Mofatteh M. Investigating the Feasibility and Safety of Osseointegration With Neural Interfaces for Advanced Prosthetic Control. Cureus. 2025;17(4):e82567. doi: 10.7759/cureus.82567.
42. Shrivas S, Samaur H, Yadav V, Boda SK. Soft and Hard Tissue Integration around Percutaneous Bone-Anchored Titanium Prostheses: Toward Achieving Holistic Biointegration. ACS Biomater Sci Eng. 2024;10(4):1966-1987. doi: 10.1021/acsbiomaterials.3c01555.
43. Frölke JP, Atallah R. Revision of Press-Fit Bone-Anchored Prosthesis After Implant Failure. JBJS Essent Surg Tech. 2024;14(4):e23.00005. doi: 10.2106/JBJS.ST.23.00005.
Review
For citations:
Emanov A.A., Kuznetsov V.P., Stogov M.V., Gorbach E.N., Tushina N.V., Komarova E.G., Tolkacheva T.V., Sharkeev Yu.P. Osseointegration of new percutaneous Press-fit implants coated with zinc-containing calcium phosphate in the limb stump: experimental study. Genij Ortopedii. 2026;32(4):529-539. https://doi.org/10.18019/1028-4427-2026-32-4-529-539
Views:
17
JATS XML
Email this article 