journal article·2025-01-15Open access

Analysis of the Feasibility of the OrthoNail Hybrid Intramedullary Implant in the Human Body with Respect to Material Durability

Dominika Grygier, Piotr Kowalewski, Mariusz Opałka, Jakub J. Słowiński, Mateusz Dziubek, Dariusz Pyka

Abstract

This study focuses on the development and evaluation of the OrthoNail hybrid intramedullary implant for lower limb lengthening in patients requiring significant skeletal reconstruction. The implant addresses the challenges in load-bearing during rehabilitation, providing a robust solution that is capable of supporting physiological loads. Mechanical tests, including axial compression, tension, torsion, and 3,4-point bending, determined the implant’s load capacity and fatigue resistance, while finite element analysis assessed stress distributions in bone tissue and around screw holes during single-leg stance, with boundary conditions derived from Orthoload database data. The OrthoNail implant demonstrated excellent mechanical stability, sustaining torsional loads of up to 19.36 Nm at maximum elongation (80 mm) and 17.16 Nm at zero elongation. Under axial compression, it withstood forces of up to 1400 N, maintaining structural integrity. Fatigue testing revealed resilience under dynamic loading conditions for over 1,000,000 cycles at a load of 500 N, with no mechanical failure or material degradation observed. Stress concentrations near screw holes indicate areas for potential optimization. The findings indicate that the OrthoNail implant demonstrates excellent mechanical stability and is well-suited for clinical application, enabling early full weight-bearing during rehabilitation.
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Research context

OpenAlex topics: Bone fractures and treatments · Orthopaedic implants and arthroplasty · Orthopedic Infections and Treatments

SciVX discovery tags are terminology-based. OpenAlex topics are source-provided classifications.

Affiliations

Department of Vehicle Engineering, Faculty of Mechanical Engineering, Wroclaw University of Science and Technology, Smoluchowskiego 25 Str., 50-370 Wroclaw, Poland

Orthoget Sp. z o.o., Muchoborska 18, 54-424 Wrocław, Poland

Department of Fundamentals of Machine Design and Mechatronic Systems, Faculty of Mechanical Engineering, Wroclaw University of Science and Technology, Łukasiewicza 5, 50-371 Wroclaw, Poland

Department of Mechanics, Materials and Biomedical Engineering, Faculty of Mechanical Engineering, Wrocław University of Science and Technology, Smoluchowskiego 25, 50-372 Wrocław, Poland

Funding

Sub-measure 1.1.1 of Smart Growth Operational Programme 2014–2020 · European Regional Development Fund · The National Centre for Research and Development (NCBR)

References (53)

Show source-provided references
1. Skull Reconstruction with Custom Made Three-Dimensional Titanium Implant10.7181/acfs.2015.16.1.11 ↗
2. Cranioplasty enhanced by three-dimensional printing: Custom-made three-dimensional-printed titanium implants for skull defects10.1097/SCS.0000000000002656 ↗
3. The application of polyetheretherketone (PEEK) implants in cranioplasty10.1016/j.brainresbull.2019.08.010 ↗
4. Clinical study of 3D printed personalized prosthesis in the treatment of bone defect after pelvic tumor resection
5. Biomechanics of Osteoporotic Fracture Fixation10.1007/s11914-019-00535-9 ↗
6. Loads acting in an intramedullary nail during fracture healing in the human femur10.1016/S0021-9290(01)00037-9 ↗
7. International recognition of the Ilizarov bone reconstruction techniques: Current practice and research (dedicated to 100th birthday of G. A. Ilizarov)10.5312/wjo.v12.i8.515 ↗
8. Osseointegration in skeletal reconstruction and rehabilitation: A review
9. Osseointegration of titanium implants10.3109/17453678608994393 ↗
10. A novel intramedullary nail for micromotion stimulation of tibial fractures10.1016/j.clinbiomech.2011.08.009 ↗
11. Pilot study of micromotion nailing for mechanical stimulation of tibial fracture healing10.1302/2633-1462.210.BJO-2021-0121.R1 ↗
12. Trends in Surgical and Nonsurgical Aesthetic Procedures: A 14-Year Analysis of the International Society of Aesthetic Plastic Surgery—ISAPS10.1007/s00266-024-04260-2 ↗
13. Current Trends of Cosmetic Surgical Procedures With the General Cosmetic Surgery Fellowships by the American Academy of Cosmetic Surgery10.1177/0748806819852014 ↗
14. Trends and Practices in Limb Lengthening: An 11-year US Database Study10.5005/jp-journals-10080-1574 ↗
15. Body image and cosmetic medical treatments10.1016/S1740-1445(03)00003-2 ↗
16. Dang, H.S., Nguyen, T.M.T., Wang, C.N., Day, J.D., and Dang, T.M.H. (2020). Grey System Theory in the Study of Medical Tourism Industry and Its Economic Impact. Int. Environ. Res. Public Health, 17.10.3390/ijerph17030961 ↗
17. Low Cost, Quality Treatment and Excellent Hospitality Makes India the Best Destination for Medical Tourism10.23958/ijirms/vol05-i01/614 ↗
18. Consensus on Changing Trends, Attitudes, and Concepts of Asian Beauty10.1007/s00266-015-0562-0 ↗
19. Aesthetic medicine tourism—Nature and scope of the services
20. Cosmetic lengthening: What are the limits?10.1007/s11832-016-0791-z ↗
21. Cosmetic bilateral leg lengthening experience of 54 cases10.1302/0301-620X.87B10.16468 ↗
22. Current trends on limb length discrepancy treatment: Results of a survey among 11 dedicated Italian centres10.1007/s12306-022-00752-z ↗
23. Cosmetic stature lengthening10.1302/2046-3758.97.BJR-2019-0379.R1 ↗
24. Standard, S.C., Herzenberg, J.E., and Green, S.A. (2019). Antegrade and Retrograde Femur Operative Technique, NuVasive.
25. Limb lengthening and deformity correction with externally controlled motorized intramedullary nails: Evaluation of 50 consecutive lengthenings10.1080/17453674.2018.1534321 ↗
26. What Are the Potential Benefits and Risks of Using Magnetically Driven Antegrade Intramedullary Lengthening Nails for Femoral Lengthening to Treat Leg Length Discrepancy?10.1097/CORR.0000000000002036 ↗
27. PRECICE intramedullary limb lengthening system10.1586/17434440.2015.1005604 ↗
28. Removal of a broken distal cannulated intramedullary femoral nail with solid reamer with closed methods and without using C-arm: A case report10.1016/j.jajs.2014.06.007 ↗
29. Pain, osteolysis, and periosteal reaction are associated with the STRYDE limb lengthening nail: A nationwide cross-sectional study10.1080/17453674.2021.1903278 ↗
30. Management of a Broken PRECICE Femoral Nail at an Ununited Distraction Osteogenesis Site: A Case Report10.2106/JBJS.CC.19.00267 ↗
31. Post-retrieval functionality testing of PRECICE lengthening nails: The “Sleeper” nail concept10.1016/j.jcot.2020.06.005 ↗
32. Breakage of a re-activated PRECICE® nail: A case report10.1016/j.ijscr.2023.108182 ↗
33. (2021). Implants for Surgery—Metallic Materials Part 3: Wrought Titanium 6-Aluminium 4-Vanadium Alloy (Standard No. ISO 5832-3:2021).
34. (2018). Metallic Materials: Vickers Hardness Test. Part 1, Test Method (Standard No. PN-EN ISO 6507-1:2018).
35. (2019). Metallic Materials—Tensile Testing (Standard No. ISO 6892-1:2019).
36. Silva Gomes, J., and Meguid, S. (2018, January 22–26). Structural validation of intramedullary nails: From experimentation to virtual testing. Proceedings of the 6th International Conference on Integrity-Reliability-Failure, Lisbon, Portugal.10.24840/978-989-20-8313-1 ↗
37. Distal locking in femoral intramedullary nailing system: Is one cross screw sufficient?10.4236/jbise.2012.510073 ↗
38. (2016). Badania Nieniszczące—Badania Wizualne—Zasady Ogólne (Standard No. PN-EN 13018:2016-04).
39. (2021). Metallic Materiale—Bend Test (ISO 7438:2020) (Standard No. PN-EN ISO 7438:2021-04).
40. (2024). Standard Specification and Test Methods for Intramedullary Fixation Devices (Standard No. ASTM F1264-16e1).
41. Little, R.E. (1975). Manual on Statistical Planning and Analysis for Fatigue Experiments, ASTM International.10.1520/STP588-EB ↗
42. Baleani, M., Erani, P., Blaise, M., Fognani, R., Palmas, M., and Manfrini, M. (2022). Intercalary reconstruction of long bones by massive allograft: Comparison of construct stability ensured by three different host-graft junctions and two types of fixations in a synthetic femur model. Front. Pediatr., 10.10.3389/fped.2022.868299 ↗
43. Internal femoral forces and moments during running: Implications for stress fracture development10.1016/j.clinbiomech.2008.06.011 ↗
44. Becerra, L.H.C., Rodríguez, M.A.L.H., Arroyo, R.L., Solís, H.E., and Castro, A.T. (2021). Effect of sterilization on 3-point dynamic response to in vitro bending of an Mg implant. Biomater. Res., 25.10.1186/s40824-021-00207-9 ↗
45. Comparison of mechanical rigidity between plate augmentation leaving the nail in situ and interlocking nail using cadaveric fracture model of the femur10.1007/s00264-010-0983-y ↗
46. Untaroiu, C., Genovese, D., Ivarsson, J., and Crandall, J. (2008, January 8–10). A Finite Element Analysis of Mid-Shaft Femoral Tolerance under Combined Axial-Bending Loading. Proceedings of the 10th International LS-DYNA Conference, Detroit, MI, USA.
47. Effect of capsaicin-sensitive sensory neurons on bone architecture and mechanical properties in the rat hindlimb suspension model
48. Bergmann, G., and Damm, P. (2024, December 01). Julius Wolff Institute, Berlin Institute of Health at Charité Universitätsmedizin Berlin, 2008. Available online: https://orthoload.com/database/?implantId=2355&activityId=2541&activityIndentationLevel=1¶meterId=1¶meterIndentationLevel=-1&patientId=h10r&fileId=h10r_260413_1_8&fileType=t&selectBox=file.
49. Effect of Early Mobilization on Hip and Lower Extremity Postoperative: A Literature Review10.1177/23779608231167825 ↗
50. Early Mobilization Post–Hip Fracture Surgery10.1177/2151459319826431 ↗
51. Mechanical Failures in Magnetic Intramedullary Lengthening Nails10.2106/JBJS.22.00283 ↗
52. PRECICE nail bending in femur lengthening10.1016/j.jor.2024.05.018 ↗
53. (2021). Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (Standard No. ASTM F136-13(2021)e1).