Role of the anisotropy of the regeneration of the tubular bone of the residuum in ensuring their reliable integration with the implant in direct skeletal attachment of limb prostheses

Authors:

Prof. Pitkin, M.R. Dr. Tech. Sci. Tufts University, Boston, MA 02111, USA. Phone 617-636-7000, e-mail: mpitkin@tuftsmedicalcenter.org

Annotation:

Introduction. The use of a medullary canal to place implants in total joint replacement has been a paradigm in orthopedics for more than a century, and in the technology of direct attachment of limb prostheses to the skeleton for about three decades. This situation remains as such, despite the fact that the inner walls of the canal can be resorbed, increasing its diameter and, as a result, reducing its ability to hold the implant. Resorption, or negative remodeling, is an inevitable physiological component of bone development and growth and is one of the factors in the loosening of the implanted rod.

Aim. As a possible avenue for reducing the effects of negative medullary remodeling, this paper draws attention to the anisotropy of bone remodeling and proposes an implantation methodology that activates positive remodeling.

Materials and methods. The methodology we discuss here utilizes circumferential osteogenesis, which occurs in response to distraction of pre-cut grooves in the bone tube. We call this technique distraction implantation by analogy with the classic version of distraction osteogenesis by Dr. Ilizarov. Namely, with distraction osteogenesis, carried out not for lengthening, but for broadening the limb, when the bone is cut in the longitudinal direction.

Results. The method of distraction implantation is presented by the appropriate design of the implant stem and illustrated by a pilot animal study.
Discussion. Similarities and distinctions between classical distraction osteogenesis and the new distraction implantation have been discussed.

Conclusion. The similarity of the new method of distraction implantation was shown with the classical method of distraction osteogenesis in its modification for widening of the bone.
A temporary decrease in the strength of the bone tube due to longitudinal cuts is compensated by a significant increase in the strength of both bone and implant attachment after completion of cortical remodeling.
The new method of distraction implantation may represent an alternative to currently accepted technologies, provided that sufficient bone strength is ensured in a period between the implantation and completion of circular regeneration within the cuts.
After additional studies, it seems promising to use a new method of distraction implantation for direct skeletal attachment of limb prostheses, as well as for total joint arthroplasty.

List of cited literature:

1. Hall CW. Developing a permanently attached artificial limb, Bull Prosthetics Res 1974;22:144-57.

2. Mooney V, Predecki PK, Renning J, Gray J. Skeletal extension of limb prosthetic attachment-problems in tissue reaction, Journal of Biomedical Materials Research 1971;5(6):143-59.

3. Owens LJ. Apparatus for connecting a prosthesis to a bone, US Patent 3,947,897, 1976.

4. Branemark P-I. Vital microscopy of bone marrow in rabbit, Scand J Clin Lab Invest Suppl 1959;38(11):1-82.

5. Branemark P-I. Anchoring element for implantation in tissue, for holding prosthesis, artificial joint components or the like, United States Patent 5,702,445, 1997.

6. Sooriakumaran S, Robinson KP, Ward DA. Pattern of Infection of Transfemoral Osseointegration, Proc. 11th World Congress, International Society for Prosthetics & Orthotics, Hong Kong, 2004. p. 252.

7. Branemark R, Berlin O, Hagberg K, Bergh P, Gunterberg B, Rydevik B. A novel osseointegrated percutaneous prosthetic system for the treatment of patients with transfemoral amputation: A prospective study of 51 patients, Bone Joint J. 2014;96-B(1):106-13.

8. Tsikandylakis G, Berlin O, Branemark R. Implant Survival, Adverse Events, and Bone Remodeling of Osseointegrated Percutaneous Implants for Transhumeral Amputees, Clinical Orthopaedics and Related Research. 2014:472(10):2947-56.

9. Leventhal GS, Titanium, a metal for surgery, J Bone Joint Surg Am. 1951;33-A(2):473-4.

10. Branemark PI, Hansson BO, Adell R, Breine U, Lindstrom J, Hallen O, Ohman A. Osseointegrated implants in the treatment of the edentulous jaw. Experience from a 10-year period, Scand J Plast Reconstr Surg Suppl. 1977;16:1-132.

11. lbrektsson A, Branemark PI, Hansson HA, Lindstrom J. Osseointegrated titanium implants. Requirements for ensuring a long-lasting, direct bone-to-implant anchorage in man, Acta Orthop Scand. 1981;52(2):155-70.

12. Nebergall A, Bragdon C, Antonellis A, Karrholm J, Branemark R, Malchau H. Stable fixation of an osseointegated implant system for above-the-knee amputees, Acta orthopaedica. 2012;83(2):121-8.

13. Bozic KJ, Kurtz SM, Lau E, Ong K, Vail TP, Berry DJ. The epidemiology of revision total hip arthroplasty in the United States, The Journal of Bone & Joint Surgery. 2009;91(1):128-33.

14. Malchau H, Herberts P, Eisler T, Garellick G, Soderman P. The Swedish total hip replacement register, The Journal of Bone & Joint Surgery. 2002;84(suppl 2):S2-S20.

15. Melvin JS, Karthikeyan T, Cope R, Fehring TK. Early failures in total hip arthroplasty — a changing paradigm, The Journal of arthroplasty. 2014;29(6):1285-8.

16. Bozic KJ, Berry J. Modes of failure in revision hip and knee replacement, Center for Disease Control, National Center for Health Statistics. 2004.

17. Doblare M, Garcia JM. Anisotropic bone remodelling model based on a continuum damage-repair theory, J Biomech. 2002;35(1):1-17.

18. Green PB. Cell Walls and the Geometry of Plant Growth, Brookhaven Symp Biol. 1964;16:203-17.

19. Thompson DAW. On growth and form, University press, Cambridge [Eng.], 1917.

20. Pitkin M. Design features of the implants for direct skeletal attachment of limb prostheses, Journal of Biomedical Materials Research Part A. 2013;101(11):3339-48. DOI: 10.1002/jbm.a.34606. [PMCID: PMS3758435].

21. Charnley J. Arthroplasty of the hip. A new operation, Lancet. 1961;1(7187):1129-32.

22. Frossard LA, Tranberg R, Haggstrom E, Pearcy M, Branemark R. Load on osseointegrated fixation of a transfemoral amputee during a fall: loading, descent, impact and recovery analysis, Prosthetics and orthotics international. 2010;34(1):85.

23. Pitkin M. One lesson from arthroplasty to osseointegration in a search for better fixation of in-bone implanted prosthesis, J Rehabil Res Dev. 2008;45(4):vii-xiv [PMC3178830].

24. Helgason B, Palsson H, Runarsson TP, Frossard L, Viceconti M. Risk of failure during gait for.direct skeletal attachment of a femoral prosthesis: A finite element study, Medical engineering & physics. 2009;31(5):595-600.

25. Al Muderis M, Khemka A, Lord SJ, Van de Meent H, Frolke JP. Safety of Osseointegrated Implants for Transfemoral Amputees: A Two-Center Prospective Cohort Study, J Bone Joint Surg Am. 2016;98(11):900-9.

26. Hagberg K, Branemark R. One hundred patients treated with osseointegrated transfemoral amputation prostheses–rehabilitation perspective, J Rehabil Res Dev. 2009;46(3):331.

27. Mohamed J, Reetz D, Van de Meent H, Schreuder H, Frolke JP, Leijendekkers R. What Are the Risk Factors for Mechanical Failure and Loosening of a Transfemoral Osseointegrated Implant System in Patients with a Lower-limb Amputation?, Clinical Orthopaedics and Related Research®. 2021;10:1097.

28. Ilizarov GA. Clinical application of the tension-stress effect for limb lengthening, Clin Orthop. 1990;(250):8-26.

29. Ilizarov G.A. The tension-stress effect on the genesis and growth of tissues. Part I. The influence of stability of fixation and soft-tissue preservation, Clin Orthop. 1989;(238):249-81.

30. Bowlby AA. Surgical Pathology and Morbid Anatomy, page 329, J. & A. Churchill. 640 p., London, 1895.

31. Pitkin M. In-bone implantable shaft for prosthetic joints or for direct skeletal attachment of external limb prostheses and method of its installation. US Patent No. 8992615 https://patents.google.com/patent/ US8992615B2/en, 2015.

32. Pitkin M. In-bone implantable shaft for prosthetic joints or for direct skeletal attachment of external limb
prostheses and method of its installation, US Patent Application No. 11/899068, 2007.

33. Bloebaum RD, Rebuttal to Pitkin JRRD Guest Editorial, J Rebabil Res Dev. 2008; 45 (4): vii-xiv, Journal of Rehabilitation Research and Development 2008;45(9).

34. Pitkin M, Raykhtsaum G, Pilling J, Shukeylo Y, Moxson V, Duz V, Lewandowski J, Connolly R, Kistenberg R, Dalton J, Prilutsky B, Jacobson S. Mathematical modeling and mechanical and histopathological testing of porous prosthetic pylon for direct skeletal attachment, J Rehabil Res Dev. 2009;46(3):315-30 [PMC2905739].

35. Pitkin M, Cassidy C, Muppavarapu R, Raymond J, Shevtsov M, Galibin O, Rousselle S. New method of fixation of in-bone implanted prosthesis, J Rehabil Res Dev. 2013;50(5)709-22; [PMC3785305].

36. Pitkin M. Distraction Implantation. A New Technique in Total Joint Arthroplasty and Direct Skeletal Attachment, EC Orthopaedics. 2018;9(5):285-92.

37. Compton J, Fragomen A, Rozbruch SR. Skeletal Repair in Distraction Osteogenesis: Mechanisms and Enhancements, JBJS Reviews. 2015;3(8):e2.

38. Ai-Aql ZS, Alagl AS, Graves DT. Gerstenfeld LC, Einhorn TA. Molecular mechanisms controlling bone formation during fracture healing and distraction osteogenesis, J Dent Res. 2008;87(2):107-18.