Complications of Osseointegrated Prostheses and Comparison of Quality of Life in Patients with Different Prosthetic Systems: A Review
- Authors: Sinegub A.V.1, Kovalenko D.А.1, Chupryaev V.А.2, Nikolaenko A.N.3, Borisov A.P.3
-
Affiliations:
- NewStep LLP
- Kirov Military Medical Academy
- Samara State Medical University
- Issue: Vol 31, No 2 (2025)
- Pages: 178-189
- Section: Reviews
- URL: https://journal-vniispk.ru/2311-2905/article/view/314146
- DOI: https://doi.org/10.17816/2311-2905-17663
- ID: 314146
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Abstract
Background. Despite recent advances in medicine, the amputation rate remains quite high. Among civilians, vascular diseases (82%) and injuries (17%) are the main causes leading to disability. Half of the patients who have undergone amputation have difficulty using a traditional prosthetic socket (PS). An alternative to PS are osseointegrated (OI) prostheses that transmit loads through the bones, provide increased comfort and the possibility of fitting faulty and short stumps.
The aim — based on a literature review, to determine the mechanical and infectious complications rate of osseointegrated prosthetic systems and compare the quality of life in patients with osseointegrated prostheses and prosthetic in sockets.
Methods. The search for scientific publications was performed in Scopus, PubMed, ResearchGate, Google Scholar, and eLIBRARY databases using the keywords related to osseointegration and quality of life, from 2000 to 2024.
Results. Infections in the stoma area may develop in 11-67% of patients, with 5-8% of cases requiring surgical intervention. Use of ОI prostheses significantly improved functional indicators: the proportion of patients with a K-level ≥3 increased from 5 to 100%, and the results of the six-minute walk test increased from 292 to 448 meters. All indicators of quality of life according to the SF-36 scale improved, and the proportion of patients using the prosthesis for more than 13 hours a day increased from 43 to 95%. Osseointegrated prosthetics is superior to traditional methods in all Q-TFA indicators.
Conclusions. Osseointegrated implants improve patient’s perception of the prosthesis and feel like a part of the body rather than a prosthetic device compared to dentures with stump sleeves. Osseointegrated prosthetics is a promising technology, but requires further research and improvement of the soft tissue interface for wider application.
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##article.viewOnOriginalSite##About the authors
Andrey V. Sinegub
NewStep LLP
Email: a.sinegub@yandex.ru
ORCID iD: 0000-0003-2619-3691
SPIN-code: 7170-6994
Cand. Sci. (Tech.)
Russian Federation, St. PetersburgDenis А. Kovalenko
NewStep LLP
Email: den.kovalencko@mail.ru
ORCID iD: 0009-0009-7843-6828
Russian Federation, St. Petersburg
Victor А. Chupryaev
Kirov Military Medical Academy
Email: v.chupryaev@gmail.com
ORCID iD: 0009-0005-6030-6460
SPIN-code: 5007-7607
Russian Federation, St. Petersburg
Andrey N. Nikolaenko
Samara State Medical University
Email: a.n.nikolaenko@samsmu.ru
ORCID iD: 0000-0003-3411-4172
SPIN-code: 2651-4331
Dr. Sci. (Med.), Associate Professor
Russian Federation, SamaraAlexander P. Borisov
Samara State Medical University
Author for correspondence.
Email: dr_borisov71@mail.ru
ORCID iD: 0009-0008-9562-6394
Cand. Sci. (Med.), Associate Professor
Russian Federation, SamaraReferences
- Dillingham T.R., Pezzin L.E., MacKenzie E.J. Limb amputation and limb deficiency: epidemiology and recent trends in the United States. South Med J. 2002;95: 875-883. doi: 10.1097/00007611-200208000-00018.
- Almohammadi A.A., Alnashri M.M., Abdulrahman T., Harun R., Alsamiri S.M., Alkhatib M.T. Pattern and type of amputation and mortality rate associated with diabetic foot in Jeddah, Saudi Arabia: A retrospective Cohort Study. Ann Med Surg (Lond). 2021;73:103174. doi: 10.1016/j.amsu.2021.103174.
- Giurato L., Meloni M., Izzo V., Uccioli L. Osteomyelitis in diabetic foot: a comprehensive overview. World J Diabetes. 2017;8(4):135-142. doi: 10.4239/wjd.v8.i4.135.
- Low E.E., Inkellis E., Morshed S. Complications and revision amputation following trauma-related lower limb loss. Injury. 2017;48(2):364-370. doi: 10.1016/j.injury.2016.11.019.
- Siracuse J.J., Farber A., Cheng T.W., Jones D.W., Kalesan B. Lower extremity vascular injuries caused by firearms have a higher risk of amputation and death compared with non-firearm penetrating trauma. J Vasc Surg. 2020;72(4):1298-1304.e1. doi: 10.1016/j.jvs.2019.12.036.
- Dudek N.L., Marks M.B., Marshall S.C., Chardon J.P. Dermatologic conditions associated with use of a lower-extremity prosthesis. Arch Phys Med Rehabil. 2005;86(4):659-663. doi: 10.1016/j.apmr.2004.09.003.
- Лёвкин В.Г., Лецкая О.А. Характеристика инвалидности вследствие травм и увечий, полученных в ходе Специальной военной операции, и реабилитационные мероприятия. Физическая и реабилитационная медицина. 2022;4(4):7-16. doi: 10.26211/2658-4522-2022-4-4-7-16. Levkin V.G., Letskaya O.A. Characteristics of disability due to injuries received during a special military operation and rehabilitation measures. Physical and Rehabilitation Medicine. 2022;4(4):7-16. (In Russian). doi: 10.26211/2658-4522-2022-4-4-7-16.
- Сусляев В.Г., Владимирова О.Н., Щербина К.К., Сокуров А.В., Жданов Ю.И., Чупряев В.А. Роль раннего протезирования в системе реабилитации военнослужащих вследствие военной травмы: организационные, юридические и методические аспекты. Вестник Российской Военно-медицинской академии. 2018;62(2): 40-47. doi: 10.17816/brmma12218. Suslyaev V.G., Vladimirova O.N., Shcherbina K.K., Sokurov A.V., Zhdanov Y.I., Chupryaev V.A. The role of early prosthetic help in the system of rehabilitation of the military personnel with military trauma: organizational, legal and methodical aspects. Bulletin of the Russian Military Medical Academy. 2018;62(2): 40-47. (In Russian). doi: 10.17816/brmma12218.
- Смирнова Л.М., Сусляев В.Г., Янковский В.М., Большаков В.А. Персонифицированный синтез протеза нижней конечности: требования к назначению амортизационных модулей со стратегией на импортозамещение. Физическая и реабилитационная медицина. 2023;3(3):8-19. doi: 10.26211/2658-4522-2023-5-3-8-19. Smirnova L.M., Suslyaev V.G., Yankovsky V.M., Bolshakov V.A. Personalized synthesis of lower prosthesis limbers: requirements for the purpose of shock absorber modules with a strategy for import substitution. Physical and Rehabilitation Medicine. 2023;3(3):8-19. (In Russian). doi: 10.26211/2658-4522-2023-5-3-8-19.
- Шурыгин К.Н., Матвеев Р.С., Ханбиков Б.Н. Проблемы адаптации пациентов различных возрастных групп к съемным протезам. Acta Medica Eurasica. 2023;2: 53-59. doi: 10.47026/2413-4864-2023-2-53-59. Shurygin K.N., Matveev R.S., Khanbikov B.N. Problems of adaptation to removable prostheses in patients of different age groups. Acta Medica Eurasica. 2023;2:53-59. (In Russian). doi: 10.47026/2413-4864-2023-2-53-59.
- Thesleff A., Ludvigsson S., Ohr E., Ortiz-Catalan M. Load exposure of osseointegrated implants for transfemoral limb prosthesis during running. Annu Int Conf IEEE Eng Med Biol Soc. 2018;2018:1743-1746. doi: 10.1109/EMBC. 2018.8512592.
- Hoellwarth J.S., Tetsworth K., Akhtar M.A., Al Muderis M. The Clinical History and Basic Science Origins of Transcutaneous Osseointegration for Amputees. Adv Orthop. 2022;2022: 7960559. doi: 10.1155/2022/7960559.
- Madry H., Grässel S., Nöth U., Relja B., Bernstein A., Docheva D. et al. The future of basic science in orthopaedics and traumatology: Cassandra or Prometheus? Eur J Med Res. 2021;26(1):56. doi: 10.1186/s40001-021-00521-x.
- Eshraghi A. Osman N.A., Gholizadeh H., Karimi M., Ali S. Pistoning assessment in lower limb prosthetic sockets. Prosthet Orthot Int. 2012;36(1):15-24. doi: 10.1177/0309364611431625.
- Чупряев В.А., Кудяшев А.Л., Хоминец В.В., Бадалов В.И., Стрельба А.А. Особенности лечения раненых с ампутационными дефектами нижних конечностей в сочетании с переломами костей. Вестник Национального медико-хирургического центра им. Н.И. Пирогова. 2024;19(1):143-148. doi: 10.25881/20728255_2023 _19_1_143. Chupryaev V.A., Kudyashev A.L., Khominets V.V., Badalov V.I., Strelba A.A. Features of the treatment of wounded with amputation defects of the lower extremities in combination with bone fractures. Bulletin of Pirogov National Medical & Surgical Center. 2024;19(1):143-148. (In Russian). doi: 10.25881/20728255_2023 _19_1_143.
- Li Y., He L., Lu X., Du Q., Yu S., Huang X. Clinical Characteristics, Quality of Life, and Risk Factors of Amputation Stump Skin Disease and Stump Fungal Infection in Adult Amputees in Shanghai, China. Front Microbiol. 2022;13:868431. doi: 10.3389/fmicb. 2022.868431.
- Hagberg K., Brånemark R. Consequences of non‐vascular trans‐femoral amputation: a survey of quality of life, prosthetic use and problems. Prosthet Orthot Int. 2001;25(3):186-194. doi: 10.1080 /03093640108726601.
- Beeharry M.W., Walden-Smith T., Moqeem K. Limb Salvage vs. Amputation: Factors Influencing the Decision-Making Process and Outcomes for Mangled Extremity Injuries. Cureus. 2022;14(10):e30817. doi: 10.7759/cureus.30817.
- Li Y., Brånemark R. Osseointegrated prostheses for rehabilitation following amputation: The pioneering Swedish model. Unfallchirurg. 2017;120(4):285-292. doi: 10.1007/s00113-017-0331-4.
- Jah F., Blöchle C., Aschoff H.H. Comparative analysis between bone-guided (endo-exo) prostheses and soft-tissue guided shaft prostheses for rehabilitation after thigh amputation, with special emphasis on its socio-economic aspects. J Surg Rehabil. 2019;1(1):2-9. doi: 10.31487j.JSR.2019.01.03.
- Karimi M.T., Kavyani M., Mehrvar A. Osseointegration: A new approach to improve functional performance of prostheses – a systematic review of the literature. Current Orthopaedic Practice. 2024;35(6):229-236. doi: 10.1097/BCO.0000000000001275.
- Banda R., Castillo J., Velez J.C. A case report: Transhumeral amputee treatment with osseointegrated prosthesis and rehabilitation. J Hand Ther. 2020;33(2): 263-268. doi: 10.1016/j.jht.2020.03.003.
- McMenemy L., Ramasamy A., Sherman K., Mistlin A., Phillip R., Evriviades D. et al. Direct Skeletal Fixation in bilateral above knee amputees following blast: 2 year follow up results from the initial cohort of UK service personnel. Injury. 2020;51(3):735-743. doi: 10.1016/j.injury.2020.01.006.
- Handford C., McMenemy L., Kendrew J., Mistlin A., Akhtar M.A., Parry M. et al. Improving outcomes for amputees: The health-related quality of life and cost utility analysis of osseointegration prosthetics in transfemoral amputees. Injury. 2022;53(12):4114-4122. doi: 10.1016/j.injury.2022.10.007.
- Overmann A.L., Forsberg J.A. The state of the art of osseointegration for limb prosthesis. Biomed Eng Lett. 2019;10(1):5-16. doi: 10.1007/s13534-019-00133-9.
- Hoellwarth J.S., Tetsworth K., Akhter M.A., Al Muderis M. Transcutaneous Osseointegration for Amputees: What Is It, How Did It Evolve, and What May Develop? Curr Phys Med Rehabil Rep. 2023;11:6-15. doi: 10.1007/s40141-023-00376-9.
- Black G.G., Jung W., Wu X., Rozbruch S.R., Otterburn D.M. A Cost-Benefit Analysis of Osseointegrated Prostheses for Lower Limb Amputees in the US Health Care System. Ann Plast Surg. 2022;88(3 Suppl 3):S224-S228. doi: 10.1097/SAP.0000000000003183.
- Al Muderis M., Lu W., Li J.J. Osseointegrated Prosthetic Limb for the treatment of lower limb amputations: Experience and outcomes. Unfallchirurg. 2017;120(4):306-311. doi: 10.1007/s00113-016-0296-8.
- Al Muderis M., Khemka A., Lord S.J., Van de Meent H., Frölke J.P. Safety of Osseointegrated Implants for Transfemoral Amputees: A Two-Center Prospective Cohort Study. J Bone Joint Surg Am. 2016;98(11):900-909. doi: 10.2106/JBJS.15.00808.
- Örgel M., Aschoff H.H., Sedlacek L., Graulich T. et al. Twenty-four months of bacterial colonialization and infection rates in patients with transcutaneous osseointegrated prosthetic systems after lower limb amputation – A prospective analysis. Front Microbiol. 2022;31(13):1002211. doi: 10.3389/ fmicb.2022.1002211.
- Reetz D., Atallah R., Mohamedet J., van de Meent H., Frölke J.P.M., Leijendekkers R. Safety and performance of bone-anchored prostheses in persons with a transfemoral amputation: a 5-year follow-up study. J Bone Joint Surg Am. 2020;102(15):1329-1335. doi: 10.2106/JBJS.19.01169.
- Tropf J.G., Potter B.K. Osseointegration for Amputees: Current State of Direct Skeletal Attachment of Prostheses. Orthop Surg. 2023;12:20-28. doi: 10.1016/j.orthop.2023.05.004.
- Atallah R., Rutjes E., Frölke J.P.M., Leijendekkers R.A. 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.
- Hagberg K., Brånemark R., Hägg O. Questionnaire for Persons with a Transfemoral Amputation (Q-TFA): initial validity and reliability of a new outcome measure. J Rehabil Res Dev. 2004;41(5):695-706. doi: 10.1682/JRRD.2003.11.0167.
- Brånemark R.P., Hagberg K., Kulbacka-Ortizet K., Berlin Ö., Rydevik B. Osseointegrated Percutaneous Prosthetic System for the Treatment of Patients With Transfemoral Amputation: A Prospective Five-year Follow-up of Patient-reported Outcomes and Complications. J Am Acad Orthop Surg. 2019;27(16):e743-e751. doi: 10.5435/JAAOS-D-17-00621.
- McGough R.L., Goodman M.A., Randall R.L., Forsberg J.A., Potter B.K., Lindsey B. The Compress® transcutaneous implant for rehabilitation following limb amputation. Unfallchirurg. 2017;120(4):300-305. doi: 10.1007/s00113-017-0339-9.
- Al Muderis M., Tetsworth K., Khemka A., Wilmot S., Bosley B., Lord S.J. et al. The Osseointegration Group of Australia Accelerated Protocol (OGAAP-1) for two-stage osseointegrated reconstruction of amputated limbs. Bone Joint J. 2016;98-B(7):952-960. doi: 10.1302/0301-620X.98B7.37547.
- Van de Meent H., Hopman M.T., Frölke J.P. Walking ability and quality of life in subjects with transfemoral amputation: a comparison of osseointegration with socket prostheses. Arch Phys Med Rehabil. 2013;94(1):2174-2178. doi: 10.1016/j.apmr.2013.05.020.
- Atallah R., Leijendekkers R.A., Hoogeboom T.J., Frölke J.P. 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.
- Hagberg K., Ghasemi Jahani S.A., Omar O., Thomsen Р. Osseointegrated prostheses for the rehabilitation of patients with transfemoral amputations: A prospective ten-year cohort study of patient-reported outcomes and complications. J Orthop Translat. 2023;38:56-64. doi: 10.1016/j.jot.2022.09.004.
- Tillander J., Hagberg K., Berlin Ö., Hagberg L., Brånemark R. Osteomyelitis Risk in Patients With Transfemoral Amputations Treated With Osseointegration Prostheses. Clin Orthop Relat Res. 2017; 475(12):3100-3108. doi: 10.1007/s11999-017-5507-2.
- Reif T.J., Khabyeh-Hasbani N., Jaime K.M., Sheridan G.A., Otterburn D.M., Rozbruch S.R. Early Experience with Femoral and Tibial Bone-Anchored Osseointegration Prostheses. JBJS Open Access. 2021;6(3):e21.00072. doi: 10.2106/JBJS.OA.21.00072.
- Juhnke D.L., Beck J.P., Jeyapalina S., Aschoff H.H. Fifteen years of experience with Integral-Leg-Prosthesis: Cohort study of artificial limb attachment system. J Rehabil Res Dev. 2015;52(4):407-420. doi: 10.1682/ JRRD.2014.11.0280.
- Sinclair S., Beck J.P., Webster J., Agarwal J., Gillespie B., Stevens P. et al. The first FDA approved early feasibility study of a novel percutaneous bone anchored prosthesis for transfemoral amputees: a prospective 1-year follow-up cohort study. Arch Phys Med Rehabil. 2022;103(11):2092-2104. doi: 10.1016/j.apmr.2022. 06.008.
- Hagberg K., Ghassemi Jahani S.A., Kulbacka-Ortiz K., Thomsen P., Malchau H., Reinholdt C. A 15-year follow-up of transfemoral amputees with bone-anchored transcutaneous prostheses. Bone Joint J. 2020;102-B(1): 55-63. doi: 10.1302/0301620X.102B1.BJJ-2019-0611.R1.
- Hoellwarth J.S., Tetsworth K., Oomatia A., Akhtar M.A., Xu H., Al Muderis M. Association Between Osseointegration of Lower Extremity Amputation and Mortality Among Adults. JAMA Netw Open. 2022;5(10):e2235074. doi: 10.1001/jamanetworkopen.2022.35074.
- Thesleff A., Brånemark R., Håkansson B., Ortiz-Catalan M. Biomechanical characterisation of bone-anchored implant systems for amputation limb prostheses: a systematic review. Ann Biomed Eng. 2018;46(3):377-391. doi: 10.1007/s10439-017-1976-4.
- Al Muderis M., Tan Y.C., Lu W., Tetsworth K., Axelrod D., Haque R. et al. Transtibial osseointegration following unilateral traumatic amputation: An observational study of patients with at least two years follow-up. Injury. 2024;55(6):111568. doi: 10.1016/j.injury.2024.111568.
- Li Y., Felländer-Tsai L. The bone anchored prostheses for amputees – Historical development, current status, and future aspects. Biomaterials. 2021;273:120836. doi: 10.1016/j.biomaterials.2021.120836.
- Healy A., Farmer S., Eddison N., Allcock J., Perry T., Pandyan A. et al. A scoping literature review of studies assessing effectiveness and cost-effectiveness of prosthetic and orthotic interventions. Disabil Rehabil Assist Technol. 2020;15(1):60-66. doi: 10.1080/17483107.2018.1523953.
- Healy A., Farmer S., Pandyan A., Chockalingam N. A systematic review of randomised controlled trials assessing effectiveness of prosthetic and orthotic interventions. PLoS One. 2018;13(3):e0192094. doi: 10.1371/journal.pone.0192094.
- Al Muderis M., Lu W., Glatt V., Tetsworth K. Two-Stage Osseointegrated Reconstruction of Post-traumatic Unilateral Transfemoral Amputees. Mil Med. 2018;183(suppl 1):496-502. doi: 10.1093/milmed/usx185.
- Atallah R., van de Meent H., Verhamme L., Frölke J.P., Leijendekkers R.A. Safety, prosthesis wearing time and health-related quality of life of lower extremity bone-anchored prostheses using a press-fit titanium osseointegration implant: a prospective one-year follow-up cohort study. PloS One. 2020;15(3):e0230027. doi: 10.1371/journal.pone.0230027.
- Brånemark 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. Bone Joint J. 2014;96-B(1):106-113. doi: 10.1302/0301-620X.96B1.31905.
- Frossard L., Stevenson N., Sullivanet J., Uden M., Pearcy M. Categorization of activities of daily living of lower limb amputees during short-term use of a portable kinetic recording system: a preliminary study. J Prosthet Orthot. 2011;23(1):2-11. doi: 10.1097/JPO.0b013e318207914c.
- van Eck C.F., McGough R.L. Clinical outcome of osseointegrated prostheses for lower extremity amputations: a systematic review of the literature. Curr Orthop Pract. 2015;26(4):349-357. doi: 10.1097/ВСО.00000000000 00248.
- Kooiman V., van der Cruijsen J., Leijendekkers R., Verdonschot N., Solis-Escalante T., Weerdesteyn V. The influence of prosthetic suspension on gait and cortical modulations is persons with a transfemoral amputation: socket-suspended versus bone-anchored prosthesis. J Neuroeng Rehabil. 2024;21(1):35. doi: 10.1186/s12984-024-01331-y.
- Kooiman V., Haket L., Verdonschot N., Leijendekkers R., Weerdesteyn V. Oxygen consumption and gait dynamics in transfemoral bone anchored prosthesis users compared to socket prosthesis users: a cross-sectional study. Gait Posture. 2023;103:12-18. doi: 10.1016/j.gaitpost.2023.04.008.
- Leijendekkers R.A., van Hinte G., Frölke J.P., van de Meent H., Atsma F., Nijhuis-van der Sanden M.W. et al. Functional performance and safety of bone-anchored prostheses in persons with a transfemoral or transtibial amputation: a prospective one-year follow-up cohort study. Clin Rehabil. 2019;33(3):450-464. doi: 10.1177/0269215518815215.
- Vernice N.A., Askinas C.A., Black G.G., Truong A.Y., Reif T.J., Rozbruch S.R. et al. Osseointegration for Lower-Extremity Amputees. JBJS Rev. 2022;10(11): e22.00125. doi: 10.2106/JBJS.RVW.22.00125.
- Örgel M., Aschoff H.H., Sedlacek L., Graulich T., Krettek C., Roth S. et al. Analysis of Stomal Bacterial Colonialization After Transcutaneous Osseointegrated Prosthetic Systems Surgery. JAMA Netw Open. 2022;5(7):e2223383. doi: 10.1001/jamanetworkopen.2022.23383.
- van Vliet-Bockting C., Atallah R., Frölke J.P.M., Leijendekkers R.A. How To Improve Patient Selection in Individuals With Lower Extremity Amputation Using a Bone-anchored Prosthesis. Clin Orthop Relat Res. 2025:10.1097. doi: 10.1097/CORR.0000000000003369.
- Rehani M., Stafinski T., Round J., Jones C.A., Hebert J.S. 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.
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