Osseointegration for Insurers

Socket prostheses often require frequent adjustments, repairs, and replacements due to wear and tear and changes in the residual limb’s size and shape. Sockets need to be tailored to the specific individual needs of the amputee. Many patients would have to try multiple designs before they could find a reasonable fit. Evaluating diverse models, materials, mounting techniques and liners, would generate high costs before finding the definitive socket fit. It has been reported, that up to 82% of lower limb amputees would develop socket- related problems hindering their mobility, despite time and funds invested in multiple fitting efforts. Moreover, even up to 57 % of lower limb amputees would completely abandon their prosthesis due to skin ulcerations and impossible-to-overcome discomfort. In contrast, limb osseointegration offers a more durable solution, reducing the need for frequent replacements and minimising associated long-term costs. **

While limb osseointegration may have a higher initial cost than socket prostheses, it offers numerous advantages that enhance the quality of life for amputees, resulting in improved mobility, functionality, and comfort[1] [2] [3] [4] [5] [6] [7]. You can read more about osseointegration´s clinical benefits here.

The Osseointegration Group of Australia Osseointegration Prosthetic Limb Implant (OGAP-OPL) has been shown to provide consistent quality of life and cost-effectiveness benefits in patients who cannot mobilize satisfactorily with traditional prostheses. In the latest study, eighty amputees received osseointegration and were followed up for 10.5 years. The research questionnaire called EQ-5D HUV, which measured five dimensions of life, was used as a tool to evaluate the patient´s quality of life. Pre-operatively, the mean score was 0.64, and it went up to 0.73 at 5 years, and 0.78 at 6 years after osseointegration. The EQ5D score continued to increase until 10.5 years when the follow-up finished 8.

The study showed that those with a starting EQ5D score of less than 0.60 significantly improved their score after osseointegration and reached a cost/QALY of <£30,000 at 5 years. The UK military patients showed a mean pre-operative EQ5D score of 0.48 and significant improvements at each point in time, getting a cost/QUALY of £28,616.89 at 5 years. These results reinforce the evidence that advocates for the use of osseointegration through the NHS and other publicly funded healthcare services. 8

In an Australian context, lower limb osseointegration costed 21%±41% more than socket prosthesis but improved QUALYs by 17%±5% in patients. Osseointegration proved to be cost-saving for 19% of the study’s participants, cost-effective for 88% of them, with AU$17,000 per quality-adjusted life-year9.  In a European context for transfemoral amputated patients OI proved better cost-effectiveness compared to sockets when patients experienced a decline in the use of their socket prosthesis with time. With an annual socket usage decline of 2%, and 3%, OI resulted in cost per QALY gained , €24 662, and €18 952, respectively. In the US context, OI offers a better quality of life with an affordable cost in patients who have problems with their socket prosthesis. The cost-effectiveness of OI is determined by OI´s frequency and cost of mechanical failure and the patient’s previous socket-prosthesis costs

Osseointegration also improves sensory feedback, proprioception, stability, and control [10] [11] [12] [13]. These benefits can help many patients return to perform physically demanding jobs, continue to have an active lifestyle, and practice sports. Many patients become more active with OI than prior to the amputation if the amputation wasn’t traumatic, but was a consequence of a prolonged disease.

[1] Hagberg, K. et al. (2005) “Socket versus bone-anchored trans-femoral prostheses,” Prosthetics & Orthotics International, 29(2), pp. 153–163. Available at: https://doi.org/10.1080/03093640500238014

[2]
Tranberg, R., Zügner, R. and Kärrholm, J. (2011) “Improvements in hip- and pelvic motion for patients with osseointegrated trans-femoral prostheses,” Gait & Posture, 33(2), pp. 165–168. Available at: https://doi.org/10.1016/j.gaitpost.2010.11.004.

[3]
Kahle, J.T. and Muderis, M.A. (2016) “What science says about the clinical outcome of osseointegration,” Technology Review, December, pp. 38–41.

[4]
Van de Meent, H., Hopman, M.T. and Frölke, J.P. (2013) “Walking ability and quality of life in subjects with transfemoral amputation: A comparison of osseointegration with socket prostheses,” Archives of Physical Medicine and Rehabilitation, 94(11), pp. 2174–2178. Available at: https://doi.org/10.1016/j.apmr.2013.05.020.

[5]
Hagberg, K. et al. (2008) “Osseointegrated trans-femoral amputation prostheses: prospective results of general and condition-specific quality of life in 18 patients at 2-year follow-up,” Prosthetics & Orthotics International, 32(1), pp. 29–41. Available at: https://doi.org/10.1080/03093640701553922.

[6]
Muderis, M.A. et al. (2016) “The Osseointegration Group of Australia accelerated protocol (OGAAP-1) for two-stage osseointegrated reconstruction of amputated limbs,” The Bone & Joint Journal, 98-B(7), pp. 952–960. Available at: https://doi.org/10.1302/0301-620x.98b7.37547

[7]
Nebergall, A. et al. (2012) “Stable fixation of an osseointegated implant system for above-the-knee amputees,” Acta Orthopaedica, 83(2), pp. 121–128. Available at: https://doi.org/10.3109/17453674.2012.678799

[8]
Frossard, L.A. et Häggström, E. et al. (2013) “Vibrotactile evaluation: Osseointegrated versus socket-suspended transfemoral prostheses,” Journal of Rehabilitation Research and Development, 50(10), pp. 1423–1434. Available at: https://doi.org/10.1682/jrrd.2012.08.013.al. (2018) ‘Cost-effectiveness of bone-anchored prostheses using osseointegrated fixation’, Prosthetics & Orthotics International, 42(3), pp. 318–327. doi:10.1177/0309364617740239.

[9]
.Lee, W.C.C. et al. (2004) “Finite element modeling of the contact interface between trans-tibial residual limb and prosthetic socket,” Medical Engineering & Physics, 26(8), pp. 655–662. Available at: https://doi.org/10.1016/j.medengphy.2004.04.010.

[10]
Hagberg K, Haggstrom E, Jonsson S, Rydevik Hagberg, K. et al. (no date) “Osseoperception and osseointegrated prosthetic limbs,” Psychoprosthetics, pp. 131–140. Available at: https://doi.org/10.1007/978-1-84628-980-4_10.

[11]
Hagberg, K. et al. (2008) “Osseointegrated trans-femoral amputation prostheses: prospective results of general and condition-specific quality of life in 18 patients at 2-year follow-up,” Prosthetics & Orthotics International, 32(1), pp. 29–41. Available at: https://doi.org/10.1080/03093640701553922.

[12]
Häggström, E. et al. (2013) “Vibrotactile evaluation: Osseointegrated versus socket-suspended transfemoral prostheses,” Journal of Rehabilitation Research and Development, 50(10), pp. 1423–1434. Available at: https://doi.org/10.1682/jrrd.2012.08.0135.

*** Paternò, Linda, et al. “Sockets for limb prostheses: a review of existing technologies and open challenges.” IEEE Transactions on Biomedical Engineering (2018).

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