Osseointegration for Insurers

Socket prostheses typically require frequent adjustment, repair, and replacement due to wear and tear and change in the size and shape of a person’s residual limb.

A socket must be tailored to the needs of each individual person, and most will try multiple prosthetic designs before finding one tolerable. This evaluation process, including multiple models, materials, mounting techniques and liners, would generate significant costs.

Studies have shown that up to 82% of lower limb amputees develop socket-related complications, despite these costly and, typically, long-term, efforts. Up to 57 % of people with lower limb socket prosthetics eventually abandon them due to associated pain and soft tissue problems.

Osseointegration offers a more durable alternative solution, reducing the need for frequent replacements and minimising associated long-term costs.**

Although associated with a higher initial cost than socket prostheses, osseointegration offers numerous advantages over socket technology that can improve mobility, functionality, comfort and quality of life.[1] [2] [3] [4] [5] [6] [7] 

The Osseointegration Prosthetic Limb (OPL) implant has been shown to provide consistent quality of life and cost benefits in patients unable to mobilize satisfactorily with traditional prostheses. One study, following eighty osseointegrated amputees over 10.5 years, measured quality of life using the EQ-5D HUV questionnaire. It identified a mean score increase from a preoperative baseline of 0.64 to 0.78 at 6 years after osseointegration, with further increases for the lifetime of the study.8

Those with a baseline score of <0.60 showed significant post-operative improvement and achieved a cost/QALY of <£30,000 at 5 years. UK military patients demonstrated consistent score improvements over time and a cost/QUALY of £28,616.89 at 5 years. These results support the delivery of osseointegration through the U.K. NHS and other public health services. 8

For Australian patients, lower limb osseointegration cost 21% (±41%) more than socket prosthesis, but improved QUALYs by 17% (±5%). Osseointegration proved to be cost-saving for 19% of the study’s participants and cost-effective for 88%, at an average cost of AU$17,000 per quality-adjusted life-year.9 

In Europe, osseointegration proved to be more cost effective for transfemoral osseointegrated patients. Compared to an annual decline in socket usage between 2%, and 3%, osseointegration resulted in a cost per QALY-gained of €24 662 and €18 952, respectively. In the US, osseointegration has been shown to deliver affordable quality-of-life improvements for socket users. Cost-effectiveness here is calculated with reference to the frequency of osseointegration, cost of mechanical failure and the historical socket prosthetic costs associated with the patient.

Osseointegration improves sensory feedback, proprioception, stability and control. [10] [11] [12] [13]

These benefits can help patients to return to physically-demanding jobs, engage in an active lifestyle, and enjoy sports. Indeed, for patients who owe their amputation to disease, rather than trauma, many are able to substantially increase their activity post-operatively, compared to pre-operative baselines.

[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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