Researchers at the Radboud University Medical Center, Nijmegen, Netherlands, published the first long-term evaluation of osseointegrated prostheses. The researchers found that the procedure involves some problems with the stoma, but that they can usually be treated with simple measures, and the osseointegration implant system led to a permanent improvement in mobility and quality of life.
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The clinical researchers in the rehabilitation and orthopedics department at the medical center evaluated 42 patients who had undergone osseointegration, and performed a follow-up study of 39 of the patients five years after surgery. The most common complication was infection, in 77 percent of patients, which were mostly superficial and in the first two years. The majority of infections (95 percent) were mild to moderate and did not require surgical treatment. Fourteen patients experienced irritation around the stoma where the pin protrudes through the skin, and they underwent minor surgery to reshape the soft tissue.
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After receiving the implants, the patients increased the number of hours per week they could use their prosthesis from an average of 56 hours with their previous socket prosthesis to 101 hours with the bone-anchored prosthesis. On a 100-point scale, the average health-related quality of life score increased from 33 to 75.
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“Next steps in clinical research should include studies aimed at optimizing the stoma using a unified registry system, and further developing the implant design and safety of bone-anchored prostheses in patients with vascular disease,” said David Reetz, a PhD candidate and one of the study’s researchers. “This is by far the largest group but has not been taken into account in this study.”
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The study, Safety and Performance of Bone-Anchored Prostheses in Persons with a Transfemoral Amputation: A 5-Year Follow-up Study, was published in the Journal of Bone and Joint Surgery.
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Editor’s note: This story was adapted from materials provided by Radboud University Medical Center.
