A multidisciplinary team from Health Quality Ontario, Canada, conducted a health technology assessment of osseointegrated prosthetic implants compared with conventional socket prostheses for people with lower-limb amputations who experienced chronic problems with their prosthetic socket that led to prosthesis intolerance and reduced mobility. Nine of 13 people interviewed for the assessment who had received an osseointegrated prosthetic implant said they had better mobility and quality of life than before osseointegration but had concerns about the ongoing risk of infection and potential for problems with implant maintenance. The three people using a conventional socket prosthesis said cost was the only factor preventing them from undergoing an osseointegration procedure, according to the report.
The team’s analysis included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding osseointegrated prosthetic implants, and patient preferences and values. They performed a systematic literature search of the clinical evidence on the safety and effectiveness of the latest iterations of three implant systems: the Osseointegrated Prostheses for the Rehabilitation of Amputees Implant System, the Endo-Exo-Femur-Prosthesis, and the Osseointegration Group of Australia-Osseointegration Prosthetic Limb.
The report said that the nine studies included in the clinical evidence review included patients with transfemoral amputations who underwent two-stage surgery and mostly had short-term follow-up. With osseointegrated prosthetic implants, scores for functional outcomes improved significantly as measured by the six-minute walk test, Timed Up and Go test, and Questionnaire for Persons with a Transfemoral Amputation. The scores for quality of life measured by the 36-Item Short Form Survey showed significant improvement in the physical component summary but a nonsignificant decline for the mental component summary. The most frequently seen adverse event was superficial infection, which occurred in about half of patients in some studies.
Assessment of the quality of the clinical evidence found low certainty in terms of improvement in functional outcomes, low certainty for quality of life, and high certainty of an increase in adverse events; all findings compared receiving an osseointegrated prosthetic implant with not receiving an osseointegrated prosthetic implant, according to the report.
In the economic model, osseointegrated prosthetic implants were found to be more effective and more expensive than having people continue to use an uncomfortable socket prosthesis, the report concluded.
The report, Osseointegrated prosthetic implants for people with lower-limb amputation: a health technology assessment, can be read in full atwww.hqontario.ca/evidence-to-improve-care/journalontario-health-technology-assessment-series.
