According to new study, people with lower-limb amputations who received osseointegration (OI) reported high levels of satisfaction compared with those who received conventional prosthetic devices.
The researchers reviewed the medical records of 31 men and women who underwent OI procedures at the Hospital for Special Surgery (HSS), New York, New York, starting in October 2017 under the US Food and Drug Administration’s compassionate use exception. Eighteen patients had implants in the femur, and 13 had implants in the tibia.
The primary outcome of the study assessed changes in the Questionnaire for Persons with a Transfemoral Amputation (QTFA), which patients complete before and after surgery. The researchers used the same questionnaire for patients with transtibial amputations. They also gathered data on a range of quality-of-life (QOL) measures including patient-reported functional activity, mental health, pain, and self-image, as well as adverse events such as serious infections, fractures at the site of the implant, and other complications of the procedure.
Researchers found that scores across all domains of the QTFA improved significantly throughout the study period. Prosthetic mobility rose from 49.7 to 81.4, while prosthetic problems fell from 46.4 to 9.1. Patients also experienced substantial gains in function with the implants, as measured by two- and six-minute walking tests.
Although some patients experienced early complications, 93 percent were managed without removing the implant. Some patients developed minor infections where the titanium post exits the skin, most of which were resolved with the use of oral antibiotics. Only one patient had an infection in the bone itself leading to removal.
“This is a disruptive technology to improve the life quality of amputees,” said study co-author S. Robert Rozbruch, MD, chief of the Limb Lengthening and Complex Reconstruction Service and director of the Limb Salvage and Amputation Reconstruction Center at HSS. “With a direct skeletal connection of the prosthetic limb, amputees report big improvements in function, comfort, balance, proprioception and even emotional connection with their limb.”
The study, “Early Experience with Femoral and Tibial Bone-Anchored Osseointegration Prostheses,” was published in JBJS Open Access.