A new Hospital for Special Surgery (HSS) study, “Early Experience with Femoral and Tibial Bone-Anchored Osseointegration Prostheses,” has found that the devices, which are not yet FDA approved—but are available for humanitarian exceptions—result in high levels of patient satisfaction compared with conventional devices.
The team, which included co-author Taylor Reif, M.D., a member of the HSS Limb Lengthening and Complex Reconstruction Service, conducted a retrospective review of the first 31 patients who were implanted with a press-fit osseointegration implant of the femur or tibia.
The study, which provided data for at least six months of follow-up, relied on a patient-reported Questionnaire for persons with a Transfemoral Amputation (preoperatively and 6 to 12 months postoperatively). The research team also collected data from the Patient-Reported Outcomes Measurement Information System, the Limb Deformity-Scoliosis Research Society scores, and 2-minute and 6-minute walk tests.
Increasing Globally
OTW asked the research team why bone-anchored osseointegration implants for amputation reconstruction are on the rise. Dr. Reif explained, “Bone-anchored osseointegration implants eliminate wearing a socket around the residual limb, which for most patients is frustrating, painful, and limits what they want to do. So, patients are highly motivated to seek other treatment options.
“This, combined with the functional gains and relatively low rate of complications in studies of the implants, means surgeons are willing to adopt a new procedure to support their patients.”
The study team looked at 18 femoral reconstructions and 13 tibial reconstructions, with 28 reconstructions being single-stage implantations. All domains on the Questionnaire for persons with a Transfemoral Amputation improved significantly preop to postop, including the global score, prosthetic use, prosthetic mobility, and prosthetic problems.
The remaining outcome measures (Patient-Reported Outcomes Measurement Information System, Limb Deformity-Scoliosis Research Society scores, 2-minute and 6-minute walk tests) also improved significantly.
“This study demonstrated after osseointegration patients use their prosthesis more, with better mobility, and fewer problems,” explained Dr. Reif to OTW. “This leads to a substantially better quality of life as an amputee. Clinically, this work supports the ongoing growth, utilization, and refinement of this technology so it can be expanded to a broader group of amputees, including as a primary reconstruction option in certain patients undergoing amputation.”
