Prospective study of percutaneous bone-anchored implants in transfemoral amputees: Brain-machine platform technology for external prosthetic control and feedback

Abstract

Osseointegration, which describes the direct biological connection between bone and metal, has emerged as a promising method of increasing function and mobility in amputees. This technology holds significant potential, including the ability to harness an integrated neuromuscular interface to allow for volitional motor and sensory control of an external neural prosthesis. While orthopaedic osseointegration has been underway internationally for many years with a variety of implant systems, the practice is still in its early phases in the United States. Here we present the early outcomes of the first American trial for the Osseoanchored Prosthesis for the Rehabilitation of Amputees (OPRA). Our study demonstrates that one year following osseointegration, patients experience a significant improvement in function and health-related outcomes.

Bone-anchored prostheses for transfemoral amputation: a systematic review of outcomes, complications, patient experiences, and cost-effectiveness

“…Table 2 shows the inclusion and exclusion criteria in each of the included studies. The most common inclusion criteria are recurrent problems or the inability to use socket prostheses ( 28 , 44 – 52 , 54 – 58 , 63 ), mature skeleton ( 28 , 44 , 45 , 47 – 49 , 52 ), or normal residual skeletal anatomy ( 44 , 45 , 47 ), the ability to comply with the treatment and follow-up requirements ( 45 – 48 , 52 , 54 , 56 , 62 ), and pre-surgical evaluation by a clinical team ( 44 , 46 , 51 , 52 , 57 , 63 ) along with physical and medical examinations and imaging ( 44 , 45 , 47 ). There also are several contraindications to the OI surgery.…”

“…All types of implants (screw-type or press-fit type) showed an improvement to varying degrees in HRQoL, mobility, and prosthesis usage when the pre-surgical condition (with socket prosthesis) of the patients is compared to their postsurgical condition. Most studies were based on the duration of follow-up of 1 year ( 28 , 48 , 51 , 54 – 56 , 58 , 62 , 63 ) or 2 years ( 44 , 45 , 57 ) post-intervention. There were three studies based on a 5-year follow-up ( 46 , 47 , 52 ) and one study each for 10-year ( 50 ) and 15-year ( 49 ) follow-ups, respectively, post-intervention.…”

“…The condition-specific HRQoL measure, Q-TFA global score, showed an improvement at 1-year ( 28 , 51 , 54 – 56 , 58 , 62 ), 2-year ( 44 , 45 ), 5-year ( 46 , 47 , 52 ), 10-year ( 50 ), and 15-year ( 49 ) follow-up. Reduction in problems due to the prosthesis, measured by Q-TFA problem score, was reported at 1-year ( 48 , 58 , 62 ), 2-year ( 44 , 45 ), 5-year ( 46 , 47 ), 10-year ( 50 ), and 15-year ( 49 ) follow-up. Two articles ( 46 , 47 ) presented 5-year follow-up data and reported the interim 2-year follow-up data.…”

“…It should be noted that this review excluded papers on gait parameters as this was recently reviewed ( 105 ) and the relationship between gait parameters and clinical outcomes needs to be further examined. Lastly, two of the included studies were reported to have been conducted as a clinical trial ( 48 , 62 ), and one of these is under regulatory oversight by the FDA ( 62 ). These studies may be subject to different obligations to report outcomes and adverse events; however, we assessed their quality and risks of bias using appropriate tools.…”

“…Studies on press-fit implants more commonly used performance-based outcome measures that specifically measured mobility and function. Although observer-based mobility performance measures were not used or reported by the studies on screw-type implants (44)(45)(46)(47)(48)(49)(50), information on mobility and prosthesis usage in these studies based on the self-reported Q-TFA did show improvements. Prosthesis use as measured by Q-TFA prosthetic use score was reported to have increased significantly at 1-year (28, 55, 58), 2-year (44,45), 5-year (46, 47, 52), and 10-year (50), but not at 15-year (49), follow-up.…”