Safety, prosthesis wearing time and health-related quality of life of lower extremity bone-anchored prostheses using a press-fit titanium osseointegration implant: A prospective one-year follow-up cohort study

Abstract

Background We described safety and functional one-year follow-up outcomes of individuals with lower limb amputation treated with bone-anchored prostheses using titanium press-fit osseointegration implants. Methods All consecutive individuals treated between March 2015 and June 2018 with curved osseointegration femur implant (OFI-C) indicated for a long femoral remnant, gamma osseointegration femur implant (OFI-Y) indicated for a short femoral remnant, or osseointegration tibia implant (OTI) were eligible for this study. All adverse events were evaluated, infections were graded as follows: grade 1 and 2: low-and high-grade soft tissue infection, respectively, grade 3: deep bone infection, grade 4: septic implant failure. Functional outcome measures included prosthesis wearing time (PUS), health-related quality of life (GS), and the overall situation as an amputee (GS Q3); evaluated with the Questionnaire of persons with trans-femoral amputation (Q-TFA) before surgery and at one-year follow-up. Results Ninety of 91 individuals were included (mean age: 54±14 yrs, 26 females); treated with 53, 16 and 21 OFI-C, OFI-Y and OTI, respectively. Soft tissue infections (grade 1: 11 events, grade 2: 10 events) were treated successfully with antibiotics except in two (OFI-C and OFI-Y), who required additional surgery due to recurrent stoma irritation and peri-stoma abscess drainage. One individual with dysvascular amputation (OTI) developed septic implant loosening and occlusion of the femoral artery resulting in a transfemoral amputation. No aseptic

Load applied on osseointegrated implant by transfemoral bone-anchored prostheses fitted with state-of-the-art prosthetic components

“…No exclusion criteria were applied for gender, ethnicity, height or functional level. A total of 13 TFAs fitted with a non-FDA approved press-fit implant were assessed in Sydney, Australia between Sept 2017 and Aug 2018 (i.e., Integral leg prosthesis, Eska Orthopedics GmbH, Germany; Osseointegration Prosthetic Limb, Permedica SPA, Italy) (Atallah et al, 2020). Each participant signed a written ethical consent form approved by research organization's human ethics committee (Human Research Ethics Committee Certificate No 1600000332, Queensland University of Technology, Brisbane, Australia).…”

“…Alternatively, TFAs could be fitted with bone-anchored prostheses (BAP) attached to an osseointegrated implant surgically inserted into the residual femur (Branemark et al, 2001;Pitkin, 2013). Several studies demonstrated that transfemoral BAP could improve functions and health-related quality of life, particularly for young and active individuals experiencing overwhelming socket issues (Atallah et al, 2020;Hagberg and Branemark, 2009;Hebert et al, 2017;Hoyt et al, 2020;Leijendekkers et al, 2017;van Eck and McGough, 2015). Management of residual soft tissues as well as risks of infections, loosening, periprosthetic fracture and breakage of osseointegrated implant parts are deemed acceptable by treating teams, although they are yet to be satisfactorily resolved (Atallah et al, 2018;Atallah et al, 2020;Hoyt et al, 2020;Kunutsor et al, 2018;van Eck and McGough, 2015).…”

“…Several studies demonstrated that transfemoral BAP could improve functions and health-related quality of life, particularly for young and active individuals experiencing overwhelming socket issues (Atallah et al, 2020;Hagberg and Branemark, 2009;Hebert et al, 2017;Hoyt et al, 2020;Leijendekkers et al, 2017;van Eck and McGough, 2015). Management of residual soft tissues as well as risks of infections, loosening, periprosthetic fracture and breakage of osseointegrated implant parts are deemed acceptable by treating teams, although they are yet to be satisfactorily resolved (Atallah et al, 2018;Atallah et al, 2020;Hoyt et al, 2020;Kunutsor et al, 2018;van Eck and McGough, 2015). Preliminary health economic analyses suggested the cost-effectiveness of BAP compared to socket prostheses from a governmental prosthetic care perspective (Frossard et al, 2017;Frossard et al, 2018a;Frossard et al, 2018b;Frossard et al, 2019a).…”

Unexpected positive intraoperative cultures (UPIC) at index osseointegration do not lead to increased postoperative infectious events

“…Unsurprisingly, the most common adverse event following osseointegration is infection (Reif et al, 2021), which may require oral antibiotics, operative debridement with implant retention, or implant removal with additional debridement (Al Muderis et al, 2017). Prior investigations of post-osseointegration infection have reported postoperative occurrence rates and management (Al Muderis et al, 2017;Reif et al, 2021;Hoffmeister et al, 2017;Atallah et al, 2020). However, it is currently unknown to what extent UPIC impacts the risk of subsequent infection.…”

Patient-reported benefits of bone-anchored transfemoral prostheses as assessed by MedTech20: A general outcome measure for medical products

“…9 Today, bone-anchored prostheses (BAPs), directly attached to a percutaneous implant, have become an alternative to socketsuspended prostheses (SSPs), especially in patients who have undergone transfemoral amputation (TFA) for reasons other than vascular disease and who have difficulty obtaining adequate and comfortable socket suspension. [10][11][12][13] Among patients using BAPs, improvements in patient-reported outcomes with regard to prosthetic function and HRQL have been reported as compared to their previous situation, [14][15][16][17][18] although in conjunction with implantrelated complications. 14,[17][18][19][20][21] Health economic evaluations of BAPs have shown higher costs, fewer visits, and some gain of qualityadjusted life-years (QALYs) as measured by the use of SF-36/SF-6D and as compared to the SSPs.…”