The First FDA Approved Early Feasibility Study of a Novel Percutaneous Bone Anchored Prosthesis for Transfemoral Amputees: A Prospective 1-year Follow-up Cohort Study

Sinclair, Sarina; Beck, James P.; Webster, Joseph B.; Agarwal, Jayant P.; Gillespie, Bart; Stevens, Phil; Gililland, Jeremy M.; Kubiak, Erik N.

doi:10.1016/j.apmr.2022.06.008

Cited by 9 publications

(33 citation statements)

References 52 publications

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“…Prior work examining other BAP implant systems suggests activity levels increase after transition to a BAP [ 37 ], supporting the notion that increased activity overall likely contributed to increased muscle strength and an improved gait. While activity levels were not analyzed as part of this kinematics study, improvements for the group in mobility-related outcomes [ 19 ] suggest the activity levels may have increased.…”

Section: Discussionmentioning

confidence: 99%

“…Study participants were individuals with traumatic unilateral TFA enrolled in a United States Food and Drug Administration (FDA) Early Feasibility Study (EFS) for a new BAP device named the Percutaneous Osseointegrated Prosthesis (POP) [ 19 , 20 ]. This Level II therapeutic prospective, single-center, nonrandomized clinical trial (ClinicalTrials.gov Identifier: NCT02720159) was approved to enroll a total of 10 individuals.…”

Section: Methodsmentioning

confidence: 99%

“…These individuals were 18 years of age or older and had a non-dysvascular disease related TFA at least 6 months prior. A complete list of clinical trial inclusion and exclusion criteria was reported in a separate manuscript describing the overall outcomes of the FDA EFS [ 19 ]. Participants provided written informed consent prior to completing the testing procedures approved by the University of Utah Institutional Review Board.…”

Section: Methodsmentioning

confidence: 99%

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Changes in frontal plane kinematics over 12-months in individuals with the Percutaneous Osseointegrated Prosthesis (POP)

et al. 2023

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Background A bone-anchored prosthesis (BAP) eliminates the need for a conventional socket by attaching a prosthesis directly to the user’s skeleton. Currently, limited research addresses changes in gait mechanics post BAP implantation. Objective Examine changes in frontal plane movement patterns after BAP implantation. Methods Participants were individuals with unilateral transfemoral amputation (TFA) enrolled in the US Food and Drug Administration (FDA) Early Feasibility Study examining the Percutaneous Osseointegrated Prosthesis (POP). The participants completed overground gait assessments using their conventional socket and at 6-weeks, 12-weeks, 6-months, and 12-months following POP implantation. Statistical parameter mapping techniques were used in examining changes in frontal plane kinematics over the 12-months and differences with reference values for individuals without limb loss. Results Statistically significant deviations were found pre-implantation compared to reference values for hip and trunk angles during prosthetic limb stance phase, and for pelvis and trunk relative to the pelvis angles during prosthetic limb swing. At 6-weeks post-implantation, only the trunk angle demonstrated a statistically significant reduction in the percent of gait cycle with deviations relative to reference values. At 12-months post-implantation, results revealed frontal plane movements were no longer statistically different across the gait cycle for the trunk angle compared to reference values, and less of the gait cycle was statistically different compared to reference values for all other frontal plane patterns analyzed. No statistically significant within-participant differences were found for frontal plane movement patterns between pre-implantation and 6-weeks or 12-months post-implantation. Conclusions Deviations from reference values displayed prior to device implantation were reduced or eliminated 12-months post-implantation in all frontal plane patterns analyzed, while within-participant changes over the 12-month period did not reach statistical significance. Overall, the results suggest the transition to a BAP aided in normalizing gait patterns in a sample of relatively high functioning individuals with TFA.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Changes in frontal plane kinematics over 12-months in individuals with the Percutaneous Osseointegrated Prosthesis (POP)

et al. 2023

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“…No exclusion criteria were applied for gender, ethnicity, age, weight and height or level of activity. Non-Microprocessor-controlled knee 7 [6] 7 [7] Microprocessor-controlled knee 2 [8] 2 [9] Energy storing and return ankle/ foot 9 [10] 9 [11] Apparatus Length of walkway with BAP worldwide at the time of the recording; [3] participants used their own usual footwear as well as knee and ankle/foot components; [4] participants were fitted with instrumented prosthesis included a transducer and their own footwear as well as usual knee and ankle/foot components; [5] the alignment with the instrumented prosthesis was mainly preserved for all participants except one when the knee was dropped by a few centimetres to fit the transducer; [6] on lower limbs; [13] additional trials were recorded, when needed, to achieve at least three complete landings of both feet on the hidden force plates; [14] participants landed their prosthetic and sound feet on the first and second force-plate so that the direction on the walkway was inverted depending on the side of amputation so that the prosthetic limb always stepped on the force plate first.…”

Section: Methodsmentioning

confidence: 99%

“…[1][2][3][4][5][6][7] Functional outcomes of transfemoral bone-anchored prostheses are commonly reported using basic cadence and speed of walking. [8][9][10] As a result, our understanding of the effects of this type of prostheses on gait parameters is limited. 11 There is a need for the comparisons of a series of gait parameters produced by individuals with transfemoral bone-anchored and socket-suspended prostheses as well as able-bodied participants (Supplemental Table S1).…”

Section: Introductionmentioning

confidence: 99%

Walking ability of individuals fitted with transfemoral bone-anchored prostheses: A comparative study of gait parameters

et al. 2023

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Objective This study presents the walking abilities of participants fitted with transfemoral bone-anchored prostheses using a total of 14 gait parameters. Design Two-centre retrospective cross-sectional comparative study. Setting Research facilities equipped with tridimensional motion capture systems. Participants Two control arms included eight able-bodied participants arm (54 ± 9 years, 1.75 ± 0.07 m, 76 ± 7 kg) and nine participants fitted with transfemoral socket-suspended prostheses arm (59 ± 9 years, 1.73 ± 0.07 m, 80 ± 16 kg). The intervention arm included nine participants fitted with transfemoral bone-anchored prostheses arm (51 ± 13 years, 1.78 ± 0.09 m, 87.3 ± 16.1 kg). Intervention Fitting of transfemoral bone-anchored prostheses. Main measures Comparisons were performed for two spatio-temporal, three spatial and nine temporal gait parameters. Results The cadence and speed of walking were 107 ± 6 steps/min and 1.23 ± 0.19 m/s for the able-bodied participants arm, 88 ± 7 steps/min and 0.87 ± 0.17 m/s for the socket-suspended prosthesis arm, and 96 ± 6 steps/min and 1.03 ± 0.17 m/s for bone-anchored prosthesis arm, respectively. Able-bodied participants and bone-anchored prosthesis arms were comparable in age, height, and body mass index as well as cadence and speed of walking, but the able-bodied participant arm showed a swing phase 31% shorter. Bone-anchored and socket-suspended prostheses arms were comparable for age, height, mass, and body mass index as well as cadence and speed of walking, but the bone-anchored prosthesis arm showed a step width and duration of double support in seconds 65% and 41% shorter, respectively. Conclusions Bone-anchored and socket-suspended prostheses restored equally well the gait parameters at a self-selected speed. This benchmark data provides new insights into the walking ability of individuals using transfemoral bionics bone-anchored prostheses.

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Association between blood markers and the progression of osseointegration in percutaneous prostheses patients—A pilot study

Miller,

Jeyapalina,

Agarwal

et al. 2024

J Biomed Mater Res

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Patients implanted with osseointegrated (OI) prosthetic systems have reported vastly improved upper and lower extremity prosthetic function compared with their previous experience with socket‐suspension systems. However, OI systems have been associated with superficial and deep‐bone infections and implant loosening due, in part, to a failure of the osseointegration process. Although monitoring the osseointegration using circulating biomarkers has clinical relevance for understanding the progression of osseointegration with these devices, it has yet to be established. Ten patients were enrolled in this study. Blood samples were collected at pre‐selected times, starting before implantation surgery, and continuing to 12 months after the second surgery. Bone formation markers, bone resorption markers, and circulating amino acids were measured from blood samples. A linear mixed model was generated for each marker, incorporating patient ID and age with the normalized marker value as the response variable. Post hoc comparisons were made between 1 week before Stage 1 Surgery and all subsequent time points for each marker, followed by multiple testing corrections. Serial radiographic imaging of the residual limb containing the implant was obtained during follow‐up, and the cortical index (CI) was calculated for the bone at the porous region of the device. Two markers of bone formation, specifically bone‐specific alkaline phosphatase (Bone‐ALP) and amino‐terminal propeptide of type I procollagen (PINP), exhibited significant increases when compared with the baseline levels of unloaded residual bone prior to the initial surgery, and they subsequently returned to their baseline levels by the 12‐month mark. Patients who experienced clinically robust osseointegration experienced increased cortical bone thickness at the porous coated region of the device. A medium correlation was observed between Bone‐ALP and the porous CI values up to PoS2‐M1 (p = .056), while no correlation was observed for PINP. An increase in bone formation markers and the lack of change observed in bone resorption markers likely reflect increased cortical bone formation induced by the end‐loading design of the Utah OI device used in this study. A more extensive study is required to validate the correlation observed between Bone‐ALP and porous CI values.

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The First FDA Approved Early Feasibility Study of a Novel Percutaneous Bone Anchored Prosthesis for Transfemoral Amputees: A Prospective 1-year Follow-up Cohort Study

Cited by 9 publications

References 52 publications

Changes in frontal plane kinematics over 12-months in individuals with the Percutaneous Osseointegrated Prosthesis (POP)

Changes in frontal plane kinematics over 12-months in individuals with the Percutaneous Osseointegrated Prosthesis (POP)

Walking ability of individuals fitted with transfemoral bone-anchored prostheses: A comparative study of gait parameters

Association between blood markers and the progression of osseointegration in percutaneous prostheses patients—A pilot study

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