Transhumeral prosthesis use affects upper body kinematics and kinetics.

BACKGROUND: Transhumeral (TH) limb loss leads to loss of body mass and reduced shoulder range of motion. Despite most owning a prosthesis, prosthesis abandonment is common. The consequence of TH limb loss and prosthesis use and disuse during gait may be compensation in the upper body, contributing to back pain or injury. Understanding the impact of not wearing a TH prosthesis on upper body asymmetries and spatial-temporal aspects of gait will inform how TH prosthesis use and disuse affects the body. RESEARCH QUESTION: Does TH limb loss alter upper body asymmetries and spatial-temporal parameters during gait when wearing and not wearing a prosthesis compared to able-bodied controls? METHODS: Eight male TH limb loss participants and eight male control participants completed three gait trials at self-selected speeds. The TH limb loss group performed trials with and without their prosthesis. Arm swing, trunk angular displacement, trunk-pelvis moment, and spatial-temporal aspects were compared using non-parametric statistical analyses. RESULTS: Both TH walking conditions showed greater arm swing in the intact limb compared to the residual (p≤0.001), resulting in increased asymmetry compared to the control group (p≤0.001). Without the prosthesis, there was less trunk flexion and lateral flexion compared to the control group (p≤0.001). Maximum moments between the trunk and pelvis were higher in the TH group than the control group (p≤0.05). Spatial-temporal parameters of gait did not differ between the control group and either TH limb loss condition. SIGNIFICANCE: Prosthesis use affects upper body kinematics and kinetics, but does not significantly impact spatial-temporal aspects of gait, suggesting these are compensatory actions. Wearing a prosthesis helps achieve more normative upper body kinematics and kinetics than not wearing a prosthesis, which may help limit back pain. These findings emphasize the importance of encouraging at least passive use of prostheses for individuals with TH limb loss.

Extended physiological proprioception is affected by transhumeral Socket-Suspended prosthesis use.

The objective of this study was to define targeted reaching performance without visual information for transhumeral (TH) prosthesis users, establishing baseline information about extended physiological proprioception (EPP) in this population. Subjects completed a seated proprioceptive targeting task under simultaneous motion capture, using their prosthesis and intact limb. Eight male subjects, median age of 58 years (range 29-77 years), were selected from an ongoing screening study to participate. Five subjects had a left-side TH amputation, and three a right-side TH amputation. Median time since amputation was 9 years (range 3-54 years). Four subjects used a body-powered prosthetic hook, three a myoelectric hand, and one a myoelectric hook. The outcome measures were precision and accuracy, motion of the targeting hand, and joint angular displacement. Subjects demonstrated better precision when targeting with their intact limb compared to targeting with their prosthesis, 1.9 cm2 (0.8-3.0) v. 7.1 cm2 (1.3-12.8), respectively, p = 0.008. Subjects achieved a more direct reach path ratio when targeting with the intact limb compared to with the prosthesis, 1.2 (1.1-1.3) v. 1.3 (1.3-1.4), respectively, p = 0.039 The acceleration, deceleration, and corrective phase durations were consistent between conditions. Trunk angular displacement increased in flexion, lateral flexion, and axial rotation while shoulder flexion decreased when subjects targeted with their prosthesis compared to the intact limb. The differences in targeting precision, reach patio ratio, and joint angular displacements while completing the targeting task indicate diminished EPP. These findings establish baseline information about EPP in TH prosthesis users for comparison as novel prosthesis suspension systems become more available to be tested.

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

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.

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.

OBJECTIVE: Evaluate the safety and efficacy of a novel press-fit bone-anchored prosthesis in an FDA approved study. DESIGN: Single-center, prospective 1-year follow-up cohort study of a percutaneous bone anchored prosthesis. SETTING: Veterans Health Administration Hospital. PARTICIPANTS: Ten male Veterans with unilateral transfemoral amputation that occurred at least 6 months prior to enrollment and was not the result of dysvascular disease (N=10). INTERVENTIONS: All participants received the novel press-fit Percutaneous Osseointegrated Prosthesis (POP) and a minimum of 10 days supervised rehabilitation therapy. OUTCOME MEASURES: Adverse events and radiographs were collected to assess device safety. Temporal assessments of bone density, stomal skin, prosthetic don/doff, functional ambulation, and patient-reported outcome compared our POP to a socket suspension system. RESULTS: Ten male participants mean age 48.8±12.1 years (range, 32-68 y) with mean time since amputation of 9.4± years (range 1-18 y) completed a two-staged implantation protocol and progressed to ambulation with an assistive device by post-operative day 14. Eight of 10 completed all study procedures. One implant loosened at 5 weeks, requiring removal. A second was removed after periprosthetic fracture from a non-device-related fall at 28 weeks. One patient required oral antibiotics for superficial infection. There were significant (P<.05) increases in bone density in the lumbar spine and adjacent to the distal porous coating with no radiographic evidence of bone resorption. Compared to the socket system, the use of POP significantly (P<.05) reduced prosthetic don and doff times and patient-reported prosthetic problem scores. Significant improvements (P<.05) in mean mobility, global health, and walking test scores were also observed. CONCLUSIONS: Improvements in bone density, function, and patient reported outcomes were observed with the POP device when compared to a socket suspension system. This Early Feasibility Study established initial safety and effectiveness of the POP device, supporting expanded investigation as an alternative to socket prostheses.

Use of computer tomography imaging for analyzing bone remodeling around a percutaneous osseointegrated implant.

Osseointegration (OI) is being used for the direct skeletal attachment of prosthetic limbs using an intramedullary stem that extends percutaneously from the subject's residual limb. For this technology to be successful, bone ingrowth and remodeling around the implant must occur. Physicians need an effective way to assess bone remodeling to make informed treatment and rehabilitation decisions. Previous studies utilizing two-dimensional imaging X-ray as a tool to monitor bone-remodeling around OI devices have limitations. This study describes methodology that was developed utilizing computed tomography (CT) imaging as a tool for analyzing bone remodeling around a percutaneous OI implant. Six transfemoral amputees implanted with a percutaneous osseointegrated prosthesis (POP) had CT scans taken of their residual femur at 6 and 52 weeks postoperatively. Three-dimensional femoral models were processed using custom MATLAB script to collect cortical and medullary morphology measurements. Morphology data from 6- and 52-week scans were compared to quantify bone remodeling around the POP implant. Fifty-two weeks after implantation of the POP device, increases in cortical bone area and thickness were observed around the porous-coated stem. Minimal changes were observed in the medullary canal parameters within the periprosthetic regions. This study successfully utilized CT imaging and three-dimensional modeling techniques to analyze longitudinal data of bone remodeling around a transfemoral percutaneous implant. These methods have the potential to be used as a clinical tool for evaluating orthopedic implants in vivo. Data collected suggests that the POP device achieved the desired bone remodeling around the porous-coated region of the implanted stem.

Analysis of the Stomal Microbiota of a Percutaneous Osseointegrated Prosthesis: A Longitudinal Prospective Cohort Study.

Percutaneous osseointegrated (OI) prostheses (POPs) are used to skeletally attach artificial limbs in amputees. While any permanent percutaneous interface is at risk of becoming infected by the resident microbiota colonizing the stoma, most of these patients remain infection-free. Avoidance of infection likely depends upon a mechanically and/or biologically stable skin-to-implant interface. The ultimate question remains, "why do some stomata become infected while others do not?" The answer might be found in the dynamic bacterial communities of the patient and within the stomal site itself. This study is an appendix to the first Food and Drug Administration approved prospective early feasibility study of OI prosthetic docking, in which, 10 transfemoral amputees were implanted with a unique POP device. In this analytical, longitudinal cohort study, each patient's skin and stomal microbiota were analyzed from the initial surgery to 1 year following the second-stage surgery. During each follow-up visit, three swab samples-stomal, device thigh skin and contralateral thigh skin-were obtained. DNA was extracted, and bacterial 16S ribosomal RNA (rRNA) genes were amplified and sequenced to profile microbial communities. The stomal microbiota were distinct from the microbiota on the adjacent thigh skin and the skin of the contralateral thigh, with a significantly increased abundance of Staphylococcus aureus within the stoma. Early on stomal microbiota were characterized by high diversity and high relative abundance of obligate anaerobes. Over time, the stomal microbiota shifted and stabilized in communities of lower diversity dominated by Streptococcus, Corynebacterium, and/or Staphylococcus spp. © 2019 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 37:2645-2654, 2019.

Development of a step counting algorithm using the ambulatory tibia load analysis system for tibia fracture patients.

Introduction: Ambulation can be used to monitor the healing of lower extremity fractures. However, the ambulatory behavior of tibia fracture patients remains unknown due to an inability to continuously quantify ambulation outside of the clinic. The goal of this study was to design and validate an algorithm to assess ambulation in tibia fracture patients using the ambulatory tibial load analysis system during recovery, outside of the clinic. METHODS: Data were collected from a cyclic tester, 14 healthy volunteers performing a 2-min walk test on the treadmill, and 10 tibia fracture patients who wore the ambulatory tibial load analysis system during recovery. RESULTS: The algorithm accurately detected 2000/2000 steps from simulated ambulatory data. During the 2-min walk test, step counts derived from the algorithm and treadmill showed a strong correlation (r2>0.98) to the visual ("actual") step count. Applying the algorithm to continuous data from tibia fracture patients revealed qualitative differences in gait between the initial and later stages of recovery. Additionally, a relatively large standard deviation (≤3000 steps) in the daily average step count indicated a variety of patient ambulatory behaviors. CONCLUSION: The algorithm reported in this study can assess the ambulatory activity of tibia fracture patients during the recovery period.

Fat Layer from Medullary Canal Reamer Aspirate for Potential Use as a Supplemental Osteoinductive Bone Graft Material.

Mesenchymal stem cells (MSCs) are of therapeutic interest to clinicians and researchers, as they have been shown to augment the osteogenic properties of bone grafts. MSCs are known to be prevalent in bone marrow, but are still limited in numbers. Hence, additional sources of MSCs are beneficial to increasing grafting potential. Aspirate material collected using the Reamer/Irrigator/Aspirator (RIA) device (Synthes; Paoli, PA) during reaming of the femoral shaft consists of three main components: bone fragments, liquid flow-through, and a fat layer. Currently, only the bone and liquid layers have been examined for osteoinductive elements, and the bone fragments are exclusively used as autologous bone graft. In the present study, a method to promote cellular outgrowth, tapping proliferative capacity from the previously discarded fatty layer of RIA aspirate, is described. Proliferating cells were successfully isolated from the bone and fatty layers of a consenting patient and found to be viable after liquid nitrogen storage. The osteogenic differentiation potential of the cells isolated from the fat and bone layers was assessed. Cells from both layers of the aspirate expressed statistically significant levels (p < 0.05) of the bone cell marker alkaline phosphatase compared to the control cells, suggesting differentiation along the osteoblastic pathway. Results from this pilot study indicate that the traditionally discarded fatty element of RIA aspirate may be a source of MSCs with bone-forming capabilities and the described isolation technique is effective. Combining the aspirate fatty and bony elements may enhance the clinical success of the RIA autograft.

The effect of aging on posterior intertransverse lumbar fusion: a New Zealand white rabbit model.

STUDY DESIGN: In vivo assessment of lumbar spinal fusion between a younger and older cohort of New Zealand white rabbits. OBJECTIVE: Directly compare fusion within young and aged New Zealand white rabbits to establish an aged spinal fusion model translational research. SUMMARY OF BACKGROUND DATA: Prior studies have utilized skeletally mature young rabbits (6-12 mo old) that may not be appropriate as an analog for studying the aging human spine. METHODS: Ten aged (>36 mo old) and 10 young (12 mo old) New Zealand white rabbits underwent a single-level, bilateral, L5-6 posterolateral intertransverse fusion using autogenous iliac crest bone graft. The animals were killed at 6 weeks postoperatively, and the specimens were then evaluated with quantitative microcomputerized tomography and manual palpation by 6 orthopedic surgeons. The fusions were graded as either fused or not fused by each examiner. The spines were then embedded in poly(methyl methacrylate) and cut into 2-mm-thick sections for histologic analysis. RESULTS: A higher percentage of young rabbits were determined to be successfully fused through manual palpation testing compared with the aged rabbits. Micro-computed tomography (CT) analysis revealed a significantly greater fusion mass volume in the younger rabbits than in the older cohort. In addition, the fusion density of the younger rabbits was found to be significantly lower than that of the older rabbits when normalized to the bone density in the nonfused portion of the spine. Histologic analysis showed that the quality of the bone within the fusion mass was consistent between the young and old rabbits. A greater number of young animals had bilateral continuous bone graft compared with the aged animals. CONCLUSIONS: The aged (>36 mo) New Zealand white rabbit model appears to be a valid model to evaluate the effect of aging on lumbar fusion and has the potential to more accurately model conditions that are present in the older human spine.

The significance of calcified fibrocartilage on the cortical endplate of the translational sheep spine model.

To gain an understanding of the vertebral cortical endplate and factors that may affect the ability to achieve skeletal attachment to intervertebral implants and fusion, this study aimed to characterize the hypermineralized tissue on the cortical endplate of the vertebral body on a commonly used animal model. Skeletally mature sheep were injected with tetracycline prior to euthanasia and the C2-C3, T5-T6, and L2-L3 spinal motion segments were excised and prepared. Vertebral tissues were imaged using backscatter electron (BSE) imaging, histology, and tetracycline labeling was used to assess bone remodeling within different tissue layers. It was determined that the hypermineralized tissue layer was calcified fibrocartilage (CFC). No tetracycline labels were identified in the CFC layer, in contrast to single and double labels that were present in the underlying bone, indicating the CFC present on the cortical endplate was not being actively remodeled. The average thickness of the CFC layer was 146.3 ± 70.53 µm in the cervical region, 98.2 ± 40.29 µm in the thoracic region, and 150.89 ± 69.25 µm in the lumbar region. This difference in thickness may be attributed to the regional biomechanical properties of the spine. Results from this investigation indicate the presence of a nonremodeling tissue on the cortical endplate of the vertebral body in sheep spines, which attaches the intervertebral disc to the vertebrae. This tissue, if not removed, would likely prevent successful bony attachment to an intervertebral device in spinal fusion studies and total disc replacement surgeries.

Host bone response to polyetheretherketone versus porous tantalum implants for cervical spinal fusion in a goat model.

STUDY DESIGN: In vivo assessment of polyetheretherketone (PEEK) and porous tantalum (TM) cervical interbody fusion devices in a goat model. OBJECTIVE: Directly compare host bone response to PEEK and TM devices used for cervical interbody fusion. SUMMARY OF BACKGROUND DATA: PEEK devices are widely used for anterior cervical discectomy and fusion but are nonporous and have limited surface area for bone attachment. METHODS: Twenty-five goats underwent single-level anterior cervical discectomy and fusion and were alternately implanted with TM (n = 13) or PEEK devices (n = 12) for 6, 12, and 26 weeks. Both devices contained a center graft hole (GH), filled with autograft bone from the animal's own iliac crest. The percentage of bone tissue around the implant, percentage of the implant surface in direct apposition with the host bone, and evidence of bone bridging through the implant GH were assessed by using backscattered electron imaging. Bone matrix mineral apposition rate was determined through fluorochrome double labeling, and sections were stained for histological analysis. RESULTS: The TM-implanted animals had significantly greater volumes of bone tissue at the implant interface than the PEEK animals at all-time points. The TM animals also had a significantly greater average mineral apposition rate in the GH region at 6 and 12 weeks than the PEEK animals. No difference was observed at 26 weeks. A greater number of TM-implanted animals demonstrated connection between the autograft bone and both vertebrae compared with the PEEK implants. Histological staining also showed that the TM devices elicited improved host bone attachment over the PEEK implants. CONCLUSION: The TM implants supported bone growth into and around the implant margins better than the PEEK devices. TM's open cell porous structure facilitated host bone ingrowth and bone bridging through the device, which could be beneficial for long-term mechanical attachment and support in clinical applications.

Effect of osteoclast co-culture on the differentiation of human mesenchymal stem cells grown on bone graft granules.

Traditional approaches to bone repair are currently being integrated with innovative tissue-engineering techniques, as researchers and clinicians shift their treatment focus toward regenerating functional tissue rather than just filling a defect to provide structural support. Cells are expanded and incorporated into implantable systems in hopes of enhancing the bone-forming capabilities of traditional bone graft substitutes. The present study examined how osteoclasts might be used to stimulate the differentiation of human mesenchymal stem cells (hMSCs) into bone forming cells. The two cell types were co-cultured on a resorbable, three-dimensional bone graft substitute. Osteoclasts were seeded prior to the addition of hMSCs, as well as simultaneously, to determine if resorption of the scaffold would have any bearing on observed response by hMSCs. When seeded directly with hMSCs on the 3-D substrates, the osteoclasts had an increase in TRAP expression over time if seeded simultaneously. The co-culture setup had a positive influence on the proliferation of hMSCs. Late stage osteoblast differentiation markers (bone sialoprotein) were positively affected by direct co-culture with osteoclasts. The addition of RANKL to the culture medium for osteoclastogenesis appears to be a factor in the observed responses by hMSCS, but is not the only factor influencing the MSCs. Osteoclasts were shown to have an influence on the development of mesenchymal stem cells into osteoblasts when cultured in vitro. Findings from this study, coupled with the knowledge obtained from our previous work, will aid in the development of a clinically viable mesenchymal stem cell based bone graft system.

Evaluation of the lipid-rich layer of reamer aspirate.

The fatty layer of aspirate obtained by reaming the femoral shaft using a reamer/irrigator/aspirator (RIA) device was characterized for fatty acid content and the presence of adult stem cells. Gas chromatography analysis was performed on samples taken from multiple patients to determine and compare the fatty acid contents of aspirate lipid samples. All four patients had the same four fatty acids present in the highest percentages: oleic, palmitic, linoleic and stearic. After successful isolation from bulk material, cells isolated from this lipid-rich layer were studied to determine their osteogenic and growth potential on a clinically available ceramic bone graft substitute. The results of metabolic activity and intracellular protein assays indicated that the ceramics supported growth of the cells isolated from the aspirate fat layer, although levels of alkaline phosphatase (ALP) expression were low for cells grown on the ceramics. Cells will not transition along the osteogenic pathway when they are actively dividing, and active growth may have contributed to the lack of ALP expression in this study. Isolated cells grown on tissue culture plastic expressed significant levels of the bone marker ALP. The results of this study suggest that cells isolated from the fat layer of RIA aspirate proliferate on ceramic bone void filler and have the potential to differentiate along an osteogenic pathway. Previously considered waste, the lipid-rich fat layer of aspirate may be a source of mesenchymal stem cells that, either alone or in conjunction with currently available synthetic bone graft material, could be used to stimulate new bone growth.