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Bone & Joint Open
Vol. 5, Issue 1 | Pages 20 - 27
17 Jan 2024
Turgeon TR Vasarhelyi E Howard J Teeter M Righolt CH Gascoyne T Bohm E

Aims. A novel enhanced cement fixation (EF) tibial implant with deeper cement pockets and a more roughened bonding surface was released to market for an existing total knee arthroplasty (TKA) system.This randomized controlled trial assessed fixation of the both the EF (ATTUNE S+) and standard (Std; ATTUNE S) using radiostereometric analysis. Methods. Overall, 50 subjects were randomized (21 EF-TKA and 23 Std-TKA in the final analysis), and had follow-up visits at six weeks, and six, 12, and 24 months to assess migration of the tibial component. Low viscosity bone cement with tobramycin was used in a standardized fashion for all subjects. Patient-reported outcome measure data was captured at preoperative and all postoperative visits. Results. The patient cohort mean age was 66 years (SD seven years), 59% were female, and the mean BMI was 32 kg/m. 2. (SD 6 kg/m. 2. ). Mean two-year subsidence of the EF-TKA was 0.056 mm (95% confidence interval (CI) 0.025 to 0.086) versus 0.006 mm (95% CI -0.029 to 0.040) for the Std-TKA, and the two-year maximum total point motion (MTPM) was 0.285 mm (95% upper confidence limit (UCL) ≤ 0.363) versus 0.346 mm (95% UCL ≤ 0.432), respectively, for a mean difference of -0.061 mm (95% CI -0.196 to 0.074). Inducible displacement also did not differ between groups. The MTPMs between 12 and 24 months for each group was below the published threshold of 0.2 mm for predicting early aseptic loosening (p < 0.001 and p = 0.001, respectively). Conclusion. Both the enhanced fixation and the standard tibial implant design showed fixation with a predicted low risk of long-term aseptic loosening. Cite this article: Bone Jt Open 2024;5(1):20–27


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_1 | Pages 32 - 32
1 Feb 2020
Maag C Peckenpaugh E Metcalfe A Langhorn J Heldreth M
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Introduction. Aseptic loosening is one of the highest causes for revision in total knee arthroplasty (TKA). With growing interest in anatomically aligned (AA) TKA, it is important to understand if this surgical technique affects cemented tibial fixation any differently than mechanical alignment (MA). Previous studies have shown that lipid/marrow infiltration (LMI) during implantation may significantly reduce fixation of tibial implants to bone analogs [1]. This study aims to investigate the effect of surgical alignment on fixation failure load after physiological loading. Methods. Alignment specific physiological loading was determined using telemetric tibial implant data from Orthoload [2] and applying it to a validated finite element lower limb model developed by the University of Denver [3]. Two high demand activities were selected for the loading section of this study: step down (SD) and deep knee bend (DKB). Using the lower limb model, hip and ankle external boundary conditions were applied to the ATTUNE. ®. knee system for both MA and AA techniques. The 6 degree of freedom kinetics and kinematics for each activity were then extracted from the model for each alignment type. Mechanical alignment (MA) was considered to be neutral alignment (0° Hip Knee Ankle Angle (HKA), 0° Joint Line (JL)) and AA was chosen to be 3° varus HKA, 5° JL. It is important not to exceed the limits of safety when using AA as such it is noted that DePuy Synthes recommends staying within 3º varus HKA and 3º JL. The use of 5º JL was used in this study to account for surgical variation [Depuy-Synthes surgical technique DSUS/JRC/0617/2179]. Following a similar method described by Maag et al [1] ATTUNE tibial implants were cemented into a bone analog with 2 mL of bone marrow in the distal cavity and an additional reservoir of lipid adjacent to the posterior edge of the implant. Tibial implant constructs were then subjected to intra-operative ROM/stability evaluation, followed by a hyperextension activity until 15 minutes of cement curing time, and finally 3 additional ROM/stability evaluations were performed using an AMTI VIVO simulator. The alignment specific loading parameters were then applied to the tibial implants using an AMTI VIVO simulator. Each sample was subjected to 50,000 DKB cycles and 120,000 SD cycles at 0.8 Hz in series; approximating 2 years of physiological activity. After physiological loading the samples were tested for fixation failure load by axial pull off. Results. Following alignment specific physiological loading the average fixation pull-off load for MA was 3289 ± 400 N and for AA was 3378 ± 133 N (Figure 1). There was no statistically significant difference fixation failure load by axial pull-off between the two alignment types (p=0.740). Conclusion. This study indicated that anatomic alignment, as defined with the alignment limits of this study, does not adversely affect the fixation failure load of ATTUNE tibial implants. For any figures or tables, please contact the authors directly


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_I | Pages 101 - 101
1 Mar 2006
Hernigou P Poignard A Manicom O Fillipini P Mathieu G
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The purpose was to assess the effect of the posterior slope on the long-term outcome of unicompartmental arthroplasty in knees with intact and deficient anterior cruciate ligaments. We retrospectively reviewed ninety-nine unicompartmental arthroplasties after a mean duration of follow-up of sixteen years (12 to 20 years). At the time of the arthroplasty, the anterior cruciate ligament was considered to be normal in fifty knees, damaged in thirty-one, and absent in eighteen. At the most recent follow-up, we measured the posterior tibial slope and the anterior tibial translation on standing lateral radiographs. In the group of seventy-seven knees that had not been revised by the time of the most recent follow-up, there was a significant linear relationship between anterior tibial translation (mean, 3.7 mm) and posterior tibial slope (mean, 4.3) (p = 0.01). The mean posterior slope of the tibial implant was significantly less in the group of seventy-seven knees without loosening of the implant than it was in the group of seventeen knees with loosening of the implant (p = 0.03). Five ruptures of the anterior cruciate ligament occurred in knees in which the ligament had been considered to be normal at the time of implantation; the posterior tibial slope in these five knees was greater than 13 degrees. Clinical evaluation revealed normal or nearly normal anteroposterior stability at the time of the most recent follow-up in all sixty-six unrevised knees in which the anterior cruciate ligament had been present at the time of implantation. Of the eighteen knees in which the anterior cruciate ligament had been absent at the time of the arthroplasty, eleven still had the implant in situ at the time of the most recent follow-up; the mean posterior tibial slope in these 11 knees was less than 5 degrees. Seven knees in which the anterior cruciate ligament had been absent at the time of the arthroplasty were revised. In these 7 knees, the tibial prosthesis was implanted with a posterior slope greater than 8 degrees. These findings suggest that more than 7 degrees of posterior slope of the tibial implant should be avoided, particularly if the anterior cruciate ligament is absent at the time of implantation. An intact anterior cruciate ligament, even when partly degenerated, was associated with the maintenance of normal anteroposterior stability of the knee for an average of sixteen years following unicompartmental knee arthroplasty


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 11 - 11
1 Feb 2017
Parker A Ali A Nambu S Obert R
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Objectives. Modularity in total knee arthroplasty, particularly in revisions, is a common method to fit the implants to a patient's anatomy when additional stability or fixation is needed. In such cases, it may be necessary to employ multiple points of modularity to better match the anatomy. Taper junction strength at each of these levels is critical to maintain the mechanical stability of the implant and minimize micromotion. This effect of distributed assembly loads through multiple tapers and the resulting strength of the construct have not been previously evaluated on this revision tibial implant. The purpose of this study was to evaluate the possible dissipation of impaction force through multiple taper connections as compared to a single connection. Methods. Two different constructs representative of modular implants were studied: a construct with a single axial taper connection (Group A; representing implant-stem) was compared to a construct with an adaptor that included two, offset, modular taper connections (Group B; representing implant-adapter-stem). For Group A, the stem taper was assembled and impacted through the stem. For Group B, the two tapers of the adapter and stem were hand assembled with the mating components and impacted simultaneously through the stem. Assembly load for each construct was recorded. As shown in Figure 1, the constructs were then fixed in a mechanical test frame and an axial distraction force was applied to the end of the stem at a constant displacement rate of 0.075 mm/sec until taper separation or mechanical failure occurred. Force and displacement data were recorded at 50 Hz. Disassembly force was normalized to assembly force for each component. Minitab software was used to analyze the data using a t-test. Results. Separation occurred at the implant-stem interface for all components of Group A, without component fracture. Separation occurred at the adapter-stem interface for all components of Group B. There were neither component fractures nor separation of the implant-adapter interface. As seen in Figure 2, the disassembly force for Group A was greater than Group B (p = 0.456), likely due to the higher assembly forces. However, the ratio of these forces (disassembly/assembly) was greater for Group B than Group A, but not statistically significant (0.794 vs. 0.754 with p = 0.657). Discussion. There are no applicable standards for required taper disassembly strength. However, the results of this study indicate that the addition of a second taper connection and offset does not significantly change the static ratio of disassembly to assembly force of the studied constructs. Axial distraction forces vary with activity and constraint afforded by a particular prosthesis. Future work to further characterize the behavior of these constructs could include varying loading rate to determine if that affects the location of taper disassociation. A period of fatigue testing could also be added to evaluate the effect of cyclic loading on the taper connections


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 528 - 528
1 Nov 2011
Picard F Page S Willcox N Deakin A Pinzuti J Payne A
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Purpose of the study: Rotation of the tibial implant is an important factor for the functional outcome of total knee arthroplasty (TKA). Any rotational malposition will cause eccentric loading of the plateau. Several techniques have been recommended to avoid malposition, but none has proven superior over the others in terms of reliability or reproductibility. The landmark used to establish rotation must meet two prerequisites: easy identification and reliable representation of the anatomic rotation of the proximal tibia. This study was conducted to compare seven different techniques for landmarking used for choosing the rotation of the tibial base in TKA. Material and methods: An optoelectronic method was used to measure 50 tibia selected among a collection of 600 skeletons. A palper was used to locate 34 distinct landmarks and institute each reference system. The groups of anatomic points were reconstructed to form lines and plans depending on the comparisons to make: posterior condylar alignment (PCA), transversal alignment (TA), anterior condylar alignment (ACA), alignment of the anterior tibial tuberosity (ATT), the transmalleolar alignment (TMA), the line of the tibial crest (LTC) and a new line, the anterior distal line (ADL). The PCA was used as the reference. Results: Intra-observer variation was determined in a preliminary study using ten consecutive measurements. The standard deviation was 0.5° with a distribution of 1.8°. Angle: mean [-:internal rotation; +external rotation], standard deviation: difference between the minimum and the maximum. TA: −5.13; 9.2; 38.03; ACA: −12.81; 6.7; 41.74; ATT: 68.72; 8.6; 58.46; TMA: −22.68; 11.6; 72.84; LTC: 67.56; 10.3; 46.11; ADL: 16.61; 13.2; 74.93. Discussion: This study did not prove convincingly that any one of the tibial alignments was better than another; which demonstrates that use of a single reference is probably inappropriate to determine the rotational alignment of the tibial base for TKA. It was noted however that the anterior condylar line (mean external rotation 12.8°-SD< 7° relative to the PCA) could be pertinent for future research since this line is easily accessible and palpable, particularly during navigated surgery


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_12 | Pages 44 - 44
1 Oct 2018
Ji G Xu R Niu Y Turajane K Li N Greenblatt MB Yang X Bostrom M
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Introduction

Poor osseointegration of cementless implants is the leading clinical cause of implant loosening, subsidence, and replacement failure, which require costly and technically challenging revision surgery. The mechanism of osseointegration requires further elucidation. We have recently developed a novel titanium implant for the mouse tibia that maintains in vivo knee joint function and allows us to study osseointegration in an intra-articular, load-bearing environment.

Vascular endothelial growth factor (VEGF) is one of the most important growth factors for regulation of vascular development and angiogenesis. It also plays critical roles in skeletal development and bone repair and regeneration. A specialized subset of vascular endothelium, CD31hiEMCNhi cells displaying high cell surface expression of CD31 and Endomucin, has been reported to promote osteoblast maturation and may be responsible for bone formation during development and fracture healing.

Because of their potential role in osseointegration, the aim of this study was to use our mouse implant model to investigate the role of VEGF and CD31hiEMCNhi endothelium in osseointegration.

Methods

Under an IACUC-approved protocol, the implant was inserted into the right tibia of 16-week-old female C57BL/6 mice (N = 38). The mice were then randomized into 2 groups: Control group (N=19) and Anti-VEGFR group (N=19). A cocktail of VEGFR-1 antibody (25mg/kg) and VEGFR-2 antibody (25mg/kg) was given to the mice in the Anti-VEGFR group by intraperitoneal injection every third day starting immediately after surgery until euthanasia. An equivalent amount of an isotype control antibody was given to the control group. Flow cytometric (N = 4/group) and immunofluorescencent (N = 3/group) analyses were performed at 2 weeks post-implantation to detect the distribution and density of CD31hiEMCNhi endothelium in the peri-implant bone. Pull-out testing was used at 4 weeks post-implantation to determine the strength of the bone-implant interface.


Bone & Joint Research
Vol. 11, Issue 2 | Pages 91 - 101
1 Feb 2022
Munford MJ Stoddart JC Liddle AD Cobb JP Jeffers JRT

Aims. Unicompartmental and total knee arthroplasty (UKA and TKA) are successful treatments for osteoarthritis, but the solid metal implants disrupt the natural distribution of stress and strain which can lead to bone loss over time. This generates problems if the implant needs to be revised. This study investigates whether titanium lattice UKA and TKA implants can maintain natural load transfer in the proximal tibia. Methods. In a cadaveric model, UKA and TKA procedures were performed on eight fresh-frozen knee specimens, using conventional (solid) and titanium lattice tibial implants. Stress at the bone-implant interfaces were measured and compared to the native knee. Results. Titanium lattice implants were able to restore the mechanical environment of the native tibia for both UKA and TKA designs. Maximum stress at the bone-implant interface ranged from 1.2 MPa to 3.3 MPa compared with 1.3 MPa to 2.7 MPa for the native tibia. The conventional solid UKA and TKA implants reduced the maximum stress in the bone by a factor of 10 and caused > 70% of bone surface area to be underloaded compared to the native tibia. Conclusion. Titanium lattice implants maintained the natural mechanical loading in the proximal tibia after UKA and TKA, but conventional solid implants did not. This is an exciting first step towards implants that maintain bone health, but such implants also have to meet fatigue and micromotion criteria to be clinically viable. Cite this article: Bone Joint Res 2022;11(2):91–101


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_16 | Pages 16 - 16
1 Dec 2021
Munford M Stoddart J Liddle A Cobb J Jeffers J
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Abstract. Objectives. Unicompartmental and total knee arthroplasty (UKA and TKA) are successful treatments for osteoarthritis, but monolithic implants disrupt the natural homeostasis of bone which leads to bone loss over time. This can cause problems if the implant needs to be revised. This study aimed to demonstrate that tibial implants made from titanium lattice could replace the tibial condyle surface while minimising disruption of the bone's natural mechanical loading environment. A secondary aim was to determine whether implants perform better if they replicate more closely bone's mechanical modulus, anisotropy and spatial heterogeneity. This study was conducted in a human cadaveric model. Methods. In a cadaveric model, UKA and TKA procedures were performed on 8 fresh-frozen knee specimens by a board-certified consultant orthopaedic surgeon, using tibial implants made from conventional monolithic material and titanium lattice structures. Stress at the bone-implant interfaces was measured with pressure film and compared to the native knee. Results. Titanium lattice implants were able to restore the mechanical environment seen in the native tibia for both UKA and TKA designs. Maximum stress at the bone-implant interface ranged from 1.2–3.3MPa compared to 1.3–2.7MPa for the native tibia. The conventional UKA and TKA implants reduced the maximum stress in the bone by a factor of 10 and 9.7 respectively. The conventional UKA and TKA implants caused 71% and 77% of bone surface area to be underloaded compared to the native tibia. Conclusions. Titanium lattice implants can maintain the natural mechanical loading in the proximal tibia after UKA and TKA. This may help maintain normal bone homeostasis throughout the life of the implant. These encouraging data indicate normal bone homeostasis can be maintained after arthroplasty using manufacturing methods already in widespread use. This would maintain bone quality throughout the life of the implant and alleviate complications at revision surgery


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_7 | Pages 128 - 128
4 Apr 2023
Li M Wu G Liu Y
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Miniscrew implants (MSIs) are widely used to provide absolute anchorage for the orthodontic treatment. However, the application of MSIs is limited by the relatively high failure rate (22.86%). In this study, we wished to investigate the effects of amorphous and crystalline biomimetic calcium phosphate coating on the surfaces of MSIs with or without the incorporated BSA for the osteointegration process with an aim to facilitate the early loading of MSIs. Amorphous and crystalline coatings were prepared on titanium mini-pin implants. Characterizations of coatings were examined by Scanning electron microscopy (SEM), Confocal laser-scanning dual-channel-fluorescence microscopy (CLSM) and Fourier-transform infrared spectroscopy (FTIR). The loading and release kinetics of bovine serum albumin (BSA) were evaluated by Enzyme linked immunosorbent assay (ELISA). Activity of alkaline phosphate (ALP) was measured by using the primary osteoblasts. In vivo, a model of metaphyseal tibial implantation in rats was used (n=6 rats per group). We had 6 different groups: no coating no BSA, no coating but with surface adsorption of BSA and incorporation of BSA in the biomimetic coating in the amorphous and crystalline coatings. Time points were 3 days, 1, 2 and 4 weeks. Histological and histomorphometric analysis were performed and the bone to implant contact (BIC) of each group was compared. In vitro, the incorporation of BSA changed the crystalline coating from sharp plates into curly plates, and the crystalline coating showed slow-release profile. The incorporation of BSA in crystalline coating significantly decreased the activity of ALP in vitro. In vivo study, the earliest significant increase of BIC appeared in crystalline coating group at one week. The crystalline coating can serve as a carrier and slow release system for the bioactive agent and accelerate osteoconductivity at early stage in vivo. The presence of BSA is not favorable for the early establishment of osteointegration


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_7 | Pages 42 - 42
4 Apr 2023
Benca E van Knegsel K Zderic I Caspar J Strassl A Hirtler L Fuchssteiner C Gueorguiev B Windhager R Widhalm H Varga P
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Screw fixation is an established method for anterior cruciate ligament (ACL) reconstruction, although with a high rate of implant-related complications. An allograft system for implant fixation in ACL reconstruction, the Shark Screw ACL (surgebright GmbH) could overcome some of the shortcomings of bioabsorbable screws, such as foreign body reaction, need for implant removal and imaging artefacts. However, it needs to provide sufficient mechanical stability. Therefore, the aim of this study was to investigate the biomechanical stability, especially graft slippage, of the novel allograft system versus a conventional bioabsorbable interference screw (BioComposite Interference Screw; Arthrex Inc.) for tibial implant fixation in ACL reconstruction. Twenty-four paired human proximal tibiae (3 female, 9 male, 72.7 ± 5.6 years) underwent ACL reconstruction. The quadrupled semitendinosus and gracilis tendon graft were fixed in one specimen of each pair using the allograft fixation system Shak Screw ACL and the contralateral one using an interference screw. All specimens were cyclically loaded at 1 Hz with peak load levels monotonically increased from 50 N at a rate of 0.1 N/cycle until catastrophic failure. Relative movements of the graft versus the tibia were captured with a stereographic optical motion tracking system (Aramis SRX; GOM GmbH). The two fixation methods did not demonstrate any statistical difference in ultimate load at graft slippage (p = 0.24) or estimated survival at slippage (p = 0.06). Both, the ultimate load and estimated survival until failure were higher in the interference screw (p = 0.04, and p = 0.018, respectively). Graft displacement at ultimate load reached values of up to 7.2 mm (interference screw) and 11.3 mm (Shark Screw ACL). The allograft screw for implant fixation in ACL reconstruction showed similar behavior in terms of graft slippage compared to the conventional metal interference screw but underperformed in terms of ultimate load. However, the ultimate load may not be considered a direct indicator of clinical failure


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_19 | Pages 59 - 59
22 Nov 2024
Peterlin AA Gottlieb H Birch JM Jensen LK
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Aim. The osteolytic process of osteomyelitis is, according to textbooks, caused by increased osteoclast activity due to RANKL production by osteoblasts. However, recent findings contradict this theory. Therefore, the aim was to investigate, in a porcine osteomyelitis model, how osteolysis is affected by massive inflammation and RANKL blocking, respectively. In parallel, patients with chronic osteomyelitis, diabetes, foot osteomyelitis, and fracture related infections (FRI) were included for advanced histological analysis of osteolysis. Methods. In pigs, a tibial implant cavity was created and inoculated with 10. 4. CFU of Staphylococcus aureus: Group A (n=7). Group B (n=7); + 1cm. 3. spongostan into the cavity. Group C (n=4); + systemic Denosumab treatment. Spongostan was used as an avascular material to support bacterial growth and thus increase the inflammatory response. Denosumab treatment was administrated to suppress osteoclast activity by RANKL inhibition (as in osteoporotic patients). The volume of osteolysis was accessed by CT scans. Immunohistochemistry with antibodies towards Cathepsin K was used to identify osteoclasts within the bone lesions. Briefly, the number of Cathepsin K positive cells, i.e., both precursors and bone resorbing osteoclasts, respectively, were counted in 10 high power fields (400x). In total, 50 bone infection patients were included (Herlev Hospital). From each patient five parried samples were taken for histology and microbiology, respectively. Histopathology, CT osteolysis volume estimation, and molecular expression of osteoclasts and inflammatory markers are ongoing. One FRI patient was osteoporotic and treated with Denosumab for 6 years. Results. All pigs were confirmed infected in the implant cavity. The volume (2.41 ± 1.29cm. 3. ) of osteolysis was significantly increased in the spongostan group in comparison to Group A (1.24 ± 0.59 cm. 3. ) (p=0.04). Thereby, the spongostan group had bacteria deeper into the bone from the inoculation point. Sufficient Denosumab treatment, i.e. reduced serum Ca was seen in 3 pigs. None of the Denosumab treated pigs showed reduced osteolysis in comparison to Group A (1.42 ± 0.63 cm. 3. ). The Cathepsin K score of Group C was 17 (15-23 IQR) of precursor osteoclasts and 2 (0-2 IQR) of osteoclasts in Howship lacunae. The Denosumab treated patient showed substantial osteolysis and histological analysis confirmed acute inflammatory. Conclusions. Application of spongostan, i.e., bacterial host optimization and massive inflammation promotes osteolysis and local bacterial dissemination. Osteoclast blocking with Denosumab showed no impact on osteolysis. Elucidation of the pathophysiology causing bone loss in osteomyelitis is fundamental. However, the widely accepted osteoclast-based theory might not be the only relevant


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_5 | Pages 131 - 131
1 Apr 2019
Peckenpaugh E Maag C Metcalfe A Langhorn J Heldreth M
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Introduction. Aseptic loosening of total knee replacements is a leading cause for revision. It is known that micromotion has an influence on the loosening of cemented implants though it is not yet well understood what the effect of repeated physiological loading has on the micromotion between implants and cement mantle. This study aims to investigate effect of physiological loading on the stability of tibial implants previously subjected to simulated intra-operative lipid/marrow infiltration. Methods. Three commercially available fixed bearing tibial implant designs were investigated in this study: ATTUNE. ®. , PFC SIGMA. ®. CoCr, ATTUNE. ®. S+. The implant designs were first prepared using a LMI implantation process. Following the method described by Maag et al tibial implants were cemented in a bone analog with 2 mL of bone marrow in the distal cavity and an additional reservoir of lipid adjacent to the posterior edge of the implant. The samples were subjected to intra- operative range of motion (ROM)/stability evaluation using an AMTI VIVO simulator, then a hyperextension activity until 15 minutes of cement cure time, and finally 3 additional ROM/stability evaluations were performed. Implant specific physiological loading was determined using telemetric tibial implant data from Orthoload and applying it to a validated FE lower limb model developed by the University of Denver. Two high demand activities were selected for the loading section of this study: step down (SD) and deep knee bend (DKB). Using the above model, 6 degree of freedom kinetics and kinematics for each activity was determined for each posterior stabilized implant design. Prior to loading, the 3-D motion between tibial implant and bone analog (micromotion) was measured using an ARAMIS Digital Image Correlation (DIC) system. Measurement was taken during the simulated DKB at 0.25Hz using an AMTI VIVO simulator while the DIC system captured images at a frame rate of 10Hz. The GOM software calculated the distance between reference point markers applied to the posterior implant and foam bone. A Matlab program calculated maximum micromotion within each DKB cycle and averaged that value across five cycles. The implant specific loading parameters were then applied to the three tibial implant designs. Using an AMTI VIVO simulator each sample was subjected to 50,000 DKB and 120,000 SD cycles at 0.8Hz in series; equating to approximately 2 years of physiological activity. Following loading, micromotion was measured using the same method as above. Results. Initial micomotion measurements during DKB activity for ATTUNE. ®. , PFC SIGMA. ®. CoCr, ATTUNE. ®. S+ were 155µm, 246µm, and 104µm, respectively, and following physiological loading were 159µm, 264µm, and 112µm, respectively. While there was statistical significance between the micromotion of implant designs (p<0.05), there was no significance between before and after loading. Conclusion. This study shows there is no significant change in micromotion after approximately 2 years of physiological loading. However, there is a significant difference in micromotion between implant designs


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_10 | Pages 33 - 33
1 Oct 2020
Bostrom MPG
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Introduction. Patients with aseptic loosening, a cause of failure in uncemented total joint arthroplasty (TJA), often present with fibrous tissue at the bone-implant interface. 1. In this study, we characterize the presence of neutrophil extracellular traps (NETs) in the intramedullary fibrotic membrane of aseptic loosening patients. We further explore the role of NETs, mediated by peptidyl arginine deiminase (PAD4), in peri-implant fibrosis and osseointegration failure through a murine model of unstable tibial implantation. 2–4. Methods. Peri-implant membrane was retrieved from five patients during total hip revision surgery and analyzed for the presence of NETs (citH3+ with extracellular DNA) via immunofluorescence. A Ti-6Al-4V implant was inserted in an oversized drill-hole in the right proximal tibia of 8-week-old C57BL/6J and PAD4 knockout mice (n=3 per group). Fourteen days later, all mice were euthanized, and implanted tibias were dissected. Fibrosis and osseointegration at the bone-implant interface were assessed by micro-computed tomography (microCT) and hematoxylin and eosin (H&E) staining. H&E samples were scored blindly by the investigator and another observer for signs of poor (score=0) to excellent osseointegration (score=3) using a rubric established in our lab. Results. NETs were found in peri-implant membrane collected from aseptic loosening patients (Figure 1a) and at the bone-implant interface in a murine model (Figure 1b). Unstable implants in wild type mice failed to osseointegrate, indicated by presence of fibroblast-like cells (dashed arrow), immature bone matrix (Figure 1c), low bone volume fraction (BV/TV) and bone surface area (BS) (Figure 1e). Unstable implants in PAD4. −/−. mice showed signs of good osseointegration such as mature trabeculae (solid arrow) (Figure 1d), higher BV/TV (p<0.10) and BS (p<0.05) (Figure 1f). Histological osseointegration scoring indicated wildtype mice exhibited an average score of 0.83 and PAD4. −/−. exhibited an average score of 2.5 (p<0.05, weighted Cohen's kappa = 0.714) (Figure 1g). Conclusion. NETs were characterized in fibrotic tissue in both aseptic loosening patients and in a murine model of unstable tibial implantation. NET inhibition was able to successfully prevent peri-implant fibrosis and osseointegration failure, leading the way for a potential novel non-invasive therapeutic approach for the treatment of aseptic loosening. For any figures, tables, or references, please contact the authors directly


Bone & Joint Research
Vol. 9, Issue 4 | Pages 162 - 172
1 Apr 2020
Xie S Conlisk N Hamilton D Scott C Burnett R Pankaj P

Aims. Metaphyseal tritanium cones can be used to manage the tibial bone loss commonly encountered at revision total knee arthroplasty (rTKA). Tibial stems provide additional fixation and are generally used in combination with cones. The aim of this study was to examine the role of the stems in the overall stability of tibial implants when metaphyseal cones are used for rTKA. Methods. This computational study investigates whether stems are required to augment metaphyseal cones at rTKA. Three cemented stem scenarios (no stem, 50 mm stem, and 100 mm stem) were investigated with 10 mm-deep uncontained posterior and medial tibial defects using four loading scenarios designed to mimic activities of daily living. Results. Small micromotions (mean < 12 µm) were found to occur at the bone-implant interface for all loading cases with or without a stem. Stem inclusion was associated with lower micromotion, however these reductions were too small to have any clinical significance. Peak interface micromotion, even when the cone is used without a stem, was too small to effect osseointegration. The maximum difference occurred with stair descent loading. Stress concentrations in the bone occurred around the inferior aspect of each implant, with the largest occurring at the end of the long stem; these may lead to end-of-stem pain. Stem use is also found to result in stress shielding in the bone along the stem. Conclusion. When a metaphyseal cone is used at rTKA to manage uncontained posterior or medial defects of up to 10 mm depth, stem use may not be necessary. Cite this article:Bone Joint Res. 2020;9(4):162–172


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_2 | Pages 22 - 22
1 Jan 2016
Hafez M
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Aim. To create a more “normal” anatomy for the repaired joint structure, which can be provided that by the following factors: (1) the available implant component require a normalized anatomical support structure, (2) the available repair components are designed and/or tested to only recreate and/or replicate more normalized anatomical structures and/or joint motion, (3) the surgeon is familiar and comfortable with more normalized joint motion and thus attempts to create such “normal” motion within the repaired anatomical structures. Methods. We could discover a method of making an implant component for a knee joint of a patient which includes deriving information regarding a first joint line of the joint based on patient-specific information. This method also includes determining a planned level of resection for a first portion of a bone of the joint based on the patient-specific information. Further, the dimension of the implant component is determined based on the derived information regarding the first joint line and the planned level of resection for the first portion of the bone. Also, we discovered an implant component for treating a patient's joint that includes a medial bone-facing surface. The medial bone-facing surface is positioned to engage a cut bone surface of a medial portion of a proximal tibia at a first level. The implant component also includes a lateral bone-facing surface. The lateral bone-facing surface is positioned to engage a cut bone surface of a lateral portion of the proximal tibia at a second level. The first level is offset from the second level. The implant component additionally includes one or more joint-facing surfaces having a curvature based on patient-specific information. Furthermore, we discovered a system for treating a joint of a patient that includes one or more patient-specific instruments. The system further includes a medial tibial implant component. The medial tibial implant component has a bone-facing surface and a joint-facing surface. The joint-facing surface has a curvature based on patient-specific information. The system also includes a lateral tibial implant component, which has a bone-facing surface and a joint-facing surface. The joint-facing surface of the lateral tibial implant has a curvature based on patient-specific information. The bone-facing surface of the medial tibial implant component is configured to engage a cut bone surface that is at a level offset from the level of a cut bone surface to which the bone-facing surface of the lateral tibial implant component is configured to engage. The system further includes a femoral implant component, which has a joint-facing surface with a curvature based on patient-specific information. Results. Patient-specific instruments that can be used for double joint line knee joint replacement surgical procedures are disclosed. Severe varus deformity has been corrected through bilateral joint replacement


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_9 | Pages 11 - 11
1 Jun 2021
Munford M Jeffers J
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OSSTEC is a pre-spin-out venture at Imperial College London seeking industry feedback on our orthopaedic implants which maintain bone quality in the long term. Existing orthopaedic implants provide successful treatment for knee osteoarthritis, however, they cause loss of bone quality over time, leading to more dangerous and expensive revision surgeries and high implant failure rates in young patients. OSSTEC tibial implants stimulate healthy bone growth allowing simple primary revision surgery which will provide value for all stakeholders. This could allow existing orthopaedics manufacturers to capture high growth in existing and emerging markets while offering hospitals and surgeons a safer revision treatment for patients and a 35% annual saving on lifetime costs. For patients, our implant technology could mean additional years of quality life by revising patients to a primary TKA before full revision surgery. Our implants use patent-filed additive manufacturing technology to restore a healthy mechanical environment in the proximal tibia; stimulating long term bone growth. Proven benefits of this technology include increased bone formation and osseointegration, shown in an animal model, and restoration of native load transfer, shown in a human cadaveric model. This technology could help capture the large annual growth (24%) currently seen in the cementless knee reconstruction market, worth $1.2B. Furthermore, analysis suggests an additional market of currently untreated younger patients exists, worth £0.8B and growing by 18% annually. Making revision surgery and therefore treatment of younger patients easier would enable access to this market. We aim to offer improved patient treatment via B2B sales of implants to existing orthopaedic manufacturer partners, who would then provide them with instrumentation to hospitals and surgeons. Existing implant materials provide good options for patient treatments, however OSSTEC's porous titanium structures offer unique competitive advantages; combining options for modular design, cementless fixation, initial bone fixation and crucially long term bone maintenance. Speaking to surgeons across global markets shows that many surgeons are keen to pursue bone preserving surgeries and the use of porous implants. Furthermore, there is a growing demand to treat young patients (with 25% growth in patients younger than 65 over the past 10 years) and to use cementless knee treatments, where patient volume has doubled in the past 4 years and is following trends in hip treatments. Our team includes engineers and consultant surgeons who have experience developing multiple orthopaedic implants which have treated over 200,000 patients. To date we have raised £175,000 for the research and development of these implants and we hope to gain insight from industry professionals before further development towards our aim to begin trials for regulatory approval in 2026. OSSTEC implants provide a way to stimulate bone growth after surgery to reduce revision risk. We hope this could allow orthopaedic manufactures to explore high growth markets while meaning surgeons can treat younger patients in a cost effective way and add quality years to patients' lives


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_1 | Pages 50 - 50
1 Feb 2021
Sanchez E Schilling C Grupp T Giurea A Verdonschot N Janssen D
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Introduction. Cementless total knee arthroplasty (TKA) implants use an interference fit to achieve fixation, which depends on the difference between the inner dimensions of the implant and outer dimensions of the bone. However, the most optimal interference fit is still unclear. A higher interference fit could lead to a superior fixation, but it could also cause bone abrasion and permanent deformation during implantation. Therefore, this study aims to investigate the effect of increasing the interference fit from 350 µm to 700 µm on the primary stability of cementless tibial implants by measuring micromotions and gaps at the bone-implant interface when subjected to two loading conditions. Methods. Two cementless e.motion® tibial components (Total Knee System, B. Braun) with different interference fit and surface coating were implanted in six pairs of relatively young human cadaver tibias (47–60 years). The Orthoload peak loads of gait (1960N) and squat (1935N) were applied to the specimens with a custom made load applicator (Figure 1A). The micromotions (shear displacement) and opening/closing gaps (normal displacement) were measured with Digital Image Correlation (DIC) in 6 different regions of interest (ROIs - Figure 1B). Two General Linear Mixed Models (GLMMs) were created with micromotions and interfacial gaps as dependent variables, bone quality, loading conditions, ROIs, and interference fit implants as independent variables, and the cadaver specimens as subject variables. Results. No significant difference was found for the micromotions between the two interference fit implants (gait p=0.755, squat p=0.232), nor for interfacial gaps (gait p=0.474, squat p=0.269). In contrast, significant differences were found for the ROIs in the two dependent variables (p < 0.001). The micromotions in the anterior ROIs (AM and AL) showed fewer micromotions for the low interference fit implant (Figure 2). More closing gaps (negative values) were seen for all ROIs (Figure 3), except in AM ROI during squat, which showed opening gaps (positive values). The posterior ROIs (PM and PL) showed more closing than seen in the anterior ROIs (AM and AL) for both loading configurations. Discussion. The results presented here demonstrate that increasing the interference fit from 350 µm to 700 µm does not affect the micromotions at the implant-bone interface of tibial TKA. While micromotions values were all below the threshold for bone ingrowth (40 µm), closing gaps were quite substantial (∼−150 µm). Since cementless e.motion® TKA components with an interference fit of 350 µm had shown a survival rate of 96.2% after 8.3 years postoperatively, interfacial gaps can be expected to be within a threshold value that can guarantee good primary stability. Moreover, increasing the interference fit to 700 µm can be considered a good range for an interference fit. For any figures or tables, please contact the authors directly


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_9 | Pages 5 - 5
1 Oct 2020
Zamora T Garbuz DS Greidanus NV Masri BA
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Introduction. Our objective is to describe early and midterm results with the use of a new knee prosthesis as an articulating spacer in planned two-stage management for infected total knee arthroplasty. As a second objective, we compared outcomes between the group with a retained first stage and those with a completed 2-stage revision. Methods. Forty-seven patients (48 knees) from January 2012 and November 2017 underwent a 2-stage exchange with an articulating spacer with new implants was used for a chronic knee periprosthetic joint infection with a mean follow-up of 3.7 years (2–6.5 years). The most frequently identified infecting organism was MSSA (31%), MRSA (21%) or MRSE (20%). At the first stage, a new PS femoral component and a new all-polyethylene posterior stabilized (PS) tibial component or a standard PS tibial liner were cemented with antibiotic-cement, typically 3.6 gm tobramycin and vancomycin 1.5 gm. IV antibiotics for six weeks were administered. The planned reimplantation was at 3 months, but ninetteen spacers (14 all poly tibias and 5 tibial liner) were retained for over 12 months. Postoperative assessment included knee range of motion (ROM), quality of life (QOL) scores (SF-12, WOMAC, KOOS, Oxford, and UCLA scores), and a satisfaction scale from 0–100%. Results. Of the 48 knees, 8 failed due to lack of infection control, and 2 died within the first year for medical reasons (4%), giving a failure rate of 17% (8/46). One of these knees was not revised due to poor medical status. Of the remaining 7, 2 had a repeat 2-stage exchange, one a single stage revision and 4 irrigation and debridement with retained implants. All 7 had a successful outcome with infection control after this, leaving a permanent failure rate of 2% (1/46). Five of the 19 knees with initially retained implants were revised to a second stage after 12 months for continued pain or instability (1/14 all poly tibia and 4/5 PS liner). There were no significant differences in final range of motion or QOL scores between patients with a retained first stage procedure and those who underwent a second stage operation. Also, there was no statistically significant difference in the initial failure rate due to infection between patients with a complete 2-stage revision and those with a retained first stage (19% (6/31) vs. 14% (2/14), respectively; p=0.613). Conclusions. When an all poly tibial implant is used a spacer in two-stage exchange arthroplasty, it may be retained for over 12 months, with no difference in infection control, range of motion, and quality of life assessment to patients with complete 2-stage revision surgery. With this technique, the second stage may be delayed in patients who are doing well, and may never need to be revised, hence we propose the new term “one-and-a-half stage exchange”


Bone & Joint Open
Vol. 4, Issue 9 | Pages 682 - 688
6 Sep 2023
Hampton M Balachandar V Charalambous CP Sutton PM

Aims

Aseptic loosening is the most common cause of failure following cemented total knee arthroplasty (TKA), and has been linked to poor cementation technique. We aimed to develop a consensus on the optimal technique for component cementation in TKA.

Methods

A UK-based, three-round, online modified Delphi Expert Consensus Study was completed focusing on cementation technique in TKA. Experts were identified as having a minimum of five years’ consultant experience in the NHS and fulfilling any one of the following criteria: a ‘high volume’ knee arthroplasty practice (> 150 TKAs per annum) as identified from the National joint Registry of England, Wales, Northern Ireland and the Isle of Man; a senior author of at least five peer reviewed articles related to TKA in the previous five years; a surgeon who is named trainer for a post-certificate of comletion of training fellowship in TKA.


Aims

The tibial component of total knee arthroplasty can either be an all-polyethylene (AP) implant or a metal-backed (MB) implant. This study aims to compare the five-year functional outcomes of AP tibial components to MB components in patients aged over 70 years. Secondary aims are to compare quality of life, implant survivorship, and cost-effectiveness.

Methods

A group of 130 patients who had received an AP tibial component were matched for demographic factors of age, BMI, American Society of Anesthesiologists (ASA) grade, sex, and preoperative Knee Society Score (KSS) to create a comparison group of 130 patients who received a MB tibial component. Functional outcome was assessed prospectively by KSS, quality of life by 12-Item Short-Form Health Survey questionnaire (SF-12), and range of motion (ROM), and implant survivorships were compared. The SF six-dimension (6D) was used to calculate the incremental cost effectiveness ratio (ICER) for AP compared to MB tibial components using quality-adjusted life year methodology.