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Bone & Joint Open
Vol. 5, Issue 7 | Pages 592 - 600
18 Jul 2024
Faschingbauer M Hambrecht J Schwer J Martin JR Reichel H Seitz A

Aims

Patient dissatisfaction is not uncommon following primary total knee arthroplasty. One proposed method to alleviate this is by improving knee kinematics. Therefore, we aimed to answer the following research question: are there significant differences in knee kinematics based on the design of the tibial insert (cruciate-retaining (CR), ultra-congruent (UC), or medial congruent (MC))?

Methods

Overall, 15 cadaveric knee joints were examined with a CR implant with three different tibial inserts (CR, UC, and MC) using an established knee joint simulator. The effects on coronal alignment, medial and lateral femoral roll back, femorotibial rotation, bony rotations (femur, tibia, and patella), and patellofemoral length ratios were determined.


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_6 | Pages 30 - 30
2 May 2024
Dhesi E Salih S Tomlinson R Salih S
Full Access

Polymethylmethacrylate (PMMA) bone cement is strong in compression, however it tends to fail under torsion. Sufficient pressurisation and subsequent interdigitation between cement and bone are critical for the mechanical interlock of cemented orthopaedic implants, and an irregular surface on the acetabular cup is necessary for reasonable fixation at the cup-cement interface. There is limited literature investigating discrepancies in the failure mechanisms of cemented all-polyethylene acetabular cups with and without cement spacers, under torsional loading. In vitro experimental comparison of three groups of polyethylene acetabular prosthesis (PAP) cemented into prepared sawbone hemipelvises:. * PAP without PMMA spacers maintaining an equal cement mantle circumferentially. (Group 1 n=3). * PAP without PMMA spacers cemented deliberately ‘bottoming-out’ the implant within the acetabulum. (Group 2 n=3). * PAP with PMMA spacers. (Group 3 n=3). The constructs were tested to torstional failure on a custom designed setup, and statistical analysis done by a one-way ANOVA and Tukey-Welsh test. Group 3 demonstrated superior torsional resistance with a statistically significant torque of 145Nm (SD±12Nm) at failure, compared to group 2 (109Nm, SD±7Nm) and group 1 (99Nm, SD±8Nm). Group 3 experienced failure predominantly at the bone-cement interface, in contrast, Groups 1 and 2 exhibited failure predominantly at the cup-cement interface. There was no significant difference between Group 1 and 2. Qualitative analysis of the failure mode indicates the efficient redistribution of stress throughout the cement mantle, consistent with the greater uniformity of cement. PMMA spacers increase the resistance to torsional failure at the implant-cement interface. Acetabular components without spacers (Groups 1 and 2) failed at the implant-cement interface before the cement-bone interface, at a statistically significantly lower level of torque to failure. Although the PMMA spacers may reduce cement interdigitation at the cement-bone interface the torsional forces required to fail are likely supraphysiological


The Bone & Joint Journal
Vol. 105-B, Issue 11 | Pages 1168 - 1176
1 Nov 2023
Yüksel Y Koster LA Kaptein BL Nelissen RGHH den Hollander P

Aims. Conflicting clinical results are reported for the ATTUNE Total Knee Arthroplasty (TKA). This randomized controlled trial (RCT) evaluated five-year follow-up results comparing cemented ATTUNE and PFC-Sigma cruciate retaining TKAs, analyzing component migration as measured by radiostereometric analysis (RSA), clinical outcomes, patient-reported outcome measures (PROMs), and radiological outcomes. Methods. A total of 74 primary TKAs were included in this single-blind RCT. RSA examinations were performed, and PROMs and clinical outcomes were collected immediate postoperatively, and at three, six, 12, 24, and 60 months’ follow-up. Radiolucent lines (RLLs) were measured in standard anteroposterior radiographs at six weeks, and 12 and 60 months postoperatively. Results. At five-year follow-up, RSA data from 61 patients were available and the mean maximum total point motion (MTPM) of the femoral components were: ATTUNE: 0.96 mm (95% confidence interval (CI) 0.79 to 1.14) and PFC-Sigma 1.37 mm (95% CI 1.18 to 1.59) (p < 0.001). The PFC-Sigma femoral component migrated more in the first postoperative year, but stabilized thereafter. MPTM of the tibial components were comparable at five-year follow-up: ATTUNE 1.12 mm (95% CI 0.95 to 1.31) and PFC-Sigma 1.25 mm (95% CI 1.07 to 1.44) (p = 0.438). RLL at the medial tibial implant-cement interface remained more prevalent for the ATTUNE at five-year follow-up compared to the PFC-Sigma (20% vs 3%). RLL did not progress over time, and varied between patients at different timepoints for both TKA systems. Clinical outcomes and PROMs improved compared with preoperative scores, and were not different between groups. Conclusion. MTPM migration at five-year follow-up of the femoral and tibial component of the ATTUNE were similar and as low as that of the PFC-Sigma. MTPM migration of both knee implants did not significantly change from one year post-surgery, indicating stable fixation. Long-term ATTUNE performance may be expected to be comparable to the clinically well-performing PFC-Sigma. We have not found evidence of increased tibial component migration as measured by RSA to support concerns about cement debonding and a higher risk of aseptic loosening with the ATTUNE TKA. Cite this article: Bone Joint J 2023;105-B(11):1168–1176


The Bone & Joint Journal
Vol. 105-B, Issue 6 | Pages 610 - 621
1 Jun 2023
Prodromidis AD Chloros GD Thivaios GC Sutton PM Pandit H Giannoudis PV Charalambous CP

Aims

Loosening of components after total knee arthroplasty (TKA) can be associated with the development of radiolucent lines (RLLs). The aim of this study was to assess the rate of formation of RLLs in the cemented original design of the ATTUNE TKA and their relationship to loosening.

Methods

A systematic search was undertaken using the Cochrane methodology in three online databases: MEDLINE, Embase, and CINAHL. Studies were screened against predetermined criteria, and data were extracted. Available National Joint Registries in the Network of Orthopaedic Registries of Europe were also screened. A random effects model meta-analysis was undertaken.


Bone & Joint Open
Vol. 3, Issue 6 | Pages 495 - 501
14 Jun 2022
Keohane D Sheridan GA Masterson E

Aims. Total knee arthroplasty (TKA) is a common and safe orthopaedic procedure. Zimmer Biomet's NexGen is the second most popular brand of implant used in the UK. The primary cause of revision after the first year is aseptic loosening. We present our experience of using this implant, with significant concerns around its performance with regards early aseptic loosening of the tibial component. Methods. A retrospective, single-surgeon review was carried out of all of the NexGen Legacy Posterior Stabilized (LPS) TKAs performed in this institute. The specific model used for the index procedures was the NexGen Complete Knee System (Legacy Knee-Posterior Stabilized LPS-Flex Articular Surface, LPS-Flex Femoral Component Option, and Stemmed Nonaugmentable Tibial Component Option). Results. Between 2013 and 2016, 352 NexGen TKAs were carried out on 331 patients. A total of 62 TKAs have been revised to date, giving an all-cause revision rate of 17.6% at a minimum of five years. Three of these revisions were due to infection. Overall, 59 of the revisions were performed for aseptic loosening (16.7%) of the tibial component. The tibial component was removed intraoperatively without instrumentation due to significant tibial debonding between the implant-cement interface. Conclusion. While overall, we believe that early aseptic loosening is multi-factorial in nature, the significantly high aseptic revision rate, as seen by an experienced fellowship-trained arthroplasty surgeon, has led us to believe that there is a fundamental issue with this NexGen implant design. Continued implant surveillance and rigorous review across all regions using this particular implant is warranted based on the concerning findings described here. Cite this article: Bone Jt Open 2022;3(6):495–501


Bone & Joint Research
Vol. 11, Issue 4 | Pages 210 - 213
1 Apr 2022
Fontalis A Haddad FS


The Bone & Joint Journal
Vol. 103-B, Issue 6 Supple A | Pages 137 - 144
1 Jun 2021
Lachiewicz PF Steele JR Wellman SS

Aims

To establish our early clinical results of a new total knee arthroplasty (TKA) tibial component introduced in 2013 and compare it to other designs in use at our hospital during the same period.

Methods

This is a retrospective study of 166 (154 patients) consecutive cemented, fixed bearing, posterior-stabilized (PS) TKAs (ATTUNE) at one hospital performed by five surgeons. These were compared with a reference cohort of 511 knees (470 patients) of other designs (seven manufacturers) performed at the same hospital by the same surgeons. There were no significant differences in age, sex, BMI, or follow-up times between the two cohorts. The primary outcome was revision performed or pending.


The Bone & Joint Journal
Vol. 103-B, Issue 2 | Pages 309 - 320
1 Feb 2021
Powell-Bowns MFR Oag E Ng N Pandit H Moran M Patton JT Clement ND Scott CEH

Aims

The aim of this study was to determine whether fixation, as opposed to revision arthroplasty, can be safely used to treat reducible Vancouver B type fractures in association with a cemented collarless polished tapered femoral stem (the Exeter).

Methods

This retrospective cohort study assessed 152 operatively managed consecutive unilateral Vancouver B fractures involving Exeter stems; 130 were managed with open reduction and internal fixation (ORIF) and 22 with revision arthroplasty. Mean follow-up was 6.5 years (SD 2.6; 3.2 to 12.1). The primary outcome measure was revision of at least one component. Kaplan–Meier survival analysis was performed. Regression analysis was used to identify risk factors for revision following ORIF. Secondary outcomes included any reoperation, complications, blood transfusion, length of hospital stay, and mortality.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_1 | Pages 35 - 35
1 Feb 2021
Hall T van Arkel R Cegla F
Full Access

Introduction & Aims. In other medical fields, smart implantable devices are enabling decentralised monitoring of patients and early detection of disease. Despite research-focused smart orthopaedic implants dating back to the 1980s, such implants have not been adopted into regular clinical practice. The hardware footprint and commercial cost of components for sensing, powering, processing, and communicating are too large for mass-market use. However, a low-cost, minimal-modification solution that could detect loosening and infection would have considerable benefits for both patients and healthcare providers. This proof-of-concept study aimed to determine if loosening/infection data could be monitored with only two components inside an implant: a single-element sensor and simple communication element. Methods. The sensor and coil were embedded onto a representative cemented total knee replacement. The implant was then cemented onto synthetic bone using polymethylmethacrylate (PMMA). Wireless measurements for loosening and infection were then made across different thicknesses of porcine tissue to characterise the sensor's accuracy for a range of implantation depths. Loosening was simulated by taking measurements before and after compromising the implant-cement interface, with fluid influx simulated with phosphate-buffered saline solution. Elevated temperature was used as a proxy for infection, with the sensor calibrated wirelessly through 5 mm of porcine tissue across a temperature range of 26–40°C. Results. Measurements for loosening and infection could be acquired simultaneously with a duration of 4 s per measurement. For loosening, the debonded implant-cement interface was detectable up to 10 mm with 95% confidence. For temperature, the sensor was calibrated with a root mean square error of 0.19°C at 5 mm implantation depth and prediction intervals of ±0.38°C for new measurements with 95% confidence. Conclusions. This study has demonstrated that with only two onboard electrical components, it is possible to wirelessly measure cement debonding and elevated temperature on a smart implant. With further development, this minimal hardware/cost approach could enable mass-market smart arthroplasty implants


The Bone & Joint Journal
Vol. 102-B, Issue 9 | Pages 1158 - 1166
14 Sep 2020
Kaptein BL den Hollander P Thomassen B Fiocco M Nelissen RGHH

Aims. The primary objective of this study was to compare migration of the cemented ATTUNE fixed bearing cruciate retaining tibial component with the cemented Press-Fit Condylar (PFC)-sigma fixed bearing cruciate retaining tibial component. The secondary objectives included comparing clinical and radiological outcomes and Patient Reported Outcome Measures (PROMs). Methods. A single blinded randomized, non-inferiority study was conducted including 74 patients. Radiostereometry examinations were made after weight bearing, but before hospital discharge, and at three, six, 12, and 24 months postoperatively. PROMS were collected preoperatively and at three, six, 12, and 24 months postoperatively. Radiographs for measuring radiolucencies were collected at two weeks and two years postoperatively. Results. The overall migration (mean maximum total point motion (MPTM)) at two years was comparable: mean 1.13 mm (95% confidence interval (CI), 0.97 to 1.30) for the ATTUNE and 1.16 mm (95% CI, 0.99 to 1.35) for the PFC-sigma. At two years, the mean backward tilting was -0.43° (95% CI, -0.65 to -0.21) for the ATTUNE and 0.08° (95% CI -0.16 to 0.31), for the PFC-sigma. Overall migration between the first and second postoperative year was negligible for both components. The clinical outcomes and PROMs improved compared with preoperative scores and were not different between groups. Radiolucencies at the implant-cement interface were mainly seen below the medial baseplate: 17% in the ATTUNE and 3% in the PFC-sigma at two weeks, and at two years 42% and 9% respectively (p = 0.001). Conclusion. In the first two postoperative years the initial version of the ATTUNE tibial component was not inferior with respect to overall migration, although it showed relatively more backwards tilting and radiolucent lines at the implant-cement interface than the PFC-sigma. The version of the ATTUNE tibial component examined in this study has subsequently undergone modification by the manufacturer. Level of Evidence: 1 (randomized controlled clinical trial). Cite this article: Bone Joint J 2020;102-B(9):1158–1166


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_1 | Pages 52 - 52
1 Feb 2020
Sadhwani S Picache D Janssen D de Ruiter L Rankin K Briscoe A Verdonschot N Shah A
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Introduction. Polyetheretherketone (PEEK) has been proposed as an implant material for femoral total knee arthroplasty (TKA) components. Potential clinical advantages of PEEK over standard cobalt chrome alloys include modulus of elasticity and subsequently reduced stress shielding potentially eliminating osteolysis, thermal conduction properties allowing for a more natural soft tissue environment, and reduced weight enabling quicker quadriceps recovery. Manufacturing advantages include reduced manufacturing and sterilization time, lower cost, and improved quality control. Currently, no PEEK TKA implants exist on the market. Therefore, evaluation of mechanical properties in a pre-clinical phase is required to minimize patient risk. The objectives of this study include evaluation of implant fixation and determination of the potential for reduced stress shielding using the PEEK femoral TKA component. Methods and Materials. Experimental and computational analysis was performed to evaluate the biomechanical response of the femoral component (Freedom Knee, Maxx Orthopedics Inc., Plymouth Meeting, PA; Figure 1). Fixation strength of CoCr and PEEK components was evaluated in pull-off tests of cemented femoral components on cellular polyurethane foam blocks (Sawbones, Vashon Island, WA). Subsequent testing investigated the cemented fixation using cadaveric distal femurs. The reconstructions were subjected to 500,000 cycles of the peak load occurring during a standardized gait cycle (ISO 14243-1). The change from CoCr to PEEK on implant fixation was studied through computational analysis of stress distributions in the cement, implant, and the cement-implant interface. Reconstructions were analyzed when subjected to standardized gait and demanding squat loads. To investigate potentially reduced stress shielding when using a PEEK component, paired cadaveric femurs were used to measure local bone strains using digital image correlation (DIC). First, standardized gait load was applied, then the left and right femurs were implanted with CoCr and PEEK components, respectively, and subjected to the same load. To verify the validity of the computational methodology, the intact and reconstructed femurs were replicated in FEA models, based on CT scans. Results. The cyclic load phase of the pull-off experiments revealed minimal migration for both CoCr and PEEK components, although after construct sectioning, debonding at the implant-cement interface was observed for the PEEK implants. During pull-off from Sawbones the ultimate failure load of the PEEK and CoCr components averaged 2552N and 3814N respectively. FEA simulations indicated that under more physiological loading, such as walking or squatting, the PEEK component had no increased risk of loss of fixation when compared to the CoCr component. Finally, the DIC experiments and FEA simulations confirmed closer resemblance of pre-operative strain distribution using the PEEK component. Discussion. The biomechanical consequences of changing implant material from CoCr to PEEK on implant fixation was studied using experimental and computational testing of cemented reconstructions. The results indicate that, although changes occur in implant fixation, the PEEK component had a fixation strength comparable to CoCr. The advantage of long term bone preservation, as the more compliant PEEK implant is able to better replicate the physiological loads occurring in the intact femur, may reduce stress shielding around the distal femur, a common clinical cause of TKA failure. For any figures or tables, please contact the authors directly


The Bone & Joint Journal
Vol. 101-B, Issue 10 | Pages 1280 - 1284
1 Oct 2019
Kang JR Logli AL Tagliero AJ Sperling JW

Aims

A number of methods have been described to remove a well-fixed humeral implant as part of revision shoulder arthroplasty. These include the use of cortical windows and humeral osteotomies. The router bit extraction technique uses a high-speed router bit to disrupt the bone-implant interface. The implant is then struck in a retrograde fashion with a square-tip impactor and mallet. The purpose of this study was to determine the characteristics and frequency of the different techniques needed for the removal of a well-fixed humeral stem in revision shoulder arthroplasty.

Patients and Methods

Between 2010 and 2018, 288 revision shoulder arthroplasty procedures requiring removal of a well-fixed humeral component were carried out at a tertiary referral centre by a single surgeon. The patient demographics, indications for surgery, and method of extraction were collected.


Bone & Joint Research
Vol. 8, Issue 3 | Pages 136 - 145
1 Mar 2019
Cerquiglini A Henckel J Hothi H Allen P Lewis J Eskelinen A Skinner J Hirschmann MT Hart AJ

Objectives

The Attune total knee arthroplasty (TKA) has been used in over 600 000 patients worldwide. Registry data show good clinical outcome; however, concerns over the cement-tibial interface have been reported. We used retrieval analysis to give further insight into this controversial topic.

Methods

We examined 12 titanium (Ti) PFC Sigma implants, eight cobalt-chromium (CoCr) PFC Sigma implants, eight cobalt-chromium PFC Sigma rotating platform (RP) implants, and 11 Attune implants. We used a peer-reviewed digital imaging method to quantify the amount of cement attached to the backside of each tibial tray. We then measured: 1) the size of tibial tray thickness, tray projections, peripheral lips, and undercuts; and 2) surface roughness (Ra) on the backside and keel of the trays. Statistical analyses were performed to investigate differences between the two designs.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_3 | Pages 74 - 74
1 Apr 2018
Chevalier Y Chamseddine M Santos I Müller P Pietschmann M
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Introduction. Glenoid loosening, still a main complication for shoulder arthroplasty, was suggested to be related implant design, surgical aspects, and also bone quality. However, typical studies of fixation do not account for heterogeneity in bone morphology and density which were suggested to affect fixation failure. In this study, a combination of cyclic rocking horse tests on cadaver specimens and microCT-based finite element (microFE) analysis of specimens of a wide range of bone density were used to evaluate the effects of periprosthetic bone quality on the risks of loosening of anatomical keeled or pegged glenoid implants. Methods. Six pairs of cadaveric scapulae, scanned with a quantitative computer tomography (QCT) scanner to calculate bone mineral density (BMD), were implanted with either cemented anatomical pegged or keeled glenoid components and tested under constant glenohumeral load while a humeral head component was moved cyclically in the inferior and superior directions. Edge displacements were measured after 1000, 4000 and 23000 test cycles, and tested for statistical differences with regards to changes or implant design. Relationships were established between edge displacements and QCT-based BMD below the implant. Four other specimens were scanned with high-resolution peripheral QCT (82µm) and implanted with the same 2 implants to generate virtual models. These were loaded with constant glenohumeral force, varying glenohumeral conformity and superior or inferior load shifts while internal stresses at the cement-bone and implant-cement interfaces were calculated and related to apparent bone density in the periprosthetic zone. Results. Mean displacements at the inferior and superior edges showed no statistical difference between keeled and pegged designs (p>0.05). Compression and distraction were however statistically different from the initial reference measurement at even 1000 and 4000 cycles for both implant designs (p<0.05). For both implant designs, superior and inferior distractions were generally highest at each measurement time in specimens where BMD below the lifting edge was lower, showing a trend of increased distraction with decreased BMD. Moreover, the microFE models predicted higher bone and cement stresses for specimens of lower apparent bone density. Finally, highest peak stresses were located at the cement-bone interface, which seemed the weaker part of the fixation. Discussion. With this combined experimental and numerical study, it was shown that implant distraction and stresses in the cement layer are greater in glenoids of lower bone density for both implant designs. This indicates that fixation failure will most likely occur in bone of lower density, and that fixation design itself may play a secondary role. These results have important impact for understanding the mechanisms of glenoid component failure, a common complication of total shoulder arthroplasty


Bone & Joint Research
Vol. 6, Issue 5 | Pages 323 - 330
1 May 2017
Pijls BG Sanders IMJG Kuijper EJ Nelissen RGHH

Objectives

Infection of implants is a major problem in elective and trauma surgery. Heating is an effective way to reduce the bacterial load in food preparation, and studies on hyperthermia treatment for cancer have shown that it is possible to heat metal objects with pulsed electromagnetic fields selectively (PEMF), also known as induction heating. We therefore set out to answer the following research question: is non-contact induction heating of metallic implants effective in reducing bacterial load in vitro?

Methods

Titanium alloy cylinders (Ti6Al4V) were exposed to PEMF from an induction heater with maximum 2000 watts at 27 kHz after being contaminated with five different types of micro-organisms: Staphylococcus epidermidis; Staphylococcus aureus; Pseudomonas aeruginosa; spore-forming Bacillus cereus; and yeast Candida albicans. The cylinders were exposed to incremental target temperatures (35°C, 45°C, 50°C, 55°C, 60°C, 65°C, 70°C) for up to 3.5 minutes.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 513 - 513
1 Dec 2013
Ruiter L Janssen D Briscoe A Verdonschot N
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Introduction. Current clinical practice in total knee arthroplasty (TKA) is largely based on metal on polyethylene bearing couples. A potential adverse effect of the stiff metal femoral component is stress shielding, leading to loss of bone stock, periprosthetic bone fractures and eventually aseptic loosening of the component. The use of a polymer femoral component may address this problem. However, a more flexible material may also have consequences for the fixation of the femoral component. Concerns are raised about its expected potential to introduce local stress peaks on the interface. The objective of this study was to analyze the effect of using a polyether-etherketone (PEEK-Optima®) femoral component on the cement-implant interface. We analyzed the interface stress distribution occurring during normal gait, and compared this to results of a standard CoCr component. Materials and methods. An FEA model was created, consisting of a femoral component cemented onto a femur, and a polyethylene tibial component. A standard loading regime was applied mimicking an adapted gait cycle, according to ISO14243-1. The implant-cement interface was modelled as a zero-thickness layer connecting the implant to the cement layer. Femoral flexion/extension was prescribed for the femur in a displacement controlled manner, while the joint loads were applied to pivoting nodes attached to the tibial construct, consistent with the ISO standard. Implant-cement interface properties were adopted from a previous study on CoCr interface debonding. [1]. . Results. The highest stresses were found during the heel strike phase of the walking cycle (Figure 1). Both for the PEEK-Optima® (A) and CoCr implant (B), the highest stresses were found near the chamfers of the posterior condyles, which is the location where tibiofemoral contact occurred. Also around the pegs, small stress intensities were found. Surprisingly, the CoCr implant produced higher peak Von Mises stresses than the PEEK-Optima® implant. Figure 1. Von Mises stress distribution at the implant-cement interface in case of a PEEK-Optima® (A) and a CoCr (B) femoral component. Discussion. In contrast with our initial assumption, the current results show that the cement-implant interface stresses with a PEEK-Optima® component were lower and more focal than with a CoCr component. However, the significance of this difference is yet unknown, as additional data on the strength of the implant-cement interface strength of PEEK-Optima® components is needed for the prediction of implant loosening. We furthermore intend to expand the current simulations with more demanding tasks, such as stair climbing and rising from a chair, as such high flexion tasks may be more detrimental to the implant-cement interface. In conclusion, this study warrants further investigation of the use of PEEK-Optima® as a replacement for CoCr in femoral TKA components


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_15 | Pages 360 - 360
1 Mar 2013
Wang T Pelletier M Bertollo N Crosky A Walsh W
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Introduction. Implant contamination prior to cement application has the potential to affect the cement-implant bond. the consequences of implant contamination were investigated in vitro using static shear loading with bone cement and titanium dowels of differing surface roughness both with, and without contamination by substances that are likely to be present during surgery. Namely; saline, fat, blood and oil, as a negative control. Methods. Fifty Titanium alloy (Ti-6Al-4V) dowels were prepared with two surface finishes comparable to existing stems. The roughness (Ra and Rq) of the dowel surface was measured before and after the pushout test. Four contaminants (Phosphate Buffered Saline (PBS), ovine marrow, ovine blood, olive oil) were prepared and heated to 37°C. Each contaminant was smeared on the dowel surface completely and uniformly approximately 4 minutes prior to implantation. Samples were separated into ten groups (n=5 per group) based on surface roughness and contaminant. Titanium alloy dowels was placed in the center of Polyvinyl chloride (PVC) tubes with bone cement, and equilibrated at 37°C in PBS for 7 days prior to mechanical testing. The push out test was performed at 1 mm per minute. The dowel surface and cement mantel were analyzed using a Scanning Electron Microscopy (SEM) to determine the distribution and composition of any debris and contaminates on the surface. Results. All contaminants decreased stem-bone cement interfacial shear strength. Saline produced the greatest decrease, followed by blood. The effect of fat was less pronounced and similar to that of oil likely due to the strong lipid solvent properties of the methacrylate monomer. For rough dowels, there were differences in ultimate shear strength between control and contaminated groups (p<0.001). Blood and saline groups had lower ultimate shear strength compared to fat and oil (p<0.05) (fig. 1). The ultimate shear strength for smooth samples was not significantly affected by contamination. Increasing surface roughness increased the interfacial bonding strength, even in the presence of contaminants. In control, fat and oil groups, the effect of roughness are significant (p<0.001, p<0.05 and p<0.001 respectively) (fig. 1). Scanning Electron Microscopy (SEM) showed that contaminants influence the interfacial bond by different mechanisms. Although rough surfaces were associated with higher bond strength, they also generated more debris, which could negatively affect the longevity of the implant bond (fig. 2 and fig. 3). Conclusion. The results of this study underscores the importance of keeping an implant free from contamination, and that if contamination does occur, a saline rinse may further decrease the stability of an implant. Contaminants did not significantly affect the bond strength between bone cement and smooth Ti stem, although a trend of improved properties was seen in the presence of lipid based contaminants. Therefore, the influence of contaminants is more important to the shape-closed type stem. Increasing surface roughness dramatically improved the load carrying capability of the implant-cement interface even with contaminants


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 370 - 370
1 Sep 2012
Schlegel U Siewe J Püschel K Gebert De Uhlenbrock A Eysel P Morlock M
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Despite proven advantages, pulsatile lavage seems to be used infrequently during preparation in cemented total knee arthroplasty. This remains irritating, as the technique has been suggested to improve radiological survival in cemented TKA, where aseptic loosening of the tibial component represents the main reason for revision. Furthermore, there may be a potential improvement of fixation strength for the tibial tray achieved by increased cement penetration. In this study, the influence of pulsed lavage on mechanical stability of the tibial component and bone cement penetration was analyzed in a cadaveric setting. Six pairs of cadaveric, proximal tibia specimen underwent computed tomography (CT) for assessment of bone mineral density (BMD) and exclusion of osseous lesions. Following surgical preparation, in one side of a pair, the tibial surface was irrigated using 1800ml normal saline and pulsatile lavage, while in the other side syringe lavage using the identical amount of fluid was applied. After careful drying, bone cement was hand-pressurized on the bone surface, tibial components were inserted and impacted in an identical way. After curing of cement, specimen underwent a postimplantation CT analysis). Cement distrubution was then assessed using a three-dimenionsional visualization software. Trabecular bone, cement and implant were segmented based on an automatic thresholding algorithm, which had been validated in a previous study. This allowed to determine median cement penetration for the entire cemented area. Furthermore, fixation strength of the tibial trays was determined by a vertical pull-out test using a servohydraulic material testing machine. Testing was performed under displacement control at a rate of 0,5mm/sec until implant failure. Data was described by median and range. Results were compared by a Wilcoxon matched pairs signed rank test with a type 1 error probability of 5 %. Median pull-out forces in the pulsed lavage group were 1275N (range 864–1391) and 568N (range 243–683) in the syringe lavage group (p=0.031). Cement penetration was likewise increased (p=0.031) in the pulsed lavage group (1.32mm; range 0.86–1.94), when compared to the syringe irrigated group (0.79mm; range 0.51–1.66). Failure occurred in the pulsatile lavage group at the implant-cement interface and in the syringe lavage group at the bone-cement interface, which indicates the weakness of the latter. Altogether, improved mechanical stability of the tibial implant and likewise increased bone cement interdigitation could be demonstrated in the current study, when pulsed lavage is implemented. Enhanced fixation strength was suggested being a key to improved survival of the implant. If this is the case, pulsatile lavage should be considered being a mandatory preparation step when cementing tibial components in TKA


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXV | Pages 255 - 255
1 Jun 2012
Zelle J Malefijt MDW Verdonschot N
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Introduction. High-flexion knee implants have been developed to accommodate a large range of motion (ROM > 120°) after total knee arthroplasty (TKA). In a recent follow-up study, Han et al. [1] reported a disturbingly high incidence of femoral loosening for high-flexion TKA. The femoral component loosened particularly at the implant-cement interface. Highly flexed knee implants may be more sensitive to femoral loosening as the knee load is high during deep knee flexion [2], which may result in increased tensile and/or shear stresses at the femoral implant fixation. The objective of this study was to analyse the load-transfer mechanism at the femoral implant-cement interface during deep knee flexion (ROM = 155°). For this purpose, a three-dimensional finite element (FE) knee model was developed including high-flexion TKA components. Zero-thickness cohesive elements were used to model the femoral implant-cement interface. The research questions addressed in this study were whether high-flexion leads to an increased tensile and/or shear stress at the femoral implant-cement interface and whether this would lead to an increased risk of femoral loosening. Materials & methods. The FE knee model utilized in this study has been described previously [3] and consisted of a proximal tibia and fibula, TKA components, a quadriceps and patella tendon and a non-resurfaced patella. For use in this study, the distal femur was integrated in the FE model including cohesive interface elements and a 1 mm bone cement layer. High-flexion TKA components of the posterior-stabilised PFC Sigma RP-F (DePuy, J&J, USA) were incorporated in the FE knee model following the surgical procedure provided by the manufacturer. A full weight-bearing squatting cycle was simulated (ROM = 50°-155°). The interface stresses calculated by the FE knee model were decomposed into tension, compression and shear components. The strength of the femoral implant-cement interface was determined experimentally using interface specimens to predict whether a local interface stress-state calculated by the FE knee model would lead to interface debonding. Results. During deep knee flexion, tensile stress concentrations were found at the femoral implant-cement interface particularly beneath the anterior flange. Shear stress concentrations were observed at the interface beneath the anterior flange and the posterior femoral condyles. The peak tensile interface stress increased from 1.6 MPa at 120° of flexion to 5.5 MPa during deep knee flexion at the interface beneath the anterior flange. The peak shear stress was even higher at this interface location and increased from 4.1 MPa at 120° of flexion to 11.0 MPa at maximal flexion (155°). Based on the interface strength experiments, 5.8% of the interface beneath the anterior flange was predicted to debond at 120° of flexion, which increased to 10.8% during deep knee flexion. Discussion. Obviously, the FE knee model utilized in this study contains limitations which may have affected the interface stresses calculated. However, the results presented here clearly demonstrate increasing tensile and shear stresses in substantial parts of the femoral implant-cement beneath the anterior flange during deep knee flexion. Based on the interface strength experiments the anterior interfacial stress-state calculated by the FE knee model leads to local interface debonding during deep knee flexion, which increases the risk of femoral loosening. Proper anterior fixation of the femoral component is essential to reduce the risk of femoral loosening for high-flexion TKA


The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 10 | Pages 1355 - 1361
1 Oct 2011
Bollars P Luyckx J Innocenti B Labey L Victor J Bellemans J

High-flexion total knee replacement (TKR) designs have been introduced to improve flexion after TKR. Although the early results of such designs were promising, recent literature has raised concerns about the incidence of early loosening of the femoral component. We compared the minimum force required to cause femoral component loosening for six high-flexion and six conventional TKR designs in a laboratory experiment.

Each TKR design was implanted in a femoral bone model and placed in a loading frame in 135° of flexion. Loosening of the femoral component was induced by moving the tibial component at a constant rate of displacement while maintaining the same angle of flexion. A stereophotogrammetric system registered the relative movement between the femoral component and the underlying bone until loosening occurred.

Compared with high-flexion designs, conventional TKR designs required a significantly higher force before loosening occurred (p < 0.001). High-flexion designs with closed box geometry required significantly higher loosening forces than high-flexion designs with open box geometry (p = 0.0478). The presence of pegs further contributed to the fixation strength of components.

We conclude that high-flexion designs have a greater risk for femoral component loosening than conventional TKR designs. We believe this is attributable to the absence of femoral load sharing between the prosthetic component and the condylar bone during flexion.