Does Maximal External Tibial Component Rotation Influence Tibiofemoral Load Distribution in the Primary Knee Arthroplasty Setting: A Comparison of Neutral vs Maximal Anatomical External Rotatory States.

BACKGROUND: Tibial component rotation at time of knee arthroplasty can influence conformity, load transmission across the polyethylene surface, and perhaps ultimately determined survivorship. Optimal tibial component rotation on the cut surface is reliant on standard per operative manual stressing. This subjective assessment aims to balance constraint and stability of the articulation through a full arc of movement. METHODS: Using a cadaveric model, computer navigation and under defined, previously validated loaded conditions mimicking the in vivo setting, the influence of maximal tibial component external rotation compared with the neutral state was examined for changes in laxity and tibiofemoral continuous load using 3D displacement measurement and an orthosensor continuous load sensor implanted within the polyethylene spacer in a simulated single radius total knee arthroplasty. RESULTS: No significant difference was found throughout arc of motion (0-115 degrees of flexion) for maximal varus and/or valgus or rotatory laxity between the 2 states. The neutral state achieved equivalence for mediolateral load distribution at each point of flexion. We have found that external rotation of the tibial component increased medial compartment load in comparison with the neutral position. Compared with the neutral state, external rotation consistently effected a marginal, but not significant reduction in lateral load under similar loading conditions. The effects were most pronounced in midflexion. CONCLUSION: On the basis of these findings, we would advocate for the midtibial tubercle point to determine tibial component rotation and caution against component external rotation.

Changes in surface topography at the TKA backside articulation following in vivo service: a retrieval analysis.

PURPOSE: With the advent of modular total knee arthroplasty (TKA) systems, backside wear at the articulation between the ultra-high-molecular-weight-polyethylene (UHMWPE) component undersurface and the tibial baseplate has received increasing attention as a source of clinically significant polyethylene wear debris. The aim of this study was to investigate the reciprocating interface at the TKA undersurface articulation using profilometry after in vivo service. Our null hypothesis was that there would be no discernible pattern or relationship between the metal tibial baseplate and UHMWPE surface profile. METHODS: A nanoscale analysis of thirty retrieved fixed-bearing TKA explants was performed. Surface roughness (Sa) and skewness (Ssk) were measured on both the UHMWPE component undersurface and the tibial baseplate of explants using a non-contacting profilometer (1 nm resolution). Four pristine unimplanted components of two different designs (Stryker Kinemax and DePuy PFC) were examined for control purposes. RESULTS: Mean explant baseplate surface roughness was 1.24 µm (0.04-3.01 µm). Mean explant UHMWPE undersurface roughness was 1.16 µm (0.23-2.44 µm). Each explant had an individual roughness pattern with unique baseplate and undersurface UHMWPE surface roughness that was different from, but closely related to, surface topography observed in control implants of the same manufacturer and design. Following in vivo service, UHMWPE undersurface showed changes towards a negative skewness, demonstrating that wear is occurring at the backside interface. CONCLUSION: In vivo loading of the TKA prosthesis leads to measurable changes in surface profile at the backside articulation, which appear to be dependent on several factors including implant design and in vivo duration. These findings are consistent with wear occurring at this surface. Findings of this study would support the use of a polished tibial tray over an unpolished design in total knee arthroplasty with the goal of reducing PE wear by means of providing a smoother backside countersurface for the UHMWPE component.

No functional benefit of larger femoral heads and alternative bearings at 6 months following primary hip replacement.

BACKGROUND AND PURPOSE: There has been a recent trend towards the use of greater femoral head sizes in an attempt to improve function and enhance stability after primary hip replacement. This has been associated with the use of alternative bearings, theoretically to reduce wear and improve implant longevity. METHODS: We examined the influence of these variables on patient-reported outcome measures (PROMs) for a consecutive series of primary hip replacements using National Joint Registry (NJR) and PROMs-linked data. To minimize the confounding influence of implant design factors, the single most commonly used brand in England and Wales (DePuy Corail Pinnacle) was examined. Improvement in patient hip-specific outcomes (Oxford hip score, OHS), general health outcomes (Euroqol, EQ-5D), and rates of self-reported complications (bleeding, wound problems, re-admission, and reoperation) were compared for different head sizes (28-mm, 32-mm, and 36-mm) and bearings (metal-on-polyethylene (MoP), ceramic-on-polyethylene (CoP), and ceramic-on-ceramic (CoC)), adjusting for differences in case mix. RESULTS: At a mean follow-up of 7 months, improvements in OHS and EQ5D index were similar for 28-mm and 36-mm heads. A 32-mm head was associated with poorer function (OHS: 20, 99% CI: 19-21, p = 0.002; EQ5D index: 0.39, 99% CI: 0.36-0.42, p = 0.004), although these small differences may not be of clinical importance. There were no statistically significant benefits of either CoP or CoC bearings compared to a MoP bearing. Complication rates were similar within comparisons of head sizes or bearings. INTERPRETATION: In this short-term study, we did not find any functional benefits of larger head sizes or alternative bearings, after adjusting for other influences. We question their use in routine primary hip replacement given the lack of evidence of improved long-term survival in the literature.

Have cementless and resurfacing components improved the medium-term results of hip replacement for patients under 60 years of age?

BACKGROUND AND PURPOSE: The optimal hip replacement for young patients remains unknown. We compared patient-reported outcome measures (PROMs), revision risk, and implant costs over a range of hip replacements. METHODS: We included hip replacements for osteoarthritis in patients under 60 years of age performed between 2003 and 2010 using the commonest brand of cemented, cementless, hybrid, or resurfacing prosthesis (11,622 women and 13,087 men). The reference implant comprised a cemented stem with a conventional polyethylene cemented cup and a standard-sized head (28- or 32-mm). Differences in implant survival were assessed using competing-risks models, adjusted for known prognostic influences. Analysis of covariance was used to assess improvement in PROMs (Oxford hip score (OHS) and EQ5D index) in 2014 linked procedures. RESULTS: In males, PROMs and implant survival were similar across all types of implants. In females, revision was statistically significantly higher in hard-bearing and/or small-stem cementless implants (hazard ratio (HR) = 4) and resurfacings (small head sizes (< 48 mm): HR = 6; large head sizes (≥ 48 mm): HR = 5) when compared to the reference cemented implant. In component combinations with equivalent survival, women reported significantly greater improvements in OHS with hybrid implants (22, p = 0.006) and cementless implants (21, p = 0.03) (reference, 18), but similar EQ5D index. For men and women, National Health Service (NHS) costs were lowest with the reference implant and highest with a hard-bearing cementless replacement. INTERPRETATION: In young women, hybrids offer a balance of good early functional improvement and low revision risk. Fully cementless and resurfacing components are more costly and do not provide any additional benefit for younger patients.

Factors influencing revision risk following 15 740 single-brand hybrid hip arthroplasties: a cohort study from a National Joint Registry.

This retrospective cohort study of a National Joint Registry data examines survival time to revision following the commonest brand of primary hybrid THA, exploring risk factors independently associated with failure. Overall 5-year revision was 1.56%. In the final adjusted model, revision risk was significantly higher with standard polyethylene (PE) liners (metal-on-PE: hazard ratio [HR]=2.52, P=0.005, ceramic-on-PE: HR=2.99, P=0.025) when compared to metal-on-highly-cross-linked (XL) PE. Risk of revision with ceramic-on-ceramic bearings was borderline significant (HR=1.86, P=0.061). A significant interaction between age and acetabular shell type (solid or multi-hole) was found (P=0.022), suggesting that solid shells performed significantly better in younger patients. In summary, we found that there were significant differences in implant failure between different bearing surfaces and shell types after adjusting for a range of covariates.

The addition of a flange does not improve the pressure generated during cemented acetabular cup implantation.

Flanged acetabular cups were developed with the rationale that, at insertion, they would increase the pressure of the cement and improve penetration of cement into the acetabular bone. Various studies have been inconclusive regarding their effectiveness. In this work, we aimed to eliminate all confounding factors and measure the pressures generated during acetabular pressurization and cup implantation using a simplified steel acetabulum, high precision pressure transducers, proper surgical techniques and two acetabular cups, identical apart from the addition of a flange to one. It was found that the flanged acetabular component did not significantly increase the pressure in the acetabulum and in some cases reduced the pressures generated when compared to an unflanged cup. The addition of a flange did not reduce the pressure differential between the pole and the rim of the acetabulum, nor did it have a significant effect on pressure lost over the cup implantation period. It was concluded that flanged acetabular cups provide no significant improvement in the pressures generated in the acetabulum during acetabular cup implantation. It is hypothesized that the flange may be seen as a design feature intended to slow the insertion of the cup into the cement, thus requiring the surgeon to apply a larger load in order to correctly position the acetabular cup; in this way larger pressure will be generated.

Does vacuum mixing affect diameter shrinkage of a PMMA cement mantle during in vitro cemented acetabulum implantation?

Radiolucent lines on immediate postoperative cemented acetabular component radiographs between the PMMA bone cement mantle and bone are an indicator of an increased risk of early loosening. The cause of these lines has yet to be identified. Thermal and chemical necrosis, fluid interposition and cement shrinkage have all been suggested in the literature. The aim of the study reported here was to take an engineering approach - eliminating confounding variables present during surgery - to quantify the size of the interstice created by cement shrinkage when a 50 mm diameter flanged acetabular cup is implanted in a model acetabulum with a 52 mm hemispherical bore under controlled conditions using vacuum and non-vacuum mixed cement. Irrespective of the mixing method used, a significant interstice was created between the bone cement and the mock acetabulum. When the cement was mixed under vacuum the interstice created between the mock acetabulum and the cement mantle was 0.60 mm ± 0.09 mm; when the cement was mixed under non-vacuum conditions the interstice created was 0.39 mm ± 0.15 mm. Possible explanations for radiolucent lines are discussed.

Conventional Versus Highly Cross-Linked Polyethylene in Primary Total Knee Replacement: A Comparison of Revision Rates Using Data from the National Joint Registry for England, Wales, and Northern Ireland.

BACKGROUND: There is evidence to support the use of highly cross-linked polyethylene (HXLPE) in patients undergoing total hip arthroplasty. However, the benefits for those undergoing total knee arthroplasty are uncertain, with conflicting reports based on previous cohort analyses. The purpose of the present study was to compare the revision rates following primary total knee arthroplasty with use of HXLPE as compared with conventional polyethylene (CPE) using data from the National Joint Registry (NJR) for England, Wales and Northern Ireland. METHODS: We performed a retrospective analysis of primary total knee arthroplasties recorded in the NJR from 2003 to 2014. Cobalt-chromium (CoCr)-CPE and CoCr-HXLPE bearing surfaces were compared using all-cause revision, aseptic revision, and septic revision as end points. Survival analyses were conducted using rates per 100 years observed, Kaplan-Meier survival estimates, and Cox regression hazard ratios (HRs) adjusted for age, sex, American Society of Anesthesiologists (ASA) classification, body mass index (BMI), lead surgeon grade, and implant constraint. Secondary analyses compared the most commonly used HXLPEs (Zimmer Prolong, DePuy XLK, and Stryker X3) against CPE for the 3 most common total knee arthroplasty systems (NexGen, PFC Sigma, and Triathlon). RESULTS: In the present study of 550,658 total knee arthroplasties, the unadjusted aseptic revision rates were significantly lower following procedures performed with CPE (n = 513,744) as compared with those performed with HXLPE total knee replacements (n = 36,914) (0.29 [95% confidence interval (CI), 0.28 to 0.30] compared to 0.38 [95% CI, 0.35 to 0.42], p < 0.01). The 10-year HR associated with CPE was 0.4 (95% CI, 0.1 to 0.8, p = 0.03). There were no significant differences between the adjusted revision rates of HXPLE compared with CPE in individual analyses of the most common total knee arthroplasty systems. However, for the subset of patients who were both <60 years of age and had a BMI of >35 kg/m, the "second-generation" Stryker X3 HXLPE demonstrated significantly better survival than its respective CPE, with CPE having an HR of 2.6 (95% CI, 1.2 to 5.9) (p = 0.02). CONCLUSIONS: Alternative bearings are marketed as having improved wear properties over traditional CoCr-CPE. This registry-based analysis demonstrated no overall survival benefit of HXLPE after a maximum duration of follow-up of 12 years. Because of their increased cost, the routine use of HXLPE bearings may not be justified. However, they may have a role in specific "higher demand" groups such as patients <60 years of age and/or those with a BMI of >35 kg/m. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete list of levels of evidence.

Implant Optimisation for Primary Hip Replacement in Patients over 60 Years with Osteoarthritis: A Cohort Study of Clinical Outcomes and Implant Costs Using Data from England and Wales.

BACKGROUND: Hip replacement is one of the most commonly performed surgical procedures worldwide; hundreds of implant configurations provide options for femoral head size, joint surface material and fixation method with dramatically varying costs. Robust comparative evidence to inform the choice of implant is needed. This retrospective cohort study uses linked national databases from England and Wales to determine the optimal type of replacement for patients over 60 years undergoing hip replacement for osteoarthritis. METHODS AND FINDINGS: Implants included were the commonest brand from each of the four types of replacement (cemented, cementless, hybrid and resurfacing); the reference prosthesis was the cemented hip procedure. Patient reported outcome scores (PROMs), costs and risk of repeat (revision) surgery were examined. Multivariable analyses included analysis of covariance to assess improvement in PROMs (Oxford hip score, OHS, and EQ5D index) (9159 linked episodes) and competing risks modelling of implant survival (79,775 procedures). Cost of implants and ancillary equipment were obtained from National Health Service procurement data. RESULTS: EQ5D score improvements (at 6 months) were similar for all hip replacement types. In females, revision risk was significantly higher in cementless hip prostheses (hazard ratio, HR = 2.22, p<0.001), when compared to the reference hip. Although improvement in OHS was statistically higher (22.1 versus 20.5, p<0.001) for cementless implants, this small difference is unlikely to be clinically important. In males, revision risk was significantly higher in cementless (HR = 1.95, p = 0.003) and resurfacing implants, HR = 3.46, p<0.001), with no differences in OHS. Material costs were lowest with the reference implant (cemented, range £1103 to £1524) and highest with cementless implants (£1928 to £4285). Limitations include the design of the study, which is intrinsically vulnerable to omitted variables, a paucity of long-term implant survival data (reflecting the duration of data collection), the possibility of revision under-reporting, response bias within PROMs data, and issues associated with current outcome scoring systems, which may not accurately reflect level of improvement in some patients. CONCLUSIONS: Cement fixation, using a polyethylene cup and a standard sized head offers good outcomes, with the lowest risks and at the lowest costs. The most commonly used cementless and resurfacing implants were associated with higher risk of revision and were more costly, while perceptions of improved function and longevity were unsupported.

Biocompatibility and enhanced osteogenic differentiation of human mesenchymal stem cells in response to surface engineered poly(D,L-lactic-co-glycolic acid) microparticles.

Tissue engineering strategies can be applied to enhancing osseous integration of soft tissue grafts during ligament reconstruction. Ligament rupture results in a hemarthrosis, an acute intra-articular bleed rich in osteogenic human mesenchymal stem cells (hMSCs). With the aim of identifying an appropriate biomaterial with which to combine hemarthrosis fluid-derived hMSCs (HF-hMSCs) for therapeutic application, this work has investigated the biocompatibility of microparticles manufactured from two forms of poly(D,L-lactic-co-glycolic acid) (PLGA), one synthesized with equal monomeric ratios of lactic acid to glycolic acid (PLGA 50:50) and the other with a higher proportion of lactic acid (PLGA 85:15) which confers a longer biodegradation time. The surfaces of both types of microparticles were functionalized by plasma polymerization with allylamine to increase hydrophilicity and promote cell attachment. HF-hMSCs attached to and spread along the surface of both forms of PLGA microparticle. The osteogenic response of HF-hMSCs was enhanced when cultured with PLGA compared with control cultures differentiated on tissue culture plastic and this was independent of the type of polymer used. We have demonstrated that surface engineered PLGA microparticles are an appropriate biomaterial for combining with HF-hMSCs and the selection of PLGA is relevant only when considering the biodegradation time for each biomedical application.

Oxidation and fusion defects synergistically accelerate polyethylene failure in knee replacement.

We have previously reported upon a cohort of patients with premature failure of such material and postulated upon the impact of abnormally high concentrations of type 2 fusion defects whereby there is a lack of particle cohesion due to incomplete diffusion. In vivo oxidation has been purported to underscore the premature failure of polyethylene. The mechanism of such remains poorly delineated. New data has now been obtained by determining substrata oxidative profiles of 10 failed Kinemax Plus modular tibial insert analyses in conjunction with fusion defect detection. The full thickness of a series of cores was analysed using infra-red spectroscopy to identify higher levels of oxidation in loaded used material at both the articulating and non-articulating regions. A comparison was made to an unused control. Articulating, loaded, areas exhibited greater local concentrations of oxidised material and wider variation of such consistent with the higher presence of fusion defects. Subsurface analysis confirmed the presence of a major oxidative peak 2mm below the surface for all loaded areas irrespective of wear. Additionally we were able to identify a second major oxidative focus about halfway between the inferior (tibial baseplate) surface and the articulating area. We believe that the combination of high oxidation and fusion defects represents a second high stress zone consistent with the observation of tibial baseplate polyethylene dissociation and backside wear with resultant catastrophic material failure.