Introduction: Excellent long-term survival has been reported for both the Taperloc and the Mallory-Head cementless stems. However, little is known about the migration behaviour of these stems which have different design rationales. The purpose of this randomised clinical trial was to compare the migration and clinical outcomes of these stems during 5 years of follow-up. Methods: 42 consecutive hips in 38 patients scheduled to receive cementless THA were randomised to either a Taperloc or a Mallory-Head stem. Evaluation took place preoperatively and postoperatively on the second day, at 6, 12, 26, and 52 weeks, and annually thereafter. Primary outcome was stem migration measured using roentgen stereophotogrammetric analysis (RSA) and secondary outcomes were the Harris Hip Score (HHS) and 36-Item Short-Form Health Survey (SF-36). No patients were lost to follow-up; in 1 patient the THA was removed due to deep infection 3 months postoperatively. In 6 hips migration measurements were not possible due to insufficient marker configuration. Results: Throughout the follow-up period of 5 years, 3-dimensional migration was comparable between the Taperloc and the Mallory-Head stems (p-values > 0.05). However, at the 5-year follow-up point the retroversion of the Mallory-Head stem was 0.9° more than the Taperloc stem (p = 0.04). Initial subsidence and retroversion were respectively as large as 6.8 mm and 3.6° for the Taperloc stem and 5 mm and 3.6° for the Mallory-Head stem. After the first postoperative year, both implants had stabilised. The mean increment of HHS, as well as the SF-36 scores during the 5-year follow-up, were comparable between the 2 stems. Conclusions: The excellent long-term survival of both designs was confirmed in this study showing comparable initial migration with subsequent stabilisation. However, the Taperloc design with a flat, wedged geometry showed better rotational stability.

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Background and purpose — Little is known about the long-term migration pattern of cementless stems in total hip arthroplasty (THA). Furthermore, the role of bioactive coatings in fixation, and thus migration, remains uncertain. Hydroxyapatite (HA) is the most commonly used bioactive coating. However, delamination of the coating might induce loosening. Alternatively, fluorapatite (FA) has proved to be more thermostable than HA, thereby potentially increasing longevity. We assessed the long-term migration of cementless stems with different coatings using radiostereometric analysis (RSA), thereby establishing a reference for acceptable migration. Patients and methods — 61 THAs in 53 patients were randomized to receive either a HA, FA, or uncoated Mallory-Head Porous stem during the years 1992 to 1994. Primary outcome was stem migration measured using RSA and secondary outcome was the Harris Hip Score (HHS). Evaluation took place preoperatively and postoperatively on the second day, at 6, 12, 25 and 52 weeks, and annually thereafter. At the 25-year follow-up, 12 patients (17 THAs) had died and 1 patient (1 THA) was lost to follow-up. Due to the high number of missing second-day postoperative RSA radiographs, the 1-year postoperative RSA radiograph was used as baseline for the comparative analyses. Results — Mean follow-up was 17 years (SD 6.6). All stems showed initial rapid migration with median subsidence of 0.2 mm (–0.1 to 0.6) and median retroversion of 0.9° (–3.2 to 2) at 12 months, followed by stable migration reaching a plateau phase. No stem was revised, albeit 1 stem showed continuous subsidence up to 1.5 mm. Comparing the different coatings, we could not find a statistically significant difference in overall 25-year migration (p-values > 0.05). Median subsidence at 15-year follow-up was for HA –0.1 mm (–0.4 to 0.2), for FA 0 mm (–0.1 to 0.2), and for uncoated stems 0.2 mm (–0.1 to 0.5). Median internal rotation at 15-year follow-up was for HA not available, for FA 1.1° (–0.5 to 2.6), and for uncoated stems 0° (–0.5 to 0.4). HHS were also comparable (p-values > 0.05), with at 15-year follow-up for HA 85 points (41–99), for FA 76 points (61–90), and for uncoated stems 79 points (74–90). Interpretation — The long-term migration pattern of cementless stems using different bioactive coatings has not previously been described. No beneficial effect, or side effect at long-term follow-up of bioactive coatings, was found. The provided migration data can be used in future research to establish thresholds for acceptable migration patterns cementless stem designs.

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Mechanical loosening of implants is in the majority accompanied with a periprosthetic interface membrane, which has to be removed during revision surgery. The same is true if a minimal invasive (percutaneous) refixation of a loose implant is done. We describe the requirements for a waterjet applicator for interface tissue removal for this percutaneous hip refixation technique. The technical requirements were either obtained from a literature review, a theoretical analysis, or by experimental setup. Based on the requirements, a waterjet applicator is designed which is basically a flexible tube (outer diameter 3 mm) with two channels. One channel for the water supply (diameter 0.9 mm) and one for suction to evacuate water and morcellated interface tissue from the periprosthetic cavity. The applicator has a rigid tip (length 6 mm), which directs the water flow to create two waterjets (diameter 0.2 mm), both focused into the suction channel. The functionality of this new applicator is demonstrated by testing a prototype of the applicator tip in an in vitro experimental setup. This testing has shown that the designed applicator for interface tissue removal will eliminate the risk of water pressure buildup; the ejected water was immediately evacuated from the periprosthetic cavity. Blocking of the suction opening was prevented because the jets cut through interface tissue that gets in front of the suction channel. Although further development of the water applicator is necessary, the presented design of the applicator is suitable for interface tissue removal in a minimally invasive hip refixation procedure.

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Background and purpose — Mobile-bearing total knee prostheses (TKPs) were developed in the 1970s in an attempt to increase function and improve implant longevity. However, modern fixed-bearing designs like the single-radius TKP may provide similar advantages. We compared tibial component migration measured with radiostereometric analysis (RSA) and clinical outcome of otherwise similarly designed cemented fixed-bearing and mobile-bearing single-radius TKPs. Patients and methods — RSA measurements and clinical scores were assessed in 46 randomized patients at baseline, 6 months, 1 year, and annually thereafter up to 6 years postoperatively. A linear mixed-effects model was used to analyze the repeated measurements. Results — Both groups showed comparable migration (p = 0.3), with a mean migration at 6-year follow-up of 0.90 mm (95% CI 0.49–1.41) for the fixed-bearing group compared with 1.22 mm (95% CI 0.75–1.80) for the mobile-bearing group. Clinical outcomes were similar between groups. 1 fixed-bearing knee was revised for aseptic loosening after 6 years and 2 knees (1 in each group) were revised for late infection. 2 knees (1 in each group) were suspected for loosening due to excessive migration. Another mobile-bearing knee was revised after an insert dislocation due to failure of the locking mechanism 6 weeks postoperatively, after which study inclusion was preliminary terminated. Interpretation — Fixed-bearing and mobile-bearing single-radius TKPs showed similar migration. The latter may, however, expose patients to more complex surgical techniques and risks such as insert dislocations inherent to this rotating-platform design.@en

Background Periprosthetic osteolysis is the most common long-term complication of a total joint arthroplasty, often resulting in aseptic loosening of the implant. As we aim at developing a safe and minimally invasive implant refixation procedure, thorough characterisation of the properties of the periprosthetic tissue is needed. Methods In this pilot study, the periprosthetic tissue of eleven patients undergoing hip revision surgery due to aseptic loosening was obtained. Histology, confocal microscopy, atomic force microscopy (AFM) and nanoindentation were performed to structurally and mechanically characterise the tissue. The study was approved by the Medical Ethical Committee of the Leiden University Medical Center. Results Using a Sirius Red staining and Movat staining, samples were shown to contain collagen fibers and a ground substance consisting of glycosoaminoglycans and mucopolysaccharides. However, the relative proportions of these tissue components differed between as well as within samples. Confocal microscopy revealed differences in collagen fiber orientation and thickness between tissues. Certain samples showed increased collagen staining intensity as well as increased fiber directionality, indicating higher degrees of tissue maturation. Using AFM and nanoindentation, the Young's modulus of the tissue was determined, which is a measure of tissue stiffness. The ranges of Young's moduli observed (generally 0–250 kPa) were relatively low when compared to other collagen-rich soft tissues (e.g. 500 kPa in skin and even 25 MPa in pericardium). Since the periprosthetic tissue develops at a site of friction, cells at the bone-implant interface seem not able to produce a matrix with optimal strength and properties. Conclusions This study provides new insights on the structural organization and mechanical properties of the periprosthetic tissue. Large inter-patient as well as intra-patient variations in tissue characteristics at all levels studied were observed, which strengthens the need for further research and underscores the need for tailored solutions in the field of treating aseptic loosening.@en

During the process of aseptic loosening of prostheses, particulate wear debris induces a continuous inflammatory-like response resulting in the formation of a layer of fibrous peri-prosthetic tissue at the bone-prosthesis interface. The current treatment for loosening is revision surgery which is associated with a high-morbidity rate, especially in old patients. Therefore, less invasive alternatives are necessary. One approach could be to re-establish osseointegration of the prosthesis by inducing osteoblast differentiation in the peri-prosthetic tissue. Therefore, the aim of this study was to investigate the capacity of peri-prosthetic tissue cells to differentiate into the osteoblast lineage. Cells isolated from peri-prosthetic tissue samples (n = 22)−obtained during revision surgeries−were cultured under normal and several osteogenic culture conditions. Osteogenic differentiation was assessed by measurement of Alkaline Phosphatse (ALP), mineralization of the matrix and expression of several osteogenic genes. Cells cultured in osteogenic medium showed a significant increase in ALP staining (p = 0.024), mineralization of the matrix (p < 0.001) and ALP gene expression (p = 0.014) compared to normal culture medium. Addition of bone morphogenetic proteins (BMPs), a specific GSK3β inhibitor (GIN) or a combination of BMP and GIN to osteogenic medium could not increase ALP staining, mineralization, and ALP gene expression. In one donor, addition of GIN was required to induce mineralization of the matrix. Overall, we observed a high-inter-donor variability in response to osteogenic stimuli. In conclusion, peri-prosthetic tissue cells, cultured under osteogenic conditions, can produce alkaline phosphatase and mineralized matrix, and therefore show characteristics of differentiation into the osteoblastic lineage.@en

Background and purpose — Stability and survival of cemented total hip prostheses is dependent on a multitude of factors, including the type of cement that is used. Bone cements vary in viscosity, from low to medium and high. There have been few clinical RSA studies comparing the performance of low- and high-viscosity bone cements. We compared the migration behavior of the Stanmore hip stem cemented using novel low-viscosity Palamed bone cement with that of the same stem cemented with conventional high-viscosity Palacos bone cement. Patients and methods — We performed a randomized controlled study involving 39 patients (40 hips) undergoing primary total hip replacement for primary or secondary osteoarthritis. 22 patients (22 hips) were randomized to Palacos and 17 patients (18 hips) were randomized to Palamed. Migration was determined by RSA. Results — None of these 40 hips had been revised at the 10-year follow-up mark. To our knowledge, the patients who died before they reached the 10-year endpoint still had the implant in situ. No statistically significant or clinically significant differences were found between the 2 groups for mean translations, rotations, and maximum total-point motion (MTPM). Interpretation — We found similar migration of the Stanmore stem in the high-viscosity Palacos cement group and the low-viscosity Palamed cement group. We therefore expect that the risk of aseptic loosening with the new Palamed cement would be comparable to that with the conventional Palacos cement. The choice of which type of bone cement to use is therefore up to the surgeon’s preference.

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Very little is known about the structure and properties of peri-prosthetic fibrous tissue that is found around loose orthopaedic implants. We describe a method for characterizing the structural organisation (histology, confocal microscopy) as well as the nano- and micro-scale mechanical behaviour (atomic force microscopy, nanoindentation) of peri-prosthetic fibrous tissue. The tissue was collected from 11 patients undergoing revision surgery due to aseptic loosening. Sirius Red and Movat histological staining procedures indicated that the tissue mainly consists of collagen fibres and ground substance. However, large inter- and intra-patient variations in the relative proportions of these tissue components were found, as well as in collagen fibre orientation and possibly also maturation. The nano-scale Young's moduli ranged from 0-950 kPa, but showed large inter-patient variability. When the results per sample were presented in a probability density function, we could roughly discriminate one peak in the 0-100 kPa range and/or one peak in the 100-500 Pa range. These nano-scale moduli seem to respectively present the mechanical properties of glycosaminoglycan (GAG) and collagen molecules. The majority of the micro-scale Young's moduli ranged between 0.5 and 2.0 kPa for all samples. This explorative study provides new insights in (the variations of) structural organisation and mechanical properties of peri-prosthetic tissue.

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