The Avantage ® dual mobility cup in primary total hip arthroplasty: A registry study.

Background: Avantage Cup has been widely used in dual mobility implants. However, in Swedish Registry, the outcome of the Avantage Cup is reported with higher implants revision compared to control. The aim of our study was to verify if the same results are present in the Registry of Prosthetic Orthopedic Implants (RIPO) of Emilia Romagna (ER, Italy), as the Avantage cup was the most implanted dual mobility cup for a long follow-up reported in this Registry (2000-2012). Furthermore, we assessed the survival rate of the implant over the time. Methods: We included all patients that underwent a primary THA using the Avantage cup during the period 2000-2020 in RIPO Registry. The survivorship of the primary THA implants was calculated and plotted according to Kaplan-Meier method. Results: 886 Avantage cups were included in the analysis. During the observational period 44 hips were revised. The most common reasons for revision were: periprosthetic fractures (PPF) (n = 7, 0.8 %), deep infection (n = 7, 0.8 %), and cup aseptic loosening (n = 13, 1.5 %).The survival rate of the implant was 96.8 % (95.3-97.8) at 5 years, 95.7 at 10 years (94.0-97.0) and 92.1 at 15 years (88.5-94.6). Conclusion: In conclusion, this study has demonstrated that the Avantage cup in primary hip arthroplasty implanted with a "friendly" femoral stem granted satisfactory long-term survival. Therefore, in the Swedish Registry, the cause of the poor results presented for Avantage Cup could be the thick, rough neck stem of the widely used Lubinus stem.

Constraint degree in revision total knee replacement: a registry study on 1432 patients.

PURPOSE: Total knee replacement (TKR) failure represents a hard challenge for knee surgeons. TKR failure can be managed in revision with different constraint, related with soft and bone knee damages. The choice of the right constraint for every failure cause represents a not summarized entity. The purpose of this study is identifying distribution of different constraints in revision TKR (rTKR) for failure cause and the overall survival. METHODS: A registry study based on the Emilia Romagna Register of the Orthopaedic Prosthetic Implants (called RIPO) was performed with a selection of 1432 implants, in the period between 2000 and 2019. Selection implants including primary surgery constraint, failure cause and constraint revision for every patient, and divided for constraint degrees used during procedures (Cruciate Retaining-CR, Posterior Stabilized-PS, Condylar Constrained Knee-CCK, Hinged). RESULTS: The most common cause of primary TKR failure was aseptic loosening (51,45%), followed by septic loosening (29,12%). Each type of failure was managed with different constraint, the most used was CCK in the most of failure causes, such as to manage aseptic and septic loosening in CR and PS failure. Overall survival of TKA revisions has been calculated at 5 and 10 years for each constraint, with a range of 75.1-90.0% at 5 years and 75.1-87.5% at 10 years. CONCLUSION: Constraint degree in rTKR is typically higher than primary, CCK is the most used constraint in revision surgery with an overall survival of 87.5% at 10 years.

Unicompartmental knee arthroplasty has higher revisions than total knee arthroplasty at long term follow-up: a registry study on 6453 prostheses.

PURPOSE: The purpose of this study is to analyse long-term unicompartmental knee arthroplasty (UKA) focusing on survivorship, causes of failure and revision strategy. METHODS: This study is a retrospective analysis of data from a regional arthroplasty registry for cases performed between 2000 and 2017. A total of 6453 UKAs were identified and the following information was analysed: demographic data, diagnosis leading to primary implant, survivorship, complication rate, causes of failure, revision strategies. UKA registry data were compared with total knee arthroplasty (TKA) registry data of 54,012 prostheses, which were implanted in the same time period. RESULTS: 6453 UKAs were included in the study: the vast majority of them (84.4%) were implanted due to primary osteoarthritis followed by deformity (7.1%) and necrosis of the condyle (5.1%). When compared to TKA, UKA showed lower perioperative complication rate (0.3% compared to 0.6%) but higher revision rate (18.2% at 15 years, compared to 6.2% for TKA). No correlation was found between diagnosis leading to primary implant and prosthesis survival. The most frequent cause of failure was total aseptic loosening (37.4%), followed by pain without loosening (19.8%). Of the 620 UKAs requiring revision, 485 were revised with a TKA and 61 of them required a re-revision; on the other hand, of the 35 cases where another UKA was implanted, 16 required a re-revision. CONCLUSION: UKA is associated with fewer perioperative complications but higher revision rates when compared to TKA. Its survivorship is not affected by the diagnosis leading to primary implant. Revision surgery of a failed UKA should be performed implanting a TKA, which is associated with a lower re-revision rate when compared to another UKA. LEVEL OF EVIDENCE: Level 3, therapeutic study.

The biological acetabular reconstruction with bone allografts in hip revision arthroplasty.

BACKGROUND: Reconstructions in case of acetabular bone loss in hip revision arthroplasty are challenging. A few techniques have been proposed, with inconstant outcomes. Biological reconstructions using bone allografts may address the acetabular bone loss and restore the hip anatomy. Aim of this work was the description of the surgical technique and the evaluation of the outcomes using a regional arthroplasty register. MATERIALS AND METHODS: Minor or massive bone allografting was performed in hip revision arthroplasties in a tertiary center. Bulk allografts were used in severe acetabular bone losses. Fresh-frozen femoral heads were impacted in the bone cavity and porous cups were implanted; multihole sockets were used when necessary. In DeLee A zone, no grafts were used in order to reduce overstress graft resorption. The results were evaluated using a regional arthroplasty register, and a comparison with revisions without bone grafts was performed investigating re-revision rates and reasons for further revisions. RESULTS: At 10 years, acetabular revisions with bone allografts achieved a similar survival rate than revisions without bone grafts. The re-revisions occurred more frequently in revisions without bone allografts (10.8 vs. 9.7%). In the allograft cohort, septic loosening was lower (0.3 vs. 2.6%), whereas a higher rate of aseptic cup loosening was experienced (2.7 vs. 1.4%). CONCLUSIONS: Bone allografts may provide a good restoration of the acetabular bone stock and the hip biomechanics. Septic loosening does not seems a major concern, whereas a higher rate of aseptic cup loosening should be expected when bone grafts are used.

The experience of the RIPO, a shoulder prosthesis registry with 6-year follow-up.

BACKGROUND: Implant registries have proved valuable in assessing the outcomes of arthroplasty procedures. Moreover, by identifying lesser quality implants they have indirectly improved the quality of care. The registry of prosthetic shoulder implants was established in 2008. METHODS: It records information on all types of primary and revision arthroplasty procedures involving the glenohumeral joint, including reverse and total arthroplasty, hemiarthroplasty, resurfacing, removal, and any other surgical procedures that are required to manage these patients. The collected data include patient demographics, weight, height, operated side, cuff status, and diagnosis/reason for revision surgery, information on previous surgical procedures involving either shoulder, comorbidities, antibiotic and thromboembolic prophylaxis, blood transfusions, surgical approach, cuff repair procedures performed during arthroplasty, bone grafts, drains, and perioperative complications, and data about the prosthetic components implanted, including the fixation method. RESULTS: Procedures were performed on 3754 shoulders. They included 2226 RSA, 320 TSA, 730 HA, 233 resurfacing procedures, 245 revisions, and 77 "other" procedures. The survival curves of the implants are greater than 90%, and no differences were found among prosthesis from different manufacturers. The diagnosis that prompted to arthroplasty was: osteoarthritis in 60.9% of cases and fractures, bone necrosis, sequelae of fracture and rotator cuff tear arthropathy for the rest of implants. DISCUSSION AND CONCLUSION: This study describes the epidemiological data and mid-term implant outcomes of the shoulder arthroplasty procedures performed in our region, from 2008 to 2014, and compares them with published data from national registries of similar size. LEVEL OF EVIDENCE: III.

Vanadium release in whole blood, serum and urine of patients implanted with a titanium alloy hip prosthesis.

INTRODUCTION: Vanadium (V) is a minor constituent of the Titanium-Aluminum-Vanadium (TiAlV) alloy currently used in cementless hip prostheses. Present study aimed at verifying the correlation of vanadium levels among different matrices and assessing reference levels of the ion in a population of patients wearing a well-functioning hip prosthesis. METHODS: Vanadium was measured using Inductive Coupled Plasma Mass Spectrometry (ICP-MS) in whole blood, serum and urine of 129 patients implanted with a TiAlV-alloy hip prosthesis. RESULTS: The values in the serum were above the upper limit of the reference values in 42% of patients (29% in urine and 13% in whole blood). A good correlation among matrices was observed (p < 0.001). The cohort of patients (N = 32) complaining of pain or in which a loosening or damage to the prosthesis was assessed showed a significantly higher excretion of vanadium in urine as compared with the remaining asymptomatic patients (p = 0.001). The 95th percentile distribution of vanadium in the cohort of patients with a well-functioning prosthesis was 0.3 µg/L in whole blood, 0.5 µg/L in serum and 2.8 µg/L in urine, higher that in the unexposed population, especially for urine. CONCLUSIONS: The presence of a prosthesis, even though well-functioning, may cause a possible release of vanadium into the blood and a significant urinary excretion. The reference values of vanadium of the asymptomatic patients with titanium alloy hip prostheses supplied information regarding the background exposure level of the ions and their lower and upper limits.

First hip arthroplasty register in Italy: 55,000 cases and 7 year follow-up.

The Register for Orthopaedic Prosthetic Implantation (RIPO) has been prospectively collecting data on hip prostheses performed in all the orthopaedic units in the region Emilia-Romagna since January 2000. The register aims to determine the characteristics of patients, evaluate the effectiveness of prostheses, and allow internal audit. Adherence to the register is compulsory (93% capture). By 31 December 2006 the register contained data on 35,041 primary total hip arthroplasty (THA), 14,613 hemiarthoplasties, and 5,878 revisions. All prosthetic components are registered on an individual basis. Survival analysis is done following the Kaplan Meier method. Cumulative survival rate at 7 years is 96.8% (95% CI: 96.4-97.1%) for THA and 97.6% (97.0-98.3%) for hemiarthroplasties. Multivariate analysis verified that survival of the THA is affected by pathology, where the worst conditions are rheumatoid arthritis, femoral neck fracture, and sequelae of coxitis or Paget's disease. Results are comparable to other major registers of Northern Europe and Australia.

Preclinical assessment of the long-term endurance of cemented hip stems. Part 2: in-vitro and ex-vivo fatigue damage of the cement mantle.

Fatigue damage in the cement mantle surrounding hip stems has been studied in the past. However, so far no quantitative method has been validated for assessing ex-vivo damage and for predicting the in-vitro risk of cement fracture. This work presents a method for measuring cement damage; the cement mantle was sliced and sections were inspected with dye penetrants and an optical microscope. Cracks were counted, measured, and classified by type in each region of the cement mantle. Statistical indicators (in total and per unit volume of cement) were proposed that allow quantitative comparison. The method was first validated on two implant types with known clinical success rate, which were tested in vitro using a physiological loading profile (described in Part 1 of this work). The most relevant indicators were able to detect statistical differences between the two designs. Retrieved cement mantles (the same design as one of the in-vitro stems) from revision surgery were also processed with the same inspection method. Excellent qualitative and quantitative agreement was found between the in-vitro generated fatigue damage and the cracking pattern found in the ex-vivo retrieved cement mantles. This demonstrated the effectiveness of the cement inspection protocol and provided a further validation to the in-vitro testing method.

MicroCT examination of human bone specimens: effects of polymethylmethacrylate embedding on structural parameters.

X-ray microtomography permits the nondestructive investigation of trabecular and cortical bone specimens without special preparation of the sample. To do a quantitative characterization, the cross-section images have to be binarized, separating bone from nonbone. For this purpose, a widely used method is uniform thresholding. However, for commonly available microtomography scanners which use a polychromatic X-ray source, it is unclear what effect the surrounding medium (e.g. air, saline solution, polymethylmethacrylate) has on the threshold value used for the binarization. In the literature an easy procedure to find the optimal uniform threshold value for a given acquisition condition is reported. By applying this procedure, the present work investigated whether a microtomography scan of trabecular bone samples in air or embedded in polymethylmethacrylate gave the same results in terms of structural parameters. The gold standard, that is, histological sections, was used as a reference. Two fixed threshold values were found, one for the microtomography scans performed in air and one for the scans with the same samples embedded in polymethylmethacrylate. These were applied on the correspondent microtomography images for the estimation of structural parameters, such as bone volume fraction, direct trabecular thickness, direct trabecular separation and structure model index. Paired comparisons were made in bone volume fraction between histological sections and microtomography cross-sections for the same bone samples scanned first in air and then embedded in polymethylmethacrylate, by which no significant differences were found. Paired comparisons were also made in bone volume fraction, direct trabecular thickness, direct trabecular separation and structure model index for the same samples over volumes of interest of 4 x 4 x 4 mm3 between microtomography scans in air and scans with the samples embedded in polymethylmethacrylate. Neither these comparisons showed significant differences. This leads to the conclusion that structural parameters estimated by microtomography for human trabecular bone samples scanned either in air or embedded in polymethylmethacrylate are not affected by the surrounding medium (i.e. presence or absence of polymethylmethacrylate), provided that the corresponding optimal threshold value is applied for each acquisition condition.

A case report of fracture of ceramic head in total hip arthroplasty: histological and biochemical features of perimplant tissues.

The authors analyzed the case of a patient with a non-cemented hip prosthesis with a ceramic-ceramic coupling. As a consequence of trauma the head fractured. Although the patient could feel the joint grinding, there was no pain and he continued daily living activities for nearly six months, which led to marked wearing of the ceramic head. SEM analysis with microprobe showed 'planed' surfaces on the ceramic head, suggesting repeated movements between the fractured components. Inside the cone of the head, signs of TiAlV, which is an alloy of the prosthetic stem, could be seen. Periprosthetic tissues were packed with ceramic wear particles of sizes ranging between 0.2 and 10 microns, according to the harvest site. Metal and mixed particles were also found. IL1, IL6, IL8 and IL10 assays in the synovial liquid confirmed the inflammatory state and a modest induction of bone resorption, which was less than that observed in patients with loosened metal-polyethylene couplings. The humoral picture was compatible with the radiological aspect, which did not show marked signs of bone resorption. In revision surgery both ceramic components were replaced by a metal head and polyethylene liner. The clinical outcome after 12 months was very good.

Behavior of Hylamer polyethylene in hip arthroplasty: comparison of two gamma sterilization techniques.

Hylamer polyethylene was introduced in the 1990s as an alternative to conventional polyethylene. Its chemical and physical properties, and especially its high crystallinity, were claimed to improve resistance to wear. Initially Hylamer devices were sterilized by gamma radiation in air, then the technique was changed and gamma radiation was performed in the absence of oxygen. Clinical experience has shown the early loosening of some devices made from Hylamer. The aim of this study was to ascertain whether early wear and consequent osteolysis was linked to the sterilization method. We retrospectively compared 31 patients with hip prostheses with Hylamer liners sterilized by gamma radiation in air (group 1) with 30 patients with the same prosthesis, but sterilized in the absence of oxygen (group 2). The groups were similar for sex, age, disease, head diameter and material. Mean follow-up was 84 months and no clinical signs of failure were present. Radiographic measurement revealed that wear of group 1 was significantly greater than that of group 2 (0.23 mm/year vs 0.09 mm/year, p=0.001). Periacetabular and femoral osteolysis in group 1 was significantly greater than group 2. In conclusion, the method of sterilization might have influenced the outcome of Hylamer polyethylene liners.

Effects of the sterilisation method on the wear of UHMWPE acetabular cups tested in a hip joint simulator.

Ultra-high molecular-weight-polyethylene is the most commonly used bearing material in total joint replacement. Wear of polyethylene is a Serious Clinical problem that limits the longevity of orthopaedic implants. Information on degradative changes in the material properties and on the methods used for the sterilisation of polyethylene may help in the selection process of orthopaedic implants with the best wear resistance. This study was performed to investigate the effects of the sterilisation method (gamma irradiation and ethylene oxide treatment) on the wear and on the changes in physical properties of polyethylene acetabular cups. At this purpose, gamma-sterilised and ethylene oxide (EtO)-sterilised acetabular cups were tested against CoCr femoral heads in a hip joint simulator run for 5 million cycles in bovine calf serum. The crystallinity of the cups was evaluated by micro-Raman spectroscopy as a function of the inner surface position. The partial least square calibration was used to correlate the Raman spectra with the crystallinity of the polymer measured by differential scanning calorimetry. The analysis performed on soak control acetabular cups demonstrated that the gamma-sterilised cups are significantly more crystalline than the EtO-sterilised ones. The mean crystallinity values obtained for the gamma-sterilised and EtO-sterilised soak control cups were 65.0% and 63.4%, respectively. Weight loss measurements revealed that the gamma-sterilised acetabular cups exhibited a lower wear rate than that by EtO-sterilised. Thc Raman results obtained on gamma-sterilised and EtO-sterilised acetabular cups showed that the changes in surface crystallinity were mainly caused by irradiation rather than by the mechanical friction during the in vitro tests.

Statistical analysis in hip prosthesis evaluation.

None.

The use of extra-long stems in total hip reimplantation.

The authors report their experience in the use of extra-long stems for total hip reimplantations, and they then compare them with the results obtained when short or standard stems were used. The use of the extra-long stem is reserved for special cases, such as those where there is osteolysis extending to the proximal femur and diaphysis, distal diaphyseal fractures, and when the trans-femoral technique is used to remove the stem. A total of 246 prosthetic stem reimplantations were carried out between 1985 and 1999, and in most of the cases (86.2%) the cause of reimplantation was aseptic loosening of the stem alone or of both prosthetic components, while in the remaining cases it involved the sequelae of endoprosthesis or cotyloiditis (8.5%), the sequelae of septic explantation (2.1%), breakage of the prosthetic head and cone wear (1.2%), breakage of the prosthetic stem (0.8%), fracture of the femoral diaphysis on a loosened cemented prosthesis (0.4%), breakage of the prosthetic neck (0.4%), dislocation of the prosthesis (0.4%). A stem equal to or longer than 22 cm had to be used in 13 cases (5.3%), while a short stem (12-13 cm) or a standard stem (17-18 cm) was sufficient in the remaining 233 cases. The results were worse for the extra-long stem group as compared to those for the short/standard group; that is, there was 1 case (7.7%) of septic loosening that resulted in explantation, as compared to 2.6% (6 cases) of explantation resulting from aseptic loosening (3 cases) or septic loosening (3 cases) of the short/standard group. As concerns radiographic assessment, extra-long stems show bone stability in 69.2% of cases, fibrous in 23.1%, and loosened in 7.7%, while 97.7% of short/standard stems show bone stability, 0.9% fibrous stability, 1.4% instability.

Fluid absorption study in ultra-high molecular weight polyethylene (UHMWPE) sterilized and unsterilized acetabular cups.

The weight gain due to fluid absorption was measured in gamma-sterilized, ethylene oxide (ETO) gas-sterilized, and unsterilized ultra-high molecular weight (UHMW) polyethylene acetabular cups. After about 2 months the total average fluid absorption gain of the polyethylene cups was: 1.76 +/- 0.45 mg (average +/- standard deviation) for the unsterilized polyethylene cups, 2.81 +/- 0.95 mg for the gamma-sterilized polyethylene cups and 1.51 +/- 0.34 for the ETO gas-sterilized polyethylene cups. There was little difference in fluid absorption between the sterilized and unsterilized specimens. In particular, the gamma-sterilized acetabular cups absorbed more than the ETO gas-sterilized and the unsterilized cups. However, the weight gain was higher in serum compared with that in water.