Since 2000, the Register of Prosthetic Orthopedic Implants (RIPO) has been following all hip, kne... more Since 2000, the Register of Prosthetic Orthopedic Implants (RIPO) has been following all hip, knee, and shoulder arthroplasties in the Emilia-Romagna region, comprising 4.5 million inhabitants, in northern Italy. The aim of the present analysis was to present the main figures of unicompartmental knee implants processed from the Registry. During the period 2000-2011, 3929 unicompartmental knee arthroplasties were performed on 3645 resident patients, of which 71% were females. The medial condyle was treated in 94% of cases, where mean age at surgery was 67.3 years and mean body weight was 76.6 kg. The main outcome measure was time to revision of at least one single component. The Kaplan-Meier survival and Cox multivariate analyses have been applied. At 10-year follow-up, the percentage of survival was 86.8% (confidence interval (CI) at 95% was 84.1-89.5); total aseptic loosening represented 42% of the causes of failure, pain represented 15%, and sepsis represented 11%. Age at surgery significantly influences the survival of the prosthesis, whatever the reason for revision, while the type of tibial component (monoblock or metal tray) does not appear to be a determinant. Septic failure is not prevented by the use of antibiotic-loaded cement. Results are comparable to main orthopedic registries from Scandinavia, Australia, and New Zealand, even if some differences can be highlighted.
Journal of Bone and Joint Surgery-british Volume, 2016
The RIPO register collects data of all primary and revision hip replacement surgeries performed i... more The RIPO register collects data of all primary and revision hip replacement surgeries performed in Region Emilia-Romagna, Italy since 1stJanuary 2000. The present study is aimed to analyze the survival rate of patients with Biolox®delta and Biolox®forte components, (CeramTec, Plochingen Germany) considering possible confounding factors. Only patients living in the region are considered in analysis, to avoid the bias resulting from the ‘loss’ of non-resident patients. The analysis has been conducted only on uncemented THA and monoblock, double mobility cups as well as such with pre-assembled inserts were excluded. Therefore, the finally analyzed database consists of 30’617 cases; 13’323 Biolox®forte and 17’294 Biolox®delta heads, articulating against ceramic or PE. Unadjusted survival analysis was calculated according to Kaplan Meier method; with prosthesis failure as end point, defined as the revision of any prosthetic component for any cause. To avoid a possible bias, revision of t...
In order to evaluate in vitro the suitability of various prosthetic materials for endothelial see... more In order to evaluate in vitro the suitability of various prosthetic materials for endothelial seeding, human endothelial cells derived from the umbilical vein were placed in direct contact with a variety of polymers. As a control, endothelial cells were cultured in the absence of material. After 24, 48, 72 and 96 hours, the cells were counted and a viability test with neutral red was performed. Assays of 6-keto prostaglandinFla (6-keto-PGF1a), tissue plasminogen activator (tPA) and plasminogen activator inhibitor 1 (PAI-1) were carried out on the supernatants. The cell counting technique demonstrated growth inhibition in the cell populations in contact with Woven Dacron® and Double Velour Dacron® in comparison with control cell cultures. Vital staining with neutral red, always sharply positive in the controls, was weak in the cells placed in contact with the materials. The 6-keto-PGF1a concentration in the supernatant was similar to the control level in the populations in contact wi...
Orthopaedics & Traumatology: Surgery & Research, 2019
BACKGROUND Body mass index is used by the World Health Organization to classify obesity. While ob... more BACKGROUND Body mass index is used by the World Health Organization to classify obesity. While obesity influences the onset of arthritis and type-2 diabetes, its effect on implant survival is still open to debate, with conflicting results from clinical and registry studies, as well as meta-analyses. Other known factors such as gender or diabetes status could ponderate or mask the effect of BMI on implant survival. HYPOTHESIS Our hypothesis was BMI influenced hip and knee arthroplasty survival, when results were made independent of gender and diabetes status. PATIENT AND METHODS A registry study was designed on 30733 Total Hip Arthroplasties (THA), 28483 Total Knee Arthroplasties (TKA), 3754 Uni compartmental Knee Arthroplasties (UKA) and 649 Hinged Knee arthroplasties (HK), from 01/01/2003 to 31/12/2015. Mean follow-up was 5.5 years. Diabetes status was added to the model. Each arthroplasty survival was tested for age at implantation, gender, diabetes status, implant characteristics and specifically BMI, taking into account gender and diabetes status. RESULTS Gender had a strong influence on arthroplasty results. Age also influenced arthroplasty survival, especially aseptic loosening; a young age would lower implant survival. Diabetes had an influence in hip survival, but its influence on septic loosenings in TKA wasn't proven (p=0.065). A mobile liner and/or a cruciate retaining knee were factors increasing the risk of revision. Weight influenced THA survival, especially aseptic loosening, but didn't have a measurable effect in any other arthroplasty. BMI was not found to influence any arthroplasty survival, whatever the endpoint, when diabetes and gender were taken into account. DISCUSSION Gender, age and diabetes influenced survival of the lower limb arthroplasties, whereas BMI did not. Only weight did influence THA results and should be used instead of BMI. CONCLUSION Studies on arthroplasty survival should systematically mention gender and diabetes status and beware of potential group incomparability. LEVEL OF EVIDENCE III, cohort study.
Introduction:Noise in ceramic-on-ceramic (CoC) total hip arthroplasty (THA) is a potential sympto... more Introduction:Noise in ceramic-on-ceramic (CoC) total hip arthroplasty (THA) is a potential symptom of abnormal bearing wear. Squeaking and other prosthetic hip noises are multi-factorial phenomena that can be analysed and may provide prognostic information.Methods:46 patients with noisy CoC bearings were investigated using X-ray, computed tomography and joint fluid analysis, and classified into either high or low risk of ceramic liner fracture groups according to previously published guidelines. Noise events from the bearings of 16 high risk cases which were subsequently revised were compared with 30 patients in the low risk control group who did not undergo revision. Noise events were analysed for their physical characteristics using a standardised protocol and classified as either low frequency and short duration ‘clicking’ or long duration and high frequency ‘squeaking’.Results:The peak frequency of squeaking during forward walking was significantly higher for patients in the cas...
BACKGROUND Ischemia-modified albumin (IMA) derives from naive albumin, modified in the binding re... more BACKGROUND Ischemia-modified albumin (IMA) derives from naive albumin, modified in the binding region of bivalent ions, as cobalt and iron. The cobalt, released from some types of hip prosthesis seems to be metabolized differently in males and females but the iron ion is more prevalent than cobalt and is detectable in the healthy population. Our aim was to verify if there are any gender- and age-related differences in IMA concentrations and if IMA correlates with cobalt and iron-related proteins. METHODS IMA, albumin, iron, ferritin, transferrin, and cobalt were measured in 50 men and 50 women divided into two age/fertility-homogeneous groups. RESULTS Men < 45-years-old showed a statistically significant lower IMA concentration than men ≥ 45 and fertile and menopausal women. Considering all the population studied, IMA does not seem to be correlated with age and is distributed differently by gender; also, Co distribution was different between males and females. CONCLUSIONS IMA did not correlate with cobalt, iron, ferritin, and transferrin in any group, except for fertile women where IMA presented a statistically significant correlation with serum iron values. Minor expression of IMA in young males together with the results obtained on serum iron in fertile females, could explain the higher accumulation of circulating Co in women compared to men and their different cobalt metabolism.
The International Journal of Artificial Organs, 2006
The authors analyzed the case of a patient with a non-cemented hip prosthesis with a ceramic-cera... more 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 pi...
The International Journal of Artificial Organs, 1998
One-hundred-eighty cylindrical monocortical titanium implants, 4mm diameter and 12mm long, with t... more One-hundred-eighty cylindrical monocortical titanium implants, 4mm diameter and 12mm long, with three different coatings: fluorohydroxyapatite (group A), hydroxyapatite (group B), and titanium oxide (group C), all applied by vacuum plasma spray were bilaterally, randomly implanted into the femurs and tibiae of twelve adult mongrel sheep. The sheep were divided into four groups (1, 2, 3 and 4) numbering three sheep each. Sheep of groups 1, 2, 3 and 4 were euthanized at two weeks, one month, three and nine months after implantation, respectively. Biomechanical and histomorphological analysis were performed. Extraction torque increased over time in all groups until the nine months period. At all the studied periods, the bone-implant contact was higher in Groups A and B compared to Group C. However, only at nine months did this difference reach statistical significance (p<0.005 comparing Groups A and B to C). The results of this study show that all the three coatings could be recomme...
Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine, 2009
Modification of knee joint wear simulation methods has included ‘anatomic attachment’ of unicondy... more Modification of knee joint wear simulation methods has included ‘anatomic attachment’ of unicondylar knee replacements (UKR) onto synthetic femurs with material properties and morphology similar to human femurs. The present study assesses the effect of such modification by comparing the damage patterns on UKR polyethylene inserts after in vitro simulation using standard and modified simulation methods with those on inserts retrieved after in vivo function. Three groups of UKR inserts were evaluated after retrieval (Explant Group, n = 17) or after knee joint wear simulation with the components attached to standard metal blocks (Standard Group, n = 6) or synthetic femurs (Anatomic Group, n = 6). All UKR had similar non-conforming articular surfaces. Articular damage patterns (mode, frequency, and area) were quantified using digital image photogrammetry. Although some common damage modes were noted, knee joint wear simulation with standard or ‘anatomic’ attachment did not generate dama...
Since 2000, the Register of Prosthetic Orthopedic Implants (RIPO) has been following all hip, kne... more Since 2000, the Register of Prosthetic Orthopedic Implants (RIPO) has been following all hip, knee, and shoulder arthroplasties in the Emilia-Romagna region, comprising 4.5 million inhabitants, in northern Italy. The aim of the present analysis was to present the main figures of unicompartmental knee implants processed from the Registry. During the period 2000-2011, 3929 unicompartmental knee arthroplasties were performed on 3645 resident patients, of which 71% were females. The medial condyle was treated in 94% of cases, where mean age at surgery was 67.3 years and mean body weight was 76.6 kg. The main outcome measure was time to revision of at least one single component. The Kaplan-Meier survival and Cox multivariate analyses have been applied. At 10-year follow-up, the percentage of survival was 86.8% (confidence interval (CI) at 95% was 84.1-89.5); total aseptic loosening represented 42% of the causes of failure, pain represented 15%, and sepsis represented 11%. Age at surgery significantly influences the survival of the prosthesis, whatever the reason for revision, while the type of tibial component (monoblock or metal tray) does not appear to be a determinant. Septic failure is not prevented by the use of antibiotic-loaded cement. Results are comparable to main orthopedic registries from Scandinavia, Australia, and New Zealand, even if some differences can be highlighted.
Journal of Bone and Joint Surgery-british Volume, 2016
The RIPO register collects data of all primary and revision hip replacement surgeries performed i... more The RIPO register collects data of all primary and revision hip replacement surgeries performed in Region Emilia-Romagna, Italy since 1stJanuary 2000. The present study is aimed to analyze the survival rate of patients with Biolox®delta and Biolox®forte components, (CeramTec, Plochingen Germany) considering possible confounding factors. Only patients living in the region are considered in analysis, to avoid the bias resulting from the ‘loss’ of non-resident patients. The analysis has been conducted only on uncemented THA and monoblock, double mobility cups as well as such with pre-assembled inserts were excluded. Therefore, the finally analyzed database consists of 30’617 cases; 13’323 Biolox®forte and 17’294 Biolox®delta heads, articulating against ceramic or PE. Unadjusted survival analysis was calculated according to Kaplan Meier method; with prosthesis failure as end point, defined as the revision of any prosthetic component for any cause. To avoid a possible bias, revision of t...
In order to evaluate in vitro the suitability of various prosthetic materials for endothelial see... more In order to evaluate in vitro the suitability of various prosthetic materials for endothelial seeding, human endothelial cells derived from the umbilical vein were placed in direct contact with a variety of polymers. As a control, endothelial cells were cultured in the absence of material. After 24, 48, 72 and 96 hours, the cells were counted and a viability test with neutral red was performed. Assays of 6-keto prostaglandinFla (6-keto-PGF1a), tissue plasminogen activator (tPA) and plasminogen activator inhibitor 1 (PAI-1) were carried out on the supernatants. The cell counting technique demonstrated growth inhibition in the cell populations in contact with Woven Dacron® and Double Velour Dacron® in comparison with control cell cultures. Vital staining with neutral red, always sharply positive in the controls, was weak in the cells placed in contact with the materials. The 6-keto-PGF1a concentration in the supernatant was similar to the control level in the populations in contact wi...
Orthopaedics & Traumatology: Surgery & Research, 2019
BACKGROUND Body mass index is used by the World Health Organization to classify obesity. While ob... more BACKGROUND Body mass index is used by the World Health Organization to classify obesity. While obesity influences the onset of arthritis and type-2 diabetes, its effect on implant survival is still open to debate, with conflicting results from clinical and registry studies, as well as meta-analyses. Other known factors such as gender or diabetes status could ponderate or mask the effect of BMI on implant survival. HYPOTHESIS Our hypothesis was BMI influenced hip and knee arthroplasty survival, when results were made independent of gender and diabetes status. PATIENT AND METHODS A registry study was designed on 30733 Total Hip Arthroplasties (THA), 28483 Total Knee Arthroplasties (TKA), 3754 Uni compartmental Knee Arthroplasties (UKA) and 649 Hinged Knee arthroplasties (HK), from 01/01/2003 to 31/12/2015. Mean follow-up was 5.5 years. Diabetes status was added to the model. Each arthroplasty survival was tested for age at implantation, gender, diabetes status, implant characteristics and specifically BMI, taking into account gender and diabetes status. RESULTS Gender had a strong influence on arthroplasty results. Age also influenced arthroplasty survival, especially aseptic loosening; a young age would lower implant survival. Diabetes had an influence in hip survival, but its influence on septic loosenings in TKA wasn't proven (p=0.065). A mobile liner and/or a cruciate retaining knee were factors increasing the risk of revision. Weight influenced THA survival, especially aseptic loosening, but didn't have a measurable effect in any other arthroplasty. BMI was not found to influence any arthroplasty survival, whatever the endpoint, when diabetes and gender were taken into account. DISCUSSION Gender, age and diabetes influenced survival of the lower limb arthroplasties, whereas BMI did not. Only weight did influence THA results and should be used instead of BMI. CONCLUSION Studies on arthroplasty survival should systematically mention gender and diabetes status and beware of potential group incomparability. LEVEL OF EVIDENCE III, cohort study.
Introduction:Noise in ceramic-on-ceramic (CoC) total hip arthroplasty (THA) is a potential sympto... more Introduction:Noise in ceramic-on-ceramic (CoC) total hip arthroplasty (THA) is a potential symptom of abnormal bearing wear. Squeaking and other prosthetic hip noises are multi-factorial phenomena that can be analysed and may provide prognostic information.Methods:46 patients with noisy CoC bearings were investigated using X-ray, computed tomography and joint fluid analysis, and classified into either high or low risk of ceramic liner fracture groups according to previously published guidelines. Noise events from the bearings of 16 high risk cases which were subsequently revised were compared with 30 patients in the low risk control group who did not undergo revision. Noise events were analysed for their physical characteristics using a standardised protocol and classified as either low frequency and short duration ‘clicking’ or long duration and high frequency ‘squeaking’.Results:The peak frequency of squeaking during forward walking was significantly higher for patients in the cas...
BACKGROUND Ischemia-modified albumin (IMA) derives from naive albumin, modified in the binding re... more BACKGROUND Ischemia-modified albumin (IMA) derives from naive albumin, modified in the binding region of bivalent ions, as cobalt and iron. The cobalt, released from some types of hip prosthesis seems to be metabolized differently in males and females but the iron ion is more prevalent than cobalt and is detectable in the healthy population. Our aim was to verify if there are any gender- and age-related differences in IMA concentrations and if IMA correlates with cobalt and iron-related proteins. METHODS IMA, albumin, iron, ferritin, transferrin, and cobalt were measured in 50 men and 50 women divided into two age/fertility-homogeneous groups. RESULTS Men < 45-years-old showed a statistically significant lower IMA concentration than men ≥ 45 and fertile and menopausal women. Considering all the population studied, IMA does not seem to be correlated with age and is distributed differently by gender; also, Co distribution was different between males and females. CONCLUSIONS IMA did not correlate with cobalt, iron, ferritin, and transferrin in any group, except for fertile women where IMA presented a statistically significant correlation with serum iron values. Minor expression of IMA in young males together with the results obtained on serum iron in fertile females, could explain the higher accumulation of circulating Co in women compared to men and their different cobalt metabolism.
The International Journal of Artificial Organs, 2006
The authors analyzed the case of a patient with a non-cemented hip prosthesis with a ceramic-cera... more 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 pi...
The International Journal of Artificial Organs, 1998
One-hundred-eighty cylindrical monocortical titanium implants, 4mm diameter and 12mm long, with t... more One-hundred-eighty cylindrical monocortical titanium implants, 4mm diameter and 12mm long, with three different coatings: fluorohydroxyapatite (group A), hydroxyapatite (group B), and titanium oxide (group C), all applied by vacuum plasma spray were bilaterally, randomly implanted into the femurs and tibiae of twelve adult mongrel sheep. The sheep were divided into four groups (1, 2, 3 and 4) numbering three sheep each. Sheep of groups 1, 2, 3 and 4 were euthanized at two weeks, one month, three and nine months after implantation, respectively. Biomechanical and histomorphological analysis were performed. Extraction torque increased over time in all groups until the nine months period. At all the studied periods, the bone-implant contact was higher in Groups A and B compared to Group C. However, only at nine months did this difference reach statistical significance (p<0.005 comparing Groups A and B to C). The results of this study show that all the three coatings could be recomme...
Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine, 2009
Modification of knee joint wear simulation methods has included ‘anatomic attachment’ of unicondy... more Modification of knee joint wear simulation methods has included ‘anatomic attachment’ of unicondylar knee replacements (UKR) onto synthetic femurs with material properties and morphology similar to human femurs. The present study assesses the effect of such modification by comparing the damage patterns on UKR polyethylene inserts after in vitro simulation using standard and modified simulation methods with those on inserts retrieved after in vivo function. Three groups of UKR inserts were evaluated after retrieval (Explant Group, n = 17) or after knee joint wear simulation with the components attached to standard metal blocks (Standard Group, n = 6) or synthetic femurs (Anatomic Group, n = 6). All UKR had similar non-conforming articular surfaces. Articular damage patterns (mode, frequency, and area) were quantified using digital image photogrammetry. Although some common damage modes were noted, knee joint wear simulation with standard or ‘anatomic’ attachment did not generate dama...
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