Anti-resorptive therapy in the osteometabolic patient affected by periodontitis. A joint position paper of the Italian Society of Orthopaedics and Traumatology (SIOT) and the Italian Society of Periodontology and Implantology (SIdP).

This joint report from the Italian Society of Orthopaedics and Traumatology (SIOT) and the Italian Society of Periodontology and Implantology (SIdP) aims for a consensus around the scientific rationale and clinical strategy for the management of osteoporotic patients affected by periodontitis who are undergoing anti-resorptive (AR) therapy to manage the risk of the occurrence of a medication-related osteonecrosis of the jaws (MRONJ). Osteoporosis and periodontitis are chronic diseases with a high prevalence in aging patients, and they share some of the same pathogenetic mechanisms based upon inflammation. Available evidence shows the relationship among osteoporosis, AR agents, periodontitis and implant therapy in relation to the incidence of MRONJ. Uncontrolled periodontitis may lead to tooth loss and to the need to replace teeth with dental implants. Tooth extraction and surgical dental procedures are recognized as the main risk factors for developing MRONJ in individuals taking AR therapy for osteometabolic conditions. Although the incidence of MRONJ in osteometabolic patients taking AR therapy may be as low as 0.9%, the increasing prevalence of osteoporosis and the high prevalence of periodontitis suggest that this potential complication should not be overlooked. Good clinical practice (GCP) guidelines are proposed that aim at a more integrated approach (prescriber, dentist, periodontist and dental hygienist) in the management of periodontitis patients undergoing AR therapy for osteometabolic disorders to reduce the risk of MRONJ. Dental professional and prescribers should educate patients regarding the potential risk associated with the long-term use of AR therapy and oral health behavior.

Optimisation of perioperative procedural factors to reduce the risk of surgical site infection in patients undergoing surgery: a systematic review.

Surgical site infections (SSI) are the leading cause of hospital readmission after surgical procedures with significant impact on post-operative morbidity and mortality. Modifiable risk factors for SSI include procedural aspects, which include the possibility of instrument contamination, the duration of the operation, the number of people present and the traffic in the room and the ventilation system of the operating theatre.The aim of this systematic review was to provide literature evidence on the relationship between features of surgical procedure sets and the frequency of SSI in patients undergoing surgical treatment, and to analyse how time frames of perioperative processes and operating theatre traffic vary in relation to the features of the procedure sets use, in order tooptimise infection control in OT. The results of the systematic review brought to light observational studies that can be divided into two categories: evidence of purely clinical significance and evidence of mainly organisational, managerial and financial significance. These two systems are largely interconnected, and reciprocally influence each other. The decision to use disposable devices and instruments has been accompanied by a lower incidence in surgical site infections and surgical revisions for remediation. A concomitant reduction in post-operative functional recovery time has also been observed. Also, the rationalisation of traditional surgical sets has also been observed in conjunction with outcomes of clinical significance.

Guidelines for improvement of the procedural aspects of devices and surgical instruments in the operating theatre.

Surgical site infections are a major complication for patients undergoing surgical treatment and a significant cause of mortality and morbidity. Many international guidelines suggest measures for the prevention of surgical site infections (SSI) in perioperative processes and the decontamination of surgical devices and instruments. This document proposes guidelines for improving the perioperative setting in view of the devices and instrumentation required for surgical procedures, aiming to reduce contamination rates and improve clinical performance and management for patients undergoing surgical treatment. This document is intended for doctors, nurses and other practitioners involved in operating theatre procedures, resource management and clinical risk assessment processes, and the procurement, organisation, sterilisation and reprocessing of surgical instruments.

Liner dissociation in total hip arthroplasty: a systematic review.

OBJECTIVE: Liner dissociation (LD) is a rare catastrophic mechanical failure of total hip arthroplasty (THA). The study aims at reviewing the available literature regarding liner dissociations to point out their prevalence, describing any possible association and highlighting the surgical management at the time of revision. MATERIALS AND METHODS: A systematic review of the literature was conducted from January 2002, until February 2022, according to the PRISMA guidelines. The main keywords were: "dissociation" AND "liner" OR "hip arthroplasty" OR "THA" and their MeSH terms in any possible combination. Cases of liner dissociation with all levels of evidence of any age published in indexed journals were included. The study quality of all included studies was evaluated using the MINORS criteria. The kappa (k) value was used to assess the consensus between reviewers in the selection of articles and methodological quality assessment. Finally, a sub-analysis was performed specifically concerning the elderly population. RESULTS: Thirty-one manuscripts met the inclusion criteria of the systematic review (21 case reports and 10 case series). 124 LD in 123 patients, (53% females and 47% males) were evaluated. The overall prevalence of LD was 0.15%. The mean age at surgery was of 56.5 years (range 31-75 years). LD occurred in a primary surgery setting in 86% of the cases, at a mean time of presentation of 45.8 months after replacement surgery. 39.5% of the cups and 8.8% of the stems required revision. The mean follow-up after the revision was 18.4 months. Complications after revision occurred in 19.6% of cases, including 3 cases of re-dissociations. Re-revision was required in 13.6% of the revisions. The sub-analysis of the elderly population included 28 cases of LD identified in 10 manuscripts, with an average age of 73.5 years. CONCLUSIONS: LD is a rare but catastrophic mechanical complication of modular THA that requires implant revision. The LD is not related to a specific prosthetic implant, liner material or design, acetabular positioning within the safe zone or age group.

Prevention of surgical site infections in orthopaedic surgery: a synthesis of current recommendations.

Despite adopted precautions, surgical site infection (SSI) rate in orthopaedic surgery and its consequences still remain a major problem. Worldwide, infection prevention and control in perioperative settings are considered of primary importance for every healthcare system. The management of perioperative infections carries a heavy psychological and financial burden, since patients who experience SSI have increased hospital length of stay, morbidity and mortality rates, and higher hospital costs. As the treatment of such infections is particularly difficult in the presence of an implanted biomaterial, the prevention of SSI in orthopaedic surgery represents a challenging key issue, requiring the integration of a range of measures before, during and after surgery. In fact, over the years several aspects of SSI prevention have been studied in order to identify the best SSI prevention strategies and set out appropriate clinical practices. This article will review and summarize the recent international guidelines released on this subject together with other published relevant evidence.

Comparison of high-intensity laser therapy and combination of ultrasound treatment and transcutaneous nerve stimulation in patients with cervical spondylosis: a randomized controlled trial.

The aim of the study was to compare the effect of high-intensity laser therapy (HILT) and a combination of ultrasound (US) treatment and transcutaneous nerve stimulation (TENS) on pain, range of motion (ROM), and functional activity in patients with cervical spondylosis (CS). A total of 84 patients with a mean age of 51.54 years (52 women and 32 men) affected by CS were enrolled in this study. Patients were randomly divided into two groups. In group A (42 subjects), patients received 12 sessions of HILT plus exercise, while in group B (42 subjects), they received a combination of US, TENS, and exercise. The outcomes measured were cervical segment ROM, pain level measured by visual analogue scale (VAS), and functional activity measured by neck disability index (NDI) at the end of the therapy. The level of statistical significance was set as p < 0.05. In the two groups, cervical ROM, VAS, and functional scores showed significant changes. Both HILT plus exercise and US/TENS plus exercise effectively increased cervical ROM and reduced pain (with a significant greater decrease in group A). Statistically significant differences in NDI scores were observed after treatment sessions with better results for participants enrolled in group A (HILT plus exercise) Both therapeutic modalities demonstrated analgesic efficacy and improved function in patients affected by cervical spondylosis 4 weeks after the therapy. HILT plus exercise was more effective than US/TENS plus exercise. HILT can be promoted and used in this pathology with positive outcomes. However, further studies are needed to optimize the dose and duration of HILT therapy.

II Italian intersociety consensus statement on antithrombotic prophylaxis in orthopedics and traumatology.

Pharmacological prophylaxis for preventing venous thromboembolism (VTE) is a worldwide established procedure in hip and knee replacement surgery, as well as in the treatment of femoral neck fractures, but few data exist to its regard in other fields of orthopedics and traumatology. Indeed, no guidelines or recommendations are available in the literature, except for a limited number of weak statements about knee arthroscopy and lower limb fractures. The present paper represents the first multidisciplinary effort to provide suggestions on the prophylaxis of VTE in the remaining fields of orthopedic surgery (minor orthopedic surgery and orthopedic trauma). The Italian Society for Studies on Hemostasis and Thrombosis (SISET), the Italian Society of Orthopedics and Traumatology (SIOT) and the association of Orthopedic Traumatology of Italian Hospitals (OTODI) together with the Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care (SIAARTI) and the Italian Society of General Medicine (SIMG) have set down quick and easy suggestions for VTE prophylaxis in a number of surgical conditions for which only scarce evidence is available. This inter-society consensus statement aims at simplifying the approach to VTE prophylaxis in the single patient with the goal of improving its clinical application.

II Italian intersociety consensus statement on antithrombotic prophylaxis in orthopaedics and traumatology: arthroscopy, traumatology, leg immobilization, minor orthopaedic procedures and spine surgery.

Pharmacological prophylaxis for preventing venous thromboembolism (VTE) is a worldwide established procedure in hip and knee replacement surgery, as well as in the treatment of femoral neck fractures, but few data exist in other fields of orthopaedics and traumatology. Thus, no guidelines or recommendations are available in the literature except for a limited number of weak statements about knee arthroscopy and lower limb fractures. In any case, none of them are a multidisciplinary effort as the one here presented. The Italian Society for Studies on Haemostasis and Thrombosis (SISET), the Italian Society of Orthopaedics and Traumatology (SIOT), the Association of Orthopaedic Traumatology of Italian Hospitals (OTODI), together with the Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care (SIAARTI) and the Italian Society of General Medicine (SIMG) have set down easy and quick suggestions for VTE prophylaxis in a number of surgical conditions for which only scarce evidence is available. This inter-society consensus statement aims at simplifying the approach to VTE prophylaxis in the single patient with the goal to improve its clinical application.

[Innovative materials in orthopaedics: the crosslinked polyethylene (XPE)]. / Materiali innovativi in ortopedia: il polietilene reticolato.

More than 150.000 hip and knee arthroplasties are performed every year in Italy. More than 50% of the patients receive a polyethylene component (Ultra High Molecular Weight PolyEthylene, UHMWPE). Polyethylene abrasive wear induces over time in vivo a foreign-body response and consequently osteolysis, pain and need of implant revision. Furthermore, oxidative wear due to gamma-rays sterilization caused in the '90ies several and severe failures. To solve these problems, since then, the orthopaedics research has been addressed to: 1) develop new cross linked polyethylene with a higher molecular mass than UHMWPE and, consequently, a higher abrasive wear resistance; 2) avoid the oxidative wear induced by gamma-rays sterilization, by using other sterilization methods and by stabilizing UHMWPE by means of antioxidants such as Vitamin E. According to the most recent studies, performed on limited cohorts and mostly funded by manufacturers, cross linked polyethylene shows a better abrasive wear resistance if compared to the conventional polyethylene but no significant differences have been detected in the clinical outcomes. Clinical follow up of Vitamin E stabilized PE are not yet available. The organization of national arthroplasties registries, able to trace and characterize the implanted devices and based on the whole patients population, will facilitate the early detection of devices that show a performance inferior than the expected one. In Italy, the National Institute of Health has been entrusted by the Ministry of Health to organize the national arthroplasty registry.

Group rehabilitation versus individual rehabilitation following knee and hip replacement: a pilot study with randomized, single-blind, cross-over design.

BACKGROUND: In recent years a vast literature has been dedicated to cost effectiveness analysis. In the rehabilitation field, the search for less costly forms of treatment is an area under intense discussion by the rehabilitation scientific community. Group rehabilitation programs for some pathological conditions could permit better allocation of economic resources, but few studies evaluated the efficacy of group physiotherapy as opposed to individual physiotherapy. AIM: The purpose of this study is to compare the effects of group rehabilitation (GrpR) with individual rehabilitation (IndR) for inpatients that have undergone knee and hip replacement. Design. This is a pilot study with randomized, single-blind, cross-over design. SETTING: Inpatients Physiotherapy Department of Don Gnocchi Foundation. METHODS: Clinical disability evaluation (JOASH, IKS, DI) and patient-oriented assessment (SF-36, WOMAC and VAS) were performed on 27 patients undergoing a physical therapy program after knee or hip replacement. Patients having partial weight-bearing postoperatively (about 50% of the total) and a range of motion >50% of the total in the joint replaced were included and then randomized (T0) in two intervention programs: GrpR/IndR - who performed GrpR for 15 days (T1), followed by the IndR for 15 days (T2); and IndR/GrpR - who performed the IndR for 15 days (T1), followed by GrpR for 15 days (T2). RESULTS: Comparing the changes from baseline T1-T0 and T2-T1 separately in the two groups most outcomes showed no significant difference. CONCLUSION: This pilot trial suggests that the group rehabilitation program is just as efficient as the individual rehabilitation for inpatients that have undergone knee and hip replacement and are able to weight-bear postoperatively. A potential benefit of group-based therapy is that it is less resource intensive.

Comparison of the performance of hip implants with data from different arthroplasty registers.

This study evaluated the feasibility of using published data from more than one register to define the performance of different hip implants. In order to obtain estimates of performance for specific types of hip system from different register, we analysed data from the annual reports of five national and one Italian regional register. We extracted the number of implants and rates of implant survival at different periods of follow-up. Our aim was to assess whether estimates of cumulative survival rate were comparable with data from registers from different countries, and our conclusion was that such a comparison could only be performed incompletely.

[Interregional mobility for total knee arthroplasty]. / Mobilità interregionale e chirurgia protesica del ginocchio.

45.049 primary total knee replacements were performed in Italy in 2005, with large distribution all over the country. However referral to centers of excellence far from the area of residency is still common with massive interregional mobility. Aim of this study is to define this issue both in quantitative and qualitative terms. For the timeframe 2001-2005 the SDO database was used to calculate the number of discharges of both residents and non residents for each Region and for each year and the ability of each region to attract patients from other regions or the tendency of the resident population to migrate. Only 8 Regions present an attraction index better than the escape index. Among those 4 are located in the North of Italy, 2 in the Center and 2 in the South. Migration from the North or Center to the South was never observed. Interregional mobility for knee replacement is noteworthy. Such phenomenon is comparable to migration for other major procedures, especially the steady tendency of a south to north mobility. An accurate analysis of potential causes of migration as well as the empowering of southern and central centers is needed.

[Epidemiology of femur fracture and characteristics of hospital care in Lazio]. / Epidemiologia della frattura del femore e fattori correlati alla mortalità intraospedaliera nel Lazio.

UNLABELLED: We aimed at describing the epidemiology of femur fracture in elderly hospitalized for femur fracture in Lazio (Italy), and evaluating the association between patient's and hospital characteristics on in-hospital mortality. We conducted a population- and hospital-based study (Lazio region: 5.233.233 inhabitants) among people 65+ years aged. SOURCE OF DATA: regional hospital register 2002-2003; ICD-9-CM codes for patients' selection 820 e 821. Direct standardization (rate x 1000) and logistic regression analysis (OR, 95% CI) were performed. Overall hospitalization rate in elderly was 7.5%o (10.l%o females vs. 3.9%0 males). 12.033 patients with femur fractures were enrolled in the study period; 21,6% were not treated surgically: in comparison with those who underwent surgery, they were males, residents out of Rome, older and with worst health status. In-hospital mortality rate was 7,97%. In-hospital mortality determinants were: male gender (OR=0.56), older age (85+, OR=3.30), living out of Rome (OR=0.50), comorbidities (Charlson 'index 3: OR=4.44), "others and unspecified parts of femur" as site of fracture (OR=1.84), admission to a private hospital (OR=O. 79) and a surgical treatment (OR=0.20). In conclusion, this study showed the effect of selected individual characteristics on in hospital mortality and suggested a role of early surgical treatment and access to private sector. Regional hospital information systems represent useful tools to address epidemiological impact of hip fracture and its health care resources utilization.

Cambios en la expresión inmunohistoquímica del protooncogen Bcl2 y apoptosis por acción de estimulación colinergica en pacientes con síndrome de Sjõgren primario (SSp) / Changes in Bcl2 immunochemical expresión and apoptosis due to cholinergic stimulation from Systemic Lupus Erythematosus (SLE)

El síndrome de Sjõgren es una enfermedad reumática autoinmune, sistémica, que supone la destrucción de la glándula exocrina y órganos internos por medio de grandes infiltraciones mononucleares asociadas con los anticuerpos Ro/SSA, La/SSB y factores reumáticos, ambos síntomas principales de los factores celulares y humorales de la xeroftalmia y la xerostomía. Los infiltrados mononucleares más comunes son los linfocitos CD4, CD8 y B. Los pacientes que sufren de síndrome de Sjõgren corren el riesgo de desarrollar linfoma no Hodgkin. El linfoma folicular es el resultado de una traslocación no homóloga cromosómica 14; 18 produciendo la desregulación de la transcripción y síntesis de la proteína Bcl2. Las proteínas de la familia Bcl2 son reguladores clave de la apoptosis, que estimulan la supervivencia de la célula. Otros grupos de la familia Bcl2 son estimuladores pro-apoptóticos. El comportamiento de las células dependerá de la concentración de los dos miembros de la familia. Objetivos: Los niveles de expresión y apoptosis de Bcl2 en la glándula salival menor pre y pos-tratamiento con agonistas colinérgicos. Pacientes y métodos: Diagnóstico del síndrome de Sjõgren según los criterios europeos. Se eclutaron 10 pacientes, a quienes se estudió durante 5 meses y se los trató con 15 mg de clorhidrato de pilocarpina en cápsulas orales de 5 mg cada 8 horas. Se llevaron a cabo biopsias pre-tratamiento y pos-tratamiento desde el día cero (antes del tratamiento) hasta el quinto mes (después del tratamiento). Antes de ingresar al estudio clínico, los pacientes SSp voluntarios firmaron el consentimiento informado y el estudio se realizó según las normas de buenas prácticas clínicas. Se evaluó la expresión Bcl2 mediante técnicas de inmunohistoquímica y la apoptosis nucleotidil transferasa-peroxidasa mediante técnicas in situ. Diseño del estudio: Abierto, longitudinal, autocontrolado.

The Italian version of the Oxford 12-item Knee Questionnaire-cross-cultural adaptation and validation.

Questionnaires must be translated and adapted to suit the cultural characteristics of different countries with different languages; they then need to be validated using a standard process. This was done for the Italian version of the Oxford Knee Questionnaire (OKQ), and its reliability and validity were assessed in a cross-sectional study of 50 consecutive patients referred for gonarthrosis and whose knees were replaced. A "subsample" of 20 patients was assessed prospectively to confirm the reliability of the Italian version, and these results were then compared with other clinical studies. The Italian OKQ scale correlated well with other clinical studies and also showed good results with regard to reproducibility, consistency, and validity when compared to the other published versions of the OKQ.

Italian version of the Disability of the Arm, Shoulder and Hand (DASH) questionnaire. Cross-cultural adaptation and validation.

An Italian version of the Disability of the Arm, Shoulder and Hand (DASH) questionnaire has been devised and its reliability and validity have been assessed in a cross-sectional study of 108 consecutive patients with upper extremity pathologies. A sub-sample of 30 patients was used to assess re-test reliability. The principal DASH scale showed a high correlation with other patient-oriented measures and demonstrated good reproducibility, consistency and validity, which were similar to those for other languages' versions of DASH. These findings suggest that the evaluation capacities of the Italian DASH are equivalent to those of other language versions of the DASH.

Italian version of the Roland Disability Questionnaire, specific for low back pain: cross-cultural adaptation and validation.

Over the last 10 years, patient-oriented evaluations using questionnaires have become an important aspect of clinical spinal outcome studies. Any questionnaire must be translated and culturally adapted in order to be used with different language groups, and the translated version must then be evaluated for reliability and validity, which are fundamental attributes of any measurement tool. The Roland Disability Questionnaire, a low back pain disease-specific tool, was submitted to translation into Italian and to cross-cultural adaptation following the Guillemin criteria. It was then validated on 70 patients (37 male and 33 female; mean age 58, range: 28-67) suffering from low back pain as assessed by clinical examination, imaging and also electromyography in cases of suspected neurological impairment. The test-retest reliability, assessed with intraclass correlation, was 0.92 and the internal consistency reached a Cronbach's alpha of 0.82. The Italian version of the Roland Disability Questionnaire satisfied the validation criteria, showing characteristics of reliability and validity similar to previously published versions translated and adapted for other countries.

Cross-cultural adaptation of the lumbar North American Spine Society questionnaire for Italian-speaking patients with lumbar spinal disease.

STUDY DESIGN: A cross-cultural adaptation and cross-sectional study of a sample of lumbar spine patients, with a subsample followed prospectively for retest reliability. OBJECTIVES: To assess the Italian version instrument reliability and validity. SUMMARY OF BACKGROUND DATA: The orthopaedic outcome measurements have been usually focused on objective parameters as radiograph measures or other technical aspects. However, these parameters are weakly related with outcomes that are more relevant to patients as functional status and symptoms. In the last ten years, the patient-oriented measures have become an important aspect of spinal clinical outcome evaluation. The most common instruments to assess patient perspective are self-administered questionnaires that must be validated by a widely accepted process to evaluate reliability and validity, which are fundamental for every instrumental measure. METHODS: The North American Spine Society (NASS) questionnaire was culturally adapted for Italian-speaking people following the Guillemin criteria. The Italian version was tested on 74 consecutive patients who were referred to the authors' department and suffered from low back pain with leg irradiation. The results were compared with other validated patient-oriented measures. Forty-eight-hour retests were performed on a subsample of 45 patients. RESULTS: The questionnaire was favorably accepted by patients. The lumbar spine pain and disability and neurogenic symptoms subscales showed a high correlation with other patient-oriented measures, as hypothesized, and it also showed good values on test-retest. CONCLUSIONS: The questionnaire should be considered for patient health status monitoring and for clinical trials.