Giovanni Balato

Lean Six Sigma: a new approach to the management of patients undergoing prosthetic hip replacement surgery

RATIONALE, AIMS AND OBJECTIVES In 2012, health care spending in Italy reached €114.5 billion, accounting for 7.2% of the Gross Domestic Product (GDP) and 14.2% of total public spending. Therefore, reducing waste in health facilities could generate substantial cost savings. The objective of this study is to show that Lean Six Sigma represents an appropriate methodology for the development of a clinical pathway which allows to improve quality and to reduce costs in prosthetic hip replacement surgery. METHODS The methodology used for the development of a new clinical pathway was Lean Six Sigma. Problem solving in Lean Six Sigma is the DMAIC (Define, Measure, Analyse, Improve, Control) roadmap, characterized by five operational phases which make possible to reach fixed goals through a rigorous process of defining, measuring, analysing, improving and controlling business problems. RESULTS The following project indicated several variables influencing the inappropriate prolongation of the length of stay for inpatient treatment and corrective actions were performed to improve the effectiveness and efficiency of the process of care. The average length of stay was reduced from 18.9 to 10.6 days (-44%). CONCLUSION This article shows there is no trade-off between quality and costs: Lean Six Sigma improves quality and, at the same time, reduces costs.

Treatment of massive irreparable rotator cuff tears through biodegradable subacromial InSpace Balloon

The massive irreparable tears of rotator cuff represents a debilitating condition for the patient as well as it is still an hard challenge to an orthopedic surgeon [1,2]. Treating these tears is an interesting and evolving issue due to the development of arthroscopic surgery and of the materials used for treatment. There are several surgical options for treating massive tears, among these the arthroscopic debridement and the implant of a reverse prosthesis [3]. Recently, the Biodegradable InSpace Balloon device has been put on the market, once implanted between the acromion and the proximal humeral epiphysis, this device guarantees significant pain reduction and range of motion (ROM) improvement in patients affected by massive rotator-cuff shoulder tears, as it restores the correct expanse of the pathologically reduced subacromial space. Primary end-points include: pain relief, improvement in the range of motion, activities of daily living, and enhancement of shoulder strength referring to the Constant Score [5] recorded at each follow-up visit.

Knee Septic Arthritis after Arthroscopy: Incidence, Risk Factors, Functional Outcome, and Infection Eradication Rate

Purpose  Septic knee arthritis following arthroscopy is a rare but dreaded complication. Definition and management of knee deep infections are quite discussed in literature. In this review, literature regarding infections after knee arthroscopy is analyzed highlighting the incidence, causative bacteria, risk factors as well as clinical outcomes. Methods  We performed a review of the literature matching the following key words: “septic arthritis” OR “infection” AND “arthroscopy” AND “knee.” Knee arthroscopic procedures, such as debridement, meniscectomy, meniscus repair, synovectomy, microfracture, and lateral release, were considered. Complex procedures, such as ligament reconstruction, fractures, or complex cartilage repair techniques, were not included. Results  Thirteen studies were included in this review. Incidence of infection ranged from 0.009 to 1.1% in patients undergoing simple arthroscopic procedures. Staphylococci are the most commonly isolated organisms from postarthroscopy infection. Use of intraoperative intra-articular steroids, smoking, obesity, male sex, diabetes, number of procedures performed during surgery, time of surgery, and tourniquet time of more than 60 minutes have been certified as risk factors for knee infection. Conclusion  Postarthroscopy septic arthritis of the knee causes significant morbidity, usually requiring readmission to the hospital, at least one additional operation, and prolonged antibiotic therapy, both intravenous and oral. Prompt diagnosis and treatment are associated with a high success rate. Level of Evidence  Level IV, systematic review of I-IV studies.

The role of offset stems in revision knee arthroplasty

Revision total knee arthroplasty (TKA) represents a technically challenging procedure. The use of an offset stem extension can help in addressing some of the difficulties that can be encountered during surgery and, in particular, anatomical mismatch, malalignment, and gap balancing. Different offset stem extensions are available and can be classified according to four parameters: modularity, location of the offset, direction, and size of the displacement. Offset stem extensions can assist with implant alignment on the metaphysis if there is an offset diaphysis, can avoid medial-lateral or anterior-posterior component overhang, can reduce the incidence of coronal or sagittal malalignment, and can help in balancing the flexion and extension spaces by effectively translating the components. The aim of this study is to give an overview of the currently available evidence regarding the use of offset stem extensions in revision TKA as well as some useful surgical tips.

How to Manage a Failed Cartilage Repair: A Systematic Literature Review

Purpose  The aims of this paper are to report the rate and risk factors for the failure of the most common cartilage repair technique, and analyze the most important factors that could influence the choice of a specific surgical treatment to revise a failed cartilage repair. Methods  A review of the literature was performed focusing on failed cartilage repair and related treatments. Two of the authors independently screened articles. Conflicts about the inclusion of a paper was resolved by further evaluation by the senior author. Review articles, articles written in languages different from/other than English, case reports, and papers that did not evaluate the outcomes of interest were excluded. Full-text version of each included paper was obtained and relevant data were extracted and collected in a database. Results  At the end of the screening process, 31 articles were included. Microfractures and mosaicplasty showed a nonnegligible failure rate at short- and midterm. Better results, especially in terms of time to failure or revision, were reported with the use of autologous chondrocyte implantation (ACI) and osteochondral allograft (OCA) transplantation. Regarding the treatment of failed cartilage repair, the use of OCA transplantation in patients with previous failed cartilage repair may be a safe option. The revision of failed OCA transplantation with further OCA seems to have a greater failure rate. Patients with previous failed ACI or matrix-induced autologous chondrocyte implantation (MACI) who underwent further MACI or ACI reported acceptable results. Otherwise, ACI in patients with history of previous subchondral marrow stimulation (SMS) demonstrated a greater failure rate. Conclusion  From the analysis of the literature, OCA transplantation seems to be the most reliable treatment of a failed SMS. ACI or MACI showed acceptable results in patients with previously failed MACI or ACI. Level of Evidence  Level IV, systematic review of level I-IV studies.

Analytical Evaluation of a Vancomycin Immunoassay in Synovial Fluid

In clinical laboratories performing routine activities, the need to answer the burning clinical question in emerging field may be limited by lack of technology support or assays accessibility. Commercially available methods, although originally validated for specific biological matrices, may be employed for other matrices, following appropriate guidelines such as Clinical and Laboratory Standards Institute (CLSI) EP 19. We investigated the use of a vancomycin assay with synovial fluid samples, in view of a possible employment in vancomycin release study. The standard of care of periprosthetic joint infection is a two-stage revision surgery with antibiotic-loaded bone cement implantation. Vancomycin, for its activity against gram-positive bacteria even multidrug-resistant staphylococci, is the most widely used antibiotic. Despite the widespread use of such devices, little is known about the in vivo elution in the joint space. Clinical laboratories equipped with a validated, affordable method to quantify vancomycin in synovial fluid, may support clinical research, and give an important contribution to the study of the pharmacokinetics of antibiotic release from bone cement matrix.

Perspectives: How to Deal with Fever (38 °C) After Arthroplasty: The Infectivologist’s Point of View

Postoperative fever after orthopaedic surgery is a controversial clinical problem in daily practice since damaged tissue due to surgical intervention can induce the production of proinflammatory cytokines responsible for systemic inflammatory response syndrome. No current diagnostic marker is able to differentiate accurately infectious from noninfectious fever in a patient who underwent orthopaedic surgery, but early diagnosis of postoperative orthopaedic infections is important in order to rapidly confirm diagnosis, thus initiating adequate therapy. The review of clinical trials on fever did not establish the parameters having higher diagnostic accuracy. Blood cultures, white blood cell count, erythrocyte sedimentation rate and C-reactive protein have low specificity. Procalcitonin and IL-6 can be helpful diagnostic markers supporting clinical findings.

Unicompartmental knee arthroplasty in the over 70 population

Unicompartmental prosthesis (UKA) is a viable option for the treatment of unicompartmental osteoarthritis, most often confined to the medial compartment. Appear to have been well codified indications, contraindications, and surgical techniques related to unicompartmental arthroplasty. The data in the literature show that the selection criteria can be divided into general origin factors (age, weight, activity level) and local factors, more closely related to the joint to be treated [1,2]. The patients age over 65 years and the functional requirements of a sedentary activity comparable to justify its use in elderly patients with clinical signs and imaging involvement of only one of the joint compartments [3]. We agree, however, with those who recommend its use in older subjects, since it is well tolerated, with low morbidity, reduced blood loss, better preservation of the joint and saving of bone tissue. Other advantages include lower costs, shorter hospitalization, faster rehabilitation and conferment of a greater than pre-op functional efficiency that fully meets the needs of elderly patients. The authors report their experience in 12 patients treated surgically implanting a unicompartmental prosthesis.

Prosthetic joint infections: outcome after treatment in a case series

Prosthetic joint infections (PJI) are one of the most complication of joint replacement surgery and report a considerable disability and cost. This complication occurs in 0.8-1.9% of knee prostheses (TKA) and 0.3-1.7% of hip replacement (THA) [1]. These percentages may be underestimated because of the ability of some bacteria to grow in community of aggregation on the surface of the prosthesis, defined biofilm, which makes difficult their isolation by standard culture tests. In fact, in a significant percentage of prosthetic infections, the responsible agent remains unknown, and this may affect the outcome [2,3]. The classification of implant-associated infections is related to the onset of symptoms after implantation. Early infection is defined as appearance of the first signs and symptoms of infection during the first 3 months after surgery. However, some authors limit these surgical site infection to the first 4- weeks [4]. Delayed manifestation is defined as an infection in which the first signs and symptons appear between 3months and 2 years post-surgery, and late manifestation is defined as the appearance of first signs and symptons of infection > 2 years post- surgery. Each type has specific etiopathogenic properties that influence the therapeutic options. Outcome data on treatment are limited. Aim of this study was to evaluate the characteristics of patients with PJI and their outcome after treatment.