Hymovis MO.RE. in the treatment of knee and ankle chondropathy in elite athletes: preliminary results of the CHAMPS (Cohort study about HYADD4-G Administration for Pain relief on Soccer players) prospective clinical study.

OBJECTIVE: This study evaluated single intra-articular injections of Hymovis MO.RE., a hyaluronic acid hexadecyl derivative (HYADD4-G), to manage post-traumatic or degenerative knee or ankle chondropathy in professional soccer players. PATIENTS AND METHODS: Twenty-five players affected by knee (n = 12) or ankle (n = 13) chondropathy were prospectively enrolled and treated by two single Hymovis MO.RE. (32 mg/4 ml) injections at the beginning of the football season (V0, baseline) and at mid-season (V1, 19-20 weeks thereafter), and were followed-up until the end of the season (V2, after further 19-20 weeks). Knee cases were evaluated using the 2000 IKDC knee subjective examination form and the modified Lysholm scoring system. Ankle cases were evaluated using the American Orthopaedic Foot Ankle Society (AOFAS) ankle-hindfoot score. Patients were also evaluated using a VAS Likert scale and a four-category scale recording both the patient's and the doctor's assessment on joint mobility in degrees and overall treatment efficacy. Adverse events, patient withdrawals and local reaction to injections were also assessed. RESULTS: In knee patients, the 2000 IKDC subjective score improved from 46.8 ± 11.4 at V0 to 83.1 ± 12.5 at V2. Their modified Lysholm score improved from 58.8 ± 8.9 at V0 to 90.6 ± 8.3 at V2. In the ankle patients, the AOFAS score improved from 52.2 ± 5.6 at V0 to 96.4 ± 4.5 at V2. VAS Likert values and subjective evaluations improved at V1 and were maintained at V2. No side effects were recorded. CONCLUSIONS: A single Hymovis MO.RE. (32 mg/4 ml) intra-articular injection, repeated after 19-20 weeks, may be a viable option to improve symptoms and function in professional soccer players suffering from knee and ankle chondropathy.

MPFL reconstruction and tibial tuberosity transposition in patients with patellar instability: May it troubleshots also trochlear dysplasia?

PURPOSE: This study aimed to highlight short- and medium-term outcomes of combined medial patello-femoral ligament (MPFL) reconstruction and anterior tibial tuberosity (ATT) transposition surgery in patients with recurrent patellar instability and different degrees of trochlear dysplasia. METHODS: Between January 2014 and May 2019, 25 patients with patellar instability underwent a surgical procedure combining the lowering/transposition of the ATT and the MPFL reconstruction. Each patient were preoperative assessed by Kujala score, International Knee Documentation Committee (IKDC), Tegner activity level scale. The assessment of instability predisposing factors was carried out with patellar height, tibial tuberosity-trochlear groove (TT-TG) distance, trochlear dysplasia, sulcus angle, patellar tilt and MPFL injuries. Functional outcomes were evaluated with Kujala, IKDC and Tegner scores at 3, 6 and 12 months after surgery. RESULTS: The average age of the patients was 20 years (range 13-43 years). Pre- operative Caton-Deschamps index was pathological in 10 (40%). Sulcus angle was elevated in 13 patients (52%) and TT-TG distance was irregular in 17 patients (68%). Trochlear dysplasia was present in 13 patients (9 type A, 3 type B, 1 type C according to Dejour's Classification). No re-dislocation occurred during the follow-up. There was a significant increase in the Kujala, IKDC and Lysholm scores after 3, 6 and 12 months, and the results were compared for the different follow-up times and patient's trochlear dysplasia degree. CONCLUSION: This prospective observational longitudinal study identified good clinical outcomes in patients who underwent MPFL reconstruction and ATT transposition for patellar instability. Finally, the different risk factors for patellar instability examined, particularly the presence of trochlear dysplasia, did not significantly influence the final functional results, which range from good to excellent without re-dislocation episodes.

Epidemiology and microbiology of prosthetic joint infections: a nine-year, single-center experience in Pavia, Northern Italy.

BACKGROUND: Prosthetic joint infections (PJIs) are a growing matter of concern due to their economic and social burden on health systems. In Italy, surgical data on PJIs are available in a national registry, but microbiological data are still scarce. MATERIALS AND METHODS: We performed a retrospective study at a single center with records of patients treated for primary PJIs of knee or hip from January 1, 2011, to May 30, 2018. Patients with infections of osteosynthesis means and external devices were excluded, as well as PJI recurrences and polytrauma patients. Infections were diagnosed according to IDSA and MSIS criteria. We collected data on demographics, risk factors and microbiology. All patients seen at our center undergo blood cultures and synovial fluid cultures, periarticular biopsy and prosthesis sonication by Bactosonic®. This was used only after 2014. Bacterial identification is achieved by MALDI-TOF, PHOENIX 100 and standard methods. Chi-square or Fisher tests were used to test statistical differences in proportions. RESULTS: Fifty-one patients matched our inclusion criteria. Of these, 16 (31.4%) were enrolled before 2014. The median age was 68.5 (range 22-88). The most common risk factors were obesity (34%), diabetes (21%) and chronic kidney disease (14%). Seventeen patients were diagnosed with a culture-negative PJIs (33.3%). Staphylococcus aureus was the most commonly isolated pathogen (14/51, 27.5%), followed by coagulase-negative staphylococci (7/51, 13.7%). Methicillin-resistant S. aureus rate was 28.6%. The rate of culture-negative PJIs dropped from 56 to 22% after 2014, with a significant difference between the two time periods (p = 0.016). CONCLUSIONS: The introduction of sonication dramatically increased our diagnostic accuracy. Our microbiological data are in line with those from other studies conducted in Italy.

The role of six biomarkers in diagnosis of hemophilic arthropathy: review of the literature.

The aim of our narrative review of the literature is to identify the role of six important biomarkers: synovial fluid thrombomodulin, fibroblast-like synoviocytes, synovial tissue growth factor , vascular endothelial growth factor in synovium and peripheral blood, urinary C-terminal telopeptide of type II collagen, and synovial fluid tumor necrosis factor alpha. These urinary, serum and synovial biomarkers illustrated should be evaluated in patients with hemophilic arthropathy for early diagnosis of hemophilic arthropathy, because they have important implications in the development of arthrofibrosis, altered inflammatory response and bleeding. Moreover, better knowledge of their biological activity is important to identify possible new biological treatment options.

Knee arthroplasty system with medialized keel: Seven-year follow-up of a pioneer cohort.

BACKGROUND: In this clinical investigation, a new design with a progressive increased keel medialization according to the size was implanted. The cohort of patients was followed up for seven years. METHODS: From May 2012 to November 2012, we implanted 70 total knee arthroplasties in 69 patients. The mean age of the patients was 76.2 years. We followed up 56 patients for seven years; we evaluated the patients at six and 60 months after surgery by Patient Reported Outcome Measures score. During the seven-year follow-up, all patients were clinically re-evaluated using the Knee Society Score and the Forgotten Joint Score. All patients underwent a preoperative and postoperative radiographic investigation. At the last follow-up the presence of any radiolucency lines was checked using the Knee Society Total Knee Arthroplasty Radiographic Evaluation and Scoring System. RESULTS: The patients defined the surgical results as excellent in 66% of the cases, very good in 23%, good in five percent. The analysis of the functional data at seven years, performed by administering the Forgotten Joint Score, showed average values of 70.4. The clinical analysis, performed through the Knee Society Score at the same follow-up, showed average values of 90.4. The seven-year radiological analysis revealed the presence of radiolucency lines in 20 implants. The sum of the line widths never exceeded the critical value of nine millimeters, always remaining below four millimeters. Only one patient was revised. CONCLUSIONS: The results showed an excellent outcome of this design. The medialization of the tibial keel showed good bone fixation and component alignment at seven-year follow-up.

Trabecular titanium tailored implants in complex acetabular revision surgeries: our experience at minimum 3 years follow-up.

Hip revision surgery in cases with previous multiple reconstructive procedures is a challenging procedure. A custom-made product could be useful to obtain good results. Four cases (2 men and 2 women) of acetabular customized Trabecular Titanium (TT) implants made by 3D printed technology were performed. The mean age at surgery was 51.5 years (range 25-72). Patients were reviewed clinically and radiographically at follow-up. Mean Harris Hip Score increased significantly from 13.9 (range 6.9-20.6) preoperatively to 75.8 (range 53.9-94) at last follow-up (mean 43.5, range: 36-59), showing an improvement in terms of both pain relief, function and joint mobility. Radiographically neither signs of instability, migration nor tilting were observed. TT custom-implant made by high performance of the 3D-printing technology, system modularity, and patient-specific surgical tools permitted good clinical results and an effective restoration of the biomechanical joint parameters in these complex revision cases.

Megaprostheses in the treatment of complex fractures of the distal femur.

Total knee replacement (TKR) is a widely used procedure for the treatment of post-traumatic arthritis. This type of solution has also been used recently for the treatment of acute fractures around the knee, particularly in joints that already presented arthritis before the trauma. In case of complex fractures of the distal femur especially in older or very compromised patients, the use of a segmental implant can be an option of treatment in order to obtain a quicker recovery of the patient allowing early mobilization and weight bearing. The purpose of this paper is to present our experience with segmental TKR in the treatment of complex fractures of the distal femur highlighting the main problems associated with these conditions and focusing on the indications, principles of technique, tips, tricks and pitfalls of this procedure.

Acute treatment of medial collateral ligament tears: short to mid-term results.

The aim of this study is to describe the results of a consecutive set of patients treated in acute for the surgical repair of medial collateral ligament (MCL) tears with a mean follow up of 63.78±43.25 months (4- 136). This is a retrospective observational study. From January 2011 to December 2016, 56 patients within the average of 31.75±13.27 (13-55) years old at the time of injury underwent medial compartment repair in an acute setting. The sample size of our study is therefore made up of 26 patients. Patients have been evaluated with functional scores: IKDC (international knee documentation committee evaluation form), the KOOS (Knee injury and osteoarthritis outcome score) and clinical assessment. The Tegner Activity Score was evaluated retrospectively at the 12 months follow-up. The mean KOOS value at the final follow-up were 91.25±9.65 (72-100) for pain, 85.68 ± 12.34 (57-100) for the symptoms category, 94.5±8,07 (75-100) for the activity of daily life, 71.87±22.86 (35-100) for the sport category and 76.37±18.55 (38-100) for the quality of life. At the last follow up the mean IKCD value was 77.68±15.95 (55-98). The mean difference in the Tegner Activity Score between the preoperative time and the postoperative time was 1.06±1.12 with a 95% Confidence Interval 0.46-1.66. The functional outcomes underline how the surgical approach to the medial capsule-ligament compartment of the knee is a reliable treatment to restore excellent joint function. Level of evidence III retrospective observational study.

A systematic review: characteristics, complications and treatment of spondylodiscitis.

OBJECTIVE: This systematic review focuses on 5 key elements that may improve the decision-making process in spondylodiscitis: the infective agent, segmental instability, abscess development, neurological compromise and focus of infection. MATERIALS AND METHODS: We included 64 studies published between May 2012 and May 2017, that reported both a description of the discitis and comparative data regarding the disease and its complications. RESULTS: The majority of cases were caused by Staphylococcus spp (40.3%) and involved the lumbosacral region (52.3%). 27.8% of cases were associated to neurological compromise, 30.4% developed an abscess, 6.6% were associated to instability, and 54.7% underwent surgery. The abscesses mostly involved the lumbosacral region (60.4%) with paravertebral localization; 32.6% of cases involved the thoracic region, showing mostly epidural localization; a small number of cases (7%) involved the cervical region, mostly with epidural localization. 95% of paravertebral abscesses were treated percutaneously, while 85.7% of epidural cases underwent "open" surgery. Spinal cord compression mainly occurred in the cervical region (55.9%), neurological deficit was observed in over half of cases (65%), and surgery was required in most of the cases (83.9%). The majority of cases of instability involved the lumbosacral region (53.3%) and underwent surgery (87%). The focus of infection was mostly lumbosacral (61%) and almost all cases (95%) were treated surgically. CONCLUSIONS: Spondylodiscitis is a complex and multifactorial disease, whose diagnosis and management are still challenging. Due to its potential morbidity, it is extremely important to investigate the 5 key elements discussed in this paper in order to provide an early diagnosis and initiate the most effective treatment.

PEEK versus metal cages in posterior lumbar interbody fusion: a clinical and radiological comparative study.

BACKGROUND: Low back pain and sciatica represent a common disabling condition with a significant impact on the social, working and economic lives of patients. Transforaminal lumbar interbody fusion (TLIF) is a surgical procedure used in degenerative spine conditions. Several types of cages were used in the TLIF procedure. PURPOSE: To determine whether there is a difference in terms of symptomatology improvement, return to daily activities and fusion rate between metal cages and polyetheretherketone (PEEK) cages. METHODS: We have retrospectively reviewed 40 patients who have undergone TLIF from October 2015 to May 2016. All patients were clinically evaluated with questionnaires and were assessed with CT scan and standing X-ray films of the full-length spine. RESULTS: We found no significant functional differences in the two groups. At 1-year follow-up, osteolysis was present in 50% of cases of the PEEK cages and in 10% cases of the metal cages. The degree of fusion at 1  year was evaluated as complete in 40% cases of the metal cages and 15% cases of the PEEK cages. CONCLUSIONS: We have found a better fusion rate and prevalence of fusion in the group treated with metal cages, reflecting the well-known osteoinductive properties of titanium and tantalum.

Biomaterials and biophysical stimuli for bone regeneration.

First, we review basic concepts of Tissue Engineering, that is, how the tensegrity is able to modulate the cell behavior. Then, we review our experimental results regarding the bone tissue engineering via biomaterials and bioreactors.

Aggressive hemangioma starting from l5 body, treated with mass embolization and radiation therapy with protons: a case report.

A hemangioma is a benign tumor of endothelial cells, multiplying into the medullary spaces of the cancellous bone. This tumor is in most cases not symptomatic, and in this case, they do not require any specific treatment. Pain and neurological symptoms derived from hemangiomas as shown in 2-11% of the cases. The 55% of these cases presents low back pain, while the 45% presents neurological deficit from compression of the spinal cord, peripheral nerves or both. We present a clinical case report of a young woman, affected by aggressive L5 hemangioma causing a spinal canal stenosis with associated sciatalgic symptoms. We performed a review of the current literature on the treatment options, giving the rationale of our treatment choice (mass embolization and radiation therapy with protons).

Primary total knee replacement in hemophiliacs: experience of a single institution over fourteen years of surgical procedures.

This retrospective study reports clinical and functional orthopedic outcomes and complications after 14 primary total knee replacement (TKR) performed between 2000 and 2014. The mean age at surgery was 42 years (range 26-59), with a removal-free survival of 100% at the end of follow-up (months 109.85). The KSS score was 49.64 pre-operatively (range 31-63) and 78.14 at final follow-up (range 45-90), the KSS function score was 64.64 pre-operatively (range 35-80) and 84.57 at final follow-up (range 45-100). According to this study, there are three main factors that can influence long-term and early surgical outcomes: post-operative fibrosis, a previous synovectomy and presence of inhibitors. Even if our results are slightly suboptimal compared to those obtained in non-hemophilic patients, this study shows that TKR is an effective surgical procedure in hemophiliacs.

How to obtain better results, choice of implant or surgical technique? A new surgical technique with an extramedullary referenced cutting guide and a blended alignment method.

Measured resection and ligament balancing techniques are the most used in TKA; both require, in the majority of knee arthroplasty systems, a femoral intramedullary canal referencing for the distal femoral cut. Fat embolism, activation of coagulation and bleeding may occur from the reamed canal; this can be avoided with different solutions such as navigation, patient specific instruments or the use of an extramedullary device. The FuZionTM tensor was created as a blended method with the purpose to overcome the downsides of both techniques by fusing them. The aim of our study is to present the technique and the preliminary results of a cohort of patients where this instrument was customized and used as an extramedullary cutting guide for the distal femur, matching the distal femoral cut with the proximal tibial cut in order to obtain a guided, kinematically adjusted, alignment and a reduction of post-op blood loss.

Hydatid cyst in the spine. The alliance between surgeon and infectivologist is winning: a case report.

Hydatid Cyst is a protozoal disease, whose spinal localization may be cause of pain and severe inability due to neurological symptoms and instability. Treatment combines the difficulties to eradicate the cyst with the spine regional constraints. The case of a 45-year-old woman is reported, affected by hydatid cyst in the spine, submitted to combination of medical treatment and surgery (double approach gross total excision and reconstruction) and followed up for 6 years. The treatment strategy allowed an excellent quality of life without pain and neurological symptoms at the latest follow-up. This case supports the validity to combine anthelmintic medical treatment and excisional surgery in the treatment of hydatid cyst of the spine. The medical treatment makes surgery more effective maintaining the result over long term. Subtotal or total excision of the cysts can be performed, including decompression of neural structures and adequate spine reconstruction.

Treatment of Vancouver B1, C periprosthetic hip fractures with periprosthetic polyaxial locking plate system: A 3-year follow-up.

The incidence of periprosthetic fractures after primary knee and hip arthroplasty is around 2.5% and is increasing after revision surgery up to 4%. Management of these fractures is often particularly demanding and expensive. The primary aim of the presented study is to describe our experience in using a precontoured periarticular polyaxial standard plating system in a cohort of patients with homogeneous fracture type (Vancouver B1, C), comparing our experience with other surgical solutions. In stable implants, the primary strategies aim for fracture stabilization, leaving the original prosthesis in place. The results of conventional non-locking implants have been mostly poor with complication rates up to 53%. Therefore, today, monoaxial locking plates are strongly recommended. From May 2013 to December 2014, 30 "non-contact bridging plate" (NCB-PP®) were implanted. All fractures were periprosthetic Vancouver B1 or C fractures. In 24 patients, NCB-PP® plating was performed after periprosthetic femoral fracture as primary treatment, in 6 patients, it was performed as secondary fracture treatment after primary plating failure. All surgeons performed lateral femoral approach with ORIF. Average follow up was 36 months. Bony consolidation was confirmed in all patients, bar one, in an average time of 4 months; none of the patients bar one developed mechanical failure or implant breakage. The GOS at 52 weeks was back to the preoperative level in 18 patients and it did not improve at 24 months. The Harris Hip Score at 52 weeks showed a mean score of 80.14 points. Full weight bearing was allowed at mean time of 100 days. None of the patients developed complications that needed subsequent surgery. The use of NCBPP plates has given excellent results in our clinical practice, allowing early postoperative mobilization and recovery.

Dosimetric characterization of carbon fiber stabilization devices for post-operative particle therapy.

PURPOSE: The aim of this study was to evaluate the dosimetric impact caused by recently introduced carbon fiber reinforced polyetheretherketone (CF/PEEK) stabilization devices, in comparison with conventional titanium (Ti) implants, for post-operative particle therapy (PT). METHODS: As a first step, protons and carbon ions Spread-Out Bragg Peaks (SOBPs) were delivered to CF/PEEK and Ti screws. Transversal dose profiles were acquired with EBT3 films to evaluate beam perturbation. Effects on image quality and reconstruction artifacts were then investigated. CT scans of CF/PEEK and Ti implants were acquired according to our clinical protocol and Hounsfield Unit (HU) mean values were evaluated in three regions of interest. Implants and artifacts were then contoured in the sample CT scans, together with a target volume to simulate a spine tumor. Dose calculation accuracy was assessed by comparing optimized dose distributions with Monte Carlo simulations. In the end, the treatment plans of nine real patients (seven with CF/PEEK and two with Ti stabilization devices) were retrospectively analyzed to evaluate the dosimetric impact potentially occurring if improper management of the spine implant was carried out. RESULTS: As expected, CF/PEEK screw caused a very slight beam perturbation in comparison with Ti ones, leading to a lower degree of dose degradation in case of contouring and/or set-up uncertainties. Furthermore, CF/PEEK devices did not determine appreciable HU artifacts on CT images thus improving image quality and, as a final result, dose calculation accuracy. CONCLUSIONS: CF/PEEK spinal fixation devices resulted dosimetrically more suitable than commonly-used Ti implants for post-operative PT.

A multi-centre, open label, long-term follow-up study to evaluate the benefits of a new viscoelastic hydrogel (Hymovis®) in the treatment of knee osteoarthritis.

OBJECTIVE: To evaluate the long-term efficacy and safety of Hymovis® in the symptomatic treatment of knee osteoarthritis (OA). PATIENTS AND METHODS: This is a prospective, multi-center, open label, phase III clinical study. Two intra-articular injections (3 mL) of Hymovis® (8 mg/mL HYADD® 4) were administered 1 week apart at the beginning of the study on day 0 and day 7 and after 6 months from baseline, on day 182 and 189. Follow-up assessment were conducted for 52 weeks. 50 subjects, > 40 years old, with knee OA, with clinical and radiological confirm, complain pain in the target knee were enrolled. The variables considered were: WOMAC questionnaire, Joint Space Width (JSW), OMERACT OARSI responder criteria, EQ-5D questionnaire, rescue medication consumption. RESULTS: After the injections of Hymovis®, pain perceived by the patient when walking on a flat surface (WOMAC A1 score) significantly improves at the end of the study respect to the baseline. WOMAC stiffness, physical function and total score significantly improve during the study since 3 months after treatment, and it is maintained up to the end of the study (p < 0.001). By the x-ray analysis of knee, a radiological progression of OA was observed in the 26% of patients at the end of the study, while 88% of patients result to be responder to the therapy classified as per OMERACT-OARSI criteria. The EQ-5D weighted index increased significantly, against baseline, at each study time point (p < 0.001). Investigator's and patient's global assessment of the disease measured by the VAS both show a marked improvement in patient's health conditions. CONCLUSIONS: Results from this study confirm that Hymovis® alleviate the knee pain since the first treatment cycle. The patients treated with two cycles of intra-articular injections of Hymovis® have a progressive pain reduction that is maintained up to one year after the treatment start with improve of all the scores considered in this study. Hymovis® is effective and safe in symptomatic treatment of painful knee OA.