HyalOne® in the treatment of symptomatic hip OA - data from the ANTIAGE register: seven years of observation.

OBJECTIVE: Several studies on knee osteoarthritis suggest that the intra-articular administration of hyaluronic acid products may be a relevant option in the management of patients with persistent pain. The aim of this study is to report the data of efficacy of US-guided HyalOne®/Hyalubrix® 60 injections in a large population of patients with hip osteoarthritis, repeated at least 2 times per year for up to seven years. PATIENTS AND METHODS: This is a prospective, post-marketing, cohort study. Data were collected from the ANTIAGE registry. Values of Lequesne index, pain VAS, NSAIDs intake, global medical and patients assessments were evaluated every six months from the baseline to the end of the follow-up, seven years later. The inclusion criteria were: age ≥18 years, symptomatic hip osteoarthritis of at least 1-year duration, and up to 84 months of follow-up. All the patients received hyaluronic acid injections at least every six months, using ultrasound guidance to ensure accurate placement. RESULTS: 1022 patients were included in the study. The patients were categorized by age classes, gender, and body mass index (BMI). All the groups show a statistically significant reduction at all time points compared to baseline values of Lequesne index, pain VAS, NSAIDs intake, global medical and patients assessments. There are slight differences in the subgroups of overweighted, obese and over 70 years patients. CONCLUSIONS: Our study supports the clinical efficacy and safety of HyalOne®/Hyalubrix®60 in patients affected by osteoarthritis. This is the first study, reporting on a large cohort of patients in different categories with a long follow-up on seven years. The data confirm the proper use of ultrasound-guided viscosupplementation (VS) as background therapy in the management of hip osteoarthritis.

Radiologists and rheumatologists on performing and reporting shoulder ultrasound: from disagreement to consensus.

Shoulder pain is a common condition in the rheumatologist's practice, yet there are no guidelines on how to report shoulder ultrasound (US) examinations. The aim of this study was to compare scanning and reporting techniques performed by radiologists and rheumatologists and identify any discrepancies between the two. The participants in this study were five rheumatologists and two radiologists specialized in musculoskeletal US. The study was divided in 2 phases. In the first phase, each participant performed an US of 3 patients and reported the findings without knowing the patient diagnosis and the findings reported by the other operators. Other three investigators reported the US technique of each operator. Reports and images were subsequently compared to identify any discrepancies and reach consensus on a common approach. In the second phase, a US scan was performed on a fourth patient in a plenary session to assess feasibility and efficacy of the common approach The US scanning technique was similar for all operators. The differences in reporting emerged in the description of the rotator cuff disease. Radiologists provided a detailed description of lesions (measurements along 2 axis and scoring of lesions), whereas rheumatologists described carefully the inflammatory changes. The experts concluded that lesions should be measured along 2 axes and the grade of degeneration and the age of the lesion should be reported. Another difference emerged in the description of the irregularities of the bone surface. The experts concluded that the term erosion should be used only when an inflammatory joint disease is suspected. This study led to the clarification of some inconsistencies in US reporting, and represented an interesting collaborative experience between radiologists and rheumatologists.

Duration of symptom relief after intra-articular injection of hyaluronic acid combined with sorbitol (anti-ox-vs) in symptomatic hip osteoarthritis.

The intra-articular administration of hyaluronic acid (HA) in hip osteoarthritis (OA) has been recently increased following the use of ultrasound guidance to perform an accurate delivery of the injected product. Viscosupplementation in hip OA seems to show similar results to those obtained by viscosupplementation in knee OA. However, an unmet need is the duration of symptomatic relief, therefore several new products are proposed to prolong and increase symptomatic effects. Among these, an innovative viscosupplement has been produced from high a concentration of HA combined with a high concentration of sorbitol as a free radical scavenger. The aim of this study is to evaluate the mid-term pain-relief effect of an ultrasound-guided injection of SynolisV-A (ANTI-OX-VS) in patients suffering from symptomatic hip osteoarthritis. Lequesne index, Health Assessment Questionnaire (HAQ), pain reduction, Global Patient Assessment (GPA), Global Medical Assessment (GMA) and reduction in monthly analgesic consumption were assessed during the 12-month follow-up after the injection. A total of 20 patients were enrolled in the study and received one IA US-guided injection of two syringes of ANTI-OX-VS into the target hip. Eleven drop-out patients were registered, of whom 2 were for loss of efficacy at 6 months, 1 for loss of efficacy at 9 months and 8 patients for severe comorbilities. Mean scores of all clinical parameters evaluated at each control visit were significantly different when compared with baseline mean value. No systemic adverse events were observed. Even though the sample size of this study is limited, the results suggest a durable good efficacy of a 4-ml single injection of ANTI-OX-VS in hip OA, at least for the patients who completed the study. A larger number of patients and an RCT are needed to confirm these data, investigating also the predictive factors of clinical response to ANTI-OX-VS.

Safety of intra-articular hip injection of hyaluronic acid products by ultrasound guidance: an open study from ANTIAGE register.

OBJECTIVE: We developed a standardized technique for ultrasound guided intra-articular injection of the hip joint with the purpose of extending routine intra-articular injection of hyaluronans and steroids to the hip, as commonly used in the knee. In this article we report the safety of this technique in an extended series of patients. PATIENTS AND METHODS: Patients were injected supine with an anterosuperior approach under ultrasound guidance. The Us probe is applied with a target device for biopsy. RESULTS: The standardised technique was used to inject 1906 patients with 4002 injections of hyaluronan products over a four-year period. The treatment was well tolerated with few, and exclusively local, side effects. CONCLUSIONS: The administration of hyaluronans under ultrasound-guided intra-articular injection is a safe technique for treatment of rheumatic diseases of the hip.

May etanercept and PTH (1-34) association heal erosions in early rheumatoid arthritis? A pilot study.

INTRODUCTION: Rheumatoid arthritis (RA) is characterized by the formation in the joints of an inflammatory tissue, which causes the appearance of localized erosions on the margins of the joints. The molecular mechanism that causes the bone erosion is multifactorial. Inflammatory cytokines imbalance and OPG-RANK-L system are involved. OBJECTIVE OF THE STUDY: The aim of the study is to evaluate the possibility of inducing healing or reduction in the number of erosions in Rheumatoid Arthritis patients treated with anti-TNF-alpha adding Teriparatide (PTH1-34) to standard treatment with anti-TNF. PATIENTS AND METHODS: Twenty adult patients with active RA diagnosed according to American Rheumatism Association (ARA) criteria at least 6 months before study begin were enrolled. Only patients affected by established RA (6 to 18 months from symptoms beginning) were recruited. Eligible patients were randomized to receive a standard dosage of etanercept (50 mg/week) or etanercept at same dosage with an addition of teriparatide (20 mg). Evaluation of eventual healing of arthritic erosions by magnetic resonance imaging was performed at time zero and then at twelve months. The following evaluation was assessed at baseline and after 12 months according to the Outcome Measures in Rheumatology Clinical Trials (OMERACT) definitions: number of erosion and presence or absence of synovitis, effusion and bone oedema. A comparative examination of quantitative and qualitative assessment of each parameter was applied. Plain radiographs of the hands were obtained at baseline and 52 weeks. Radiographs were scored blindly using the van der Heijde modification of the Sharp method. Safety of each treatment was evaluated by means of the adverse events (AES) evaluation and report. RESULTS: There were no significant differences in baseline characteristics between the groups. The study did not achieve its primary endpoint of healing erosions. In the active arm no healing of erosions was found. At 52 weeks, there were no new MRI erosions in two arms. Bone oedema scores were significantly improved at 52 weeks in favour of both treatments versus baseline scores, without inter-groups differences. X-ray patterns were unchanged in all patients of both groups. No new erosions or previous erosions' healing were observed. No AEs were reported. Patients from both groups demonstrated a significant reduction in the DAS 28 scores at 52 weeks (p < 0.005) if compared with baseline values. CONCLUSIONS: These data confirm rapid control of inflammation and MRI damage benefits after Etanercept administration without a significant improvement in MRI findings after concomitant addition of teriparatide. Even though these results could seem to suggest to avoid the simultaneous use of these two drugs to treat RA erosions, further studies might be suggested to asses if sequential adminstration of an anabolic agent such as Teriparatide, after achieving clinical remission, may be able to improve bone damage.

The impact of treatment with hylan G-F 20 on progression to total hip arthroplasty in patients with symptomatic hip OA: a retrospective study.

INTRODUCTION: There is scarce data available on intra-articular hyaluronan's ability to modify the progression of osteoarthritis (OA). OBJECTIVE: The purpose of this retrospective pilot study was to assess the impact of treatment with hylan G-F 20 on progression to total hip replacement (THR) in patients with symptomatic hip OA. RESEARCH DESIGN AND METHODS: The records of patients presenting with symptomatic hip OA and treated with hylan G-F 20 were analysed. Endpoints were the number of THRs performed and the survival time (in months) between commencement of treatment and THR, if performed. Endpoints were evaluated for the entire study population and for those sub-groups of patients which were, or were not, defined as candidates for THR prior to intra-articular treatment. Predictive factors of progression to THR were also assessed. RESULTS: A total of 850 patients' records were evaluated and 224 patients' data were included in the study and evaluated. Eighty-four patients (37.5%) progressed to THR, 206 patients (92.0%) achieved 12 months survival, 170 patients (75.9%) achieved 24 months survival, and 69 patients (30.8%) achieved 5 years survival. Mean survival time was 36 months. Classification as a THR candidate, Lequesne score, ultrasound pattern and the presence of diabetes were predictive factors for progression to THR. CONCLUSIONS: These results suggest that hylan G-F 20 could be included in the management of symptomatic hip OA before recommendation for THR, particularly in patients presenting with milder symptoms, or in patients where, due to comorbidities or personal choice, THR is not a feasible option. Limitations of this study include the retrospective study design and the lack of a control group to determine any placebo effect of hylan G-F 20. Further prospective studies are therefore needed to corroborate these results.

Hip viscosupplementation under ultra-sound guidance riduces NSAID consumption in symptomatic hip osteoarthritis patients in a long follow-up. Data from Italian registry.

INTRODUCTION: Non-steroidal anti-inflammatory drugs (NSAIDs) consumption is strictly related to a high gastrointestinal and cardiovascular mortality and morbidity rate. Osteoarthritis Research Society International (OARSI) recommendations in patients with symptomatic hip or knee OA stated that NSAIDs should be used at the lowest effective dose but their long-term use should be avoided if possible. OARSI guidelines for the treatment of the hip OA include the use of viscosupplementation, which aims to restore physiological and rheological features of the synovial fluid. OBJECTIVE: Aim of this multicentric, open and retrospective study is to investigate if NSAID consumption may be reduced by the use of ultrasound-guided intra-articular injection of several hyaluronic acid (HA) products in hip joint administered in patients affected by symptomatic hip OA. MATERIALS AND METHODS: Patients affected by mono or bilateral symptomatic hip OA according to American Rheumatology Association (ARA) criteria, radiological OA graded II-IV (Kellgren and Lawrence) entered the study and were administered with ultrasound-guided intra-articular injection of hyaluronic acid products. As a primary endpoint, consumption of NSAIDs was evaluated by recording the number of days a month (range 0-30) the patient had used NSAID during the previous month, reported at each visit during the 24 months follow-up period. Secondary endpoints included further analysis for subgroups of patients categorized for Lequesne index score, Kellgren-Lawrence score, pain visual analogue scale (VAS) score, ultrasound pattern, age, hyaluronic acid used. RESULTS: 2343 patients entered the study. Regarding primary endpoint, the consumption of NSAIDs was reduced of 48.2% at the third month when compared with baseline values. This sparing effect increased at 12th and 24th month with a reduction respectively of 50% and 61% in comparison to baseline values. These differences were statistically significant. CONCLUSIONS: These data point out that intraarticular hyaluronan preparations provide OA pain relief and reduce NSAIDs consumption in a large cohort of patients for a long period of follow-up. Multiple courses of viscosupplementation (vs) are required to maintain low dose of NSAID consumption over time. NSAIDs consumption is strictly related to an high gastrointestinal and cardiovascular mortality and morbidity rate, instead HA intra-articular treatment is well tolerated and is associated with a low incidence of adverse effects. For these reasons further studies evaluating cost-effectiveness and cost-utility of VS in the management of hip OA are required.

A new technical contribution for ultrasound-guided injections of sacro-iliac joints.

INTRODUCTION: Sacroiliac joint (SIJ) represents a difficult location for local therapies, as intra-articular injections may be hard to execute, especially in particular conditions such as chronic inflammatory diseases. However, in selected patients, local therapies may be considered. Some recent studies demonstrated the feasibility of ultrasound (US)-guided injection of SIJ, but still a complete explanation and definition of the technique is needed. MATERIALS AND METHODS: Seven patients, four males and 3 females, affected by mono or bilateral sacroiliitis entered the study. Each patient received 40 mg of acetonide triamcinolone for each SIJ, intra articular (IA) US-guided injection. The technical originality proposed in this study consists in the spinal needle insertion in the middle of the cranial long side of the linear transducer with an orientation of about 10 degrees, determining shorter needle insertion for reaching joint space and consequently probably granting lesser pain and traumatism for patients. RESULTS: A total of 22 injections was performed. The longer follow-up time obtained was 18 months in 3 patients. All patients reached at least a 6 month follow-up. All patients reported an amelioration in pain that lasted for at least 6 months. No systemic adverse events were reported or observed. Complete visualization of SIJ and of needle placement was performed by US imaging, while compound proper injection was also visualized by Color-Doppler US imaging. DISCUSSION: Actually, sacroiliac joint intraarticular injections are often performed under fluoroscopy or Computerized Tomography guidance. Such techniques present several limitations, especially for repeated injections, such as the use of ionizing radiations, the need of a contrast agent and the direct and indirect costs connected. US guidance in IA SIJ injections may represent an easily repeatable imaging technique for needle placement and a precious tool for detecting inflammatory activity of the joint.

Viscosupplementation: a suitable option for hip osteoarthritis in young adults.

INTRODUCTION: Young adult hip osteoarthritis (OA) is a noteworthy problem, although rarer than the elderly form of the disease, causing limitations in social and working activities and prospects. Treatment options are scarce and surgical procedures, frequently necessary, imply the major drawback of revising the prostheses periodically, whereas chronic nonsteroidal anti-inflammatory drugs (NSAID) consumption may provoke side effects. To explore alternative options to both surgery and long-term NSAID use, especially in the case of young patients, viscosupplementation seems to appear as an appropriate tool to relieve pain, ameliorate the function and delay surgery. AIM OF THE STUDY: In this study we tackle the issue of the use of hyaluronic acid (HA) injections in young adults with symptomatic hip OA. RESULTS AND CONCLUSIONS: These data, collected from 78 young patients, show that viscosupplementation is a safe procedure, and may provide significant relief from pain and functional recovery. Larger controlled studies are needed to establish otpimal treatment strategies and clinical factors predictive of treatment response.

[Correlation between radiologic and ultrasonographic patterns and clinical manifestations in symptomatic hip osteoarthritis]. / Correlazione tra quadro clinico e patterns radiologici ed ecografici in pazienti affetti da artrosi sintomatica dell'anca.

Increasing amounts of data have recently been published regarding ultrasonographic (US) findings of osteoarthritic joints, but very few data concern hip joints. In the current study we described US patterns concerning 490 patients affected by symptomatic hip osteoarthritis (OA) who underwent to intra-articular injections of hyaluronic products under US guidance. All patients were studied by US and X-ray of hip, clinical evaluation was assessed by the followings indexes: Lequesne, pain VAS, ICED, Global Physician Assessment and Global Patient Assessment. US findings were summarized in four main patterns, effusion and synovial proliferation were also detected. The aim of this study was to correlate US findings with clinical assessment and radiographic findings (according to Kellgren-Lawrence classification). Pearson's r correlation coefficient were computed and come out significant and positive between X ray and US patterns and between clinical indexes and US patterns. Also the correlation between K-L score and US patterns showed a significant positive correlation indicating that higher K-L scores are associated with increasing abnormal US findings. Our data suggest that ultrasonography of the hip may give useful information about the state of synovial membrane, synovial fluid, joint margins and bone profile in hip OA. Further studies are needed to evaluate their prevalence in hip OA symptomatic and not-symptomatic patients and their correlation to treatment outcome.

[Intra-articular treatment with Hylan G-F 20 under ultrasound guidance in hip osteoarthritis. Clinical results after 12 months follow-up]. / Terapia intra-articolare con acido ialuronico (Hylan G-F 20) sotto guida ecografica nell'artrosi dell'anca. Risultati clinici a 12 mesi.

Hip is a site very commonly affected by osteoarthritis (OA), yet few data exist in literature regarding intra-articular use of hyaluronic acid in this pathology. We evaluated the efficacy of Hylan G-F 20 hip viscosupplementation performed under ultrasound guidance. We enrolled 26 patients affected by symptomatic hip OA and treated them with a single intraarticular injection of Hylan G-F 20, which could be repeated every two months. The injection was performed under ultrasound guidance with an antero-superior approach. Treatment efficacy was assessed through Lequesne index, visual analogue scale (VAS) pain quantification, and NSAID intake at the timepoint zero (baseline), and after 2, 6 and 12 months. We observed a statistically significant reduction of all considered parameters at the timepoints 2 and 6 months, when compared to baseline. At 12 months the changes were still statistically significant for all parameters for about 50% of the patients. No side effect was observed, nor systemic complication. Viscosupplementation is a promising approach for hip OA, although further and wider studies are wanted to determine how long the beneficial effect lasts, and what is the optimal number of injections to administer.

[Safety profile of 185 ultrasound-guided intra-articular injections for treatment of rheumatic diseases of the hip]. / Profilo di sicurezza di 185 iniezioni intra-articolari sotto guida ecografica nelle coxopatie.

OBJECTIVE: We have developed a standardized technique for intra-articular injection of the hip joint with the purpose of extending routine intra-articular injection of hyaluronans and steroids to the hip, as commonly used in the knee. The purpose of this study was to examine the safety of this technique in an extended series of patients. METHODS: A 7 MHz linear or 3.5 MHz convex transducer was used with a sterilized biopsy guide attached. Intra-articular (IA) injection was performed by inserting into the biopsy guide a 20 gauge needle with the anterosuperior approach. Then, using biopsy real-time guidance software, the needle was advanced into the anterior capsular recess, at the level of the femoral head. RESULTS: The standardised technique was used to inject 97 patients (114 hips) with 185 injections of either steroid/local anaesthetic (10) or hyaluronan (175) over a three-year period. The treatment was well tolerated with few, and exclusively local, side effects. No systemic side effects or joint infections were observed in our study. The colour Doppler vision allowed us to avoid injecting blood vessels. In all cases direct visualization of needle introduction and progression into the articular space was shown by on-screen guidance. Ultrasound guidance is more economic and faster in comparison to the TC or fluoroscopic guidance. Contrary to TC or fluoroscopic techniques ultrasound does not require use of radiations or iodized contrast. CONCLUSION: Our data suggest that the administration of hyaluronans or steroids with ultrasound-guided intra-articular injection is a safe technique for treatment of rheumatic diseases of the hip.

[Meniscal deformities associated with fractures of the tibial proximal extremity. Considerations in 7 cases]. / Deformazioni meniscali associate a fratture dell'estremo tibiale prossimale. Considerazioni su 7 casi.

Lateral tibial plateau fractures are a fairly frequent event in emergency clinical practice. In these fractures, when bone depression exceeds 5 mm, surgery is indicated. On the rule, conventional plain films combined with tomography can answer diagnostic questions about bone trauma. CT and MRI permit to study associated meniscocapsular injuries for better therapeutical management. Since February, 1991, we have examined 24 patients with tibial plateau fractures with conventional radiography and CT. CT was performed using thin sections, within 0 to 48 hours of the traumatic event. In our series, 7 patients had a lateral meniscal trauma associated with a fracture of the homologous tibial plateau; in all of these 7 women, surgery confirmed complete meniscal avulsion. In these cases, CT showed the following signs of meniscocapsular disinsertion: marked diastasis between capsular structure, popliteal tendon and meniscal profile; associated hypodense hemorrhagic fluid in the popliteal recess; inhomogeneous densitometry of the popliteal tendon resulting from hemorrhagic infarction. Furthermore, CT showed a characteristic and constant morphological alteration of the lateral meniscus with fibrocartilage deformation, that is with a wider or more narrow pattern relative to its normal "C"-like shape. We conclude that this morphological alteration of meniscal fibrocartilage, when associated with a tibial fracture, is a diagnostic CT sign of complete meniscal avulsion. This finding can be a useful integration to other CT signs of this meniscal injury, towards better and more complete therapeutical management.