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Background: There is conflicting evidence regarding the efficacy of viscosupplementation with intra-articular hyaluronic acid injections in knee osteoarthritis. One possible explanation for the inconsistent findings on its efficacy is that only certain subpopulations of patients benefit from this therapy., Objective: The purpose of this narrative review is to succinctly summarize the existing data on the predictive factors of clinical response to intra-articular hyaluronic acid to identify the patient profile most likely to benefit from this therapy., Methods: For this narrative review, a PubMed search was conducted in January 2023, with no date limits, to identify publications reporting predictive factors of response to viscosupplementation using the following terms: hyaluronic acid OR viscosupplem* AND osteoarthritis AND knee AND predict*. Searches were limited to randomized controlled trials, systematic reviews and meta- analyses, or observational studies written in English. Other relevant references were identified by searching the references of retrieved articles., Results: The disease severity was found to reliably predict response to intra-articular hyaluronic acid injections; patients with less severe disease consistently had a more robust therapeutic response than those with more severe disease. Other clinical variables such as level of baseline pain did not reliably predict response. Body mass index, and possibly age, may also be independent predictors of the response., Conclusion: A review of the existing literature suggests that patients with less severe clinical symptoms and radiological findings, who are younger, and with a lower or normal body mass index are the best candidates for intra-articular hyaluronic acid therapy., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)

Objectives: Up to 50% of patients with symptomatic knee osteoarthritis (OA) present with neuropathic pain (NP) features. We assessed the impact of NP according to DN4 (Douleurs Neuropathiques 4 questions) score on the response to intra-articular (IA) hyaluronic acid (HA) injections and the effects of HA injections on NP., Materials and Methods: We conducted a post hoc analysis from a multicenter, randomized, double-blind, noninferiority trial comparing the efficacy of 2 HA in symptomatic knee OA at 24 weeks. At baseline, demographic, anthropometric, radiologic data, and symptoms were recorded. The symptomatic effect of HA was assessed by VAS pain, patient global assessment (PGA), WOMAC, DN4, and OMERACT-OARSI response., Results: A total of 187 patients were included. NP according to DN4 score was present in 20 patients (10.7%) at baseline. Most common positive DN4 items were tingling (36.9%) and burning (36.4%). NP was associated with WOMAC pain score ( P = 0.02). The presence of NP at baseline did not affect the symptomatic improvement after HA injections according to the VAS pain ( P = 0.71), PGA ( P = 050), WOMAC pain ( P = 0.89), WOMAC function ( P = 0.52), and rate of OMERACT-OARSI responders ( P = 0.21). The prevalence of patients with NP decreased by 50% ( n = 10) at 24 weeks after HA injections. Most improved DN4 items were itching (90%), hypoesthesia to pinprick (88%), and burning (50%)., Conclusion: In our study, NP was associated with pain severity, but did not influence the response to IA HA. On the other hand, HA injections reduced some NP features, especially itching, sting hypoesthesia, and burning.

Objectives: The 3 aims of the work were to identify population subgroups that can benefit the most from viscosupplementation (VS), to provide recommendations on injection techniques, and to discuss VS appropriateness in clinical situations that are commonplace in daily practice., Methods: The task force members voted on their degree of agreement on 27 statements, 36 recommendations, and 22 clinical scenarios using a 9-point scale. The strength of agreement/appropriateness/recommendation (SOA/SOR) was classified as strong if the median agreement score was ≥8. The level of consensus (LOC) was also obtained., Results: Among the assumed predictors for VS failure, obesity, radiographic severity, large synovial fluid effusion, severe patellofemoral involvement, major malalignment, and gross joint instability received a large majority of agreements. The lateral mid-patellar approach was recommended for knee injection. Imaging guidance was unanimously recommended for hip and ankle. Agreement was achieved to strictly respect the dosing regimen proven by controlled trials. There was agreement for treating with VS patients with mild to moderate knee and hip OA, with normal weight or moderate overweight, insufficiently improved by first-line therapies, or who do not wish get oral treatment or who have contraindications to pain killers. The group considered the patient's wishes as a key element in therapeutic decision making., Conclusion: Based on literature data and clinical experience, the EUROVISCO group proposed a set of recommendations for optimizing the results of VS, aimed to help practitioners, especially in some cases in which the patients' specificities make the therapeutic decision difficult.

Objectives: Hyaluronic acid viscosupplementation is a commonly used intra-articular treatment for osteoarthritis (OA). Some recent preclinical and clinical trials have demonstrated a potential for its disease-modifying effects. The goal of this expert opinion, consensus-driven exercise is to provide guidelines for the design and conduct of clinical trials assessing the disease-modifying effect of viscosupplementation in the knee., Methods: The EUROVISCO group constitutes 10 members who had expertise in clinical research methodology in the field of OA and viscosupplementation. They initially drafted issues through an iterative process and had to vote on their degree of agreement on these recommendations. The scores were pooled to generate a median agreement score for each recommendation., Results: The document includes 31 recommendations regarding study population, imaging, clinical and biological assessment of disease-modifying effects of viscosupplementation. Agreements were reached on some recommendations. In particular, the experts reached unanimous agreement on double-blind study design, imaging primary outcomes, time interval between 2 radiographs, x-ray procedure standardization, and the combined use of imaging and biological markers. The group did not recommend the use of ultrasonography, computed tomography (CT) scan and CT arthrography as a tool for OA diagnosis or to assess progression over time., Conclusion: In summary, the working group identified 31 recommendations that represent the current best practices regarding clinical trials that target the assessment of viscosupplementation disease-modifying effects in patients with knee OA. These recommendations integrate new imaging technologies and soluble biomarkers.

Knee osteoarthritis -OA- is one of the most common musculoskeletal diseases. It frequently induces intense pain and functional impairment. To date, there is no treatment able to slow down the structural progression. Only the symptomatic part of knee OA is accessible to treatment. The management should be global including non-pharmacological treatments -weight loss, physiotherapy, physical exercises, orthoses, braces- and pharmacological treatments combining general and local treatments. In this review, we will discuss the benefits and risks of the main oral treatments -acetaminophen, non-steroidal anti-inflammatory drugs, weak and strong opioids- and local treatments including topics -local anti-inflammatory drugs, capsaicin- and intra-articular injections of corticosteroids, hyaluronic acid and platelet- rich plasma. The potential interest of joint irrigation will also be mentioned. Finally, we will propose a therapeutic strategy encompassing these different treatments., Competing Interests: F. Eymard déclare des liens ponctuels avec Regenlab, BMS et Pfizer et avoir été pris en charge lors de congrès par Novartis et Roche. X. Chevalier déclare des liens ponctuels avec IBSA, Pfizer, Dielen et Labrha et avoir été pris en charge lors de congrès par Nordic Pharma et Labrha.

Background Viscosupplementation (VS) is a symptomatic treatment of knee osteoarthritis. Although systematic reviews of its repeat use showed favorable benefit/risk ratio, no study has focused on the indication of retreatment. Methods A task force was created to look at issues regarding retreatment with VS in knee osteoarthritis. An attempt was made to reach consensus on several issues: (1) to define treatment "success" and "failure," (2) to determine when to retreat patients successfully treated by a previous VS, (3) to determine how to retreat patients in whom VS failed, (4) to define what to do in case of adverse reaction following previous VS, and (5) to examine the interests of soluble biomarkers to manage retreatment. After debate and review of literature the working group voted on 88 issues. Two "decision trees" were built based on the results of the votes. Results In case of failure, the authors draw attention to the need of a rigorous clinical and radiological analysis, and consider evidence-based medicine. When VS was previously successful, retreatment can be considered after recurrence or increase in pain. However, in subjects with high risk of disease progression, in young patients, and in professional sportsmen, retreatment could be considered systematically, because of the probability of hyaluronic acid to slow osteoarthritis progression. Evidence on soluble biomarkers was not considered as enough strong to support their use as decision tools for patient retreatment. Conclusion The decision algorithms are intended to facilitate consideration of the therapeutic options, in patients with knee osteoarthritis previously treated with VS.

Background: Viscosupplementation is a symptomatic treatment of the knee osteoarthritis based on the intra-articular injection of hyaluronic acid (IAHA). Although many studies have investigated its effect on symptoms, few clinical studies have focused on its effects on biologicals markers of cartilage metabolism. In this study, we assessed the effect of an intra-articular injection of a reticulated hyaluronic acid compound on the level of a specific biomarker of type II collagen degradation., Methods: Eighty one patients with symptomatic knee osteoarthritis were included in this randomized placebo controlled trial testing a reticulated hyaluronic acid (HA) with mannitol (KARTILAGE® CROSS, 16 mg/ml, one single injection of 2.2 mL; IAHA) versus saline solution. Primary outcome was the percentage of patients with a reduction of at least 10 nmol/l of serum Coll2-1 between baseline and day 90 (D90, 3 months after injection). Secondary outcomes concerned clinical evaluation and tolerance to the study product., Results: A significant effect of IAHA was revealed by the sensitivity analysis of the decrease in cartilage marker. In the intention-to-treat population, the percentage of patients showing a decrease in the levels of serum Coll2-1 between inclusion and D90 showed was higher in HA (56.8%) than in placebo group (28.6%; P = 0.01). The same significant difference was observed between groups in the per protocol population (57.1% vs 29.0%; P = 0.02) corresponding to all patients having received the intra-articular injection (IA), being evaluated for the primary outcome on D-10 and D90, and with no major defined deviation. No significant differences between groups were observed on the changes in function (Lequesne index) or pain and on the number of adverse events., Conclusions: This is the first randomized double-blind placebo controlled trial showing that IA injection of reticulated HA with mannitol in knee osteoarthritis patients can reduce the serum levels of Coll2-1, a marker specific of type II collagen degradation. This finding suggests that IAHA may have a beneficial effect on cartilage degradation and that Coll2-1 could be used for the assessment of a single intra-articular treatment in clinical trials., Trial Registration: NCT02951585 ; clinicaltrial.gov. Retrospectively registered on October 28, 2016.

Background: To compare both safety and efficacy of a novel intra-articular viscosupplement made of intermediate molecular weight (MW) hyaluronic acid (HA) mixed with high concentration of mannitol with a marketed high MW HA, in patients with knee osteoarthritis (OA)., Methods: Patients with symptomatic knee OA, with radiological OARSI grades 1 to 3, were enrolled in a controlled, double-blind, parallel-group, non-inferiority trial. They were randomized to receive three intra-articular injections, at weekly intervals, of either HAnOX-M made of a combination of HA (MW one to 1.5MDa, 31mg/2ml) and mannitol (70mg/2ml) or Bio-HA (MW 2.3 to 3.6MDa, 20mg/2ml). The primary outcome was six-month change in the WOMAC pain subscale (0 to 20). Sample size was calculated according to a non-inferiority margin of 1.35. Secondary endpoints included six-month change in function and walking pain, analgesic consumption and safety., Results: The intention-to-treat (ITT) and per-protocol (PP) populations consisted of 205 and 171 patients. HAnOX-M and Bio-Ha groups did not differ statistically at baseline. The primary analysis was conducted in the PP population, then in the ITT population. The average WOMAC pain score at baseline was 9.5 in both groups. Mean (SD) variations in WOMAC pain score were -4.4 (3.8) and -4.5 (4.3) mm, for HAnOX and Bio-HA respectively, satisfying the claim for non-inferiority. Similar results were obtained for all other secondary endpoints., Conclusion: Treatment with of HAnOX-M is effective to alleviate knee OA symptoms and to improve joint function over six months, with similar safety than conventional HA viscosupplement., (Copyright © 2016. Published by Elsevier B.V.)

Viscosupplementation (VS) with hyaluronic acid is currently used by physicians to treat osteoarthritis. However, many aspects of this treatment remain questionable and subject of controversy. A group of 8 experts in this field, from European countries, met to debate on 24 statements previously listed by the group members. Based on an extensive research of the literature and expert opinion, a consensus position has been proposed for each statement. Agreement was achieved on some recommendations. In particular, the expert achieved unanimous agreement in favor of the following statements: VS is an effective treatment for mild to moderate knee OA; VS is not an alternative to surgery in advanced hip OA; VS is a well-tolerated treatment of knee and other joints OA; VS should not be used only in patients who have failed to respond adequately to analgesics and NSAIDs; VS is a "positive" indication but not a "lack of anything better" indication; the dosing regimen must be supported by evidence-based medicine; cross-linking is a proven means for prolonging IA residence time of HA; the best approach to inject accurately knee joint is the lateral mid-patellar one; when VS is performed under fluoroscopy, the amount of radiopaque contrast agent must be as low as possible to avoid viscosupplement dilution. These clear recommendations have been established to help practitioners in the use of viscosupplementation., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Recently AAOS, ACR and OARSI revised their recommendations for the management of knee osteoarthritis (OA) and for hand, knee and hip joints. During ISIAT (International Symposium on Intra-Articular Treatments) 2013 round table on recommendations about the use of intra-articular Hyaluronic Acid (IAHA) in OA, several considerations were elaborated by the ISIAT Technical Expert Panel (TEP) regarding discrepancy between recommendations and clinical practice. The ISIAT TEP gathered the following eight suggestions regarding the drawing of recommendations on the use of IAHA in OA and its comparison with other treatments. It is necessary to merge data coming from both RCTs and registers. Only studies with a strong level of evidence should be taken into account. A common threshold of efficacy should be assessed for comparing treatments. Evaluation of hard outcomes is essential. The effect size of placebo as comparator should be attentively considered in RCTs. Particular attention should be given to different phenotypes of OA that may possibly respond differently to each treatment. Compliance and long-term side effects of different therapeutic approaches should be evaluated. Pharmacoeconomic evaluation should be performed on the long term.

To measure the evolution of the serum levels of specific Osteoarthritis (OA) biomarker, Coll2-1 and Coll2-1 NO₂ in knee osteoarthritic patients after viscosupplementation (VS). Fifty-one patients with unilateral symptomatic knee were recruited for this prospective open label study. They received three intra-articular injections of 2 ml of hyaluronic acid (Hylan GF-20) and were followed for 3 months. Walking pain was evaluated and serum samples were taken at each visit. Coll2-1 and Coll2-1 NO₂ were measured in the serum using specific immunoassays. Variations over time of each parameter and predictive factor of response were studied. Forty-five patients were analyzed. The serum concentrations of Coll2-1 and Coll2-1 NO₂ were significantly higher in KL III/IV patients compared to KL I/II patients at baseline and decreased systematically over time after VS. Its effect was ever more pronounced in patients with KL III/IV. The serum concentration of Coll2-1 was significantly lower at baseline in responders than in non-responders. This study suggests a rapid slowdown of type II collagen degradation and joint inflammation after VS with Hylan G-20 and gives additional information for the validation of accurate biomarkers for OA. The serum level of Coll2-1 appeared to be a predictive factor for response to treatment., (Copyright © 2013 Orthopaedic Research Society.)

Objectives: To compare the effects of an intermediate molecular weight (MW) intra-articular hyaluronic acid (HA) with a low MW product on knee osteoarthritis (OA) symptoms., Methods: Patients with symptomatic knee OA were enrolled inarandomised, controlled, double-blind, parallel-group, non-inferiority trial with the possibility to shift to superiority. Patients were randomised to GO-ON(MW 800-1500 kD, 25 mg/2.5 ml) or Hyalgan(MW 500-730 kD, 20 mg/2 ml) injected at 3-weekly intervals. The primary outcome was 6-month change in the WOMAC pain subscale (0-100 mm). Sample size was calculated on a non-inferiority margin of 9 mm, lower than the minimum perceptible clinical improvement. Secondary endpoints included OARSI-OMERACT responder rates, Results: The intention-to-treat (ITT) and per-protocol (PP) populations consisted of 217 and 209 patients and 171 and 172 patients in the GO-ON and Hyalgan groups, respectively. ITT WOMAC pain of 47.5±1.0(SE) and 48.8±1.0 mm decreased by 22.9±1.4 mm with GO-ON and 18.4±1.5 mm with Hyalgan after 6 months. The primary analysis was conducted in the PP population followed by the ITT population.Mean (95% CI) differences in WOMAC pain change were 5.2 (0.9 to 9.6)mm and 4.5 (0.5 to 8.5)mm, respectively,favouring GO-ON, satisfying the claim for non-inferiority (lower limit>-9 mm) and for statistical superiority (95% CI all>0, p=0.021). Ahigher proportion of OARSI/OMERACT responders was observed with GO-ONthan with Hyalgan (73.3% vs58.4%, p=0.001). Both preparations were well tolerated., Conclusions: Treatment with 3-weekly injections of intermediate MW HA may be superior to low MW HA on knee OA symptoms over 6 months, with similar safety.

The aim of the study was to investigate the effect of hyaluronic acid (HA) intra articular injections (IA) on osteoarthritis (OA) biomarkers in patients with knee OA. Prospective open label study. Fifty-one patients with unilateral symptomatic K-OA received IA injections of 2mL of HA on days (D) 1, 7, 14 and were followed 3 months. At D-15 patients were examined and X-rays performed, to exclude patients with bilateral K-OA, or those with more than three symptomatic OA joints. From 15 days (D-15) before the first injection to D90 concomitant therapies were unchanged. Walking pain (WP) on VAS was obtained at each visit. Urine (U) and serum (S) samples were obtained at D-15, D1, D30, and D90. S-C2C, S-Cartilage oligomeric matrix protein, S-HA, S-CS 846 epitope, S-type II collagen propeptide, and U-type II collagen C telopeptide (U-CTX II/creatinin) were assayed. Predictive factors of response were analyzed using logistic regression. Correlations between variables were obtained using Spearman test. Forty-five patients were analyzed. Between D-15 and D1 there was no difference for any biomarkers At D1, WP (SD) was correlated with U-CTX II/creat (p = 0.006). Between D1 and D90: U-CTX II/creat decreased significantly. After adjustment for confounding variables there was a significant correlation between clinical response and U-CTX II/creat variation. U-CTX II and S-HA at baseline were independently predictive of clinical response. This study showed that 90 days after HA IA injections, U-CTX II levels significantly decrease compared to baseline, suggesting a slowdown of type II collagen degradation., (Copyright © 2011 Orthopaedic Research Society.)

Objectives: The primary objective was to compare a single, 6 ml, intra-articular injection of hylan G-F 20 with placebo in patients with symptomatic knee osteoarthritis. The safety of a repeat injection of hylan G-F 20 was also assessed., Methods: Patients with primary osteoarthritis knee pain were randomly assigned to arthrocentesis plus a 6 ml intra-articular injection of either hylan G-F 20 or placebo in a prospective, double-blind (one injector/one blinded observer) study., Results: were evaluated at 4, 8, 12, 18 and 26 weeks post-injection. The primary outcome criterion was change from baseline over 26 weeks in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index A pain. Secondary outcome measures included WOMAC A1 and C, patient global assessment (PGA) and clinical observer global assessment (COGA) and Outcome Measures in Rheumatology, Osteoarthritis Research Society International responder rates. A 4-week, open, repeat treatment phase evaluated safety only. Results: A total of 253 patients (Kellgren-Lawrence grade II or III) was randomly assigned. Patients receiving hylan G-F 20 experienced statistically significantly greater improvements in WOMAC A pain scores (-0.15, SE 0.076, p = 0.047), and several of the secondary outcome measures (WOMAC A1, PGA and COGA), than patients receiving placebo. There was no difference between the safety results of the two groups. No increased risk of local adverse events was observed in the open, repeat treatment phase., Conclusions: This placebo-controlled study demonstrated that, in patients with knee osteoarthritis, a single 6 ml intra-articular injection of hylan G-F 20 is safe and effective in providing statistically significant, clinically relevant pain relief over 26 weeks, with a modest difference versus placebo.

Introduction: Viscosupplementation by repeated intra-articular injections of hyaluronic acid (HA) is used widely in the treatment of symptomatic knee osteoarthritis (OA). The number of injections required can limit the availability of treatment and affect patient compliance. The aim of this study was to assess different dosing regimens of hylan G-F 20, a high molecular-weight cross-linked derivative of HA, in the treatment of pain due to knee OA., Materials and Methods: Pilot, prospective, multi-centre, open-label, randomised trial in 100 patients with unilateral, symptomatic, tibio-femoral OA (Kellgren-Lawrence grade II or III), aged > or =40 years. Patients were randomised to receive varying dosing regimens of hylan G-F 20 (1 x 6 mL, 1 x 4 mL, 2 x 4 mL 2 weeks apart, 3 x 4 mL 1 week apart, or 3 x 2 mL 1 week apart). Adverse events (AE's) were monitored throughout the study. The primary efficacy endpoint was the change from baseline in the patient-rated knee OA pain assessment (100 mm visual analogue scale (VAS)) at 24 weeks. The secondary efficacy criteria included the WOMAC index, patient and physician global assessments using a 100 mm VAS, and knee OA pain assessment at all other visits. Concomitant use of permitted rescue medications (paracetamol) was also assessed., Results: The treatment was well tolerated overall. Patients in the 3 x 4 mL group reported the highest percentage of device-related local AE's (30%) while patients in the 1 x 6 mL and 3 x 2 mL groups reported only 10%. There were no serious device-related AEs. There was a statistically significant improvement from baseline at week 24 in all efficacy endpoints for all treatment regimens. The 1 x 6 and 3 x 4 and 3 x 2 mL treatment groups showed the greatest mean improvements (-34.9, -32.6 and -36.7 mm respectively) in the patient-rated knee OA pain assessment VAS., Conclusion: This study suggests that a single 6 mL injection of hylan G-F 20 may be as efficacious, and as well tolerated, as 3 x 2 mL one week apart. A double-blind, controlled trial is needed to confirm these data.

Objective: To evaluate the efficacy and tolerability of a single intraarticular (IA) injection of hyaluronic acid (HA) for the treatment of hip osteoarthritis (OA)., Methods: A multicenter, randomized, parallel-group, placebo-controlled trial was conducted over 3 months. Patients (older than 30 years) with symptomatic hip OA (pain score of >40 mm on a visual analog scale [VAS]) and a Kellgren/Lawrence grade of 2 or 3 were randomly assigned to receive 1 fluoroscopically guided IA injection of HA (2.5 ml) or placebo (2.5 ml). Patients were followed up for 3 months. The main outcome measure was pain score on a VAS (100 mm) at month 3 compared with baseline. Secondary outcome measures were the proportion of responders defined by Osteoarthritis Research Society International criteria; Western Ontario and McMaster Universities Osteoarthritis Index subscores for pain, stiffness, and disability; and patient and physician global assessment. Randomization was computer generated. HA and placebo preparations were placed in numbered identical containers, and syringes were covered with masking tape. Physicians assessing outcomes were blinded with regard to group assignment., Results: Eighty-five patients were randomized to the HA group (n = 42) or placebo group (n = 43). Baseline characteristics were similar between the 2 groups. At 3 months, the decrease in pain score did not differ between the HA and placebo groups in the intent-to-treat analysis (mean +/- SD decrease 7.8 +/- 24.9 mm with HA versus 9.1 +/- 27.4 mm with placebo; P = 0.98). The responder rates were 33.3% and 32.6% in the HA and placebo groups, respectively (P = 0.94). Other secondary end points did not differ between the groups, nor did use of rescue medication or frequency of adverse events., Conclusion: Our findings indicate that a single IA injection of HA is no more effective than placebo in treating the symptoms of hip OA.

Background: Osteoarthritis is the most frequent musculoskeletal disease and a major cause of disability in the elderly. Knee osteoarthritis is the first cause of consultations for osteoarthritis-related symptoms. Its current management requires the combination of pharmaceutical and non-pharmacological strategies, including intra-articular injections of hyaluronic acid that are aimed at decreasing pain and improving joint function by restoring joint homeostasis (viscosupplementation). Hylan GF-20 is a cross-linked hyaluronic acid derivative, FDA approved as a medical device since 1997 for the treatment of patients with symptomatic knee osteoarthritis., Objectives: This review aims to summarise recently published evidence and offer practical suggestions to clinical colleagues who are considering including viscosupplementation in their practices., Methods: The authors reviewed extensively the published papers on the topic, but selected only those that appeared to be the most relevant, on the mechanisms of action, efficacy and safety of the treatment, clinical predictors of response, ideal dosing regimen and differences between commercial preparations. They also give their own clinical experience with hylan GF-20 as a symptomatic treatment of knee osteoarthritis., Conclusion: Data of the literature clearly demonstrate that hylan GF-20 is a safe and effective treatment for decreasing pain and improving function in patients suffering from knee osteoarthritis. Its long-term (10 years) use allows knowing with accuracy the main indications, contraindications, side effects and prognostic factors of response, which are all extensively discussed throughout this review.

Objective: To assess, using the OMERACT-OARSI criteria, the clinical response of patients presenting with symptomatic hip osteoarthritis (OA) to one intra-articular injection of hylan G-F 20., Methods: Open-label, multi-centre, prospective, pilot study. Fifty-six patients presenting with primary hip OA, Kellgren-Lawrence grade II-III, age > or =40, with walking pain measuring 50-90 mm on a 100 mm visual analogue scale (VAS). Intra-articular injection of a single 2 ml dose of hylan G-F 20 into the hip joint under fluoroscopic guidance. A second injection could be administered at day (D) 30, 60 or 90 if pain was unchanged or returned to baseline levels. EFFICACY CRITERIA: The outcome of the first injection in the intent-to-treat (ITT) population was analysed 90 days after the injection in those patients that received a single injection, and on the day of the second injection in those patients that required two injections, using OMERACT-OARSI responder criteria (obtained from WOMAC A and C indices and the patient's global evaluation) and variation in walking pain on VAS., Results: The percentage of responders according to the OMERACT-OARSI response criteria was 53.6%. An inverse correlation was observed between reduction in pain and joint space narrowing score (P=0.03)., Conclusion: In the absence of a control group, the efficacy of the treatment cannot be determined conclusively. Nevertheless these data suggest that hylan G-F 20 is a symptomatic treatment of hip OA, particularly in less severe radiological cases. A double-blind, controlled study is required to confirm these data.

Objective: To obtain prospective data on feasibility and safety of intra-articular injections of hylan G-F20 in patients with symptomatic hip osteoarthritis (OA)., Methods: Fifty-seven patients with primary hip OA, Kellgren-Lawrence grade II-III, aged > or = 40 and walking pain 50-90 mm on a visual analogue scale (VAS) were enrolled in an open-label, multicentre pilot trial. Hylan G-F20 (2 ml) was injected intra-articularly (IA) in the hip under fluoroscopy at D0, and follow-up visits were performed at D7-30-60-90. The possibility of a second injection at D30-60 or 90 was considered if the reported pain level was equivalent to baseline. Adverse events, walking pain (VAS), WOMAC index, patient and physician's global assessment were recorded at each visit., Results: Twenty-five patients 1 injection and 32 received 2 injections. Transient hip pain was reported following 10.1% of injections, but no patient withdrew from the study because of this. Two mild synovial fluid aseptic effusions occurred after the first injection. No systemic device-related adverse event was reported. Walking pain decreased from 69.3 mm at entry to 39.5 mm at the end point (p < 0.0001). All other outcome measures decreased significantly., Conclusion: Viscosupplementation with hylan G-F20 is feasible, easy to perform and well-tolerated in hip OA. A double-blind, controlled study should be performed to confirm data on its efficacy.

Objective: To determine the predictive value of serum levels of TIMP-1 and hyaluronic acid in a 1 year prospective study in hip osteoarthritis (OA)., Methods: Twenty-nine patients with OA of the hip were enrolled in a 1-year prospective study (median follow-up, 13 months). Biochemical analysis was used to assess TIMP-1 and hyaluronic acid at entry and at the end of the study. Radiographic evaluation with an assisted computed program was performed to calculate progression of joint space narrowing. Statistical tests served to determine correlations between observed serum levels and radiograph joint space narrowing., Results: Among the 29 patients, 10 showed joint space narrowing greater than 0.6 mm per year. The initial concentration of TIMP-1 as well as delta value of variation in serum levels of TIMP-1 (difference between TIMP-1 concentration at entry and at the end) correlated with the progression of joint space narrowing. A cut-off value of 600 ng/ml of TIMP-1 allowed the patients who progressed slowly from those who progressed more rapidly. Hyaluronic acid serum level was not predictive of evolution., Conclusion: TIMP-1 serum level may serve to predict the evolution of patients with hip OA., (Copyright 2001 OsteoArthritis Research Society International.)

To measure the evolution of the serum levels of specific Osteoarthritis (OA) biomarker, Coll2-1 and Coll2-1 NO2 in knee osteoarthritic patients after viscosupplementation (VS). Fifty-one patients with unilateral symptomatic knee were recruited for this prospective open label study. They received three intra-articular injections of 2 ml of hyaluronic acid (Hylan GF-20) and were followed for 3 months. Walking pain was evaluated and serum samples were taken at each visit. Coll2-1 and Coll2-1 NO2 were measured in the serum using specific immunoassays. Variations over time of each parameter and predictive factor of response were studied. Forty-five patients were analyzed. The serum concentrations of Coll2-1 and Coll2-1 NO2 were significantly higher in KL III/IV patients compared to KL I/II patients at baseline and decreased systematically over time after VS. Its effect was ever more pronounced in patients with KL III/IV. The serum concentration of Coll2-1 was significantly lower at baseline in responders than in non-responders. This study suggests a rapid slowdown of type II collagen degradation and joint inflammation after VS with Hylan G-20 and gives additional information for the validation of accurate biomarkers for OA. The serum level of Coll2-1 appeared to be a predictive factor for response to treatment. © 2013 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 31: 901-907, 2013 [ABSTRACT FROM AUTHOR]