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Primary study

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Journal BMC musculoskeletal disorders
Year 2015
BACKGROUND: Studies have evaluated the concomitant use of hyaluronan (HA) with steroids, anti-inflammatory drugs and analgesic agents in an attempt to magnify the extent and duration of pain relief due to knee osteoarthritis. To date there has not been an intra-articular combination therapy available for relief of knee osteoarthritis symptoms--one that combines the fast acting onset of symptom relief provided by a corticosteroid with the long-lasting symptom relief provided by HA in a single injection. The objective of this study was to evaluate the safety and preliminary performance of two new HA formulations, Hydros (hyaluronan-based hydrogel suspended in hyaluronan solution) and Hydros-TA (HA plus 10 mg of triamcinolone acetonide [TA]) in subjects with knee osteoarthritis. METHODS: We conducted a Phase 2 prospective, multicenter, randomized, double-blind feasibility trial. Participants (n = 98; mean age 60 years) with knee osteoarthritis (Kellgren-Lawrence grade 2 or 3) were randomized to three treatment groups: Hydros, Hydros-TA, and Synvisc-One® (hylan G-F 20). Participants received one 6 ml intra-articular injection in the treatment knee and were evaluated at 2, 6, 13, and 26 weeks post-treatment. Safety was assessed from adverse events at all study visits. The primary efficacy outcome was the change from baseline on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A (Pain) score for the treatment knee. RESULTS: Adverse events were similar across treatment groups with the most common being arthralgia, joint swelling, back pain, and joint stiffness. Arthralgia was reported 5 times with Synvisc-One, 4 with Hydros, and 1 with Hydros-TA. Each group demonstrated a reduction in the WOMAC A (Pain) score over 26 weeks: [least-square mean (standard error)] 30.5 (5.1) mm for Hydros; 34.4 (4.7) mm for Hydros-TA; 28.0 (5.4) mm for Synvisc-One and an observed improvement of 2.5 mm (p = 0.64) and 6.4 mm (p = 0.24) over Synvisc-One for Hydros and Hydros-TA, respectively. CONCLUSIONS: A single injection of Hydros or Hydros-TA was well-tolerated and relieved pain associated with knee osteoarthritis over 26 weeks. Data indicate that Hydros-TA had a more rapid pain relief compared to Hydros alone. A Phase 3 trial is underway to confirm these preliminary results. TRIAL REGISTRATION NUMBER: NCT01134406.

Primary study

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Journal JAMA internal medicine
Year 2015
IMPORTANCE: Osteoarthritis (OA) of the knee is the most frequent form of arthritis and a cause of pain and disability. Combined nonpharmacologic and pharmacologic treatments are recommended as the optimal treatment approach, but no evidence supports the recommendation. OBJECTIVE: To assess the clinical benefits of an intra-articular corticosteroid injection given before exercise therapy in patients with OA of the knee. DESIGN, SETTING, AND PARTICIPANTS: We performed a randomized, blinded, placebo-controlled clinical trial evaluating the benefit of intra-articular corticosteroid injection vs placebo injection given before exercise therapy at an OA outpatient clinic from October 1, 2012, through April 2, 2014. The participants had radiographic confirmation of clinical OA of the knee, clinical signs of localized inflammation in the knee, and knee pain during walking (score >4 on a scale of 0 to 10). INTERVENTIONS: Participants were randomly allocated (1:1) to an intra-articular 1-mL injection of the knee with methylprednisolone acetate (Depo-Medrol), 40 mg/mL, dissolved in 4 mL of lidocaine hydrochloride (10 mg/mL) (corticosteroid group) or a 1-mL isotonic saline injection mixed with 4 mL of lidocaine hydrochloride (10 mg/mL) (placebo group). Two weeks after the injections, all participants started a 12-week supervised exercise program. MAIN OUTCOMES AND MEASURES: The primary outcome was change in the Pain subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire (range, 0-100; higher scores indicate greater improvement) at week 14. Secondary outcomes included the remaining KOOS subscales and objective measures of physical function and inflammation. Outcomes were measured at baseline, week 2 (exercise start), week 14 (exercise stop), and week 26 (follow-up). RESULTS: One hundred patients were randomized to the corticosteroid group (n = 50) or the placebo group (n = 50); 45 and 44 patients, respectively, completed the trial. The mean (SE) changes in the KOOS Pain subscale score at week 14 were 13.6 (1.8) and 14.8 (1.8) points in the corticosteroid and placebo groups, respectively, corresponding to a statistically insignificant mean difference of 1.2 points (95% CI, -3.8 to 6.2; P = .64). We found no statistically significant group differences in any of the secondary outcomes at any time point. CONCLUSIONS AND RELEVANCE: No additional benefit results from adding an intra-articular injection of 40 mg of corticosteroid before exercise in patients with painful OA of the knee. Further research is needed to establish optimal and potentially synergistic combinations of conservative treatments. TRIAL REGISTRATION: clinicaltrialsregister.eu Identifier: 2012-002607-18; clinicaltrials.gov Identifier: NCT01945749.

Primary study

Unclassified

Journal Clinical orthopaedics and related research
Year 2013
<b>BACKGROUND: </b>Intraarticular injections, mainly using long-lasting corticosteroid suspensions, have long been used to treat knee osteoarthritis. Viscosupplementation is a relatively new approach with injection of a variety of agents. When comparing viscosupplementation with intraarticular injections of corticosteroids from baseline to the fourth week, steroids have been more effective for pain relief. By the fourth week they provide similar relief, but beyond that viscosupplementation appears to provide greater pain reduction. The delayed onset of symptomatic improvement combined with reports of reactive synovitis may discourage physicians and patients.<b>Questions/purposes: </b>We therefore addressed three questions: Does the addition of triamcinolone to viscosupplementation (1) improve first-week pain and function compared with viscosupplementation alone, (2) diminish adverse effects of viscosupplementation alone, and (3) alter 6-month pain and function of viscosupplementation alone?<b>METHODS: </b>We prospectively enrolled 104 patients with knee osteoarthritis and randomized them to receive either a single intraarticular injection (6 mL) of hylan GF-20 (Group viscosupplementation [Group VS]), or a single intraarticular injection of hylan GF-20 (6 mL) and 1 mL (20 mg) of triamcinolone hexacetonide (Group VS + T). VAS, WOMAC™, and Lequesne questionnaires were completed at baseline and at Weeks 1, 4, 12, and 24.<b>RESULTS: </b>At Week 1 the WOMAC and VAS scores were lower in Group VS + T, compared with Group VS. There was no difference regarding the adverse effects. At Weeks 4, 12, and 24 there were no differences in the groups.<b>CONCLUSIONS: </b>The addition of triamcinolone hexacetonide improves first-week symptom and functional scores of viscosupplementation, but not beyond. It does not seem to increase the likelihood of adverse effects.<b>LEVEL OF EVIDENCE: </b>Level I, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.

Primary study

Unclassified

Journal International Journal of Rheumatic Diseases
Year 2012
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Primary study

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Journal Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA
Year 2012
PURPOSE: To compare the safety and efficacy of two different approaches of platelet-rich plasma (PRP) production methods as intra-articular injection treatment for knee cartilage degenerative lesions and osteoarthritis (OA). METHODS: The study involved 144 symptomatic patients affected by cartilage degenerative lesions and OA. Seventy-two patients were treated with 3 injections of platelet concentrate prepared with a single-spinning procedure (PRGF), the other 72 with 3 injections of PRP obtained with a double-spinning approach. The patients were evaluated prospectively at the enrollment and at 2, 6, and 12 months' follow-up with IKDC, EQ-VAS and Tegner scores; adverse events and patient satisfaction were also recorded. RESULTS: Both treatment groups presented a statistically significant improvement in all the scores evaluated at all the follow-up times. Better results were achieved in both groups in younger patients with a lower degree of cartilage degeneration. The comparative analysis showed similar improvements with the two procedures: in particular, IKDC subjective evaluation increased from 45.0 ± 10.1 to 59.0 ± 16.2, 61.3 ± 16.3, and 61.6 ± 16.2 at 2, 6, and 12 months in the PRGF group, and from 42.1 ± 13.5 to 60.8 ± 16.6, 62.5 ± 19.9, and 59.9 ± 20.0 at 2, 6, and 12 months in the PRP group, respectively. Concerning adverse events, more swelling (P = 0.03) and pain reaction (P = 0.0005), were found after PRP injections. CONCLUSIONS: Although PRP injections produced more pain and swelling reaction with respect to that produced by PRGF, similar results were found at the follow-up times, with a significant clinical improvement with respect to the basal level. Better results were achieved in younger patients with a low degree of cartilage degeneration. LEVEL OF EVIDENCE: II.

Primary study

Unclassified

Authors Beyaz SG
Journal Journal of anaesthesiology clinical pharmacology
Year 2012
Introduction: Primary therapeutic aim in treatment of osteoarthritis of the knee is to relieve the pain of osteoarthritis. The aim of this study was to compare the efficacy of intra-articular triamcinolone with intra-articular morphine in pain relief due to osteoarthritis of the knee in the elderly population. Materials and Methods: Patients between 50 and 80 years of age were randomized into three groups. Group M received morphine plus bupivacaine intra-articularly, Group T received triamcinolone plus bupivacaine intra-articularly, and Group C received saline plus bupivacaine intra-articularly. Patients were evaluated before injection and in 2nd, 4th, 6th, and 12th weeks after injection. First-line supplementary analgesic was oral paracetamol 1500 mg/day. If analgesia was insufficient with paracetamol, oral dexketoprofen trometamol 50 mg/day was recommended to patients. Results: After the intra-articular injection, there was statistically significant decrease in visual analog scale (VAS) scores in Groups M and T, when compared to Group C. The decrease of VAS scores seen at the first 2 weeks continued steadily up to the end of 12th week. There was a significant decrease in Groups M and T in the WOMAC scores, when compared to Group C. There was no significant difference in the WOMAC scores between morphine and steroid groups. Significantly less supplementary analgesics was used in the morphine and steroid groups. Conclusion: Intra-articular morphine was as effective as intra-articular triamcinolone for analgesia in patients with osteoarthritis knee. Intra-articular morphine is possibly a better option than intra-articular steroid as it has lesser side effects.

Primary study

Unclassified

Journal American journal of physical medicine & rehabilitation / Association of Academic Physiatrists
Year 2012
OBJECTIVE: This study aimed to find a simple, cost-effective, and time-efficient method for the preparation of platelet-rich plasma (PRP), so the acquired benefits will be readily available for multiple procedures in smaller outpatient clinics and to explore the safety and efficacy of the application of PRP in the treatment of degenerative lesions of articular cartilage of the knee. DESIGN: The study was designed as a prospective, cohort study with a control group. A total of 120 patients with Grade 1, 2, or 3 osteoarthritis according to the Kellgren and Lawrence grading scale were enrolled in the study. One group of patients was treated using three intra-articular applications of PRP, and the second group of patients was given three injections of hyaluronic acid. Outcome measures included the Western Ontario and McMaster Universities Osteoarthritis Index and the 11-point pain intensity Numeric Rating Scale. RESULTS: On average, a 4.5-fold increase in platelet concentration was obtained in the PRP group. No severe adverse events were observed. Statistically significantly better results in the Western Ontario and McMaster Universities Osteoarthritis Index and Numeric Rating Scale scores were recorded in a group of patients who received PRP injections after a 3- and 6-mo follow-up. CONCLUSIONS: Our preliminary findings support the application of autologous PRP as an effective and safe method in the treatment of the initial stages of knee osteoarthritis. Further studies are needed to confirm these results and to investigate the persistence of the beneficial effects observed.

Primary study

Unclassified

Journal European journal of physical and rehabilitation medicine
Year 2012
BACKGROUND: Combining different therapies, physical therapy agents, pharmacological and physical therapies, generally produces better outcomes for symptoms of knee osteoarthritis (OA) than do isolated therapies. AIM: To demonstrate if horizontal therapy (HT) and aspiration alone and corticosteroid injection alone or in combination determine pain relief and functional improvement in a group of patients with knee OA complicated with Baker's cyst (BC). DESIGN: We designed a randomized controlled trial (RCT). SETTING: Outpatients. POPULATION: Sixty patients with a knee OA and diagnosis of BC confirmed by means of standard ultrasound (US) evaluation. METHODS: The trial was conducted as a randomized, controlled trial. Patients who satisfied the inclusion criteria were randomized to either the US-guided (Ultrasound Guided BC aspiration and corticosteroid injection group (Group A), the Horizontal Therapy group (Group B) or the US-guided BC aspiration and corticosteroid injection plus Horizontal therapy group (Group C). Outcome measures included: 1) pain reduction as measured by visual analogue scale (VAS); 2) functional improvement, as measured by WOMAC; and 3) US evaluation at baseline (T0), at one (T1) and four (T2) weeks follow-up. RESULTS: A total of 60 patients were randomized into group A (N.=20), group B (N.=20) or Group C (N.=20). Patients in group A and in group C, but not those in group B maintained lower pain level at T2 than at baseline, with significant lower VAS values in Group C. As regards US measurements, the maximum axial area did not change as a consequence of the treatment in any of the three groups (P=0.259). Contrarily, sagittal area measurements were influenced by time (P<0.01). CONCLUSION: Our results show that the group with the best performance for pain, functionality and dimension of BC was that in which combined use was made of horizontal and corticosteroid injection therapies. CLINICAL REHABILITATION IMPACT: In this study we want to demonstrate the effectiveness of Horizontal Therapy in the treatment of knee OA complicated by BC.

Primary study

Unclassified

Journal Osteoarthritis and Cartilage
Year 2012
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PURPOSE: Carbylan Osteoarthritis Research 1.0 (COR 1.0) was a prospective, multicenter, randomized, double-blind feasibility study to evaluate the safety and performance of Hydros Joint Therapy (Hydros) and Hydros-TA Joint Therapy (Hydros-TA) in subjects with Kellgren&Lawrence grade 2 and 3 osteoarthritis (OA) of the knee. METHODS: A total of 98 subjects were enrolled, treated, and followed for six months post-treatment. Subjects were randomized 1:1:1 to Hydros (PEG cross linked HA without TA), Hydros-TA (PEG cross linked HA with TA), or Synvisc-One Hylan G-F 20 (Synvisc-One). Hydros is a bioresorbable hyaluronan-based hydrogel suspended in a hyaluronan solution. Hydros-TA incorporates a low dose (10mg) corticosteroid, triamcinolone acetonide, suspended within the hyaluronan hydrogel, and is designed to retain steroid locally in the joint. All randomized subjects received one 6 mL intra-articular (IA) injection in the treatment knee by an unblinded injecting physician. The treatment knee was the knee that met the inclusion criteria on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A (pain) subscale score (50-90mm on 100mm VAS). Subjects and evaluating physicians who followed subjects post-treatment were blinded to treatment. Subjects were seen by a treatment-blinded evaluating physician for post-treatment follow-up at 2 weeks, 6 weeks, 13 weeks, and 26 weeks. Subjective symptom rating and physical assessment including the full WOMAC questionnaire were obtained at screening and each follow-up visit. Subject global assessment was obtained at 13 weeks and subject and physician global assessments were obtained at 26 weeks. Adverse events were solicited at all visits. The primary efficacy endpoint was the time-weighted change from baseline in the WOMAC A (pain) subscale average score for the treatment knee over 26 weeks. Differences between treatment were assessed using an analysis of covariance (ANCOVA) model. RESULTS: For the primary outcome, Hydros demonstrated a 41.2mm reduction, Hydros-TA demonstrated a 42.2mm reduction and Synvisc-One demonstrated a 37.5mm reduction from baseline pain. These results represented an improvement of 3.7mm and 4.7mm over Synvisc-One for Hydros and Hydros-TA respectively. Greater reductions in pain for Hydros-TA vs Synvisc-One were observed at all timepoints over the course of the study. The percentage of subjects who responded favorably to the product (as measured by the OMERACT-OARSI responder rate) was also higher in the Hydros and Hydros-TA groups when compared to Synvisc-One. Hydros-TA showed a trend towards a faster onset of pain relief compared to the non-steroid containing products evaluated in the study. Hydros-TA provided a 43.5mm mean reduction from baseline pain at the 2 week time point compared to a mean reduction of 37.7mm and 32.3mm for Synvisc-One and Hydros, respectively. In the Hydros-TA treatment group there were 3 reports of product related adverse events compared to 9 reports in the Synvisc-One group and 7 events reported in the Hydros group. Arthralgia was the most commonly reported product-related adverse event (5 reports with Synvisc-One, 4 with Hydros, and 1 with Hydros-TA). CONCLUSIONS: A single injection of Hydros or Hydros-TA was well tolerated and relieved pain associated with symptomatic OA of the knee over 26 weeks. The study endpoints showed strong trends toward an enhanced effect compared to Synvisc-One. In fact, in patients with OA Grade 3, the improvement in pain scores at 2 weeks was significantly greater in the Hydros-TA group compared with the Synvisc-One group. Future clinical evaluations will be required to further demonstrate the safety and the superiority of Hydros and Hydros-TA compared to Synvisc-One.

Primary study

Unclassified

Journal Rheumatology international
Year 2012
Osteoarthritis is a chronic disease that causes serious pain and limitations in activities. Intraarticular corticosteroid injections combined with pharmacological treatment and physiotherapy have been used for years to control the local inflammation and relieve pain in the patients with osteoarthritis. There are several animal experiments which suggested that the intraarticular corticosteroid injections impair cartilage protein synthesis. However, there are no serious evidences suggesting the increase of cartilage impairment. The aim of our study was to compare the efficacy of placebo and intraarticular corticosteroid agents in the patients with symptomatic knee osteoarthritis. One hundred and twenty patients with painful knee osteoarthritis were included in the prospective, randomized, controlled study. The patients were randomized into four groups. Each group consisted of thirty patients. Intraarticular single dose of methylprednisolone acetate (40 mg, 1 ml), Betametazone disodium phosphate (3 mg, 1 ml), Triamsinolon acetonate (40 mg, 1 ml), and serum physiological (0.09% NaCl, 1 ml) were administrated to the groups, respectively. The patients were evaluated by Visual Analog Scale (0-10 cm [VAS]) for the pain severity, and by Lequesne Functional Index for functional state before treatment, and at the 1st, 3rd, 6th, and 12th weeks. Our results showed that single doses of three agents provided symptomatic and functional relief and their effects reduced at the 12th week. However, methylprednisolone acetate was a statistically more effective analgesic as compared to the other agents until the sixth week.