Primary studies included in this systematic review

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Primary study

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A randomized saline-controlled trial of NASHA hyaluronic acid for knee osteoarthritis.

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Journal Current medical research and opinion
Year 2014
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This article is included in 8 Systematic reviews Systematic reviews (8 references)

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<b>OBJECTIVE: </b>NASHA hyaluronic acid is administered as a single intra-articular injection to treat the symptoms of osteoarthritis (OA). In a previous trial, post-hoc analysis indicated that NASHA provides significantly greater pain relief than saline in patients with OA confined to the study knee. We aimed to evaluate the safety and efficacy of NASHA in patients with unilateral knee OA.<b>RESEARCH DESIGN AND METHODS: </b>This was a randomized, double-blind, saline-controlled trial. All patients had knee OA confirmed by American College of Rheumatology criteria and a WOMAC pain score of 7-17 in the study knee, but no pain in the previous 3 months in the non-study knee. Treatment comprised a single intra-articular injection of NASHA or saline control. The follow-up period was 6 weeks.<b>Clinical Trial Registration: </b>ClinicalTrials.gov NCT01806207.<b>MAIN OUTCOME MEASURES: </b>The primary efficacy endpoint was the responder rate, defined as the percentage of patients with ≥40% improvement from baseline in WOMAC pain score and an absolute improvement of ≥5 points.<b>RESULTS: </b>A total of 218 patients received study treatment (NASHA: 108, saline: 110). In the main intention-to-treat (ITT) analysis, no statistically significant difference in responder rate was found between the two groups at 6 weeks (NASHA: 30.6%; saline: 26.4%). A post-hoc subgroup analysis of patients without clinical effusion in the study knee at baseline showed a significantly higher 6 week responder rate with NASHA than with saline: 40.6% versus 19.7% (p = 0.0084). A total of 68 adverse events were reported among 44 patients in the NASHA group, compared with 69 adverse events among 44 patients in the saline group. The main weakness of the study was the short, 6 week follow-up duration. In addition, image guidance was not used to ensure injection as intended into the intra-articular space.<b>CONCLUSIONS: </b>Single-injection NASHA was well tolerated and, although there was no significant benefit versus saline control in the primary analysis, post-hoc analysis showed a statistically significant improvement in pain relief at 6 weeks among patients without clinical effusion at baseline.

Primary study

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Treatment With Platelet-Rich Plasma Is More Effective Than Placebo for Knee Osteoarthritis: A Prospective, Double-Blind, Randomized Trial.

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Journal The American journal of sports medicine
Year 2013
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This article is included in 22 Systematic reviews Systematic reviews (22 references) 1 Broad synthesis Broad syntheses (1 reference)

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ABSTRACT: BACKGROUND: Specific growth factors have been proposed as therapeutic proteins for cartilage repair. HYPOTHESIS: Platelet-rich plasma (PRP) provides symptomatic relief in early osteoarthritis (OA) of the knee. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: A total of 78 patients (156 knees) with bilateral OA were divided randomly into 3 groups. Group A (52 knees) received a single injection of PRP, group B (50 knees) received 2 injections of PRP 3 weeks apart, and group C (46 knees) received a single injection of normal saline. White blood cell (WBC)-filtered PRP with a platelet count 3 times that of baseline (PRP type 4B) was administered in all. All the groups were homogeneous and comparable in baseline characteristics. Clinical outcome was evaluated using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire before treatment and at 6 weeks, 3 months, and 6 months after treatment. They were also evaluated for pain by a visual analog scale, and overall satisfaction with the procedure and complications were noted. RESULTS: Statistically significant improvement in all WOMAC parameters was noted in groups A and B within 2 to 3 weeks and lasting until the final follow-up at 6 months, with slight worsening at the 6-month follow-up. The mean WOMAC scores (pain, stiffness, physical function, and total score) for group A at baseline were 10.18, 3.12, 36.56, and 49.86, respectively, and at final follow-up were 5.00, 2.10, 20.08, and 27.18, respectively, showing significant improvement. Similar improvement was noted in group B (mean WOMAC scores at baseline: 10.62, 3.50, 39.10, and 53.20, respectively; mean WOMAC scores at final follow-up: 6.18, 1.88, 22.40, and 30.48, respectively). In group C, the mean WOMAC scores deteriorated from baseline (9.04, 2.70, 33.80, and 45.54, respectively) to final follow-up (10.87, 2.76, 39.46, and 53.09, respectively). The 3 groups were compared with each other, and no improvement was noted in group C as compared with groups A and B (P < .001). There was no difference between groups A and B, and there was no influence of age, sex, weight, or body mass index on the outcome. Knees with Ahlback grade 1 fared better than those with grade 2. Mild complications such as nausea and dizziness, which were of short duration, were observed in 6 patients (22.2%) in group A and 11 patients (44%) in group B. CONCLUSION: A single dose of WBC-filtered PRP in concentrations of 10 times the normal amount is as effective as 2 injections to alleviate symptoms in early knee OA. The results, however, deteriorate after 6 months. Both groups treated with PRP had better results than did the group injected with saline only.

Primary study

Unclassified

The effect of intra-articular hyaluronic acid treatment on gait velocity in older knee osteoarthritis patients: A randomized, controlled study.

Journal Archives of gerontology and geriatrics
Year 2012
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This article is included in 12 Systematic reviews Systematic reviews (12 references)

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Purpose: To determine the effect of intra-articular hyaluronic acid (HA) on gait velocity, pain, and function, in older knee osteoarthritis (OA) patients. Materials and methods: Thirty knee OA patients (Kellgren-Lawrence II-III) [72.44 (± 6.11) years old] were randomized, using the 'RANDBETWEEN' function in Microsoft Excel, to receive three weekly injections of HA (2 ml of 20 mg/ml HA), or placebo (P) (1.2 ml of 0.001 mg/ml HA), with fifteen participants per group. Patients and assessors were blind to treatment. Self-selected and fast gait velocities were measured with the GAITRite system. Knee pain, stiffness, and physical function were measured with the Western Ontario McMaster Osteoarthritis OA index (WOMAC OA index). Data from 1 week, 3 and 6 months post-treatment were analyzed using repeated measures ANOVA. Results: The HA group significantly improved self-selected and fast gait velocity, while the P group only significantly improved self-selected gait velocity. Mean improvements in self-selected gait velocity [Mean (SD); 95% CI] [1.25 (52.4)cm/s; -18.38; 20.88] and fast gait velocity [7.16 (71.75)cm/s; -19.72; 34.04] were not significantly different between groups. Improvements in WOMAC pain scores were significantly greater in the HA group than the P group [-2.47 (6.39); -4.86; -0.08], while improvements in stiffness [-0.87 (2.42); -1.77; 0.04] and physical function [-7.23 (19.77); -14.63; 0.16] scores were not. Conclusions: The overall effect of HA on gait velocity in older knee OA patients was not significant compared to placebo. The preliminary results of improved fast gait velocity following HA treatment should be investigated further, along with the incidence of falls, in a larger sample of older knee OA patients.ClinicalTrials.gov ID: NCT00778076.

Primary study

Unclassified

A multicenter, randomized controlled trial comparing a single intra-articular injection of Gel-200, a new cross-linked formulation of hyaluronic acid, to phosphate buffered saline for treatment of osteoarthritis of the knee.

Journal Osteoarthritis and cartilage / OARS, Osteoarthritis Research Society
Year 2012
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This article is included in 13 Systematic reviews Systematic reviews (13 references)

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<b>OBJECTIVE: </b>To compare the safety and efficacy of a single intra-articular (IA) injection of a new cross-linked hyaluronic acid product, Gel-200, with phosphate buffered saline (PBS, control) in a multi-center randomized controlled trial in patients with symptomatic osteoarthritis (OA) of the knee.<b>DESIGN: </b>Patients were randomized 2:1 to receive a single injection of Gel-200 or PBS, after joint aspiration. The primary measure of effectiveness was Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscores by 100-mm Visual Analog Scale (VAS); secondary outcomes included: total WOMAC, physical function, and stiffness subscores; patient and physician global assessments of disease activity, Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) strict responders, as well as safety of Gel-200.<b>RESULTS: </b>Of 379 patients randomized, safety was evaluated in 377 and efficacy in 375 (98.9% randomized) in the intent-to-treat population. Effectiveness of Gel-200 by WOMAC pain subscores was statistically significant at week 13 (P=0.037). Mean improvements from baseline in WOMAC pain subscores consistently favored Gel-200 at each visit. Effectiveness of Gel-200 treatment was statistically significant over weeks 3-13 by WOMAC total score, physical function, and physician global evaluations (P&lt;0.05). The number of "strict" OMERACT-OARSI responders was statistically significant from weeks 6 to 13 (P=0.022). Adverse events were not significantly different between treatment groups, including serious adverse events considered related to study treatment.<b>CONCLUSIONS: </b>This trial demonstrated that a single injection of Gel-200 was well tolerated and relieved pain associated with symptomatic OA of the knee over 13 weeks.<b>Trial Registration Number: </b>ClinicalTrials.gov NTC 00449696.

Primary study

Unclassified

Efficacy comparisons of the intraarticular steroidal agents in the patients with knee osteoarthritis.

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Journal Rheumatology international
Year 2012
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This article is included in 8 Systematic reviews Systematic reviews (8 references) 1 Broad synthesis Broad syntheses (1 reference)

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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.

Primary study

Unclassified

Intra-articular injections of sodium hyaluronate (Hyalgan®) in osteoarthritis of the knee. a randomized, controlled, double-blind, multicenter trial in the Asian population.

Authors Huang TL , Chang CC , Lee CH , Chen SC , Lai CH , Tsai CL
Journal BMC musculoskeletal disorders
Year 2011
Links Pubmed DOI PubMed Central

This article is included in 17 Systematic reviews Systematic reviews (17 references) 1 Broad synthesis Broad syntheses (1 reference)

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<b>BACKGROUND: </b>The efficacy and tolerability of 500-730 kDa sodium hyaluronate (Hyalgan®) for treatment of osteoarthritis (OA) pain has been established in clinical trials, but few data are available in the Asian population. We conducted a randomized, double-blind, multicenter, placebo-controlled study to evaluate the efficacy and tolerability of this preparation in a Taiwanese population.<b>METHODS: </b>Two hundred patients with mild to moderate OA of the knee were randomized to receive five weekly intra-articular injections of sodium hyaluronate or placebo. The primary efficacy outcome was the change from baseline to Week 25 in patients' evaluation of pain using a 100-mm visual analog scale (VAS) during the 50-foot walking test. Additional outcomes included Western Ontario and McMaster Universities (WOMAC) scores, time on the 50-foot walking test, patient's and investigator's subjective assessment of effectiveness, acetaminophen consumption, and the amounts of synovial fluid.<b>RESULTS: </b>The Hyalgan® treatment group showed a significantly greater improvement from baseline to Week 25 in VAS pain on the 50-foot walking test than the placebo group (p = 0.0020). The Hyalgan® group revealed significant improvements from baseline to week 25 in WOMAC pain and function score than the placebo group (p = 0.005 and 0.0038, respectively) Other outcomes, such as time on the 50-foot walking test and subjective assessment of effectiveness, did not show any significant difference between groups. Both groups were safe and well tolerated.<b>CONCLUSIONS: </b>The present study suggests that five weekly intra-articular injections of sodium hyaluronate are well tolerated, can provide sustained relief of pain, and can improve function in Asian patients with osteoarthritis of the knee.<b>Trial Registration: </b>Therapeutic study, Level I-1a (randomized controlled trial with a significant difference).

Primary study

Unclassified

A 40-month multicentre, randomised placebo-controlled study to assess the efficacy and carry-over effect of repeated intra-articular injections of hyaluronic acid in knee osteoarthritis: the AMELIA project.

Journal Annals of the rheumatic diseases
Year 2011
Links Pubmed DOI PubMed Central

This article is included in 14 Systematic reviews Systematic reviews (14 references) 1 Broad synthesis Broad syntheses (1 reference)

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OBJECTIVE: AMELIA (OsteoArthritis Modifying Effects of Long-term Intra-articular Adant) was designed to compare against placebo the efficacy and safety of repeated injections of hyaluronic acid (HA) and its effect on disease progression over 40 months. METHODS: A multicentre, randomised, patient and evaluator-blinded, controlled study in 306 patients fulfilling American College of Rheumatology criteria for knee osteoarthritis, radiological grades II-III (Kellgren-Lawrence) and joint space width ≥ 2 mm. Patients received four cycles of five intra-articular HA or placebo injections with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles. Osteoarthritis Research Society International (OARSI) 2004 responder criteria were used to assess efficacy. The consumption of rescue medication was a secondary outcome. Adverse events were recorded for safety purposes. RESULTS: At the 40-month visit significantly more patients responded to HA compared with placebo (OARSI 2004, p=0.004). The number of responders to HA increased through the study, whereas those to placebo did not change. Significant differences were also found in favour of HA for each individual component of the OARSI 2004. No safety problems were recorded. CONCLUSIONS: The results of AMELIA offer pioneer evidence that repeated cycles of intra-articular injections of HA not only improve knee osteoarthritis symptoms during the in-between cycle period but also exert a marked carry-over effect for at least 1 year after the last cycle. In this respect, it is not possible to establish if this carry-over effect reflects true osteoarthritis remission or just a modification of the disease's natural course. ClinicalTrials.gov number, NCT00669032.

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Chao, J, Chao J

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Primary study

Unclassified

Single, intra-articular treatment with 6 ml hylan G-F 20 in patients with symptomatic primary osteoarthritis of the knee: a randomised, multicentre, double-blind, placebo controlled trial.

Journal Annals of the rheumatic diseases
Year 2010
Links Pubmed DOI PubMed Central

This article is included in 19 Systematic reviews Systematic reviews (19 references)

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<b>OBJECTIVES: </b>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.<b>METHODS: </b>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.<b>RESULTS: </b>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.<b>CONCLUSIONS: </b>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.

Primary study

Unclassified

A double-blind, randomized, saline-controlled study of the efficacy and safety of Euflexxa® for treatment of painful osteoarthritis of the knee, with an open-label safety extension (the FLEXX trial)

Journal Seminars in arthritis and rheumatism
Year 2009
Links Pubmed DOI

This article is included in 21 Systematic reviews Systematic reviews (21 references)

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OBJECTIVE: To report the FLEXX trial, the first well-controlled study assessing the safety and efficacy of Euflexxa (1% sodium hyaluronate; IA-BioHA) therapy for knee osteoarthritis (OA) at 26 weeks. METHODS: This was a randomized, double-blind, multicenter, saline-controlled study. Subjects with chronic knee OA were randomized to 3 weekly intra-articular (IA) injections of either buffered saline (IA-SA) or IA-BioHA (20 mg/2 ml). The primary efficacy outcome was subject recorded difference in least-squares means between IA-BioHA and IA-SA in subjects' change from baseline to week 26 following a 50-foot walk test, measured via 100-mm visual analog scale (VAS). Secondary outcome measures included Osteoarthritis Research Society International responder index, Western Ontario McMaster University Osteoarthritis Index VA 3.1 subscales, patient global assessment, rescue medication, and health-related quality of life (HRQoL) by the SF-36. Safety was assessed by monitoring and reporting vital signs, physical examination of the target knee following injection, adverse events, and concomitant medications. RESULTS: Five hundred eighty-eight subjects were randomized to either IA-BioHA (n = 293) or IA-SA (n = 295), with an 88% 26 week completion rate. No statistical differences were noted between the treatment groups at baseline. In the IA-BioHA group, mean VAS scores decreased by 25.7 mm, compared with 18.5 mm in the IA-SA group. This corresponded to a median reduction of 53% from baseline for IA-BioHA and a 38% reduction for IA-SA. The difference in least-squares means was -6.6 mm (P = 0.002). Secondary outcome measures were consistent with significant improvement in Osteoarthritis Research Society International responder index, HRQoL, and function. Both IA-SA and IA-BioHA injections were well tolerated, with a low incidence of adverse events that were equally distributed between groups. Injection-site reactions were reported by 1 (&lt;1%) subject in the IA-SA group and 2 (1%) in the IA-BioHA group. CONCLUSIONS: IA-BioHA therapy resulted in significant OA knee pain relief at 26 weeks compared with IA-SA. Subjects treated with IA-BioHA also experienced significant improvements in joint function, treatment satisfaction, and HRQoL. Copyright © 2009 by Elsevier Inc.