P140 Chondroitin sulfate in the treatment for knee osteoarthritis: A randomized, double blind, multicenter, placebo-controlled trial

ObjectivesChondroitin sulfate 800 mg/day (CS) pharmaceutical-grade in the management of symptomatic knee osteoarthritis consistent with the European Medicines Agency guideline.MethodsA prospective, randomised, 6-month, 3-arm, double-blind, double-dummy, placebo and celecoxib (200 mg/day)-controlled trial assessing changes in pain on a Visual Analogue Scale (VAS) and in the Lequesne Index (LI) as coprimary endpoints. Minimal-Clinically Important Improvement (MCII), Patient-Acceptable Symptoms State (PASS) were used as secondary endpoints.Results604 patients (knee osteoarthritis) diagnosed according to American College of Rheumalogy (ACR) criteria, recruited in five European countries and followed for 182 days. CS and celecoxib showed a greater significant reduction in pain and LI than placebo. In the intention-to-treat (ITT) population, pain reduction in VAS at day 182 in the CS group (−42.6 mm) and in celecoxib group (−39.5 mm) was significantly greater than the placebo group (−33.3 mm) (p=0.001 for CS and p=0.009 for celecoxib), while no difference observed between CS and celecoxib. Similar trend for the LI, as reduction in this metric in the CS group (−4.7) and celecoxib group (−4.6) was significantly greater than the placebo group (−3.7) (p=0.023 for CS and p=0.015 for celecoxib), no difference was observed between CS and celecoxib. Both secondary endpoints (MCII and PASS) at day 182 improved significantly in the CS and celecoxib groups. All treatments demonstrated excellent safety profiles.ConclusionA 800 mg/day pharmaceutical-grade CS is superior to placebo and similar to celecoxib in reducing pain and improving function over 6 months in symptomatic knee osteoarthritis (OA) patients. This formulation of CS should be considered a first-line treatment in the medical management of knee OA.

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Golden plaster for pain therapy in patients with knee osteoarthritis: study protocol for a multicenter randomized, double-blind, placebo-controlled trial

Trials ◽

10.1186/1745-6215-14-383 ◽

2013 ◽

Vol 14 (1) ◽

pp. 383 ◽

Cited By ~ 3

Author(s):

Jin-Tao Liu ◽

De-Zhi Tang ◽

Xiao-Feng Li ◽

Zhi-Gang Zhang ◽

Wan-Bo Ji ◽

...

Keyword(s):

Knee Osteoarthritis ◽

Study Protocol ◽

Pain Therapy ◽

Controlled Trial ◽

Double Blind ◽

Double Blind Placebo

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Patient-specific instrumentation (PSI) Referencing High Tibial Osteotomy Technological Transfer and Education: protocol for a double-blind, randomised controlled trial (PROTECTED HTO Trial)

BMJ Open ◽

10.1136/bmjopen-2020-041129 ◽

2021 ◽

Vol 11 (2) ◽

pp. e041129

Author(s):

Lawrence Chun Man Lau ◽

Elvis Chun Sing Chui ◽

Jason Chi Ho Fan ◽

Gene Chi Wai Man ◽

Yuk Wah Hung ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Knee Osteoarthritis ◽

High Tibial Osteotomy ◽

Controlled Trial ◽

Patient Specific ◽

Tibial Osteotomy ◽

Double Blind ◽

Patient Specific Instrumentation ◽

3D Printed ◽

Randomised Controlled

IntroductionHigh tibial osteotomy (HTO) is a treatment of choice for active adult with knee osteoarthritis. With advancement in CT imaging with three-dimensional (3D) model reconstruction, virtual planning and 3D printing, patient-specific instrumentation (PSI) in form of cutting jigs is employed to improve surgical accuracy and outcome of HTO. The aim of this randomised controlled trial (RCT) is to explore the surgical outcomes of HTO for the treatment of medial compartment knee osteoarthritis with or without a 3D printed patient-specific jig.Methods and analysisA double-blind RCT will be conducted with patients and outcome assessors blinded to treatment allocation. This meant that neither the patients nor the outcome assessors would know the actual treatment allocated during the trial. Thirty-six patients with symptomatic medial compartment knee osteoarthritis fulfilling our inclusion criteria will be invited to participate the study. Participants will be randomly allocated to one of two groups (1:1 ratio): operation with 3D printed patient-specific jig or operation without jig. Measurements will be taken before surgery (baseline) and at postoperatively (6, 12 and 24 months). The primary outcome includes radiological accuracy of osteotomy. Secondary outcomes include a change in knee function from baseline to postoperatively as measured by three questionnaires: Knee Society Scores (Knee Scores and Functional Scores), Oxford Knee Scores and pain visual analogue scale (VAS) score.Ethics and disseminationEthical approval has been obtained from the Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee (CREC no. 2019.050), in accordance with the Declaration of Helsinki. The results will be presented at international scientific meetings and through publications in peer-reviewed journals.Trial registration numberNCT04000672; Pre-results.

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SAT0338 Tolerance and efficacy of a new formulation of diacerein: Results of a multicenter, randomized, double-blind, controlled trial in patients with knee osteoarthritis

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2012-eular.3284 ◽

2013 ◽

Vol 71 (Suppl 3) ◽

pp. 586.3-586

Author(s):

X. Chevalier ◽

P. Richette ◽

F. Rannou ◽

B. Avouac ◽

M. Dapoigny ◽

...

Keyword(s):

Knee Osteoarthritis ◽

Controlled Trial ◽

Double Blind ◽

New Formulation

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Effect of liraglutide on body weight and pain in patients with overweight and knee osteoarthritis: protocol for a randomised, double-blind, placebo-controlled, parallel-group, single-centre trial

BMJ Open ◽

10.1136/bmjopen-2018-024065 ◽

2019 ◽

Vol 9 (5) ◽

pp. e024065 ◽

Cited By ~ 1

Author(s):

Henrik Gudbergsen ◽

Marius Henriksen ◽

Eva Ejlersen Wæhrens ◽

Anders Overgaard ◽

Henning Bliddal ◽

...

Keyword(s):

Weight Loss ◽

Body Weight ◽

Knee Osteoarthritis ◽

Controlled Trial ◽

Single Centre ◽

Double Blind ◽

Double Blind Placebo ◽

Knee Oa ◽

Parallel Group ◽

Pain Subscale

IntroductionWith an increasing prevalence of citizens of older age and with overweight, the health issues related to knee osteoarthritis (OA) will intensify. Weight loss is considered a primary management strategy in patients with concomitant overweight and knee OA. However, there are no widely available and feasible methods to sustain weight loss in patients with overweight and knee OA. The present protocol describes a randomised controlled trial evaluating the efficacy and safety of the glucagon-like peptide-1 receptor agonist liraglutide in a 3 mg/day dosing in patients with overweight and knee OA.Methods and analysis150 volunteer adult patients with overweight or obesity and knee OA will participate in a randomised, double-blind, placebo-controlled, parallel-group and single-centre trial. The participants will partake in a run-in diet intervention phase (week −8 to 0) including a low calorie diet and dietetic counselling. At week 0, patients will be randomised to either liraglutide 3 mg/day or liraglutide placebo 3 mg/day for 52 weeks as an add-on to dietetic guidance on re-introducing regular foods and a focus on continued motivation to engage in a healthy lifestyle. The co-primary outcomes are changes in body weight and the Knee Injury and Osteoarthritis Outcome Score pain subscale from week 0 to week 52.Ethics and disseminationThe trial has been approved by the regional ethics committee in the Capital Region of Denmark, the Danish Medicines Agency and the Danish Data Protection Agency. An external monitoring committee (The Good Clinical Practice Unit at Copenhagen University Hospitals) will oversee the trial. The results will be presented at international scientific meetings and through publications in peer-reviewed journals.Trial registration numbers2015-005163-16,NCT02905864, U1111-1171-4970Based on protocol versionV.6; 30 January 2017, 15:30 hours

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