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A randomized, double-blind study on MD-knee versus HA in patients affected by knee OA: preliminary data from the JOINT study Umberto Massafra Dep of Rheumatology, S.Pietro Fatebenefratelli Hospital Rome, Italy chief resident: Prof A.Migliore
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Meta-analysis of 76 trials
viscosupplementation is effective in OA of the knee Pain Function Patient global assessment efficacy comparable with NSAIDs longer duration of benefits as compared to intra-articular corticosteroids Good safety profile
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Collagen Medical Device (MD)
Collagen (type I) + natural support components Swine Derivation High collagen concentration (22.8% Gly 13.8% Pro 13% Hidrox-Pro ) Restoring Protecting Strengthening Tendons Ligaments Joint cartilage
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US evaluation of bone aedema
Resting Pain VAS Morning stiffness D.E Ruiu walking Pain VAS US evaluation of bone aedema Rashkov R, Nestorova R, Reshkova V. Efficacy and safety of collagen injection Guna Mds in osteoarthrosis treatment of knee. IOF-ECCEO12 – March 21-24, 2012 Nestorova R, Rashkov R, Reshkova V, Kapandjieva N. Efficiency of Collagen injections “Guna MDs” in patients with gonarthrosis, assessed clinically and by US. IOF-ECCEO 12
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Aim of the study to compare symptomatic effect of intra-articular treatment with MD-knee versus Sodium Hyaluronate (HA) in patients affected by knee OA
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Materials and methods Study Design: multicentric, double-blind, randomized with active control and two parallel arms. Inclusion criteria: knee OA diagnosed according to ARA criteria age > 40 years disease activity ≥ 6 measured with Lequesne Knee Index (LKI) Exclusion Criteria Concomitant rheumatic diseases (RA; spondiloarthritis; connective tissue diseases; polimyalgia rheumatica; gout; Paget disease; septic arthritis; fractures; osteonecrosis and fibromyalgia) skin or soft tissue infections close to the joint to be injected oral, intravenous or intra-articular corticosteroid treatment in the previous 3 months local analgesics treatment anti-coagulant treatment; severe trombocytopoenia and/or other coagulation disorders Allergy to swine origin products
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Materials and methods Two arms:
Experimental Group : 2 vials (4ml) of GUNA MD-Knee Medical Device weekly for 5 consecutive weeks Control Group : 1 vial (2,5 ml) of Sodium Hyaluronate (Artz®Seikagaku, Tokyo, Japan) weekly for 5 consecutive weeks
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Enrollment and start treatment
Study design weeks Enrollment and start treatment months months stop treatment
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Study procedures basal visit Enrollment T0 second visit
First follow-up T3 3 months third visit second follow-up T6 6 months Informed consent Patient demographics data Anamnestic and clinical evaluation Concomitant diseases Lequesne Index evaluation VAS evaluation NSAIDs consumption Paracetamol consumption SF-36 Experimental treatment or control treatment Concomitant therapy due to comorbidities Previous treatment for Knee OA Evaluation injection site Adverse events
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Primary endpoint Rate of LKI score decrease at 3 months
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Secondary endpoints 6 month LKI variations
SF 36 score at 3 and 6 months VAS variations at 3 and 6 months NSAIDs consumption and analgesics consumption at 3 and 6 months Adverse events
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Statistical analysis Not inferiority evaluation
t Student test for indipendent data, one code, significativity level or U Mann-Whitney test, one code, with same level of significance for primary endpoint ANOVA test (bonferroni method) for secondary endpoints Fisher test for side effects
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Results Included 60 patients: 30 in the MD-Knee arm and 30 in the HA arm females were 65% in the HA group and 64 % in the MD group mean age 69 years (range ) mean Body Mass Index (BMI) (+/-5.1) Kellgren-Lawrence radiological grades II and III almost equally represented in both study groups
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Results at 3 months: HA -25% P < 0,00001
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Results at 3 months: HA -45% P < 0,00001
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Results at 3months: MD Knee
-24% P < 0,0005
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Results at 3months: MD Knee
-25% P < 0,0003
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Drop out and side effects
2 pts in HA group lack of efficacy lack of efficacy 2 pts in MD group 1 joint effusion after second injection 1 joint effusion due to knee trauma No sistemic side effects No infectious side effects
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Conclusion Our preliminary data confirmed good symptomatic effect of MD Knee and HA to improve function and reduce pain in patients affected by symptomatic Knee OA Both treatments showed a good safety profile
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