a randomized, double-blind study on md-knee versus ha in patients affected by knee oa: preliminary...
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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 MassafraDep of Rheumatology, S.Pietro
Fatebenefratelli HospitalRome, Italy
chief resident: Prof A.Migliore
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• Meta-analysis of Meta-analysis of 76 trials76 trials• viscosupplementation is effective in OA of the knee viscosupplementation is effective in OA of the knee
− PainPain− Function Function − Patient global assessmentPatient global assessment
• efficacy comparable with NSAIDsefficacy comparable with NSAIDs• longer duration of benefits as compared to intra-articular longer duration of benefits as compared to intra-articular
corticosteroidscorticosteroids• Good safety profileGood 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 )
RestoringProtectingStrengthening
TendonsLigamentsJoint cartilage
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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
Resting Pain VAS
walkingPain VAS
D.E Ruiu
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
Morning stiffness
US evaluation of bone aedema
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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 methodsStudy Design: multicentric, double-blind, randomized with active control and Study Design: multicentric, double-blind, randomized with active control and two parallel arms. 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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Study design
Enrollment and start treatment
stop treatment
weeks
months months
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Study procedures basal visitEnrollment
T0
second visitFirst follow-
upT3 3 months
third visitsecond follow-upT6 6 months
Adverse events
SF-36
NSAIDs consumptionParacetamol consumption
Lequesne Index evaluationVAS evaluation
Concomitant diseases
Patient demographics data
Anamnestic and clinical evaluation
Concomitant therapy due to comorbidities
Informed consent
Experimental treatment or control treatment
Previous treatment for Knee OA
Evaluation injection site
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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 0.025 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 55-84)
• mean Body Mass Index (BMI) 27.2 (+/-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
1
13
9,8
0
2
4
6
8
10
12
14
HA lequesne
leq T 0
Leq T3
-25%
P < 0,00001
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Results at 3 months: HA
7,9
4,5
0
1
2
3
4
5
6
7
8
1
VAS T 0
Vas T 3
-45%
P < 0,00001
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Results at 3months: MD Knee
13
9,7
0
2
4
6
8
10
12
14
1
Leq TO
Leq T3
-24%
P < 0,0005
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Results at 3months: MD Knee
8
6
0
1
2
3
4
5
6
7
8
1
VAS T0
VAS T3
-25%
P < 0,0003
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Drop out and side effects
2 pts in HA group lack of efficacylack of efficacy
2 pts in MD group 1 joint effusion after second injection1 joint effusion due to knee trauma
No sistemic side effectsNo 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