1. 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

2. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. Enrollment and start treatment
Study design
weeks
Enrollment and start treatment
months
months
stop treatment

10. 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

11. Primary endpoint
Rate of LKI score decrease at 3 months

12. 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

13. 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

14. 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

15. Results at 3 months: HA
-25%
P < 0,00001

16. Results at 3 months: HA
-45%
P < 0,00001

17. Results at 3months: MD Knee
-24%
P < 0,0005

18. Results at 3months: MD Knee
-25%
P < 0,0003

19. 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

20. 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