Osteoarthritis, Knee
Conditions
Brief summary
Comparison with a non-inferiority design at 12 and 24 weeks on a larger scale is real to objectively evaluate the composite measurement of ROM, pain and basic activities like walking or performing daily activities (QoL) in a population with a large coverage of age and levels of physical activity (from no physical activity history to athletes).
Detailed description
After giving their consent, subjects will undergo a screening visit to determine eligibility for study entry. After randomization, subjects will have administered medical device Iracross or Iraline. For subjects allocated to Iracross, medical device will be administered only at first visit and for subjects allocated to Iraline, medical device will be administered at visit 1, visit,2, visit 3 and optional for visit 4 and visit 5.
Interventions
DEVICEIracross
Administration of max 2ml of Iracross at first visit
DEVICEIraline
Administration of maximum 2 ml of Iraline at visit 1 to visit 3, 4 and 5 depending of suject's need
Sponsors
Opera CRO, a TIGERMED Group Company
I.R.A. Istituto Ricerche Applicate S.p.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized, controlled, open label, multicentre study with two parallel groups of patients and a non-inferiority hypothesis.
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Aged between 40 and 80 years 2. Symptomatic knee osteoarthritis as defined by the American College of Rheumatology (ACR) criteria; (for subjects with OA at both knees, the most painful one will be included in the study only, respecting KL grade II or III); 3. Ambulant without assistance; 4. Kellgren-Lawrence grade II or III on X-ray performed at maximum 6 months before screening; 5. VAS knee pain ≥40 at screening and 30 days before; 6. At least 30 days before screening oral/parenteral corticosteroid or NSAIDs (10 mg prednisone) administration. 7. Signed Informed consent
Exclusion criteria
1. Unstable knee; 2. Varus or valgus ≥ 15 degrees; 3. Active malignancy; 4. Knee trauma or lose body parts 1 year before screening; 5. Rheumatoid Arthritis, avascular necrosis, fibromyalgia; 6. Use of potent analgesics 15 days (different from ≤ 10 mg prednisone); 7. Intra-articular HA or corticosteroid injection within 6 months before screening; 8. Arthroscopic or knee open surgery within 12 months before screening; 9. Body Mass Index (BMI) ≥ 40 kg/m2; 10. Active infection around the injection site; 11. Use of anticoagulants or history of thrombocytopenia; 12. Concomitant use of disease-modifying antirheumatic drugs (DMARDs), anaesthetics; 13. Known sensitivity to HA or DVS; 14. Pregnancy, breast feeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Range Of Motion and Visual Analogue Scale | 180 days | Change in ROM and VAS for pain (at rest), at 180 (± 4 days) days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physician Efficacy Global Evaluation | 180 days | Score of Physician Efficacy Global Evaluation at final visit. Minimum value is4-poor efficacy and maximum value is 1- very good efficacy |
| Visual Analogue Scale Evaluation | 180 days | VAS for pain (on moving and on pressing). Minimum score is 0 and it means no pain. Maximum score is 100 and represents the maximum pain that patient can suffer. |
| Knee injury and Osteoarthritis Outcome Score | 180 days | Changes in KOOS score from first visit to final visit. The min value is 0 and the max value 100, were the min value represents no problem and max value represents extreme problems |
| NSAID consumption | 180 days | Incidence of NSAID consumption from first visit to final visit |
Other
| Measure | Time frame | Description |
|---|---|---|
| AE, SAE, ADE, SADE, DD incidence. | 180 days | To investigate the overall safety and tolerability of the two medical devices during the by overall study period. |
| Physician Global Tolerability | 180 days | Percentage of patients with excellent evaluations in the Physician Global Tolerability Evaluation |
Countries
Romania
Outcome results
None listed