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| Name | Class |
|---|---|
| Opera CRO, a TIGERMED Group Company | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iracross | Experimental | 1 course of IRACROSS (crosslinked 2% Hyaluronic Acid) at baseline, consisting of a mono-dose intra-articular administration (2ml). |
|
| Iraline | Active Comparator | 1 course of IRALINE (linear 2% Hyaluronic Acid); each course consists of 3-5 intra-articular administrations (2ml) at weekly intervals (from week 1 to 3, 4 or 5, depending on each patient's need) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iracross | Device | Administration of max 2ml of Iracross at first visit |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Range Of Motion and Visual Analogue Scale | Change in ROM and VAS for pain (at rest), at 180 (± 4 days) days | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Physician Efficacy Global Evaluation | Score of Physician Efficacy Global Evaluation at final visit. Minimum value is4-poor efficacy and maximum value is 1- very good efficacy | 180 days |
| Visual Analogue Scale Evaluation |
| Measure | Description | Time Frame |
|---|---|---|
| AE, SAE, ADE, SADE, DD incidence. | To investigate the overall safety and tolerability of the two medical devices during the by overall study period. | 180 days |
| Physician Global Tolerability | Percentage of patients with "excellent" evaluations in the Physician Global Tolerability Evaluation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George Puenea | Fizio Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fizio Center | Timișoara | Timiș County | 300211 | Romania |
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Randomized, controlled, open label, multicentre study with two parallel groups of patients and a non-inferiority hypothesis.
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| Iraline |
| Device |
Administration of maximum 2 ml of Iraline at visit 1 to visit 3, 4 and 5 depending of suject's need |
|
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.
| 180 days |
| Knee injury and Osteoarthritis Outcome Score | 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 | 180 days |
| NSAID consumption | Incidence of NSAID consumption from first visit to final visit | 180 days |
| 180 days |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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