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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
103
Fizio Center
Timișoara, Timiș County, Romania
Change in Range Of Motion and Visual Analogue Scale
Change in ROM and VAS for pain (at rest), at 180 (± 4 days) days
Time frame: 180 days
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
Time frame: 180 days
Visual Analogue Scale Evaluation
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.
Time frame: 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
Time frame: 180 days
NSAID consumption
Incidence of NSAID consumption from first visit to final visit
Time frame: 180 days
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