An interventional study of Iracross and Iraline in Osteoarthritis, Knee, sponsored by I.R.A. Istituto Ricerche Applicate S.p.A.. Completed at 1 site in Romania. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-04-12.
Sponsored by I.R.A. Istituto Ricerche Applicate S.p.A. · Not applicable, Interventional, and Treatment
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 103 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →I.R.A. Istituto Ricerche Applicate S.p.A. is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1 course of IRACROSS (crosslinked 2% Hyaluronic Acid) at baseline, consisting of a mono-dose intra-articular administration (2ml).
Device: Iracross
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)
Device: Iraline
Administration of max 2ml of Iracross at first visit
Administration of maximum 2 ml of Iraline at visit 1 to visit 3, 4 and 5 depending of suject's need
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
AE, SAE, ADE, SADE, DD incidence.
To investigate the overall safety and tolerability of the two medical devices during the by overall study period.
Time frame: 180 days
Physician Global Tolerability
Percentage of patients with "excellent" evaluations in the Physician Global Tolerability Evaluation
Time frame: 180 days
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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I.R.A. Istituto Ricerche Applicate S.p.A.