An interventional study of Intra-articular single injection and Intra-articular three injections in Knee Osteoarthritis, sponsored by Labrha. Completed at 2 sites in France. Open to participants aged 35 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-06-22.
Sponsored by Labrha · Not applicable, Interventional, and Treatment
The knee osteoarthritis is a frequent degenerative condition that mainly affects subjects over 60, population often weakened by numerous comorbidities and concomitant treatments, justifying the development of new therapies.
The viscosupplementation is a symptomatic treatment for knee osteoarthritis ; the objective of this intra-articular injection of hyaluronic acid is to reduce knee pain and improve mobility. In practice, there are two protocols to administer viscosupplementation : in a single injection or in three injections performed weekly.
The present clinical investigation has the objective to evaluate the safety of use of Pandora in a single injection or in three injections performed weekly.
This clinical investigation is a multicenter, prospective, open study of a class III Medical Device.
This study is designed to evaluate the safety of use of Pandora in its two forms : in a single injection or in three injections.
A descriptive analysis will be carried out to characterize the demographic data, the history of the disease and its treatments, the clinical and radiological data of the patients at inclusion.
The security of use of Pandora will be demonstrated by describing the proportion of patients with at least one adverse event attributable to the treatment, occurring during the week following each injection.
In total, 20 participants will be enrolled across two study centers in France, 10 participants in each centers.
The total duration of subjects participation is 6 months ; overall study duration including the enrollment period is expected to take approximately 9 months.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 20 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Labrha is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Twenty patients having a gonarthrosis asserted radiologically and justifying according to the opinion of the rheumatologist a viscosupplementation.
Inclusion Criteria:
Exclusion Criteria:
Hyaluronic acid associated with tranexamic acid ; 4.8 ml will be injected in one time
Device: Intra-articular single injection
Hyaluronic acid associated with tranexamic acid ; 2.2 ml will be injected in three times (one injection per week)
Device: Intra-articular three injections
Both groups will receive their first injection after a selection visit ; first injection will be planned between 7 days to 30 days after to confirm the enrollment. The injection will be performed at Day 1.
Both groups will receive their first injection after a selection visit ; first injection will be planned between 7 days to 30 days after to confirm the enrollment. The injections will be performed at Days 1, 8 and 15.
Number of adverse event attributable to the investigational Medical Device during the week following each injection.
Adverse events will be collected at : * Day 8 for Happyone arm (single injection) ; * Days 8, 15 and 22 for Happysoft arm (three injections).
Time frame: 1 month
Number of adverse events during the month following the first injection for immediate and delayed local tolerance evaluation.
All adverse events will be collected at : * Days 3, 8, 22 and 29 for Happyone arm (single injection) ; * Days 3, 8, 10, 15, 17, 22 and 29 for Happysoft arm (three injections). Number of adverse events occurring beyond the week following each injection from Day 1 to D29.
Time frame: 1 month
Patient self-assesment of the overall tolerance of the treatment based on a 5-point scale, from "Very bad" to "Very good".
This questionnaire will be completed at : * Days 3, 8, 22 and 29 for Happyone arm (single injection) ; * Days 3, 8, 10, 15, 17, 22 and 29 for Happysoft arm (three injections).
Time frame: 1 month
Variation over time of the WOMAC score, between time of injection and end point, and the WOMAC subscores A (pain) and C (function). The WOMAC-Questionnaire is based on a 11 points scale, from 0 = None to 10 = Extreme.
This questionnaire will be completed at : * Day 1, Day 8, Month 1, Month 3 and Month 6 for Happyone arm (single injection) ; * Day 1, Day 8, Day 15, Month 1, Month 3 and Month 6 for Happysoft arm (three injections).
Time frame: 6 months
Patient self-assesment of the effectiveness of the treatment based on a 11 points numeric scale, from 0 = None to 10 = Total.
This questionnaire will be completed at Months 1, 3 and 6 for both groups.
Time frame: 6 months
Plan to share: No
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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