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| Name | Class |
|---|---|
| Statitec | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medical Device : Happyone | Experimental | Hyaluronic acid associated with tranexamic acid ; 4.8 ml will be injected in one time |
|
| Medical Device : Happysoft | Experimental | Hyaluronic acid associated with tranexamic acid ; 2.2 ml will be injected in three times (one injection per week) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intra-articular single injection | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse event attributable to the investigational Medical Device during the week following each injection. | Adverse events will be collected at :
| 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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 :
| 1 month |
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Twenty patients having a gonarthrosis asserted radiologically and justifying according to the opinion of the rheumatologist a viscosupplementation.
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Charles Balblanc, MD | Hôpital Nord Franche-Comté, HNFC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Nord Franche-Comté, HNFC | Belfort | France | ||||
| Groupe Hospitalier de la Région Mulhouse Sud-Alsace, GHRMSA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32931933 | Background | Sellam J, Courties A, Eymard F, Ferrero S, Latourte A, Ornetti P, Bannwarth B, Baumann L, Berenbaum F, Chevalier X, Ea HK, Fabre MC, Forestier R, Grange L, Lellouche H, Maillet J, Mainard D, Perrot S, Rannou F, Rat AC, Roux CH, Senbel E, Richette P; French Society of Rheumatology. Recommendations of the French Society of Rheumatology on pharmacological treatment of knee osteoarthritis. Joint Bone Spine. 2020 Dec;87(6):548-555. doi: 10.1016/j.jbspin.2020.09.004. Epub 2020 Sep 12. | |
| 15455338 |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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Prospective, Multi-center, Open Clinical Investigation.
Two facilities are participating ; each facility will be in charge and perform a type of viscosupplementation procedure : single injection or three injections.
Subjects will received one or the other viscosupplementation depending of the facility in which they will be included.
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| Intra-articular three injections | Device | 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. |
|
| 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 :
| 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 :
| 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. | 6 months |
| Mulhouse |
| France |
| Background |
| Balazs EA. Viscosupplementation for treatment of osteoarthritis: from initial discovery to current status and results. Surg Technol Int. 2004;12:278-89. |
| 29268731 | Background | Concoff A, Sancheti P, Niazi F, Shaw P, Rosen J. The efficacy of multiple versus single hyaluronic acid injections: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2017 Dec 21;18(1):542. doi: 10.1186/s12891-017-1897-2. |
| 27257981 | Background | Diracoglu D, Tuncay TB, Sahbaz T, Aksoy C. Single versus multiple dose hyaluronic acid: Comparison of the results. J Back Musculoskelet Rehabil. 2016 Nov 21;29(4):881-886. doi: 10.3233/BMR-160714. |
| 28618868 | Background | Bhadra AK, Altman R, Dasa V, Myrick K, Rosen J, Vad V, Vitanzo P Jr, Bruno M, Kleiner H, Just C. Appropriate Use Criteria for Hyaluronic Acid in the Treatment of Knee Osteoarthritis in the United States. Cartilage. 2017 Jul;8(3):234-254. doi: 10.1177/1947603516662503. Epub 2016 Aug 10. |
| 33267906 | Background | Li J, Liu R, Rai S, Ze R, Tang X, Hong P. Intra-articular vs. intravenous administration: a meta-analysis of tranexamic acid in primary total knee arthroplasty. J Orthop Surg Res. 2020 Dec 2;15(1):581. doi: 10.1186/s13018-020-02119-1. |
| 25797505 | Background | Ng W, Jerath A, Wasowicz M. Tranexamic acid: a clinical review. Anaesthesiol Intensive Ther. 2015;47(4):339-50. doi: 10.5603/AIT.a2015.0011. Epub 2015 Mar 23. |
| 31800425 | Background | Jules-Elysee KM, Tseng A, Sculco TP, Baaklini LR, McLawhorn AS, Pickard AJ, Qin W, Cross JR, Su EP, Fields KG, Mayman DJ. Comparison of Topical and Intravenous Tranexamic Acid for Total Knee Replacement: A Randomized Double-Blinded Controlled Study of Effects on Tranexamic Acid Levels and Thrombogenic and Inflammatory Marker Levels. J Bone Joint Surg Am. 2019 Dec 4;101(23):2120-2128. doi: 10.2106/JBJS.19.00258. |
| D012216 |
| Rheumatic Diseases |