Ignite Creation Date:
2024-05-06 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05727371
Status:
RECRUITING
Last Update Posted:
2023-08-28
First Post:
2023-01-09
Brief Title:
Combination of PRP and XLHA Prepared With RegenMatrix Medical Device To Treat Moderate to Severe Knee Osteoarthritis
Sponsor:
RegenLab France SAS
Organization:
Regen Lab SA
Study Overview
Official Title:
Multicenter Randomized Double-blind Study to Compare the Safety and Performance of a Combination of A-PRP and XLHA Prepared With the RegenMatrix Medical Device to Hylan G-F 20 XLHA and Placebo to Treat ModerateSevere Knee Osteoarthritis
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this clinical trial the investigator assess the safety and efficacy of a single injection of a combination of cross-linked hyaluronic acid HA with autologous platelet-rich plasma PRP obtained with the RegenMatrix medical device to improve symptoms of moderate to severe knee osteoarthitis grade III-IV Kellgren-Lawrence
Detailed Description:
In this multicenter randomized double-blind three-arm study the investigator propose to evaluate the safety and efficacy at Day0 Month1 Month3 and Month6 of a single intra-articular injection of a combination RM-PRP-XLHA experimental treatment combination of cross-linked HA and PRP obtained with the RegenMatrix medical device against Hylan G-F 20 reference treatment and placebo for the treatment of moderate to severe knee osteoarthritis
The symptomatic benefit will be evaluated in terms of pain reduction and improvement of patients quality of life The functional benefit of the treatment will also be evaluated on a reduced number of participants by a gait analysis performed only in the coordinating centre
The medical device RegenMatrix is an adaptation of the medical device Cellular Matrix certified since 2013CE2797 It differs from the latter only for by presence of cross-linked HA instead of linear HA and is therefore particularly suitable for the treatment of moderate to severe knee osteoarthritis
The symptomatic benefit will be evaluated in terms of pain reduction and improvement of patients quality of life The functional benefit of the treatment will also be evaluated on a reduced number of participants by a gait analysis performed only in the coordinating centre
The medical device RegenMatrix is an adaptation of the medical device Cellular Matrix certified since 2013CE2797 It differs from the latter only for by presence of cross-linked HA instead of linear HA and is therefore particularly suitable for the treatment of moderate to severe knee osteoarthritis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None