Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-30 @ 2:16 AM
Study NCT ID:
NCT04315103
Status:
COMPLETED
Last Update Posted:
2020-03-19
First Post:
2020-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
a Single HYAJOINT Plus Combined With a Single PPR Versus a Single PRP for Knee OA
Sponsor:
Kaohsiung Veterans General Hospital.
Organization:
Study Overview
Official Title:
Efficacy of a Single Crosslinked Hyaluronan (HYAJOINT Plus) Combined With a Single Platelet-rich Plasma (PRP) Versus a Single PRP for the Treatment of Knee Osteoarthritis: A Randomized-Controlled Trial
Status:
COMPLETED
Status Verified Date:
2020-03
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:
Intraarticular hyaluronan or platelet-rich plasma (PRP) is each effective in the treatment for knee osteoarthritis (OA). The efficacy of combined hyaluronan with PRP for knee OA remained unclear. This study aimed to investigate the efficacy of a single intraarticular hyaluronan (HYAJOINT Plus) combined with a single PRP versus a single intraarticular PRP in patients with knee OA.
Detailed Description:
Intraarticular HA or PRP has been used for knee OA for years. Combined HA and PRP has not been widely used for OA because of lack of clinical evidence. Based on in vitro and animal studies, combining HA and PRP may benefit from their dissimilar biological mechanisms for tissue repair and have potentials to synergistically promote cartilage regeneration, inhibit OA inflammation, modulate the disease process, and improve joint homeostasis in OA. Combination of HA and PRP has much potential for the treatment of OA, but the clinical evidence of this combination remains unclear. The purpose of this study was to investigate the efficacy and safety of combined a single crosslinked HA (HYAJOINT Plus) with a single PRP versus a single PRP alone in patients with knee OA.
Study Oversight
Has Oversight DMC:
False
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?: