Ignite Creation Date:
2025-12-24 @ 2:09 PM
Ignite Modification Date:
2025-12-27 @ 10:41 PM
Study NCT ID:
NCT06636695
Status:
COMPLETED
Last Update Posted:
2024-10-15
First Post:
2024-10-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Efficacy of Platelet-Rich Plasma and Hyaluronic Acid Versus Hyaluronic Acid for Knee Osteoarthritis with MRI Analysis
Sponsor:
Changi General Hospital
Organization:
Study Overview
Official Title:
Clinical Efficacy of Platelet-Rich Plasma and Hyaluronic Acid Versus Hyaluronic Acid for Knee Osteoarthritis with MRI Analysis: a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-10
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:
The study hypothesizes that the combination of Cellular Matrix PRP-HA is superior to Hyaluronic Acid (HA) alone, specifically from the Orthovisc Kit, in relieving pain and function associated with knee osteoarthritis.
The primary objective is to assess pain reduction following treatment. The secondary objectives, includes assessing the treatment's impact on function, stiffness, and overall quality of life for patients. In addition, non-invasive MRI will be employed at baseline and 12 months to evaluate changes in bone marrow edema, cartilage structure, and joint effusion. The study also aims to compare the safety of Cellular Matrix PRP-HA and HA.
The primary objective is to assess pain reduction following treatment. The secondary objectives, includes assessing the treatment's impact on function, stiffness, and overall quality of life for patients. In addition, non-invasive MRI will be employed at baseline and 12 months to evaluate changes in bone marrow edema, cartilage structure, and joint effusion. The study also aims to compare the safety of Cellular Matrix PRP-HA and HA.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: