Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2026-01-01 @ 2:23 AM
Study NCT ID:
NCT04022928
Status:
COMPLETED
Last Update Posted:
2019-07-19
First Post:
2019-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Single Intraarticular Injection of Platelet-Rich Plasma on Pain and Physical Function in Patients With Ankle OA
Sponsor:
Kaohsiung Veterans General Hospital.
Organization:
Study Overview
Official Title:
Efficacy and Safety of a Single Intraarticular Injection of Platelet-Rich Plasma on Pain and Physical Function in Patients With Ankle Osteoarthritis-a Prospective Study
Status:
COMPLETED
Status Verified Date:
2019-07
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:
Platelet-rich plasma (PRP) has been reported to be an effective treatment for knee osteoarthritis (OA). The application in ankle OA has rarely been investigated. The aim was to evaluate the efficacy and safety of a single intraarticular injection of PRP for the treatment of patients with ankle OA.
Detailed Description:
Methods: In a prospective study, patients with symptomatic ankle OA for at least 6 months were recruited. Patients received a single injection of 3-ml of PRP into symptomatic ankles. The primary outcome was the change from baseline in the visual analog scale (VAS) pain score (0-10cm) at 6 months. Secondary outcomes included the Ankle Osteoarthritis Scale (AOS) score, American Orthopedic Foot and Ankle Society (AOFAS) ankle/hindfoot score, single leg stance test (SLS), use of rescue analgesics and patient satisfaction. Adverse events were recorded during the study.
Patients were followed at 1, 3 and 6 months postinjection .
Patients were followed at 1, 3 and 6 months postinjection .
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?: