Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06358807
Status:
RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-04-07
Brief Title:
Microfracture With Platelet Rich Plasma Gel Injection for Osteochondral Lesion of the Talus
Sponsor:
Peking University Third Hospital
Organization:
Peking University Third Hospital
Study Overview
Official Title:
Clinical Efficacy of Arthroscopic Microfracture Combined With Local Injection of Platelet Rich Plasma Gel in Treatment of Osteochondral Lesion of the Talus A Randomized Control Trial
Status:
RECRUITING
Status Verified Date:
2024-03
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:
The goal of this clinical trial is to learn if combined local injection of platelet rich plasma PRP gel adds clinical efficacy to isolated arthroscopic microfracture in treatment of osteochondral lesion of the talus OLT The interface integration of the injured area will also be assessed via radiographic follow-up The main questions it aims to answer are
Does arthroscopic microfracture combined with PRP gel injection improve ankle function of participants based on American Orthopedic Foot and Ankle Society AOFAS Score
Does arthroscopic microfracture combined with PRP gel injection improve interface integration of the injured cartilage on magnetic resonance imaging MRI Researchers will compare arthroscopic microfracture with concomitant local injection of PRP gel to isolated microfracture to see if intraoperative PRP gel injection adds clinical efficacy to isolated arthroscopic microfracture in treatment of OLT
Participants will
Undergo either isolated arthroscopic microfracture or microfracture with intraoperative injection of PRP gel
Receive clinical follow-up 3 6 12 and 24 months after surgery and answer scales of ankle function assessment
Take MRI preoperatively and 6 12 and 24 months after surgery
Does arthroscopic microfracture combined with PRP gel injection improve ankle function of participants based on American Orthopedic Foot and Ankle Society AOFAS Score
Does arthroscopic microfracture combined with PRP gel injection improve interface integration of the injured cartilage on magnetic resonance imaging MRI Researchers will compare arthroscopic microfracture with concomitant local injection of PRP gel to isolated microfracture to see if intraoperative PRP gel injection adds clinical efficacy to isolated arthroscopic microfracture in treatment of OLT
Participants will
Undergo either isolated arthroscopic microfracture or microfracture with intraoperative injection of PRP gel
Receive clinical follow-up 3 6 12 and 24 months after surgery and answer scales of ankle function assessment
Take MRI preoperatively and 6 12 and 24 months after surgery
Detailed Description:
None
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