Ignite Creation Date:
2024-05-05 @ 10:55 PM
Last Modification Date:
2024-10-26 @ 10:25 AM
Study NCT ID:
NCT01211119
Status:
UNKNOWN
Last Update Posted:
2011-04-26
First Post:
2010-09-20
Brief Title:
Novel One-step Repair of Knee Meniscal Tear Using Platelet-rich Fibrin
Sponsor:
Taipei Medical University WanFang Hospital
Organization:
Taipei Medical University WanFang Hospital
Study Overview
Official Title:
Novel One-step Repair of Knee Meniscal Tear Using Platelet-rich Fibrin
Status:
UNKNOWN
Status Verified Date:
2011-04
Last Known Status:
ENROLLING_BY_INVITATION
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:
Currently most knee meniscal tears are treated by partial or complete meniscectomy or by suture repair when it is possible Recently the investigators have successfully developed and implanted a novel biomaterial platelet-rich fibrin PRF to treat articular cartilage defect in pigs The PRF is autogenesis as a natural fibrin-based biomaterial favorable to the development of microvascularization and enables local and progressive delivery of growth factors providing unique properties for tissue remodeling and wound healing The advantages of using PRF implantation include no transplant rejection and no need to perform second operation Knee meniscal repair using PRF has not been reported before The aim of this study is to investigate whether PRF implantation can facilitate regeneration process of meniscectomized knee and T2-map MRI can monitor the process in those patients with meniscal tears
A total of 18 adult patients with torn menisci outer 13 posterior horn medial meniscus will be recruited and randomly divided into three groups A n6 implantation of PRF after partial menisectomy B n6 implantation of PRF after partial menisectomy and suture C n6 partial menisectomy only All studied knee will be scanned on a 15-T MRI with surface coil at baseline before surgery 3 months and 6 months and 12 months after surgery
The investigators believe that PRF enables to facilitate regeneration of meniscectomized knee and T2-map MRI enables monitoring healing process of meniscal tears
A total of 18 adult patients with torn menisci outer 13 posterior horn medial meniscus will be recruited and randomly divided into three groups A n6 implantation of PRF after partial menisectomy B n6 implantation of PRF after partial menisectomy and suture C n6 partial menisectomy only All studied knee will be scanned on a 15-T MRI with surface coil at baseline before surgery 3 months and 6 months and 12 months after surgery
The investigators believe that PRF enables to facilitate regeneration of meniscectomized knee and T2-map MRI enables monitoring healing process of meniscal tears
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None