Ignite Creation Date:
2024-05-06 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 2:22 PM
Study NCT ID:
NCT05191732
Status:
COMPLETED
Last Update Posted:
2022-01-13
First Post:
2021-09-30
Brief Title:
Effect of PRP Versus BMC in Anterior Cruciate Ligament Reconstruction
Sponsor:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Organization:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Study Overview
Official Title:
The Therapeutic Effect of Autologous Platelet-Rich Plasma Versus Bone Marrow Concentrate in Anterior Cruciate Ligament Reconstruction - A Prospective Double-Blind Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2021-09
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:
Anterior cruciate ligament ACL is an important stabilizer of knee during daily activity and exercise The ruptured ACL need to be reconstructed by a new tendon graft which passed the bone tunnel and joint during operation How to enhance the tendon graft to bone tunnel healing is critical important to prevent recurrent ligament laxity avoid secondary osteoarthritis and achieve early return to sports and work
Platelet Rich Plasma PRPharvest from peripheral blood is rich in multiple growth factorsie VEGF PDGD TGFB IGF EGF which help the injured tissue regeneration Bone marrow stem cell has been demonstrated to enhance the injured tissue repair both in vitro and in vivo study
However there is no prospective study in comparing the PRP and BMC to enhance interfacial healing between graft and bone tunnel in ACL reconstruction Investigators hypothesize that the combination of PRP and BMC has synergetic effect in interfacial healing in ACL reconstruction
Aim of this study To investigate the result of clinical functional scoring MRI and biomechanical study between PRP augmentation PRPBMC augmentation and traditional ACL reconstruction
Platelet Rich Plasma PRPharvest from peripheral blood is rich in multiple growth factorsie VEGF PDGD TGFB IGF EGF which help the injured tissue regeneration Bone marrow stem cell has been demonstrated to enhance the injured tissue repair both in vitro and in vivo study
However there is no prospective study in comparing the PRP and BMC to enhance interfacial healing between graft and bone tunnel in ACL reconstruction Investigators hypothesize that the combination of PRP and BMC has synergetic effect in interfacial healing in ACL reconstruction
Aim of this study To investigate the result of clinical functional scoring MRI and biomechanical study between PRP augmentation PRPBMC augmentation and traditional ACL reconstruction
Detailed Description:
Anterior cruciate ligament ACL is an important stabilizer of knee during daily activity and exercise According to literature there are 100000- 200000 ACL tear case annually in US The patients with ACL tear will sustain with joint pain muscle weakness giving way sensation other knee ligaments or meniscus injury and consequent osteoarthritis change However the ruptured ACL cannot heal by itself due to limited vascularity supply intraarticular inflammatory factors which inhibit the ACL cells migration and proliferation The ruptured ACL need to be reconstructed by a new tendon graft which passed the bone tunnel and joint during operation How to enhance the tendon graft to bone tunnel healing is critical important to prevent recurrent ligament laxity avoid secondary osteoarthritis and achieve early return to sports and work
Platelet Rich Plasma PRPharvest from peripheral blood is rich in multiple growth factorsie VEGF PDGD TGFB IGF EGF which help the injured tissue regeneration The PRP has been applied in treating tendinitis osteoarthritis cartilage injury and bone nonunion Bone marrow contains lots of stem cell and progenitor cells with capability of self-renewal and multi-differentiation Bone marrow stem cell has been demonstrated to enhance the injured tissue repair both in vitro and in vivo study The bone marrow concentrate BMC can be isolated from the bone marrow through the centrifuge procedure at one time which contains multiple stem cells The bone marrow can regenerate itself around 1 week
In recent years many authors uses the combination of RPP and BMC to treat injured tissue However there is no prospective study in comparing the PRP and BMC to enhance interfacial healing between graft and bone tunnel in ACL reconstruction Investigators hypothesize that the combination of PRP and BMC has synergetic effect in interfacial healing in ACL reconstruction
The purpose of this study is to investigate the clinical outcome of autologous PRP and combined BMCPRP in tendon graft augmentation in the ACL reconstruction surgery with functional score and MRI evaluation Investigators will analyze the therapeutic effect using one-way ANOVA To investigate the result of clinical functional scoring MRI and biomechanical study between PRP augmentation PRPBMC augmentation and traditional ACL reconstruction
Platelet Rich Plasma PRPharvest from peripheral blood is rich in multiple growth factorsie VEGF PDGD TGFB IGF EGF which help the injured tissue regeneration The PRP has been applied in treating tendinitis osteoarthritis cartilage injury and bone nonunion Bone marrow contains lots of stem cell and progenitor cells with capability of self-renewal and multi-differentiation Bone marrow stem cell has been demonstrated to enhance the injured tissue repair both in vitro and in vivo study The bone marrow concentrate BMC can be isolated from the bone marrow through the centrifuge procedure at one time which contains multiple stem cells The bone marrow can regenerate itself around 1 week
In recent years many authors uses the combination of RPP and BMC to treat injured tissue However there is no prospective study in comparing the PRP and BMC to enhance interfacial healing between graft and bone tunnel in ACL reconstruction Investigators hypothesize that the combination of PRP and BMC has synergetic effect in interfacial healing in ACL reconstruction
The purpose of this study is to investigate the clinical outcome of autologous PRP and combined BMCPRP in tendon graft augmentation in the ACL reconstruction surgery with functional score and MRI evaluation Investigators will analyze the therapeutic effect using one-way ANOVA To investigate the result of clinical functional scoring MRI and biomechanical study between PRP augmentation PRPBMC augmentation and traditional ACL reconstruction
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