Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06442319
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-29
Brief Title:
The Efficiency and Safety of PRP Treatment After Anterior Cruciate Ligament Reconstruction
Sponsor:
Nicolaus Copernicus University in Toruń Collegium Medicum in Bydgoszcz
Organization:
Nicolaus Copernicus University in Toruń Collegium Medicum in Bydgoszcz
Study Overview
Official Title:
The Efficiency and Safety of Platelet-rich Plasma Intra-articular Injections After Anterior Cruciate Ligament Reconstruction MRI and Clinical Outcome Analysis
Status:
RECRUITING
Status Verified Date:
2024-05
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 anterior cruciate ligament ACL is the main stabilizer of the knee joint as it controls anteroposterior and rotatory knee laxity The number of ACL injuries has increased in the past three decades because more and more people participate in recreational and competitive sporting activities Injury to the ACL often leads to functional instability damage to the meniscus and articular cartilage and an increased risk for osteoarthritis OA Emphasizes the fact that ACL has limited healing potential The gold standard treatment is ACL reconstruction with over 200000 reconstruction surgeries performed annually in the United States However despite the success of surgery in restoring functional stability it has been found so far in several studies that the prevalence of moderate to severe arthritis in long-term radiographic follow-up is more than 50 after ACL reconstruction within 5 to 15 years or sooner ACL-injured knees had at least 3 times higher risk of arthritis than uninjured contralateral knees Early osteoarthritis was observed on magnetic resonance imaging MRI up to 11 years following ACL injury after operative and nonoperative management Because ACL injuries predominantly occur in individuals between the ages of 15 and 25 years symptoms of OA most often affect patients during their most productive years This is worrisome because most patients who sustain ACL tears are free of the risk of other factors for developing OAConsequently posttraumatic OA after ACL reconstruction ultimately translates into a large economic effect on the healthcare system owing to the young age of this population Platelet-rich plasma is an autologous solution of highly concentrated platelets dispersed in a small capacity of plasma Enthusiasm for the therapeutic potential of platelets is based on its rich omplement of anabolic growth factors and anti-inflammatory cytokines in the platelets which induce cellular proliferation migration differentiation angiogenesis and extracellular matrix synthesis In addition the functional mechanisms of PRP in OA treatment have been explained by its effect on modulating critical pro-inflammatory mediators and catabolic enzymes as well as maintaining joint homeostasis The reasons for this early incidence of post-traumatic OA remain unclear but the underlying mechanisms have been speculated to involve some combination of cartilage damage at the time of injury and posttraumatic molecular changes in the joint including immune reactions or persistent secondary inflammation We hypothesized that PRP injection after ACL reconstruction could prevent cartilage damage act anti-inflammatory and provide better clinical and radiological outcomes seen in MRI
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