The Efficacy of Platelet-Rich-Plasma for prevention of the knee joint cartilage degeneration after anterior cruciate ligament reconstruction

JRCT ID: jRCTb030200391

Registered date:02/03/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients after anterior cruciate ligament reconstruction
• Date of first enrollment: 02/03/2021
• Target sample size: 80
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intervention 1: Administration of specific cell processed product (PRP)
Intervention 2: Dry needle (only synovial fluid collection)

Outcome(s)

• Primary Outcome: T2 value of knee joint cartilage

Secondary Outcome

Pain assessment (Visual Analog Scale (VAS), Knee injury and Osteoarthritis Outcome Score (KOOS))
Blood test (CBC, Biochemical examination)
Blood, urine, and synovial fluid biomarkers
X-ray (narrowing of joint space, osteophytes, cysts, Femorotibial angle (FTA))
MRI (cartilage thickness and volume by 3D-MRI, semi-quantitative whole organ MRI score (WORMS))
Physical examinations (swelling, warmth, tenderness, range of motion of joints, muscle strength measurement (muscle measuring device), joint stability measurement (three-dimensional accelerometer (KiRA))

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 50age old
• Gender: Both

Include criteria

1 At the time of obtaining consent, the age is between 20 and 50
2 Male and female
3 Kellgren-Lawrence classification 2 or less
4 Single bundle reconstruction surgery using semitendinosus tendon as reconstruction ligament
5 First injury
6 BMI is less than 35
7 Those who have received a sufficient explanation, fully understood, and obtained free written consent.
8 In addition, those who the doctor deems appropriate

Exclude criteria

1 Ligament compound injury (posterior cruciate ligament, lateral support mechanism)
2 Merge of medial collateral ligament injuries requiring repair
3 Femoro-Tibial Angle: FTA left and right difference is 10 degrees or more
4 Whole body motor disease
5 Patients with malignant neoplasms currently being treated
6 Patients with active infectious disease (including HBV, HCV, HTLV-1, HIV, syphilis)
7 Rheumatoid arthritis
8 Blood disease
9 Mental illness
10 pregnant
11 Drug addict
12 Person on dialysis
13 Those under 20 and over 50
14 Patients who cannot measure communication
15 Patients who are judged not suitable by the research doctor

Related Information

• Primary Sponsor: Yoshitomo Saita