A Prospective, Multicenter, Single-Blind, Randomized Controlled Clinical Trial of an Autologous Platelet-Rich Concentrated Growth Factor (CGF) Preparation Kit for the Treatment of Knee Osteoarthritis

NCT06869200 NA ENROLLING_BY_INVITATION

The goal of this clinical trial is to evaluate the effectiveness and safety of an autologous platelet-rich concentrated growth factor (CGF) preparation kit for the treatment of knee osteoarthritis in patients diagnosed with this condition. The main question it aims to answer is: Can the CGF preparation kit effectively improve symptoms and reduce pain in patients with knee osteoarthritis compared to a control intervention? Researchers will compare the CGF treatment group to a control group using platelet-rich plasma (PRP) to see if the CGF intervention results in greater improvements in knee function and pain relief. Participants will: Undergo three intra-articular injections of CGF or PRP into the knee joint at weekly intervals. Complete assessments including the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Visual Analog Scale (VAS) for pain at specified intervals. Be monitored for safety and potential adverse events throughout the study period.

Details

Lead sponsor	Guangdong Hongzhi Health Technology
Phase	NA
Status	ENROLLING_BY_INVITATION
Enrolment	104
Start date	2025-03
Completion	2026-02

Conditions

• Knee Osteoarthritis

Interventions

• Concentrated Growth Factor (CGF) Intra-articular Injection
• Platelet-Rich Plasma (PRP) Intra-articular Injection

Primary outcomes

• The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) — One month after the first injection
  The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is used to assess pain, stiffness, and physical function in patients with hip and knee osteoarthritis. The score ranges from 0 to 96 (using a 5-point Likert scale) or 0 to 240 (using a visual analog scale \[VAS\]), with lower scores indicating better outcomes.

Countries

China