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. Study design: Prospective, multicenter, single-blind, randomized controlled, non-inferiority clinical trial. Sample size: 104 cases, with 52 cases in the experimental group and 52 cases in the control group.
This study predefines the conversion between non-inferiority and superiority tests: first, a non-inferiority test is performed. If the non-inferiority conclusion is valid, a superiority test can be performed. If the superiority conclusion is valid, the research conclusion is superiority; if the superiority conclusion is invalid, the research conclusion is non-inferiority.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
104
Preparation Method: The CGF is prepared using an autologous platelet-rich preparation kit specifically designed to concentrate growth factors from the patient's own blood. The process involves a specialized centrifugation technique that yields a high concentration of growth factors, including platelet-derived growth factor (PDGF), transforming growth factor-beta (TGF-β), and other bioactive molecules. Rationale: This intervention leverages the body's natural healing response by utilizing autologous growth factors to enhance the repair of cartilage and other joint tissues affected by osteoarthritis. The high concentration of bioactive molecules in CGF is believed to provide a more potent therapeutic effect compared to other platelet-rich therapies.
Preparation Method: The PRP is prepared using a disposable PRP preparation device that separates and concentrates platelets from the patient's blood. This process enriches the plasma with platelets and associated growth factors. Rationale: PRP has been widely used in clinical practice for its ability to promote tissue healing and reduce inflammation in osteoarthritis. It serves as an active comparator in this study, allowing for a direct comparison of the therapeutic efficacy and safety profile of CGF against a well-established treatment modality.
Nanfang Hospital,
Guangzhou, Guangdong, China
Shantou Central Hospital
Shantou, Guangdong, China
The Third Affiliated Hospital,Sun Yat-Sen University.
Guangdong, Guangzhou, China
Absolute Change in The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score
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), with lower scores indicating better outcomes. Calculated as the absolute value of the difference between the WOMAC score at 1 month and the baseline score: \|Score at 1 month - Score at baseline\|.
Time frame: 1 month after the 1st injection
Absolute Change in The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score
Calculated as the absolute value of the difference between the WOMAC score at 2 months and the baseline score: \|Score at 2 months - Score at baseline\|.
Time frame: 2 months after the 1st injection
Absolute Change in The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score
Calculated as the absolute value of the difference between the WOMAC score at 3 months and the baseline score: \|Score at 3 months - Score at baseline\|.
Time frame: 3 months after the 1st injection
Absolute Change in The Visual Analog Scale (VAS) Score
The Visual Analog Scale (VAS) is used to measure the intensity of pain experienced by patients. The VAS score ranges from 0 to 10, with lower scores indicating better outcomes (i.e., less pain).
Time frame: 1 month after the first injection
Absolute Change in The Visual Analog Scale (VAS) Score
The Visual Analog Scale (VAS) is used to measure the intensity of pain experienced by patients. The VAS score ranges from 0 to 10, with lower scores indicating better outcomes (i.e., less pain). Calculated as the absolute value of the difference between the VAS score at 1month and the baseline score: \|Score at 2 month - Score at baseline\|.
Time frame: 2 months after the first injection
Absolute Change in The Visual Analog Scale (VAS) Score
The Visual Analog Scale (VAS) is used to measure the intensity of pain experienced by patients. The VAS score ranges from 0 to 10, with lower scores indicating better outcomes (i.e., less pain). Calculated as the absolute value of the difference between the VAS score at 3 months and the baseline score: \|Score at 3 months - Score at baseline\|.
Time frame: 3 months after the first injection
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