Comparing the Efficacy of Lyophilized Self Growth Factor Versus PRP Injection for Knee OA
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorTri-Service General Hospital
About this trial
Knee osteoarthritis(OA) is a common degenerative joint disease that often leads to knee pain, stiffness, and a decline in quality of life among middle-aged and elderly individuals. Platelet-rich plasma (PRP) is a regenerative treatment method that involves drawing a small amount of the patient's own blood and using centrifugation process to produce PRP. PRP, which is rich in growth factors and anti-inflammatory cytokines, facilitate the repair of damaged tissues and has been used in treating knee OA. Self-repair factor (SRF), an advanced form of PRP, is created using multi-step centrifugation and proprietary processes to increase platelet concentration. This enhancement may offer superior repair efficacy and faster recovery compared to traditional PRP. To explore this potential, we designed a randomized, double-blind, clinical trial to compare the effectiveness of SRF and PRP in treating degenerative knee osteoarthritis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female, aged over 20 and under 80.
Consciousness clear and able to communicate.
Unilateral or bilateral osteoarthritis of the knee with symptoms lasting more than 3 months.
X-ray imaging shows mild to moderate knee osteoarthritis (Kellgren-Lawrence grades 1-3).
Disqualifiers
Severe knee osteoarthritis (Kellgren-Lawrence grade 4).
Currently systemic infection.
Received hyaluronic acid or corticosteroid intraarticular injections within the past six months, or received NSAIDs or oral corticosteroid treatment within 7 days prior to treatment.
The treated joint has undergone joint replacement surgery or major surgery.
Trial design
Design model
Parallel
Treatments tested in this trial
Lyophilized self growth factor
Procedure/SurgeryKnee Intraarticular injection with Lyophilized self growth factor
Platelet-Rich Plasma(PRP)
Procedure/SurgeryKnee Intraarticular injection with Lyophilized self growth factor
Placebo
Procedure/SurgeryKnee Intraarticular injection with normal saline
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Lyophilized self growth factorExperimental treatment 1 intervention
Group B: Platelet-Rich Plasma(PRP)Active comparator 1 intervention
Group C: normal salinePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Western Ontario and McMaster Universities Osteoarthritis Index
The structure and function of the knee joint are assessed from three main aspects: pain, stiffness, and joint function, with a total of 24 items. The pain section consists of 5 items (24 points in total), the stiffness section has 2 items (8 points in total), and the joint function section includes 17 items (68 points in total). A lower score indicates more severe pain, stiffness, and a higher degree of disability.
Time frame
Pre-treatment, 1st month, 2nd month, 3rd month, 6th monthSecondary outcomes
1
Visual Analogue Scale
Change from baseline of pain on 1st month, 2nd month, 3rd month, 6th month after injection. Pain severity was evaluated using visual analog scale (VAS). Pain score scale ranged from 0 to 10, with 10 indicating the most severe pain
Time frame
Pre-treatment, 1st month, 2nd month, 3rd month, 6th month2
The intermittent and constant pain score , ICOAP
The content is divided into two subcategories: continuous pain (5 items) and intermittent pain (6 items), with a total of 11 items. Each item is scored from 0, representing no pain, to 4, representing extreme pain. A higher score indicates more severe pain. The Chinese version has reliable validity and reliability.
Time frame
Pre-treatment, 1st month, 2nd month, 3rd month, 6th month3
Timed Up and Go test
Align the chair legs with the starting baseline and place a cone 3 meters ahead. The participant sits in the chair with their feet naturally bent, stands up comfortably, walks forward for 3 meters, turns around, and walks back to sit down. The time taken to complete the task is recorded. This test has good validity and reliability for assessing the mobility of patients with degenerative knee osteoarthritis.
Time frame
Pre-treatment, 1st month, 2nd month, 3rd month, 6th month.Sponsors and contacts
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Source ClinicalTrials.gov