To assess the safety and tolerability of intra-articular Injection doses of Rejoint Gel after platelet-rich plasma administration in unilateral knee OA subjects.
This single-center, randomized, double-blind, feasibility study to evaluate the safety and potential for effectiveness of an intraarticular Injection of Rejoint Gel after platelet-rich plasma administration in patient with single knee OA, parallel-design study will enroll approximately eligible 30 subjects with single knee OA. The subjects will be randomized (1:1) to receive 1 of 2 treatments below: 1. Treatment Group: Rejoint Gel, intra-articular injection, with platelet-rich plasma (PRP) in 2:1 volume ratio or 2. Control Group: Normal saline, intra-articular injection with PRP in 2:1 volume ratio Beginning on treatment period, subjects will receive a single treatment cycle of either 150 mg/ml Rejoint Gel or normal saline with PRP intra-articular injection twice for one month (Visit 3 and 4). Subjects will be followed to Visit 5, 6 and 7 for safety and potential for effectiveness assessments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
30
Beginning on treatment period, subjects will receive either Rejoint Gel or normal saline with PRP intra-articular injection twice for one month (Visit 3 and 4).
National Taiwan University Hospital
Taipei, Taiwan
RECRUITINGNumber of Participants with Adverse events (AEs) and serious AEs
Adverse events (AEs) and serious AEs
Time frame: Baseline to Visit 7 (15th week)
Western Ontario and McMaster Universities Index for osteoarthritis
Change in Western Ontario and McMaster Universities (WOMAC) Index for osteoarthritis: five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time frame: Baseline to Visit 7 (15th week)
Kellgren-Lawrence grading scale
Change in the Kellgren-Lawrence (KL) Grading Scale: 0-IV (0: normal, IV: the worst)
Time frame: Baseline to Visit 7 (15th week)
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