Kaohsiung Medical University Hospital
Kaohsiung City, 807, Taiwan
NCT Number: NCT04972383
To compare the efficacy and structural change of intraarticular single platelet-rich plasma(PRP) versus novel crosslinked Hyaluronic Acid(HA)(HyajointPlus) for the treatment of early stage knee osteoarthritis(OA). This was a prospective, double-blind, RCT with an allocation ratio of 1:1.
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Notify Me50 year–85 year
All sexes
Interventional
Phase 3
Kaohsiung City, 807, Taiwan
In the PRP group, an Aeon Acti-PRP set was used and an approximately 4-mL PRP volume was yielded and was used in a single-dose treatment. In the HA group, HYAJOINT Plus containing 60 mg of purified sodium hyaluronate was used in a single-dose treatment. All PRP and HA injection syringes were covered with opaque envelop, and the intra-articular injection procedure was performed by the same physician without ultrasound or other imaging guidance.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In the Platelet Rich Plasma group, 4mL Platelet Rich Plasma was given.
In the Hyaluronic group, 3mLHYAJOINT Plus was given.
Time frame: Baseline and 1-month, 3-month, 6-month after injection
The minimum value of Western Ontario and McMaster Universities Index (WOMAC) score is zero and the maximum is 96, whether higher scores mean a worse outcome.
Time frame: Baseline and 1-month, 3-month, 6-month after injection
The Cartilage Grading System classifies the cartilage from grades 0 to 6 according to parameters of sharpness, clarity and thickness change of the cartilage band. Grade 0 refers to normal and healthy cartilage, while grade 6 refers to severely eroded cartilage, whether higher scores mean a worse outcome.
Time frame: Baseline and 1-month, 3-month, 6-month after injection
The strain represents the elasticity. We used the overlying soft tissue as reference. Larger strain ratio means the cartilage is softer, while smaller strain ratio means the cartilage is harder.
Time frame: Baseline and 6-month after injection
Fourteen subregions are defined for scoring of articular cartilage and bone marrow lesions in cluding patella, femur and tibia region. Grade 0 refers to normal and healthy cartilage without loss, while grade 3 refers >75% cartilage full thickness loss, whether higher scores mean a worse outcome.
Kaohsiung Medical University Chung-Ho Memorial Hospital
Other
A Prospective,Double-Blind Randomized Controlled Trial Comparing Effect of Autologous Platelet-Rich Plasma Versus Hyaluronic Acid Treatment on Progression of Structural Changes in Knee Osteoarthritis
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