Clinical trial NCT04972383: Comparing Effect of Autologous Platelet-Rich Plasma Versus Hyaluronic Acid Treatment on Knee Osteoarthritis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Knee Osteoarthritis
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 116
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. patients older than 50 years
2. a diagnosis of primary knee osteoarthritis
3. Kellgren-Lawrence (K-L) grading scale smaller than 3
4. both male and female.

Exclusion Criteria:

1. patients younger than 50 years of age
2. K-L grade 3 or more
3. history or active presence of clinically significant inflammatory articular or rheumatic disease other than OA
4. generalized OA
5. the detection of rapidly progressive OA before the start of the trial
6. underwent any previous lower extremity surgery
7. excessive mechanical axis deviation (varus \> 5°, valgus \> 5°)
8. body mass index larger than 30
9. history or presence of malignant disorders
10. systemic disorders such as diabetes mellitus, severe cardiovascular diseases, hematologic diseases, immune-deficiencies, and infections
11. systematic or intra-articular corticosteroid therapy in the previous 3 months
12. prior treatment with HA in the past 6 months
13. anticoagulants or antiaggregants therapy in the preceding 30 days
14. non-steroidal anti-inflammatory medications in the preceding 7 days
15. platelet count less than 150,000/ml of blood
16. hemoglobin values less than 12g/dL of blood.

Primary outcomes:
measure: The change of Western Ontario and McMaster Universities Index (WOMAC) score from baseline
timeFrame: Baseline and 1-month, 3-month, 6-month after injection
Secondary outcomes:
measure: The change of Knee Cartilage Grading System from baseline
timeFrame: Baseline and 1-month, 3-month, 6-month after injection
measure: The change of Knee Cartilage strain ratio from baseline
timeFrame: Baseline and 1-month, 3-month, 6-month after injection
measure: The change of MRI Osteoarthritis Knee Score (MOAKS) from baseline
timeFrame: Baseline and 6-month after injection
Other outcomes:
Locations:
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Medical University Hospital
Study officials:
affiliation: Kaohsiung Medical University, Orthopedics Department
name: Hsuan-Ti Huang, M.D
role: STUDY_CHAIR
References: