Comparing Effect of Autologous Platelet-Rich Plasma Versus Hyaluronic Acid Treatment on Knee Osteoarthritis

Kaohsiung Medical University

Status and phase: Completed; Phase 3

Conditions: Knee Osteoarthritis

Treatments: Combination Product: Hyaluronic Acid; Combination Product: Platelet Rich Plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT04972383

KMUHIRB-F(II)-20170062

Details and patient eligibility

About

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.

Full 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.

Enrollment: 116 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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116 participants in 2 patient groups

Platelet Rich Plasma group

Experimental group

Description:

single injection platelet rich plasma

Treatment:

Combination Product: Platelet Rich Plasma

Hyaluronic Acid group

Experimental group

Description:

single injection of hyaluronic acid

Treatment:

Combination Product: Hyaluronic Acid