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

Phase 3

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Combination Product: Hyaluronic Acid; Combination Product: Platelet Rich Plasma

• Registration Number: NCT04972383
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

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.

Study Timeline

• Study Start: 2017-11-07
• Primary Completion: 2019-10-16
• Study Completion: 2019-10-16
• Status Verified: 2021-06
• Study First Submitted: 2021-07-06
• Study First Submitted QC: 2021-07-21
• Study First Posted: 2021-07-22
• Last Update Submitted: 2023-10-08
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyaluronic Acid group	Hyaluronic Acid	single injection of hyaluronic acid
Platelet Rich Plasma group	Platelet Rich Plasma	single injection platelet rich plasma

Primary Outcome Measures

Name	Time	Method
The change of Western Ontario and McMaster Universities Index (WOMAC) score from baseline	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.

Secondary Outcome Measures

Name	Time	Method
The change of Knee Cartilage strain ratio from baseline	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.
The change of Knee Cartilage Grading System from baseline	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.
The change of MRI Osteoarthritis Knee Score (MOAKS) from baseline	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.

Trial Locations

Locations (1)

Kaohsiung Medical University Hospital; 🇨🇳 Kaohsiung City, Taiwan