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

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04972383
• Other study ID #: KMUHIRB-F(II)-20170062
• Status: Completed
• Phase: Phase 3
• Start date: November 7, 2017
• Est. completion date: October 16, 2019

Study information

• Verified date: June 2021
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: October 16, 2019
• Est. primary completion date: October 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Combination Product:
• Platelet Rich Plasma
In the Platelet Rich Plasma group, 4mL Platelet Rich Plasma was given.
• Hyaluronic Acid
In the Hyaluronic group, 3mLHYAJOINT Plus was given.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung City

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of Western Ontario and McMaster Universities Index (WOMAC) score from baseline	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.	Baseline and 1-month, 3-month, 6-month after injection
Secondary	The change of Knee Cartilage Grading System from baseline	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.	Baseline and 1-month, 3-month, 6-month after injection
Secondary	The change of Knee Cartilage strain ratio from baseline	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.	Baseline and 1-month, 3-month, 6-month after injection
Secondary	The change of MRI Osteoarthritis Knee Score (MOAKS) from baseline	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.	Baseline and 6-month after injection