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

NCT ID: NCT04972383

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-07
• Study Completion Date: 2019-10-16

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Platelet Rich Plasma group

single injection platelet rich plasma

Group Type: EXPERIMENTAL

Platelet Rich Plasma

Intervention Type: COMBINATION_PRODUCT

In the Platelet Rich Plasma group, 4mL Platelet Rich Plasma was given.

Hyaluronic Acid group

single injection of hyaluronic acid

Group Type: EXPERIMENTAL

Hyaluronic Acid

Intervention Type: COMBINATION_PRODUCT

In the Hyaluronic group, 3mLHYAJOINT Plus was given.

Interventions

Platelet Rich Plasma

In the Platelet Rich Plasma group, 4mL Platelet Rich Plasma was given.

Intervention Type: COMBINATION_PRODUCT

Hyaluronic Acid

In the Hyaluronic group, 3mLHYAJOINT Plus was given.

Intervention Type: COMBINATION_PRODUCT

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hsuan-Ti Huang, M.D

Role: STUDY_CHAIR

Kaohsiung Medical University, Orthopedics Department

Locations

Kaohsiung Medical University Hospital

Kaohsiung City, , Taiwan

Countries

Taiwan

Other Identifiers

KMUHIRB-F(II)-20170062

Identifier Type: -

Identifier Source: org_study_id