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

NCT04972383 | Completed Phase 3

• 1 other identifier: KMUHIRB-F(II)-20170062
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The change of Knee Cartilage Grading System from baseline

  Baseline and 1-month, 3-month, 6-month after injection

• The change of Knee Cartilage strain ratio from baseline

  Baseline and 1-month, 3-month, 6-month after injection

• The change of MRI Osteoarthritis Knee Score (MOAKS) from baseline

  Baseline and 6-month after injection

Study Arms (2)

Platelet Rich Plasma group

EXPERIMENTAL

single injection platelet rich plasma

Combination Product: Platelet Rich Plasma

Hyaluronic Acid group

EXPERIMENTAL

single injection of hyaluronic acid

Combination Product: Hyaluronic Acid

Interventions

Platelet Rich Plasma COMBINATION_PRODUCT

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

Platelet Rich Plasma group

Hyaluronic Acid COMBINATION_PRODUCT

In the Hyaluronic group, 3mLHYAJOINT Plus was given.

Hyaluronic Acid group

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University Hospital

Kaohsiung City, 807, Taiwan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Hsuan-Ti Huang, M.D

  Kaohsiung Medical University, Orthopedics Department

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 22, 2021
• Study Start: November 7, 2017
• Primary Completion: October 16, 2019
• Study Completion: October 16, 2019
• Last Updated: October 10, 2023

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: starting 12 months after publication
• Access Criteria: Studies involving platelet rich plasma, hyaluronic acid can contact us for additional information.

Locations

TW (1)