Comparison of Hyaluronic Acid and Platelet-rich Plasma Injections

Not Applicable

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Biological: Hyaluronic acid injection; Biological: Platelet-rich plasma injection

• Registration Number: NCT03761472
• Lead Sponsor: Bezmialem Vakif University

Brief Summary

This study aims to compare the effects of hyaluronic acid injection and platelet rich plasma injection in terms of pain, physical function and femoral cartilage thickness in short term treatment in patients with knee osteoarthritis.

Detailed Description

Platelet-rich plasma and hyaluronic acid injections are both popular treatments and commonly used for treatment of knee osteoarthritis. Even though there are many studies investigating the effectiveness of these treatments, the results are mostly qualitative. Also there are a few studies comparing these two treatment modalities. In this study the investigators aim to compare these modalities both for self-reported data (pain, physical function) and objective measurement data (femoral cartilage thickness via ultrasonography). Patients with unilateral osteoarthritis/unilateral complaint will be included in the study. Unaffected side will be controls for each group.

Study Timeline

• Study First Submitted: 2018-11-23
• Study First Submitted QC: 2018-11-30
• Study First Posted: 2018-12-03
• Study Start: 2019-01-01
• Status Verified: 2020-01
• Primary Completion: 2020-01-13
• Study Completion: 2020-01-13
• Last Update Submitted: 2020-01-13
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Subject is able to consent
• Subject meets Osteoarthritis Research Society International (OARSI) criteria for knee osteoarthritis
• Subject has radiographic Kellgren-Lawrence grade 2-3 osteoarthritis
• Unilateral osteoarthritis/complaint

Exclusion Criteria

• Past or actual knee infection
• History of surgery, fracture on knee
• Collagen tissue disease
• Systemic inflammatory disease (rheumatoid arthritis, spondyloarthritis etc.)
• Systemic diseases (diabetes, hematologic diseases, endocrinopathies, renal failure, liver failure)
• Knee injection in past 6 months
• Immunodeficiency
• Pregnant/breastfeeding
• Malignancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyaluronic acid injection	Hyaluronic acid injection	Hyaluronic acid 48 mg 2.0% in 2 ml solution, once initially.
Platelet-rich plasma injection	Platelet-rich plasma injection	Platelet-rich plasma 5 ml, once initially

Primary Outcome Measures

Name	Time	Method
Change of numeric rating scale (rest, movement)	0, 1st, 6th, months	Self reported pain scored between 0 (minimum)-10 (maximum). Higher scores represent a worse outcome.
Change of Western Ontario and McMaster Universities Osteoarthritis Index score(WOMAC)	0, 1st, 6th months	Self reported questionnaire investigating 24 daily living activities. Each item is scored 0-5 (0:none 5:worst). Yielding a total between 0-100. Higher scores represent a worse outcome.
Change of femoral cartilage thickness via ultrasonography.	0, 1st, 6th months	Transverse plane femoral cartilage thickness from three landmarks (from articular cartilage pothole,from midpoint of medial border and pothole of cartilage, from midpoint of lateral border and pothole of cartilage). Measured in millimeters. The sum of three points indicate a total thickness. A higher measurement indicates a thicker cartilage representing a better outcome.

Trial Locations

Locations (1)

Bezmialem Vakif University; 🇹🇷 Istanbul, Fatih, Turkey