Comparison of Hyaluronic Acid and Platelet-rich Plasma Injections

Knee Osteoarthritis Clinical Trial

Official title:

Comparison of Hyaluronic Acid and Platelet-rich Plasma Injection on Pain, Physical Function and Femoral Cartilage Thickness in Patients With Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03761472
• Other study ID #: 71306642-050.01.04-
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: January 13, 2020

Study information

• Verified date: January 2020
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 13, 2020
• Est. primary completion date: January 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• Hyaluronic acid injection
Hyaluronic acid 48 mg 2.0% in 2.4 ml solution
• Platelet-rich plasma injection
Platelet-rich plasma injection 5ml

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Cole BJ, Karas V, Hussey K, Pilz K, Fortier LA. Hyaluronic Acid Versus Platelet-Rich Plasma: A Prospective, Double-Blind Randomized Controlled Trial Comparing Clinical Outcomes and Effects on Intra-articular Biology for the Treatment of Knee Osteoarthritis. Am J Sports Med. 2017 Feb;45(2):339-346. doi: 10.1177/0363546516665809. Epub 2016 Oct 21. Erratum in: Am J Sports Med. 2017 Apr;45(5):NP10. — View Citation

Keen HI, Hensor EM, Wakefield RJ, Mease PJ, Bingham CO 3rd, Conaghan PG. Ultrasound assessment of response to intra-articular therapy in osteoarthritis of the knee. Rheumatology (Oxford). 2015 Aug;54(8):1385-91. doi: 10.1093/rheumatology/keu529. Epub 2015 Feb 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of numeric rating scale (rest, movement)	Self reported pain scored between 0 (minimum)-10 (maximum). Higher scores represent a worse outcome.	0, 1st, 6th, months
Primary	Change of Western Ontario and McMaster Universities Osteoarthritis Index score(WOMAC)	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.	0, 1st, 6th months
Primary	Change of femoral cartilage thickness via ultrasonography.	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.	0, 1st, 6th months