Clinical trial NCT03761472: Comparison of Hyaluronic Acid and Platelet-rich Plasma Injections
Official title: Comparison of Hyaluronic Acid and Platelet-rich Plasma Injection on Pain, Physical Function and Femoral Cartilage Thickness in Patients With Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Osteoarthritis
Hyaluronic acid
Platelet-rich plasma
Injection
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2018-12-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of numeric rating scale (rest, movement)
timeFrame: 0, 1st, 6th, months
measure: Change of Western Ontario and McMaster Universities Osteoarthritis Index score(WOMAC)
timeFrame: 0, 1st, 6th months
measure: Change of femoral cartilage thickness via ultrasonography.
timeFrame: 0, 1st, 6th months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
state: Fatih
Study officials:
affiliation: Bezmialem Vakif University
name: Teoman Aydın, Prof, MD
role: STUDY_DIRECTOR
affiliation: Bezmialem Vakif University
name: Ozan Volkan Yurdakul, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.