Comparison of Hyaluronic Acid and Platelet-rich Plasma Injections

NCT ID: NCT03761472

Last Updated: 2020-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-01-13

Brief Summary

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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

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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.

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hyaluronic acid injection

Hyaluronic acid 48 mg 2.0% in 2 ml solution, once initially.

Group Type ACTIVE_COMPARATOR

Hyaluronic acid injection

Intervention Type BIOLOGICAL

Hyaluronic acid 48 mg 2.0% in 2.4 ml solution

Platelet-rich plasma injection

Platelet-rich plasma 5 ml, once initially

Group Type ACTIVE_COMPARATOR

Platelet-rich plasma injection

Intervention Type BIOLOGICAL

Platelet-rich plasma injection 5ml

Unaffected side Hyaluronic acid

Unaffected sides of the patients will be controls for hyaluronic acid group, no intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Unaffected side Platelet-rich plasma

Unaffected sides of the patients will be controls for Platelet-rich plasma group, no intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hyaluronic acid injection

Hyaluronic acid 48 mg 2.0% in 2.4 ml solution

Intervention Type BIOLOGICAL

Platelet-rich plasma injection

Platelet-rich plasma injection 5ml

Intervention Type BIOLOGICAL

Other Intervention Names

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Reviscon Mono

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bezmialem Vakif University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Teoman Aydın, Prof, MD

Role: STUDY_DIRECTOR

Bezmialem Vakif University

Ozan Volkan Yurdakul, MD

Role: PRINCIPAL_INVESTIGATOR

Bezmialem Vakif University

Locations

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Bezmialem Vakif University

Istanbul, Fatih, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 28146403 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25691769 (View on PubMed)

Other Identifiers

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71306642-050.01.04-

Identifier Type: -

Identifier Source: org_study_id

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