NCT03761472

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 3, 2018

Completed
29 days until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2020

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

1 year

First QC Date

November 23, 2018

Last Update Submit

January 13, 2020

Conditions

Knee Osteoarthritis

Keywords

OsteoarthritisHyaluronic acidPlatelet-rich plasmaInjection

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (4)

Hyaluronic acid injection

ACTIVE COMPARATOR

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

Biological: Hyaluronic acid injection

Platelet-rich plasma injection

ACTIVE COMPARATOR

Platelet-rich plasma 5 ml, once initially

Biological: Platelet-rich plasma injection

Unaffected side Hyaluronic acid

NO INTERVENTION

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

Unaffected side Platelet-rich plasma

NO INTERVENTION

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

Interventions

Hyaluronic acid injectionBIOLOGICAL

Hyaluronic acid 48 mg 2.0% in 2.4 ml solution

Also known as: Reviscon Mono
Hyaluronic acid injection
Platelet-rich plasma injectionBIOLOGICAL

Platelet-rich plasma injection 5ml

Platelet-rich plasma injection

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Related 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.

    PMID: 28146403BACKGROUND

  • 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.

    PMID: 25691769BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Teoman Aydın, Prof, MD

    Bezmialem Vakif University

    STUDY DIRECTOR

  • Ozan Volkan Yurdakul, MD

    Bezmialem Vakif University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2018

First Posted

December 3, 2018

Study Start

January 1, 2019

Primary Completion

January 13, 2020

Study Completion

January 13, 2020

Last Updated

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)