Functional and Clinical Outcomes of Hyaluronic Acid and Steroid Injections in Bilateral Knee Osteoarthritis

November 30, 2024 updated by: Edin Mešanović
The aim of this study is to compare functional and clinical outcomes of intraarticular injections of hyaluronic acid and steroids in patients with bilateral knee osteoarthritis. We will compare clinical and functional outcomes for each knee separately after week 6, month 3, month 6, and one year after the intervention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

We will include patients with bilateral knee osteoarthritis (Kellgren Lawrence grades 2 and 3). On initial examination, we will measure active and passive range of flexion and extension, presence of swelling, joint effusion, VAS score for each knee separately, and WOMAC score for every knee separately. We will randomly apply hyaluronic acid injection in one knee and steroid injection in the other knee. We will repeat the same examination after week 6, month 3, month 6, and one year after the procedure. The main aim is to check whether there is a significant clinical or functional difference between two groups.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • bilateral knee pain
  • same grade of osteoarthritis in both knees
  • Kellgren-Lawrence grade 2 or 3 of knee osteoarthritis
  • fully completed all follow-up examinations

Exclusion Criteria:

  • unilateral knee osteoarthritis
  • different grade of osteoarthritis between knees based on Kellgren-Lawrence scale
  • positive history of previous knee interventions (injections, surgery)
  • positive history of additional knee injuries (meniscus, ligament...)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Hyaluronic acid injection
This arm will receive a hyaluronic acid injection in the knee joint.
Other: Sodium hyaluronate (hyaluronic acid)
The patient will receive one 3mL Sodium Hyaluronate injection containing 75 mg of active substance in one knee joint.
Active Comparator: Steroid injection
This arm will receive steroid injection in the knee joint.
Drug: Methylprednisolone Acetate Injection
The patient will receive 2mL of methylprednisolone acetate solution containing 80 mg of the medicine in other knee joint.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
WOMAC score
Time Frame: One year after the intervention.
Changes in WOMAC score one year after the intervention compared to the WOMAC score at the initial examination.
One year after the intervention.
VAS score
Time Frame: One year after the intervention.
Changes in VAS score after one year.
One year after the intervention.
Range of active knee joint flexion
Time Frame: One year after the intervention.
Changes in the range of active knee joint flexion
One year after the intervention.
Range of active knee joint extension
Time Frame: One year after the intervention.
Changes in the range of active knee joint extension
One year after the intervention.
Knee swelling
Time Frame: One year after the intervention.
Presence of knee joint swelling.
One year after the intervention.
Knee joint effusion
Time Frame: One year after the intervention.
The presence of knee joint effusion.
One year after the intervention.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
WOMAC score after 6 weeks
Time Frame: 6 weeks after the intervention.
Changes in WOMAC score compared to the initial examination.
6 weeks after the intervention.
VAS score after 6 weeks
Time Frame: 6 weeks after the intervention.
Changes in VAS score compared to the initial examination.
6 weeks after the intervention.
Range of active knee joint flexion after 6 weeks
Time Frame: 6 weeks after the intervention.
Changes in range of active knee joint flexion compared to the initial examination.
6 weeks after the intervention.
Range of active knee joint extension after 6 weeks
Time Frame: 6 weeks after the intervention.
Changes in the range of knee joint extension compared to the initial examination.
6 weeks after the intervention.
Knee swelling after 6 weeks
Time Frame: 6 weeks after the intervention.
Changes in the presence of knee swelling compared to the initial examination.
6 weeks after the intervention.
Knee joint effusion after 6 weeks
Time Frame: 6 weeks after the intervention.
Changes in the presence of knee joint effusion compared to the initial examination.
6 weeks after the intervention.
WOMAC score after 3 months
Time Frame: 3 months after the intervention.
Changes in WOMAC score compared to the initial examination.
3 months after the intervention.
VAS score after 3 months
Time Frame: 3 months after the intervention.
Changes in VAS score compared to the initial examination.
3 months after the intervention.
Range of active knee joint flexion after 3 months
Time Frame: 3 months after the intervention.
Changes in the range of knee joint flexion compared to the initial examination.
3 months after the intervention.
Range of active knee joint extension after 3 months
Time Frame: 3 months after the intervention.
Changes in the range of knee joint extension compared to the initial examination.
3 months after the intervention.
Knee swelling after 3 months
Time Frame: 3 months after the intervention.
Changes in the presence of knee swelling compared to the initial examination.
3 months after the intervention.
Knee joint effusion after 3 months
Time Frame: 3 months after the intervention.
Changes in the presence of knee joint effusion compared to the initial examination.
3 months after the intervention.
WOMAC score after 6 months
Time Frame: 6 months after the intervention.
Changes in WOMAC score compared to the initial examination.
6 months after the intervention.
VAS score after 6 months
Time Frame: 6 months after the intervention.
Changes in VAS score compared to the initial examination.
6 months after the intervention.
Range of active knee joint flexion after 6 months
Time Frame: 6 months after the intervention.
Changes in the range of knee joint flexion compared to the initial examination.
6 months after the intervention.
Range of active knee joint extension after 6 months
Time Frame: 6 months after the intervention.
Changes in the range of knee joint extension compared to the initial examination.
6 months after the intervention.
Knee swelling after 6 months
Time Frame: 6 months after the intervention.
Changes in the presence of knee swelling compared to the initial examination.
6 months after the intervention.
Knee joint effusion after 6 months
Time Frame: 6 months after the intervention.
Changes in the presence of knee effusion compared to the initial examination.
6 months after the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Edin Mešanović

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 01-1-1-5469/23-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected IPD, all IPD that underlie results in a publication.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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