Comparison of the Effects of Single Versus Triple Injections of Platelet-Rich Plasma in Patients With Knee Osteoarthritis

May 7, 2024 updated by: Izmir Democracy University
80 patients diagnosed with knee osteoarthritis were randomized into two groups: patients in Group 1 received a single intraarticular injection of PRP whereas those in group 2 were administered three intraarticular injections of PRP within an interval of 2 weeks between each application. Patients were evaluated before the treatment and at the 6 month after the treatment with a Visual Analog Scale (VAS) and The Western Ontario and MacMaster Universities (WOMAC) Osteoarthritis Index.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

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

  • Turkey
      • Izmir, Turkey, 35000
        • Buca Seyfi Demirsoy Training and Research Hospital

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ages of 35 and 80
  • Kellgren-Lawrence grade of 2, 3, or 4

Exclusion Criteria:

  • rheumatic diseases, coagulopathies, severe cardiovascular diseases, local infections, malignancies, immunodeficiency, schizophrenia, mental retardation, anticoagulant therapy, a hemoglobin concentration of 11 g/dL and platelets of 150,000/L, a history of severe trauma, or a history of hyaluronic acid or corticosteroid injection within the previous 6 months

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Single prp injection
single intraarticular prp injection
Other: prp injection
intraarticular prp
Active Comparator: triple prp injection
triple intraarticular prp injection
Other: prp injection
intraarticular prp

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Western Ontario and MacMaster Universities (WOMAC) Osteoarthritis Index
Time Frame: baseline and 6 months
baseline and 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Visual Analog Scale (VAS)
Time Frame: baseline and 6 months
baseline and 6 months

Collaborators and Investigators

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

Sponsor

Izmir Democracy University

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)

April 15, 2023

Primary Completion (Actual)

April 1, 2024

Study Completion (Actual)

April 15, 2024

Study Registration Dates

First Submitted

May 7, 2024

First Submitted That Met QC Criteria

May 7, 2024

First Posted (Actual)

May 10, 2024

Study Record Updates

Last Update Posted (Actual)

May 10, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • prpknee2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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