Changes in Cytokine Levels After Dextrose Injection in Stage IV Knee Osteoarthritis

August 10, 2022 updated by: Gaston Andres Topol, Fisiatria y Traumatología

Changes in Cytokines After Masked Intraarticular Injection of Dextrose or Aspiration Only in Stage IV Knee Osteoarthritis

Twenty participants with severe arthritis will be enrolled. For the first week participants will either be injected with dextrose or just have fluid withdrawn for testing. The remaining participants will be given dextrose injection at the end of the week. After one week dextrose injections will be given at one, two, three, four, five, and six months. Fluid will be withdrawn from the knee at time zero, one week, and three months. The hypothesis is that dextrose injection will cause a change in proteins in the knee consistent with improved repair signals, along with improving knee pain and function. .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants with stage IV knee osteoarthritis will be evaluated for eligibility and randomized 1 to 1 using an Internet randomization method to ensure random allocation.

At time zero all participants will receive aspiration of their knees from the suprapatellar pouch of 5.5 mL of synovial fluid for cytokine analysis. After that 10 of the participants will receive injection of 10 mL of 12.5% dextrose. The other 10 will receive no injection after aspiration. Pain levels will be measured at time zero, 15 minutes, two hours and 48 hours after aspiration with or without injection to gather information about the time course of analgesia.

At one week all participants will receive aspiration of 2.0 mL from the suprapatellar pouch for cytokine analysis, followed by injection of the remaining 10 participants with dextrose 12.5%. Pain levels will be measured at the same time intervals to complete evaluation of dextrose analgesia.

After two weeks injections will be open label with 10 mills of dextrose 12 and have percent injected at one, two, three, four, five, and six months. At the three month. Another 2 mL of synovial fluid will be sent to the laboratory for cytokine analysis.

Study Type

Interventional

Enrollment (Actual)

20

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

  • Argentina
    • Santa Fe
      • Rosario, Santa Fe, Argentina, CS2000CXP
        • Gaston Topol, M.D.. Private Office

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

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Knee pain for at least 6 months.
  • Clinically diagnosed knee osteoarthritis.
  • Weight-bearing radiograph consistent with high-grade medial compartment cartilage loss (Kellgren-Lawrence Grading Scale level IV).
  • Confirmation of exposed subchondral bone by high-resolution knee ultrasonography.

Exclusion Criteria:

  • Anticoagulation therapy.
  • Inflammatory or post-infectious knee arthritis.
  • Systemic inflammatory conditions.
  • Knee flexion of less than 100 degrees.
  • Knee extension of less than 165 degrees.
  • Any Valgus
  • Varus more than 15 degrees.
  • Any knee injection in the past 3 months.
  • BMI more than 40
  • Gross synovial folds on ultrasound
  • Elevation of sed rate, C reactive protein, rheumatoid factor or antinuclear antibody.

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dextrose 0. Aspiration 1 week.
Dextrose injection given at time 0, at 1 week aspiration only, and then open label injection of dextrose at 0, 1, 2, 3, 4, 5, and 6 months.
Drug: Dextrose 0
Dextrose injection at time 0
Drug: Aspiration 1
Aspiration only at week 1
Experimental: Aspiration 0. Dextrose 1 week.
Aspiration only at time 0. Dextrose injection given at 1 week, and then open label injection of dextrose at 0, 1, 2, 3, 4, 5, and 6 months.
Drug: Aspiration 0
Aspiration only at time 0
Drug: Dextrose 1
Dextrose injection at week 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short term change in cytokine levels
Time Frame: Obtained at baseline and 1 week
Change in cytokine levels from baseline to 1 week
Obtained at baseline and 1 week
Long term change in cytokine levels
Time Frame: Obtained at baseline and 3 months
Change in cytokine levels from baseline to 3 months
Obtained at baseline and 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post Injection Short Term Pain Course
Time Frame: 0, 15 minutes, 2 hours, and 48 hours after time 0 and 1 week injections
Numerical rating scale (NRS) 0-10 pain score measured after time 0 and 1 week injections
0, 15 minutes, 2 hours, and 48 hours after time 0 and 1 week injections
WOMAC score
Time Frame: Obtained at baseline, 3 and 6 months.
Western Ontario and McMaster Universities Arthritis Index normalized to 100
Obtained at baseline, 3 and 6 months.

Collaborators and Investigators

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

Sponsor

Fisiatria y Traumatología

Collaborators

American Association of Orthopaedic Medicine

Investigators

  • Principal Investigator: Gaston Topol, M.D., University of Argentina

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)

August 1, 2018

Primary Completion (Actual)

November 23, 2021

Study Completion (Actual)

November 23, 2021

Study Registration Dates

First Submitted

October 25, 2017

First Submitted That Met QC Criteria

January 13, 2018

First Posted (Actual)

January 17, 2018

Study Record Updates

Last Update Posted (Actual)

August 11, 2022

Last Update Submitted That Met QC Criteria

August 10, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAFOYT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

This will be available by request.

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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