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

NCT03400631 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-08-11

No results posted yet for this study

Summary

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 For the first week participants will either be injected with dextrose or just have fluid withdrawn for testing.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 Fluid will be withdrawn from the knee at time zero, one week, and three months.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. .

Conditions

  • Osteoarthritis, Knee

Interventions

DRUG

Dextrose 0

Dextrose injection at time 0

DRUG

Aspiration 0

Aspiration only at time 0

DRUG

Dextrose 1

Dextrose injection at week 1

DRUG

Aspiration 1

Aspiration only at week 1

Sponsors & Collaborators

  • American Association of Orthopaedic Medicine

    collaborator UNKNOWN

  • Fisiatria y Traumatología

    lead OTHER

Principal Investigators

  • Gaston Topol, M.D. · University of Argentina

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2021-11-23
Completion
2021-11-23

Countries

  • Argentina

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03400631 on ClinicalTrials.gov