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Completed

NCT Number: NCT03400631

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 For the first week participants will either be injected with dextrose or just have fluid withdrawn for testing.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 Fluid will be withdrawn from the knee at time zero, one week, and three months.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

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Key information

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gaston Topol, M.D.. Private Office

Rosario, Santa Fe Province, CS2000CXP, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dextrose 0

Drug

Dextrose injection at time 0

Aspiration 0

Drug

Aspiration only at time 0

Dextrose 1

Drug

Dextrose injection at week 1

Aspiration 1

Drug

Aspiration only at week 1

Primary outcomes

  1. Short term change in cytokine levels

    Time frame: Obtained at baseline and 1 week

    Change in cytokine levels from baseline to 1 week

  2. Long term change in cytokine levels

    Time frame: Obtained at baseline and 3 months

    Change in cytokine levels from baseline to 3 months

Secondary outcomes

  1. 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

  2. WOMAC score

    Time frame: Obtained at baseline, 3 and 6 months.

    Western Ontario and McMaster Universities Arthritis Index normalized to 100

Sponsors and collaborators

Lead sponsor

Fisiatria y Traumatología

Other

Collaborators

  • American Association of Orthopaedic Medicine

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jan 17, 2018
Registry last updated
Aug 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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