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

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 For the first week participants will either be injected with dextrose or just have fluid withdrawn for testing.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 Fluid will be withdrawn from the knee at time zero, one week, and three months.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

Detailed Description
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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.

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

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Drug: Dextrose 0
* Drug: Aspiration 0
* Drug: Dextrose 1
* Drug: Aspiration 1


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The first two weeks of this study involve two groups with a crossover at 1 week. From two weeks on, there is a single arm.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dextrose 0. Aspiration 1 week.<br>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<br>* Dextrose injection at time 0<br>Drug: Aspiration 1<br>* Aspiration only at week 1<br>|
| Experimental: Aspiration 0. Dextrose 1 week.<br>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<br>* Aspiration only at time 0<br>Drug: Dextrose 1<br>* Dextrose injection at week 1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short term change in cytokine levels | Change in cytokine levels from baseline to 1 week | Obtained at baseline and 1 week | 
| Long term change in cytokine levels | 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 | 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 | Western Ontario and McMaster Universities Arthritis Index normalized to 100 | Obtained at baseline, 3 and 6 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cytokine