Osteoarthritis, Knee
Conditions
Keywords
Cytokine
Brief 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 For the first week participants will either be injected with dextrose or just have fluid withdrawn for testing.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 Fluid will be withdrawn from the knee at time zero, one week, and three months.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. .
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.
Interventions
DRUGDextrose 0
Dextrose injection at time 0
DRUGAspiration 0
Aspiration only at time 0
DRUGDextrose 1
Dextrose injection at week 1
DRUGAspiration 1
Aspiration only at week 1
Sponsors
American Association of Orthopaedic Medicine
Fisiatria y Traumatología
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Masking only of above.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short term change in cytokine levels | Obtained at baseline and 1 week | Change in cytokine levels from baseline to 1 week |
| Long term change in cytokine levels | Obtained at baseline and 3 months | Change in cytokine levels from baseline to 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post Injection Short Term Pain Course | 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 |
| WOMAC score | Obtained at baseline, 3 and 6 months. | Western Ontario and McMaster Universities Arthritis Index normalized to 100 |
Countries
Argentina
Outcome results
None listed