Status:
COMPLETED
Changes in Cytokine Levels After Dextrose Injection in Stage IV Knee Osteoarthritis
Lead Sponsor:
Fisiatria y Traumatología
Collaborating Sponsors:
American Association of Orthopaedic Medicine
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
21-75 years
Phase:
NA
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 For the first week participants will either be injected with dextrose or just have fluid withdrawn for testing.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 w...
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 participant...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 23 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03400631
Start Date
August 1 2018
End Date
November 23 2021
Last Update
August 11 2022
Active Locations (1)
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1
Gaston Topol, M.D.. Private Office
Rosario, Santa Fe Province, Argentina, CS2000CXP