Intraarticular Dextrose Prolotherapy for Symptomatic Knee Osteoarthritis

• Status: Not yet recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research is to learn more about treating Symptomatic Knee Osteoarthritis (OA) with an ultrasound-guided hypertonic dextrose injection. Researchers would like to determine best practice for injection frequency and effectiveness of the dextrose injection for symptomatic knee OA.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic

Criteria

Inclusion Criteria:

• Diagnosis of knee OA by clinical criteria (American College of Rheumatology).

• Identification of knee osteoarthritis by a radiologist on an existing knee radiograph obtained within 3 years of enrollment.

• Moderate to severe knee pain for at least 3 months, defined as a score of ≥ 4 (on a 0-10 point numeric rating scale) in response to the question "What is the average level of your left/right knee pain in the past 3 months?".

Exclusion Criteria:

• Pregnancy.

• Diabetes.

• Anticoagulation therapy.

• History of total knee replacement.

• Prior knee prolotherapy or other regenerative product.

• Any knee injection within 3 months.

• Inflammatory (RA, gout, pseudogout etc.) or postinfectious knee arthritis.

• Daily use of opioid medication.

• Allergy or intolerance to study medication, corn allergy.

• Body mass index (BMI) greater than 40 kg/m^2.

• Comorbidity severe enough to prevent participation in the study protocol.