Location: Scottsdale and Phoenix, Arizona

Study Length: 1 year

Status: Open for Enrollment

Help us evaluate new ways to treat osteoarthritis in knees. Interested in participating? Get in touch with the study team via email or by phone.

If you’ve been diagnosed with knee osteoarthritis, you know that it can cause pain, stiffness and decreased joint function. With this clinical trial, we want to see if we can help minimize this pain by injecting a substance called hypertonic dextrose directly into the knee joint.

Dextrose prolotherapy (the non-surgical injection we will use in this study) has been utilized in several previous studies without any significant adverse effects.

If you'd like to learn more about knee osteoarthritis, its symptoms and treatments, click here.

Or call us at 480-301-6542

Tasks

We'll ask you to keep a symptom diary at home and complete pain and stiffness assessments at your appointments.

Study length

The study will last 52 weeks. You will need to come into our offices for 4 separate injection appointments and two follow-up visits over the course of the year.

Treatment

This is a randomized study, so you will be assigned to 1 of 4 treatment groups. 3 of the groups will receive hypertonic dextrose injections, while the 4th will get a placebo. We will be using an ultrasound to target the best spot to administer the solution. It’s important to note that patients receiving a placebo during the clinical trial experience may also see some positive effects of the therapy. 

Tests and visits

Study participation involves a screening visit where we will ask about your medical history and administer a pregnancy test (if you’re female) to determine if you are eligible to participate. If you qualify for the study you will need to come into our offices for four injection appointments and two follow-up visits over the course of a year. 

Participant eligibility for clinical trials often varies and includes factors like age, gender, type and stage of disease, and previous treatments or health concerns. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. 

Following are initial requirements to join this study:

• Knee osteoarthritis: You must have had osteoarthritis in a knee to participate.
• Age: You must be between the ages of 40 and 80.
• Pregnancy: Participants must test negative on a pregnancy test prior to the study.
• Patient status: You do not need to be an existing Mayo Clinic patient to participate.
• Ambulatory status: You must be able to routinely walk without assistance (e.g. cane, walker).
• Knee health: Your target knee must be clinically stable.
• Further requirements: There may be additional eligibility requirements that would preclude your participation in the study that may come up during your application.

When you participate in a Mayo Clinic clinical trial, you will be working with some of the world's foremost physicians and clinicians in their field.

Primary Investigator

Clinical Research Coordinator

Associate Research Coordinator

Languages: English

Languages: English

Languages: English, Spanish

To learn more or to apply for this study, please contact us using the information below.

English:

Spanish:

Katelyn Valdez

Alex Mecklburg-Cintron

Clinical Research Coordinator

Associate Clinical Research Coordinator

480-301-6542

valdez.katelyn@mayo.edu

480-301-4416

mecklburg-cintron.alexander@mayo.edu

Study ID:

Site IRB: Scottsdale/Phoenix, Arizona: 21-008778

NCT ID: NCT05160532

Participating in this clinical trial is voluntary. Participants can withdraw at any time.

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