One shot in the knee: can hyaluronic acid quiet osteoarthritis pain?
NCT ID NCT07819461
First seen Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time
Summary
Researchers are testing whether a single injection of a hyaluronic acid solution into the knee can reduce pain and improve stiffness and function in people with knee osteoarthritis. The trial enrolls about 700 adults aged 40 to 80 who have had knee osteoarthritis symptoms for at least six months and have not gotten enough relief from standard treatments like physical therapy or pain relievers. Participants receive either the hyaluronic acid injection or a saltwater placebo injection, and they track their knee pain daily along with measures of stiffness, function, and quality of life for several months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a hyaluronic acid solution injected into the knee joint
- What this could lead to
- If it works, a single knee injection could offer months of pain relief for people with osteoarthritis, without daily pills.
- What could go wrong
- Hyaluronic acid injections have shown mixed results in past studies, and any relief may be modest or temporary. Some people get swelling, stiffness, or pain right after the shot.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 704 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age is between 40 and 80 years of age * Have symptoms of knee osteoarthritis (OA) for at least 6 months * Meet American College of Rheumatology criteria (clinical and radiological) for knee OA * Body mass index (BMI) is less than or equal to 40 kg/m2 * Target knee x-ray grade Kellgren-Lawerence (KL) grade 2 or 3 * Have failed at least one prior conservative therapy for knee OA in last 12 months, which includes physical therapy, NSAIDs, and other pain medications * The knee pain scores during screening and baseline must meet specified qualifying criteria for both the target and the contralateral (non-target) knees * Willing to complete all electronic diaries and only use study-provided acetaminophen for pain management while participating in the study * Have negative pregnancy tests during Screening and prior to injection and will not be pregnant or nursing or plan to be pregnant while participating in the study * Must use a highly effective birth control method if sexually active Exclusion Criteria: * Have taken or had any prohibited medications, supplements, or therapies that could have an influence on study assessments. Some may be permitted with stable dose or after stopping for a period of time. Please refer to physician for further details. * Have active infections or target knee conditions that may compromise study drug administration * Have exclusionary lab values determined during Screening * Have severe hip OA on the same side of the target knee that interferes with assessment of pain in the target knee * Have or had primarily patellofemoral OA, severe malalignment, certain knee surgeries, or other excluded target knee conditions * Have joint disorders, uncontrolled fibromyalgia, or clinically significant conditions that could interfere with study assessments or compromise participant safety * Received another clinical trial therapy, medication, or product with 90 days of Screening * Have non-compliance with study diaries during Screening * Involved in litigation, disability, or worker's compensation matters based on OA pain * Allergic to study drug, HA, placebo, or acetaminophen
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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