Diagnosed with OSTEOARTHRITIS (OA) of the knee?
You may be eligible to participate in a clinical trial.
For full study information and to find out if there is a study site near you, please visit www.clinicaltrials.gov Study for No. NCT03281837. The study site personnel will inform you if you qualify to participate.
Why should I participate?
It is anticipated that this study treatment will provide relief of pain due to OA of the knee, but this benefit is not guaranteed.
This trial will gather more information about an approved treatment in patients who are diagnosed with pain due to OA of the knee.
This trial will assess the safety and performance of HYMOVIS® combined with a physical exercise program as compared to physical exercise alone for reducing pain.
You will be randomized to one of these treatment options. HYMOVIS® treatment consists of two weekly injections into the knee joint to relieve knee pain caused by knee OA.
How does the clinical trial work?
If you decide to participate and are eligible, you will be asked to complete:
- Screening procedures
- X-Ray & health assessments
- Report medication use & pain levels
- Between 5-7 clinic visits
You will be compensated for incidental expenses to cover out of pocket and travel expenses for follow up visits.
Hymovis is intended for those who do not get adequate pain relief from simple pain relievers like acetaminophen or from exercise and physical therapy. Voluntary participation will last approximately 6-9 months, with multiple clinic visits during this time. The physical exercise program arm will have the option later in the study to receive HYMOVIS®.
You may be eligible if you are:
- Aged 21-60 years
- Physically active
- Have persistent knee pain lasting at least 3 months
But, you may not be eligible if you:
- Had surgery to either of your knees in the last year
- Had total knee joint replacement
- Participated in a clinical drug or device study in the last 90 days.
What are the benefits and risks?
With any clinical trial, there are potential risks and benefits. The study personnel will inform you of these benefits and risks. Side effects most commonly seen after injection into the knee joint are knee pain, discomfort, swelling, stiffness, and itching at the injection site. These reactions are generally mild and do not last long.
Before receiving HYMOVIS®, tell your doctor if you are allergic to hyaluronan products, have an allergy to gram positive bacterial proteins or have an infection/skin disease in the area of the injection site.
HYMOVIS® is not approved for relieving pain in other joints besides the knee, for injection with other substances in your knee joint, or for children (<21 years of age). HYMOVIS® has not been tested in pregnant or nursing women. The effectiveness of repeat treatment cycles of HYMOVIS® has not been established.
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