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Q: What is Gel-One Hyaluronate?

A: Gel-One Hyaluronate is a transparent, sterile, and viscoelastic gel made from sodium hyaluronate (hyaluronan). Hyaluronan that is used to make Gel-One comes from rooster combs and is highly purified. Hyaluronan is also a natural substance found in the human body and is present in very high amounts in joints. The body's own hyaluronan acts like a lubricant and shock absorber in the joint and is needed for the joint to work properly. Osteoarthritis (OA) is a condition that involves the wearing down of cartilage (the protective covering on the ends of your bones). In joints with OA, there may not be enough hyaluronan, and there may be lower quality of hyaluronan in joint fluid and tissues. Gel-One Hyaluronate is available in a 3.0 mL (approximately ½ teaspoon) pre-filled syringe. Gel-One Hyaluronate is injected directly into your knee joint.

Q: Is Gel-One Hyaluronate right for me?

A: Gel-One Hyaluronate is used for patients who do not respond adequately to other available treatments for osteoarthritis such as non-steroidal anti­inflammatory drugs (NSAIDS) or from simple pain medications, such as acetaminophen, or from exercise and physical therapy.

Q: What potential benefits does Gel-One Hyaluronate treatment offer?

A: The potential benefit of Gel-One is that it may reduce knee pain due to OA for up to 26 weeks following treatment.

Q: Will Gel-One Hyaluronate interact with any of my current medications?

A: You and your doctor should discuss all medications that you are taking prior to beginning treatment with Gel-One Hyaluronate.

Q: What are possible complications?

A: Common side effects (also called reactions) are sometimes seen when Gel-One® is injected into the knee joint. These can include: knee pain; swelling; and/or fluid build-up around the knee. These reactions are generally mild and do not last long. Reactions are generally treated by resting and applying ice to the injected knee. Sometimes it is necessary to give pain relievers by mouth, such as acetaminophen or NSAIDs, or to give injections of steroids, or to remove fluid from the knee joint. Patients rarely undergo arthroscopy (a surgical inspection of the knee joint) or other medical procedures related to these reactions.

If any of these symptoms or signs appear after you are given Gel-One Hyaluronate or if you have any other problems you should call your doctor.

Q: How is Gel-One Hyaluronate given?

A: Gel-One Hyaluronate is given as a single injection directly into the joint space. Your doctor may recommend the use of a local anesthetic to reduce possible discomfort associated with an injection.

Q: What do I need to do after I get the Gel-One Hyaluronate injection?

A: For 48 hours after you receive the injection, avoid any strenuous activities (such as jogging, tennis, other active sports, heavy Iifting) and prolonged weight bearing activities (such as standing on your feet for more than one hour).

Q: When might I feel some pain relief?

A: Even though every patient responds differently to the treatment, a medical study showed that some patients experienced a reduction in pain in as little as three weeks after the injection of Gel-One Hyaluronate.1



Indications for use
Gel-One Hyaluronate is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to non-pharmacologic therapy, non-steroidal anti-inflammatory drugs (NSAIDs) or simple analgesics, e.g., acetaminophen.

Important safety information
Before using Gel-One Hyaluronate, tell your doctor if you are allergic to hyaluronan products, cinnamon, or products from birds such as feathers, eggs, and poultry. Gel-One Hyaluronate is only for injection into the knee, performed by a doctor or other qualified health care professional. You should not receive Gel-One Hyaluronate injection if you have a skin disease or infection around the area where the injection will be given. Gel-One Hyaluronate has not been tested to show pain relief in joints other than the knee and for conditions other than OA. Gel-One Hyaluronate has not been tested in patients who are pregnant, mothers who are nursing, or anyone under the age of 21. You should tell your doctor if you think you are pregnant or if you are nursing a child. Talk to your doctor before resuming strenuous or pro-longed weight-bearing activities after treatment. The effectiveness of repeat treatment cycles of Gel-One Hyaluronate has not been established. The side effects most commonly seen after injection of Gel-One Hyaluronate in the clinical trial were knee pain, swelling, and/or fluid build-up around the knee. These reactions are generally mild and do not last long. If any of these symptoms or signs appear after you are given Gel-One Hyaluronate or if you have any other problems, you should call your doctor. Ask your surgeon if you are a candidate and discuss potential risks. For additional information, call 1-800-447-5633 , or visit www.zimmerbiomet.com.

This material is intended for U.S. patients.

1 V.Strand et al. A multicenter,randomized controlled trial comparing a single intra articular injection of Gel-One, a new cross-linked formulation of hyaluronic acid, to phosphate buffered saline for treatment of osteoarthritis of the knee. Oateoarthritis and Cartilage 2012;20: 350-356.

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The information herein is of a general nature and does not represent or constitute medical advice or recommendations and is for general education purposes only. This information is not meant to replace the specific verbal and written recommendations and instructions provided by your surgeon for your specific situation. Patient treatment plans and outcomes will vary.

Results may vary.  Not all patients are candidates for this product and/or procedure. Only a medical professional can determine the treatment appropriate for your specific condition.  Appropriate post-operative activities and restrictions will differ from patient to patient. Talk to your surgeon about whether joint replacement is right for you and the risks of the procedure, including the risk of implant wear, loosening, or failure.