SUPARTZ
(Sodium Hyaluronate)

Your doctor has determined that the knee pain you are experiencing is caused by osteoarthritis and that you are a candidate for a non-surgical, non-pharmacological, pain-relieving therapy called SUPARTZ. SUPARTZ is used for the treatment of pain in osteoarthritis of the knee in patients who have failed to get adequate relief from simple painkillers or from exercise and physical therapy.

What is SUTPARTZ?

SUPARTZ is a solution made of highly purified sodium hyaluronate (hyaluronan). Hyaluronan is a natural chemical found in the body and is found in particularly high amounts in joint tissues and in the fluid (synovial fluid) that fills the joints. The body's own hyaluronan acts like a lubricant and shock absorber in synovial fluid of a healthy joint. Osteoarthritis reduces your synovial fluid's ability to protect and lubricate your joint.

SUPARTZ is available in 2.5 mL pre-filled syringes. SUPARTZ is given in a shot directly in your knee.

What are the benefits of SUPARTZ?

The safety and effectiveness of SUPARTZ were studied in five clinical trials. These studies were conducted in Germany (1991); Sweden (1993); France (1995); the UK and Australia (1996). Patients received, in one knee joint, 5 weekly injections of SUPARTZ or salt water. In the French study there were 3 treatment groups: 5 SUPARTZ injections per patient, 3 SUPARTZ injections followed by 2 injections of the salt water per patient, or 5 injections of the salt water per patient. The results of these five studies (619 patients received SUPARTZ, 537 received salt water) have shown that five weekly injections of SUPARTZ in the knee is both safe and effective for the relief of pain associated with osteoarthritis of the knee that was not relieved by simple painkillers or by exercise and physical therapy.

How is SUPARTZ given?

Your doctor will give you an injection of SUPARTZ (25mg/2.5rnL) into your knee once a week for 5 weeks (a total of 5 injections). Your doctor may recommend a local anesthetic to reduce the possible discomfort associated with an injection.

What should you expect following your series of injections?

The goal of SUPARTZ is the relief of pain. You may experience some pain relief before you receive the full series of 5 injections. However, studies suggest that most patients experiencing relief do so after the full series of 5 injections. The actual amount and duration of pain relief varies from patient to patient. Immediately after you have the injection and for the next 48 hours, you may need to avoid activities such as jogging, tennis, heavy lifting or standing on your feet for a long time.

Please note that no treatment, including SUPARTZ, helps in every single patient.

What other treatments are available for osteoarthritis?

If you have osteoarthritis, there are several things you can do that do not involve SUPARTZ injections. These include the following:

Non-drug treatments

• Avoiding activities that cause excess pain in your joints
• Exercise
• Physical therapy

• Painkillers such as acetaminohen and narcotics
• Drugs that reduce inflammation, such as aspirin, and other non-steroidal anti-inflammatory agents (NSAIDS) such as ibuprofen and naproxen
• Corticosteroids that are injected directly into the joint

• You should not use this product if you are allergic to products from birds such as feathers, eggs and poultry.
• You should not have the injection if you have infections or skin diseases in the area the injection will be given.
• You should not take this product if you have had any previous allergic reactions to SUPARTZ or similar material, i.e., hyaluronate products.
• The safety and effectiveness of SUPARTZ have not been established in pregnant women, in lactating women and in children.

• The following were the most common adverse events (occurring in greater than 4 percent of SUPARTZ-treated patients): joint pain with no evidence of inflammation, joint pain with evidence of inflammation, back pain, pain (non-specific), injection-site reaction, headache and injection-site pain. However, these adverse events also occurred at similar rates in the patients treated with salt water.
• In the five studies, five (5) allergic reactions were reported in the SUPARTZ group. No severe allergic reactions were observed in any study patients.

• SUPARTZ is only for injection into the knee, performed by a qualified physician.
• Pain and/or swelling of the injected joint may occur after injection of SUPARTZ.
• The safety and effectiveness of repeat treatment cycles of SUPARTZ have not been established.
• The effectiveness of a single treatment cycle of less than five injections has not been established.
• The safety and effectiveness of the use of SUPARTZ in joints other than the knee have not been established.
• The safety and effectiveness of the use of SUPARTZ given at the same time as other injectables have not been established.

• Ask your doctor.
• Call Smith & Nephew Customer Service at 800-821-5700.
• Consult the SUPARTZ Internet site at www.supartz.com

New for large rotator cuff tears, some of
the physicians in our group are using the Restore
graft to reinforce large repairs. See below:

DePuy OrthoTech Releases Restore. Orthobiologic Implant for soft tissue treatment

Tracy, CA--DePuy OrthoTech proudly announces availability of the Restore. Orthobiologic Soft Tissue Implant, which was recently cleared for commercial distribution via an U.S. FDA Section 510(k) Pre-market
Notification. The Restore Orthobiologic Soft Tissue Implant, a ten layer laminated device, is intended to support weak soft tissues.

"We’ve investigated the Restore Orthobiologic Implant in pre-clinical animal studies in rotator cuff, Achilles tendon, patellar tendon and tensor fascia lata repairs. The results showed healing with normal looking musculoskeletal tissues," said Dick Tarr, Senior Vice President of Research and Orthobiologics, DePuy, a Johnson & Johnson Company.

This product is one of the first of its kind to be introduced in the worldwide orthopaedic market. It is expected to revolutionize the treatment of soft tissue tears and damage. Traditionally, the treatment for reinforcing lost or damaged tissue has been to use auto- or allograft tissues. The Restore Orthobiologic Implant gives the surgeon a less invasive, alternative
treatment.

"Patients and surgeons will no longer have to agonize over the choice of what materials to use for reinforcing soft tissues in their reconstructive
surgeries. Having an off-the-shelf, biologically-based substitute to offer patients has a theoretical advantage that cannot be denied," said Leslie S.
Matthews, MD, Chief of Orthopaedic Surgery, Union Memorial Hospital, Baltimore, MD.

When the Restore Orthobiologic Implant is used in surgery, it serves as a resorbable scaffold around which the body can regenerate damaged tissues. During pre-clinical animal studies, the Restore Orthobiologic
Implant demonstrated that the healing tissue takes on the characteristics of the tissue it has been used to reinforce. The studies indicate that once implanted, the device may provide a framework around which the
body deposits new tissue, apparently identical to the tissues where the material has been implanted. As this new tissue is deposited, the scaffold framework disappears.

"What’s most amazing about the product is how it’s absorbed and incorporated into the body and replaced by the host tissue. It’s quite amazing how adaptable it is. That opens up a world of possibilities," said
Kirk L. Jensen, MD, Assistant Clinical Professor, Orinda, California.

Restore Orthobiologic Soft Tissue Implant is composed of a material called SIS, which stands for small intestine submucosa. The SIS is derived from porcine small intestines. Once these layers of intestine are
removed, they are disinfected and processed into different forms, sterilized and stored for future use. Manufacturing of the product occurs at DePuy’s Warsaw, IN facility.

The material was developed through a partnership between Purdue University and DePuy Orthopaedics, Inc. of Warsaw, IN. DePuy holds exclusive rights to all orthopaedic applications of SIS. DePuy OrthoTech plans to offer a complete line of Restore orthobiologic products, which are in development and clinical testing phases.

The Restore Orthobiologic Implant is marketed and distributed through DePuy OrthoTech, a subsidiary of DePuy, Inc., a Johnson & Johnson Company.

Based in Tracy, CA, DePuy OrthoTech also manufactures and distributes arthroscopy/sports medicine products, patient care products, orthopaedic braces and cold therapy products.

DePuy, a Johnson & Johnson Company, is the world’s oldest and largest orthopaedic company and is a leading designer, manufacturer and distributor of orthopaedic devices and supplies. Its products are
used primarily by orthopaedic medical specialists and, in the case of the company’s spinal implants, spinal and neurosurgeons. DePuy products are used in both surgical and nonsurgical therapies to treat patients
with musculoskeletal conditions resulting from degenerative diseases, deformities, trauma and sports-related injuries.

For more information about DePuy OrthoTech’s Restore Orthobiologic Soft Tissue Implant, contact Chris Butler, Product Manager, DePuy OrthoTech at (800) 227-1554.