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FAQs

Osteoarthritis (OA)

Patients- What is osteoarthritis (OA)?

Osteoarthritis (OA) is the most common type of arthritis and can cause joints to feel stiff and painful. It is more common in older people but can also affect younger people especially if there has been an injury to a joint. Sometimes OA causes the joints to swell and change shape and sometimes the joints make creaking or cracking noises.

The symptoms of osteoarthritis can vary a lot. Sometimes there is no pain at all and sometimes the pain can be severe and moving them is difficult. There can be loss of muscle around the joints and this can make them feel weaker. Almost all joints can develop osteoarthritis but the most common places are the fingers, thumbs, knees and hips as well as the low back and neck.

Patients- Can I receive Arthrosamid® treatment for hip osteoarthritis?

No - Arthrosamid® is only indicated for the knee osteoarthritis symptomatic treatment.

Patients- What other joints can the gel be used in?

Studies with Arthrosamid® have only been carried out for the treatment of Knee osteoarthritis so at this time it is only indicated for use in the knee.

What is it?

Patients- What is polyacrylamide hydrogel?

A polyacrylamide hydrogel is a group of cross-linked polymeric material, which hold large amounts of water while maintaining their structure. They possess a degree of flexibility very similar to natural tissue due to their large water content.
Arthrosamid® is a hydrogel. It is an inert, non-pyrogenic polymer gel consisting of 97.5% sterile water and 2.5% cross-linked polyacrylamide and has water exchanging capabilities.

Patients - What is Arthrosamid®?

Arthrosamid®, intra-articular polyacrylamide hydrogel injection (iPAAG), is a non-biodegradable single-dose injection that delivers long-acting symptomatic treatment to adult patients with knee osteoarthritis.

Patients - How is Arthrosamid® different than other injections ?

Arthrosamid® is different from viscosupplement injections such as Hyaluronic Acid (HA), Platelet Rich Plasma (PRP) and regenerative stem cell therapy. Unlike these treatments, Arthrosamid® becomes an integrated part of the soft synovial tissue in the joint capsule and provides long-acting and sustain pain relief.

Patients- How safe is Arthrosamid®?

Arthrosamid® intra-articular (IA) polyacrylamide gel (iPAAG) is safe for its intended use treating knee OA pain symptoms. The most common adverse events (side effects) in clinical trials were injection-related mild to moderate pain and or mild swelling during the first weeks to months after the injection.

Patients - Can Arthrosamid® be used as a treatment for hip osteoarthritis?

No - Arthrosamid® is only indicated for the knee osteoarthritis symptomatic treatment.

Patients - How effective is Arthrosamid® treatment?

Because Arthrosamid works to cushion the joint, it can reduce your pain, decrease stiffness, and help movement. It has been shown to be safe and can give long-acting relief, improving your quality of life. In a key triall more that 70% of patient experienced a minimal important clinical difference in pain (MCID) and pain relief was maintained beyond 52 weeks.

Patients - Is there any reason why I could not have a Arthrosamid® injection?

Arthrosamid® is approved for the symptomatic treatment of knee osteoarthritis so any patient with this condition may be suitable. However treatment with Arthrosamid® may not be suitable for everyone. Your doctor is the best person to advise you, but situations where you should not use Arthrosamid® (contraindications) include*:

- If you have an infection at or near the injection site

- If you have haemophilia or take anticoagulant treatment

- If you have had knee replacement or knee arthroscopy within the past 6 months

*This is not a full list of contraindications. Please refer to your doctor to see if Arthrosamid®can help you.

Patients - How does Arthrosamid® work?

• Arthrosamid® integrates into the synovial tissue of the inner joint capsule and decrease joint stiffness

• Arthrosamid® forms a cushion-like membrane comprising the hydrogel incorporated in a matrix of fine tissue network covered by a synovial lining

• Arthrosamid® diminishes pain and improves function of the knee affected by osteoarthritis

The non-absorbable, non-bio-degradable and non-migratory characteristics of Arthrosamid® provide durable cushioning of the inner joint capsular tissue.

Patients- What is osteoarthritis (OA)?

Osteoarthritis (OA) is the most common type of arthritis and can cause joints to feel stiff and painful. It is more common in older people but can also affect younger people especially if there has been an injury to a joint. Sometimes OA causes the joints to swell and change shape and sometimes the joints make creaking or cracking noises.

The symptoms of osteoarthritis can vary a lot. Sometimes there is no pain at all and sometimes the pain can be severe and moving them is difficult. There can be loss of muscle around the joints and this can make them feel weaker. Almost all joints can develop osteoarthritis but the most common places are the fingers, thumbs, knees and hips as well as the low back and neck.

Patients- How does the osteoarthritis inflammatory response get reduced with treatment?

The inflammation response comes most probably from wear and tears, Arthrosamid®, once injected into the area around the inner joint capsule, it restores viscosity within the synovial fluid, improving lubrication and load sharing. Arthrosamid® integrates into the synovium of the inner joint capsule creating a cushion-like effect.

Patients - Why are prophylactic antibiotics recommended?

Arthrosamid® must be administered with oral prophylactic antibiotics due to the permanent nature of the scaffold implant. A high concentration of antibiotics in the tissues at the time of injection (should be given only once) may reduce infection risk. Details can be found in the product IFU (Instructions For Use).

Patients - How long does Arthrosamid® last?

Studies have shown that Arthrosamid® reduces pain for up to one year, however longer lasting effects has been observed (several years) following preliminary investigations and two key trials are following up patients for 5 years to establish the extent of the long acting and sustained effect of Arthrosamid®.

Patients - Why 6ml of Arthrosamid® ?

6ml of Arthrosamid® is the dosage used in the clinical trials. These trials confirmed the safe and sustained pain relief with a single injection that Arthrosamid® provides.

Patients - What should I expect after Arthrosamid® treatment?

Arthrosamid® reduces your pain, decrease stiffness, and help movement. It has been shown to be safe and can give long-acting and sustained pain relief, improving your quality of life with a single 6ml injection.

As with any invasive joint procedure, it is recommended to advise patients to avoid strenuous activity for the first two days after an injection.

During the first week following the injection, some transient reactions related to the injection may occur such as mild to moderate pain at the injection site or swelling around the knee.

Patients - Is my condition serious enough for this treatment?

If you suffer with osteoarthritis pain and the pain is not controlled by simple pain killers and lifestyle modifications, then you could be suitable for Arthrosamid® treatment. To find out if Arthrosamid® is right for you, please consult your doctor.

Patients- Is the treatment painful?

Before you are given an Arthrosamid® injection, you will also have a local anaesthetic to numb the area around your knee. The most common adverse events (side effects) in clinical trials were Injection-related mild to moderate pain and or mild swelling during the first weeks to months after the injection.

Patients- Can I receive Arthrosamid® treatment for hip osteoarthritis?

No - Arthrosamid® is only indicated for the knee osteoarthritis symptomatic treatment.

Patients - Can I get another treatment if the 1st treatment effect wears off? After what period of time?

The treatment could be repeated if required and advised by your doctor. It is not recommended to repeat the treatment within 6 months.

Patients- How is this treatment performed?

Arthrosamid® is given as a single injection into the knee's intra-articular cavity by a qualified specialist such as an orthopaedic surgeon or rheumatologist. Unlike surgery, the injection is a minimally invasive procedure that you can receive as an outpatient. Before the injection, you will be given a local anaesthetic to numb the area around the injection site and an antibiotic to protect you from infection.

Patients - Why do I feel pain?

Pain in osteoarthritis is multifactorial. It is thought that changes through out the joint may contribute to the pain felt.

Synovial Fluid: The fluid inside the Joint becomes degraded and less able to perform its protective lubrication and cushioning function.

Joint capsule: The tissue can become thick and swollen, and sometimes inflamed which triggers pain receptors.

Cartilage surfaces: As OA progressives it degrades the cartilage tissue. On X-ray images the gap between joint bones (normally separated by cartilage) becomes narrower and all the cartilage can be removed causing “bone on bone” articulation. Often at this stage movement without pain becomes difficult.

Bones (femur and tibia): Start to grow bony spurs called ‘osteophytes’ in reaction to the wear and tear that restrict movement and are another source of pain.

Patients - Can Arthrosamid® delay joint replacement surgery?

Viscosupplementation has been shown to delay time to total knee joint replacement. The long lasting and sustained effect of Arthrosamid® should offer similar benefits.

Patients- What other joints can the gel be used in?

Studies with Arthrosamid® have only been carried out for the treatment of Knee osteoarthritis so at this time it is only indicated for use in the knee.

Patients- How does pain get reduced?

The exact way that pain gets turned off is being investigated. Arthrosamid® works to cushion the joint, it clinical trails it can reduce your pain, decrease stiffness, and helps movement. It has been shown to be safe and can give long-acting relief, improving your quality of life.

Is it Safe?

Patients- Is the treatment painful?

Before you are given an Arthrosamid® injection, you will also have a local anaesthetic to numb the area around your knee. The most common adverse events (side effects) in clinical trials were Injection-related mild to moderate pain and or mild swelling during the first weeks to months after the injection.

Patients - Why are prophylactic antibiotics recommended?

Arthrosamid® must be administered with oral prophylactic antibiotics due to the permanent nature of the scaffold implant. A high concentration of antibiotics in the tissues at the time of injection (should be given only once) may reduce infection risk. Details can be found in the product IFU (Instructions For Use).

Does it work?

Patients- How safe is Arthrosamid®?

Arthrosamid® intra-articular (IA) polyacrylamide gel (iPAAG) is safe for its intended use treating knee OA pain symptoms. The most common adverse events (side effects) in clinical trials were injection-related mild to moderate pain and or mild swelling during the first weeks to months after the injection.

Patients - Can Arthrosamid® delay joint replacement surgery?

Viscosupplementation has been shown to delay time to total knee joint replacement. The long lasting and sustained effect of Arthrosamid® should offer similar benefits.

Patients - Can I get another treatment if the 1st treatment effect wears off? After what period of time?

The treatment could be repeated if required and advised by your doctor. It is not recommended to repeat the treatment within 6 months.

What is the treatment like?

Patients - How does Arthrosamid® work?

• Arthrosamid® integrates into the synovial tissue of the inner joint capsule and decrease joint stiffness

• Arthrosamid® forms a cushion-like membrane comprising the hydrogel incorporated in a matrix of fine tissue network covered by a synovial lining

• Arthrosamid® diminishes pain and improves function of the knee affected by osteoarthritis

The non-absorbable, non-bio-degradable and non-migratory characteristics of Arthrosamid® provide durable cushioning of the inner joint capsular tissue.

Patients- How is this treatment performed?

Arthrosamid® is given as a single injection into the knee's intra-articular cavity by a qualified specialist such as an orthopaedic surgeon or rheumatologist. Unlike surgery, the injection is a minimally invasive procedure that you can receive as an outpatient. Before the injection, you will be given a local anaesthetic to numb the area around the injection site and an antibiotic to protect you from infection.

Patients- How does pain get reduced?

The exact way that pain gets turned off is being investigated. Arthrosamid® works to cushion the joint, it clinical trails it can reduce your pain, decrease stiffness, and helps movement. It has been shown to be safe and can give long-acting relief, improving your quality of life.

Patients - Is my condition serious enough for this treatment?

If you suffer with osteoarthritis pain and the pain is not controlled by simple pain killers and lifestyle modifications, then you could be suitable for Arthrosamid® treatment. To find out if Arthrosamid® is right for you, please consult your doctor.

Patients - What should I expect after Arthrosamid® treatment?

Arthrosamid® reduces your pain, decrease stiffness, and help movement. It has been shown to be safe and can give long-acting and sustained pain relief, improving your quality of life with a single 6ml injection.

As with any invasive joint procedure, it is recommended to advise patients to avoid strenuous activity for the first two days after an injection.

During the first week following the injection, some transient reactions related to the injection may occur such as mild to moderate pain at the injection site or swelling around the knee.