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Learn more about the data

Arthrosamid® has been shown to deliver long acting and sustained symptomatic pain relief whilst improving the quality of life for patients with knee osteoarthritis.

Arthrosamid® Clinical Results

Arthrosamid® provides safe and sustained pain relief with a single injection.2

Arthrosamid® delivers durable pain relief for knee OA beyond that which is typical of currently approved viscosupplements.1

Arthrosamid® has shown significant pain reduction in knee OA for up to 12 months compared with baseline.2

Adverse events observed with Arthrosamid® were similar to those for other IA injections.1

The "Daisy" Study3,4



In the pilot prospective open label cohort study ("DAISY"), Arthrosamid® was shown to provide safe and sustained pain relief with a single injection.

Arthrosamid® showed clinically significant change from baseline which was maintained out to 56 weeks.3

Arthrosamid® showed no severe AEs and was shown to have a safety profile similar to other interarticular injections.4


DAISY Graph

The "IDA" Study 2


Arthrosamid® demonstrated rapid relief in knee OA pain as early as week 4 and was sustained up to 52 weeks with significant improvement from baseline at all time points.

No severe AEs attributed to Arthrosamid® were observed.2

Most commonly reported device-related AEs with Arthrosamid® were arthralgia and joint swelling neither of which were considered to be serious.

The patients will be followed for up to 5 years.2

IDA Graph

The "ROSA" Study

"ROSA" is a multi-centre, randomised, controlled, double-blind clinical investigation of intra-articular polyacrylamide hydrogel injection (iPAAG) in subjects with knee osteoarthritis (OA) followed by an open label extension study.

The blinded phase is from screening to week 52 and extension phase from week 52 to year 5.

To compare the effectiveness of one injection of 6 mL Arthrosamid® (iPAAG) with that of one injection of 6 mL Synvisc-One on pain.

Click the link below to see the trial details:

Treatment of Knee Osteoarthritis With PAAG-OA - Full Text View - ClinicalTrials.gov


ROSA DATA

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Arthrosamid® provides safe and sustained pain relief with a single injection.

INDICATION

Arthrosamid® is intended to be used for symptomatic treatment of knee osteoarthritis in adults. 
CONTRAINDICATIONS 
Arthrosamid® should not be injected: 
If an active skin disease or infection is present at or near the injection site If the joint is infected or severely inflamed If a degradable intra-articular injectable such as hyaluronic acid is present, it must be expected to be absorbed according to manufacturer’s information for the specific product, before injection with Arthrosamid® If the patient has previously received treatment with a different non-absorbable injectable/implant If the patient has received a knee alloplasty or has any foreign material in the knee If the patient has undergone knee arthroscopy within the last 6 months In hemophilia patients or in patients in uncontrolled anticoagulant treatment Do not subsequently inject a different non-absorbable implant.
WARNINGS 
Do not inject intravascularly, extra-articularly or in the synovial tissue of the capsuleDo not inject corticosteroids along with Arthrosamid®
PRECAUTIONS 
Usual precautions associated with invasive joint procedures should be followed. Patients with acute or chronic infections in other sites of the body should be treated with caution. Arthrosamid® should be used with caution in patients with e.g. autoimmune disorders and in patients with uncontrolled diabetes as well as in patients undergoing major dental work or surgery. Safety and effectiveness has not been established in patients under 18 years, in pregnant or lactating women, or in patients having foreign material implanted in the knee. Only use the product if the packaging and products are intact and undamaged. Do not re-sterilize Arthrosamid®.Arthrosamid® is only intended for use as an intra-articular injectable. As with any invasive joint procedure, there is a small risk of infection when injecting Arthrosamid® and therefore a single dose of prophylactic antibiotics must be administered prior to injection.The Arthrosamid® syringe is intended for single patient use – do not store unsealed syringes and re-use. Re-use increases the risk of contamination and thereby increases the risk of infection. Do not use Arthrosamid® once expired.Do not inject any pharmaceuticals or biological substances into the hydrogel.
PROPHYLACTIC ANTIBIOTIC TREATMENT
Arthrosamid® must be administered with prophylactic antibiotics. The following combination of antibiotics is recommended: Azithromycin 500 mg p.o. and Moxifloxazin 400 mg p.o. administered 1-6 hours prior to injection.The above combination of antibiotics will reach a high concentration in the tissue at the time of injection and should be given only once. This combination covers up to 95 % of the normal occurring skin flora (both aerobic and anaerobic species) and has a long half-life.
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PATIENT INFORMATION

Please inform your patient
As with any invasive joint procedure it is recommended to avoid strenuous activity (e.g. tennis, jogging or long walks) during the first few days after the injection.Advise patients that if they require a surgical or dental procedure in the future, they should tell the treating physician that they have a permanent implant and they should discuss the possible need for prophylactic antibiotic therapy with their treating physicianPatients should inform health care professionals of their Arthrosamid® implant for accurate future medical assessment.The patient should be informed about indications, expected results, contraindications, warnings, precautions and potential complications.In case of complications, the patient should contact the injecting physician immediately for treatment.

References

1. Bellamy N, Campbell J, Welch V, Gee TL, Bourne R, Wells GA. Viscosupplementation for the treatment of osteoarthritis of the knee. Cochrane Database of Systematic Reviews 2006, Issue 2. Art. No.: CD005321. DOI: 10.1002/14651858.CD005321.pub2 2. OARSI CONNECT 2021 POSTER 336 POLYACRYLAMIDE HYDROGEL INJECTION FOR KNEE OSTEOARTHRITIS: RESULTS OF A 52 WEEK PROSPECTIVE STUDY Henning Bliddal, Anders Overgaard, Andreas Hartkopp, Jannie Beier, Philip G Conaghan, Marius Henriksen 3. Henriksen M et al. Intra-articular 2.5% polyacrylamide hydrogel for the treatment of knee osteoarthritis: an observational proof-of-concept cohort study. Clin Exp Rheumatol. 2018;36(6):1082 4. Overgaard A et al Safety of Intra-Articular Polyacrylamide Hydrogel for the Treatment of Knee Osteoarthritis Symptoms: A Retrospective Case Series. Clin Ortho (2019) Adv Res J: COARJ-100001

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