The clinical application of Arthrosamid® (iPAAG) is safe and effective.¹

Stable and statistically significant change on all WOMAC subscales and WOMAC total over the 56 week observation period.²

Statistically significant reduction in pain maintained at 2 years.³

80% response rate with the under 70-year-olds.⁴

Significant difference in change from baseline between Arthrosamid® and Synvisc-One® at 52 weeks.⁵

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.

For more information, read the IFU for full details about 
warnings and precautions. The IFU is also available from 
https://www.arthrosamid.com or info@arthrosamid.com.

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.

_{1.Bliddal, H., et al. (2021). Polyacrylamide Hydrogel Injection for Knee Osteoarthritis: A 6 Months Prospective Study. J Orthop Res Ther. 6(2). 1188. ISSN 2575-8241.}

_{2.Henriksen, M., et al. (2018). Intra-articular 2.5% polyacrylamide hydrogel for the treatmentof knee osteoarthritis: an observational proof-of-concept cohort study. Clin Exp Rheumatol. Nov-Dec;36(6):1082-1085. Epub 2018 Jul 18. PMID:}

_{3.Bliddal, H., et al. (2022). A Prospective Study of Polyacrylamide Hydrogel Injection forKnee Osteoarthritis: Results From 2 Years After Treatment. Poster presented at OARSI 2022.Osteoarthritis and Cartilage Vol.30, Supplement 1, S371-S372. DOI: 10.1016/j.joca.2022.02.499}

_{4.Data on file.}

_{5.Bliddal, H., et al. (2022). One-year performance of polyacrylamide hydrogel vs. hyaluronic acid in age, BMI, and Kellgren-Lawrence subgroups: A subgroup analysis of a randomised study. Poster presented at OARSI 2022. Osteoarthritis and Cartilage Vol.30, Supplement 1, S373-S374.}

_{Intra-articular 2.5% polyacrylamide hydrogel (iPAAG) for the treatment of knee OA}

_{An observational proof-of-concept cohort 13 month study (DAISY Efficacy)^1,2}

<sub>1. Data on file.
2. Henriksen, M., et al. (2018). Intra-articular 2.5% polyacrylamide hydrogel for the treatment of knee osteoarthritis: an observational proof-of-concept cohort study. Clin Exp Rheumatol. Nov-Dec;36(6):1082-1085. Epub 2018 Jul 18. PMID: 30148430.</sub>

_{Polyacrylamide hydrogel (iPAAG) injection for knee osteoarthritis}

_{A 26 week registration study (IDA 6 months)¹}

_{1. Bliddal, H., et al. (2021). Polyacrylamide Hydrogel Injection for Knee Osteoarthritis: A 6 Months Prospective Study. J Orthop Res Ther. 6(2). 1188. ISSN 2575-8241.}

_{A 52 week prospective study (IDA 1 year)^1,2}

_{1.Data on file.}

_{2. Bliddal, H., et al. (2021). Polyacrylamide Hydrogel Injection for KneeOsteoarthritis: Results of a 52 Week Prospective Study. Osteoarthritis and Cartilage Vol.29S278.}

_{Results from 104 weeks after treatment (IDA 2 years)^1,2}

_{1.Data on file.}

_{2. Bliddal, H., et al. (2022). A Prospective Study of Polyacrylamide Hydrogel Injection for Knee Osteoarthritis: Results From 2 Years After Treatment. Poster presented at OARSI 2022. Osteoarthritis and Cartilage Vol.30, Supplement 1, S371-S372. DOI:10.1016/j.j.oca.2022.02.499.}

^{One-year performance of polyacrylamide hydrogel (iPAAG) vs. hyaluronic acid}

_{A randomised controlled study (ROSA)^1,2}

^{1. Data on file}

^{2.Bliddal, H., et al. (2022). One-year performance of polyacrylamide hydrogel vs. hyaluronic acid: A randomised controlled study. Poster presented at OARSI 2022.}

_{Analysis of change from baseline of subgroup <70 years (ROSA)^1,2}

_{1. Data on file.}

^{2. Bliddal, H., et al. (2022). One-year performance of polyacrylamide hydrogel vs. hyaluronic acid in age, BMI, and Kellgren-Lawrence subgroups: A subgroup analysis of a randomised study. Poster presented at OARSI 2022. Osteoarthritis and Cartilage Vol.30, Supplement 1, S373-S374. DOI:10.1016/j.joca.2022.02.502.}

_{Response rate with Arthrosamid®^1,2,3}

_{A randomised study of one-year performance of polyacrylamide hydrogel (iPAAG) vs. hyaluronic acid.²}

_{1. Data on file.}

_{2. Bliddal, H., et al. (2022). One-year performance of polyacrylamide hydrogel vs. hyaluronic acid: A randomised controlled study. Poster presented at OARSI 2022.}

_{3. Bliddal, H., et al. (2022). One-year performance of polyacrylamide hydrogel vs. hyaluronic acid in age, BMI, and Kellgren-Lawrence subgroups: A subgroup analysis of a randomised study. Poster presented at OARSI 2022. Osteoarthritis and Cartilage Vol.30, Supplement 1, S373-S374. DOI:10.1016/j.joca.2022.02.502.}

_{A randomised study of one-year performance of polyacrylamide hydrogel vs. hyaluronic acid.¹}

_{Scatterplot of age versus change from baseline to week 52 in transformed WOMAC pain subscale for Arthrosamid®.²}

_{1. Bliddal, H., et al. (2022). One-year performance of polyacrylamide hydrogel vs. hyaluronic acid: A randomised controlled study. Poster presented at OARSI 2022}

_{2. Date on file.}

_{3. Henriksen, M., et al. (2018). Intra-articular 2.5% polyacrylamide hydrogel for the treatment of knee osteoarthritis: an observational proof-of-concept cohort study. Clin Exp Rheumatol.Nov-Dec;36(6):1082-1085. Epub 2018 Jul 18. PMID: 30148430}

_{The clinical application of Arthrosamid® (iPAAG) is safe and effective.1}

_{Safety of intra-articular polyacrylamide hydrogel (iPAAG) for the treatment of knee osteoarthritis symptoms}

_{1.Bliddal, H., et al. (2021). Polyacrylamide Hydrogel Injection for Knee Osteoarthritis: A 6 Months Prospective Study. J Orthop Res Ther. 6(2). 1188. ISSN 2575-8241.}

_{2. Data on file.}

_{3. Overgaard, A., et al. (2019). Safety of intra-articular polyacrylamide hydrogel for the treatment of knee osteoarthritis symptoms: A retrospective case series. Clin Ortho Adv Res. Osteoarthritis and Cartilage Vol.30, Supplement 1, S370-S371.DOI:10.1016/j.joca.2022.02.497.}

_{4. Bliddal, H., et al. (2021). Polyacrylamide Hydrogel Injection for Knee Osteoarthritis: Results of a 52 Week Prospective Study. Osteoarthritis and Cartilage Vol.29 S278.}

_{5. Bliddal, H., et al. (2022). A Prospective Study of Polyacrylamide Hydrogel Injection for Knee Osteoarthritis: Results From 2 Years After Treatment. Poster presented at OARSI 2022. Osteoarthritis and Cartilage Vol.30, Supplement 1, S371-S372.DOI:10.1016/j.joca.2022.02.499.}

_{6. Bliddal, H., et al. (2022). One-year performance of polyacrylamide hydrogel vs. hyaluronic acid: A randomised controlled study. Poster presented at OARSI 2022.}