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Arthrosamid® injectable polyacrylamide hydrogel (iPAAG) 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

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

79% response rate with the under 70-year-olds.³

Undergone over 20 years of research and development.³

Significant difference in change from baseline between Arthrosamid® and Synvisc-One® at 52 weeks.⁴

Statistically significant reduction in pain maintained at 3 years.⁵

IDA 3 Years

Statistically significant reduction in pain maintained at 3 years.¹

Objective

The primary objective of this study was to evaluate the efficacy and safety of a single injection of 6ml intra-articular Arthrosamid® on knee symptoms in participants with moderate to severe knee OA.

Method

Prospective, multicentre study (3 sites in Denmark) where 49 patients received a single intra-articular injection of 6ml Arthrosamid®.
Outcomes included the transformed WOMAC pain, stiffness and function subscales and PGA** of disease impact.
Changes from baseline to 52 weeks, 104 weeks and 156 weeks were analysed using the mixed model for repeated measurement (MMRM).

Conclusion

Single injections of 6 ml intra-articular Arthrosamid® are well tolerated and continue to demonstrate clinically relevant and statistically significant effectiveness 3 years after treatment.

iPAAG: injectable polyacrylamide hydrogel

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Arthrosamid clinical data graphs IDA 3 year

IDA 2 YEARS

Statistically significant reduction in pain maintained at 2 years.²

Objective

The primary objective of this study was to evaluate the efficacy and safety of a single injection of iPAAG on knee symptoms in participants with moderate to severe knee OA.

Method

Prospective, multicentre study (3 sites in Denmark) where 49 patients received a single intra-articular injection of 6ml Arthrosamid^®.
Outcomes included the transformed pain, stiffness and function subscales and PGA** of disease impact.
Changes from baseline to 52 weeks and 104 weeks were analysed using the mixed model for repeated measurement (MMRM).

Conclusion

Single injections of 6ml intra-articular Arthrosamid® continue to be well tolerated and demonstrate clinically relevant and statistically significant effectiveness, as measured by the WOMAC† pain, stiffness and physical function subscales and PGA** at 2 years after treatment.” iPAAG: injectable polyacrylamide hydrogel.

iPAAG: injectable polyacrylamide hydrogel

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IDA One Year

After 13 weeks, 64.6% of patients were OMERACT-OARSI responders, which
was also maintained to 52 weeks.²

Objective

The primary objective of this study was to evaluate the efficacy and safety of a single injection of iPAAG on knee symptoms in participants with moderate to severe knee OA.

Method

Open-label study in patients with symptomatic and radiographically confirmed knee OA.
Primary outcome was change in WOMAC† pain at 13 weeks.
Secondary outcomes were WOMAC subscales, PGA** and proportion of OMERACT-OARSI*** responders, follow up points were 4, 13, 26 and 52 weeks.

Conclusion

iPAAG can be delivered in a single injection and this non-randomised trial suggests that the good clinical effects at 13 weeks were maintained at 52 weeks in patients with moderate to severe knee OA. These encouraging results need to be confirmed in controlled studies.

iPAAG: injectable polyacrylamide hydrogel

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IDA 6 Months

Clinical application of iPAAG is safe and effective and can be conducted in a single injection.¹

Objective

This study evaluated the efficacy and safety of a single injection of 6ml of intra-articular iPAAG over 26 weeks.

Method

Open-label study in patients with symptomatic and radiographically confirmed knee OA. Primary outcome was change in WOMAC† pain at 13 weeks.
Secondary outcomes were WOMAC subscales, PGA** and proportion of OMERACT-OARSI*** responders, follow up pointswere 4, 13 and 26 weeks.

Conclusion

The study showed significant improvement in the WOMAC pain subscale at 4 and 13 weeks, which was sustained at 26 weeks. 2/3 of patients were OMERACT-OARSI responders. Clinical application of iPAAG is safe and effective and can be conducted in a single injection.

iPAAG: injectable polyacrylamide hydrogel

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ROSA 12 months

At 52 weeks after treatment, 74% of Arthrosamid® patients responded^1,3 with a 40% improvement in WOMAC pain score.²

Objective

This randomised controlled study compared the effectiveness of a single intra-articular injection of polyacrylamide hydrogel (Arthrosamid®) with that of a single injection of hyaluronic acid (Synvisc-One®) in participants with moderate to severe knee OA.

Method

Prospective, double-blind (participant and assessor) study conducted at 3 sites in Denmark.
Outcome assessments after 4, 12, 26 and 52 weeks. Subjects were randomised 1:1 to receive a single intra-articular injection of either 6ml Arthrosamid® or 6mL Synvisc-One®.

Conclusion

26 weeks after treatment, the effectiveness of Arthrosamid® was non-inferior to hyaluronic acid, as measured by the WOMAC† pain subscale. 52 weeks after treatment, the effectiveness of Arthrosamid® was numerically superior to hyaluronic acid but not statistically significantly different.²

iPAAG: injectable polyacrylamide hydrogel

Link to abstract

ROSA 12 months - Subgroup Data

Significant difference in change from baseline between Arthrosamid® and Synvisc-One® at 52 weeks.²

Objective

This randomised controlled study analysed subgroup of <70s for the effectiveness of a single intra-articular injection of polyacrylamide hydrogel (Arthrosamid®) with that of a single injection of hyaluronic acid (Synvisc-One®) in participants with moderate to severe knee OA.

Method

Prospective, double-blind, multicentre study (3 sites in Denmark) where randomised 1:1 subject received a single intra-articular injection of 6ml Arthrosamid® or 6ml Synvisc-One®.
Outcome assessments after 4, 12, 26 and 52 weeks. Subjects were randomised 1:1 to receive a single intra-articular injection of either 6ml Arthrosamid® or 6ml Synvisc-One®.

Conclusion

In participants <70 years old, Arthrosamid^® performed statistically significantly better than hyaluronic acid at 52 weeks after treatment.2 Click the link below to see the trial details: More information about this study can be found here.

iPAAG: injectable polyacrylamide hydrogel

Link to abstract

Response rate with Arthrosamid®

79% response rate with the under 70-year-olds¹.

iPAAG: injectable polyacrylamide hydrogel

ROSA 12 months

Over 60% of patients treated with Arthrosamid® achieved over the MCID of 9 points³ in WOMAC pain at 1 year.²

DAISY Efficacy 13 months

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

Objective

This study was conducted to establish an initial effectiveness of intra-articular (IA) injection of iPAAG for the treatment of knee OA symptoms.

Method

49 patients with knee OA were recruited into a prospective open-label cohort study, receiving up to 6ml of iPAAG.
Primary outcome — change from baseline of WOMAC† pain subscale after 4 months. The WOMAC questionnaire was used to estimate effectiveness and was collected at baseline and after 4, 7and 13 months.

Conclusion

The primary outcome exceeded the established MCID** of 9 points. The effect seemed to be long-term, with effectiveness maintained for up to 13 months.

iPAAG: injectable polyacrylamide hydrogel

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

16% of the participants had received arthroplasty surgery for knee OA of the treated knee.³

There were no unexpected descriptions of abnormalities that could be associated with the prior treatment with iPAAG in the surgical reports.³

“Of these patients, none reported dissatisfaction with the outcome of the surgery and the arthroplasties were well functioning.”³

iPAAG: injectable polyacrylamide hydrogel

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

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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 treatmentDo not subsequently inject a different non-absorbable implant.

WARNINGS

Do not inject intravascularly, extra-articularly or in the synovial tissue of the capsule
Do 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.

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

_References
_{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 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:}

_{3. Data on file.}

_{4. 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. Osteoarthritis and Cartilage Vol.30, Supplement 1, S373-S374.}

_{5. Henriksen, M. et al. (2023). 3-year results from a prospective study of polyacrylamide hydrogel for knee osteoarthritis. Osteoarthritis and Cartilage, Vol 31(5): P682–683. DOI:10.1016/j.joca.2023.02.023}

_{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}

_{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.}

_{iPAAG: injectable polyacrylamide hydrogel}

_{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 Knee Osteoarthritis: Results of a 52 Week Prospective Study. Osteoarthritis and Cartilage Vol.29S278.}

_{iPAAG: injectable polyacrylamide hydrogel}

_{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. Osteoarthritis and Cartilage Vol.30, Supplement 1, S371-S372. DOI:10.1016/j.j.oca.2022.02.499.}

^{Results from 156 weeks after treatment (IDA 3 years)}¹

^{1. Henriksen, M. et al. (2023). 3-year results from a prospective study of polyacrylamide hydrogel for knee osteoarthritis. Osteoarthritis and Cartilage, Vol 31(5): P682–683. DOI:10.1016/j.joca.2023.02.023}

^{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. Osteoarthritis and Cartilage. Vol 30(1): S370-71. DOI:10.1016/j.joca.2022.02.497.}

_{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. Osteoarthritis and Cartilage Vol.30, Supplement 1, S373-S374. DOI:10.1016/j.joca.2022.02.502.}

^{iPAAG: injectable polyacrylamide hydrogel}

_{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. Osteoarthritis and Cartilage. Vol 30(1): S370-71. DOI:10.1016/j.joca.2022.02.497.}

_{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. Osteoarthritis and Cartilage Vol.30, Supplement 1, S373-S374. DOI:10.1016/j.joca.2022.02.502.}

_{iPAAG: injectable polyacrylamide hydrogel}

_{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. Osteoarthritis and Cartilage. Vol 30(1): S370-71. DOI:10.1016/j.joca.2022.02.497.}

_{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.}

_{iPAAG: injectable polyacrylamide hydrogel}

_{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. 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. Osteoarthritis and Cartilage. Vol 30(1): S370-71. DOI:10.1016/j.joca.2022.02.497.}

_{iPAAG: injectable polyacrylamide hydrogel}

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Arthrosamid® Clinical Results

IDA 3 Years

Objective

Method

Conclusion

IDA 2 YEARS

Objective

Method

Conclusion

IDA One Year

Objective

Method

Conclusion

IDA 6 Months

Objective

Method

Conclusion

ROSA 12 months

Objective

Method

Conclusion

ROSA 12 months - Subgroup Data

Objective

Method

Conclusion

Response rate with Arthrosamid®

ROSA 12 months

ROSA 12 months

DAISY Efficacy 13 months

Objective

Method

Conclusion

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

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INDICATION

PATIENT INFORMATION

References

Healthcare Professionals

Arthrosamid^® Clinical Results