Our Results

Learn more about the data

Supported by more than two decades of research, Arthrosamid® is proven to be safe and effective, offering long-lasting pain relief in a single non-biodegradable injectable polyacrylamide hydrogel (2.5 iPAAG) for knee OA patients.

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Heart

Safe & Effective

Arthrosamid® remains safe and effective for its intended use 3 years after treatment.

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Pain Reduction

In all our studies , Arthrosamid® exceeds the MCID of 9 points and improvement is maintained up to 3 years after a single injection.

Group 6

Close to 80% Response rate

Patients in the under 70 years group reported close to 80% positive response rate following treatment with Arthrosamid®.

Longterm

Longterm pain reduction

Statistically significant reduction in pain maintained at 3 years.

Group 7

Significantly different

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

Stable

Stable & Significant

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

Reproducible pain reduction Results

In all our studies , Arthrosamid® exceeds the MCID of 9 points and improvement is maintained up to 3 years after a single injection.

Grouped studies

† WOMAC or The Western Ontario and McMaster Universities Osteoarthritis Index is a measure of symptoms and physical disability LSMeans are modelled/estimated means. The estimated means are using data from the other visits and also the covariates.

The minimum clinically important difference (MCID) represents the smallest improvement considered worthwhile by a patient.

What is the response rate with Arthrosamid®?

Close to 80% response rate with the under 70-year-olds

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

iPAAG: injectable polyacrylamide hydrogel

Response rate outlined

† WOMAC or The Western Ontario and McMaster Universities Osteoarthritis Index is a measure of symptoms and physical disability

 LSMeans are modelled/estimated means. The estimated means are using data from the other visits and also the covariates

IDA Studies

Statistically significant reduction in pain maintained at 3 years.

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).

Read abstract

Ida 3 year full

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.

ROSA Studies

ROSA - 3 Years

Objective

The aim of the study was to investigate the long-term efficacy and safety of a single injection of 6ml intra-articular polyacrylamide hydrogel (iPAAG, Arthrosamid®) on knee symptoms in participants with moderate to severe knee osteoarthritis (OA) for up to 5 years after treatment and to evaluate the time to start other treatments for knee OA.

Method

  • In the initial randomized controlled trial conducted at 3 sites in Denmark, participants were administered singular 6 mL intraarticular injections of Arthrosamid® or a HA (Synvisc-One).

     

  • The trial was unblinded at the one-year mark and participants were asked to continue into an open-label extension to monitor participants within the Arthrosamid® arm for a duration of up to 5 years.

     

  • Effectiveness was assessed through the WOMAC pain, stiffness, and function subscales at the 3 period.

Link to abstract

ROSA 3 year

Conclusion

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

DAISY Study

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

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.

Read research article

1 year daisy outline

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

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.

     

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

     

  • “Of these patients, none reported dissatisfaction with the outcome of the surgery, and the arthroplasties were well functioning.”
iPAAG: injectable polyacrylamide hydrogel

Indication, Patient Group and Usage

Arthrosamid® is intended to be used for symptomatic treatment of adult patients with knee osteoarthritis.