Our Results
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Supported by more than two decades of research, Arthrosamid® is proven to be safe and effective, offering long-lasting pain relief in a single injectable 2.5% iPAAG implant for knee OA patients.
Our Results
Supported by more than two decades of research, Arthrosamid® is proven to be safe and effective, offering long-lasting pain relief in a single injectable 2.5% iPAAG implant for knee OA patients.
Canada
Pain Reduction
In all our studies, Arthrosamid® exceeds the MCID of 9 points and improvement is maintained up to 5 years after a single injection.
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Close to 80% Response rate
Patients in the under 70 years group reported close to 80% positive response rate following treatment with Arthrosamid®.
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Safe & Effective
Arthrosamid® remains safe and effective for its intended use 5 years after treatment.
Longterm pain reduction
Statistically significant reduction in pain maintained at 5 years.
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Significantly different
Significant difference in change from baseline between Arthrosamid® and Synvisc-One® at 52 weeks.
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Stable & Significant
Stable and statistically significant change on all WOMAC subscales and WOMAC total over the 56 week observation period.
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WOMAC pain subscale change from baseline across 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.
A randomised study of one-year performance of polyacrylamide hydrogel (iPAAG) vs. hyaluronic acid.
iPAAG: injectable polyacrylamide hydrogel
† 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
Objective
To evaluate long term safety of intra-articular 2.5% polyacrylamide hydrogel (iPAAG).
Materials & Methods
Patients treated off-label with 2.5% iPAAG for knee OA between 2010-2017 were recalled. Medical and surgical records were obtained and scrutinized for possible adverse events (AEs) or abnormal reactions related to the injection, and in the event of subsequent surgery, for peri- and post-operative complications.
An interview was also conducted for retrospective self-reported AEs after the 2.5% iPAAG injection. The time between injection and knee surgery was recorded.
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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.
Safety Data
The primary objective of this study was to evaluate the effi cacy and safety of a single injection of 6ml intra-articular Arthrosamid® on knee symptoms in participants with moderate to severe knee OA.
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Single injections of 6 ml intra-articular Arthrosamid® are well tolerated and continue to demonstrate clinically relevant and statistically significant effectiveness 5 years after treatment.
The aim of the study was to investigate the long-term efficacy and safety of a single injection of 6 ml intra-articular polyacrylamide hydrogel (2.5% iPAAG, Arthrosamid®) on knee symptoms in participants with moderate to severe knee osteoarthritis (OA) for up to 5 years after treatment.
Single injections of 6 ml intra-articular Arthrosamid® provide sustained, clinically meaningful symptom relief and are well tolerated over a 5-year period in patients with moderate-to-severe knee OA.
Objective
The primary objective of this multicentre European study was to evaluate the safety, tolerability and efficacy of a single injection of 6 ml intra-articular Arthrosamid® on knee symptoms in participants with moderate to severe knee OA.
Method
Conclusion
A single injection of Arthrosamid® is well tolerated, giving sustained symptom relief over 12 months in patients with knee OA.
This study was conducted to establish an initial effectiveness of intra-articular (IA) injection of iPAAG for the treatment of knee OA symptoms.
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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
Arthrosamid® is intended to be used for symptomatic treatment of adult patients with knee osteoarthritis.
Contraindications
Warnings
Precautions
Prophylactic Antibiotic Treatment
Instructions for Use