Polyacrylamide hydrogel injection for knee osteoarthritis: results of a 52 week prospective study

Bliddal, Henning; Overgaard, Anders; Hartkopp, Andreas; Beier, Justus P.; Conaghan, P. G.; Henriksen, Marius

doi:10.1016/j.joca.2021.02.366

Cited by 5 publications

(10 citation statements)

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“…A recent commercialization is VS made from polyacrylamide such as Contura's Arthrosemid®. Arthrosemid® is a gel consisting of covalently crosslinked polyacrylamide, which is non‐degradable 66 . It was used initially for veterinary application in horses with OA, 108 but recently the therapeutic effect has been demonstrated to be functional up to 52 weeks in humans 67 .…”

Section: Applicationsmentioning

confidence: 99%

“…Arthrosemid® is a gel consisting of covalently crosslinked polyacrylamide, which is non‐degradable 66 . It was used initially for veterinary application in horses with OA, 108 but recently the therapeutic effect has been demonstrated to be functional up to 52 weeks in humans 67 . As the material is non‐degradable, the therapeutic effect is expected to be significantly longer.…”

Section: Applicationsmentioning

confidence: 99%

“…66 It was used initially for veterinary application in horses with OA, 108 but recently the therapeutic effect has been demonstrated to be functional up to 52 weeks in humans. 67 As the material is non-degradable, the therapeutic effect is expected to be significantly longer. An in vivo subcutaneous rat model comparing the acrylamide gel to a HA gel as soft tissue fillers suggested significantly different in vivo behavior.…”

Section: Viscosupplementationmentioning

confidence: 99%

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Design and clinical application of injectable hydrogels for musculoskeletal therapy

Øvrebø

Perale

Wojciechowski

et al. 2022

Bioengineering & Transla Med

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Musculoskeletal defects are an enormous healthcare burden and source of pain and disability for individuals. With an aging population, the proportion of individuals living with these medical indications will increase. Simultaneously, there is pressure on healthcare providers to source efficient solutions, which are cheaper and less invasive than conventional technology. This has led to an increased research focus on hydrogels as highly biocompatible biomaterials that can be delivered through minimally invasive procedures. This review will discuss how hydrogels can be designed for clinical translation, particularly in the context of the new European Medical Device Regulation (MDR). We will then do a deep dive into the clinically used hydrogel solutions that have been commercially approved or have undergone clinical trials in Europe or the United States. We will discuss the therapeutic mechanism and limitations of these products. Due to the vast application areas of hydrogels, this work focuses only on treatments of cartilage, bone, and the nucleus pulposus. Lastly, the main steps toward clinical translation of hydrogels as medical devices are outlined. We suggest a framework for how academics can assist small and medium MedTech enterprises conducting the initial clinical investigation and post‐market clinical follow‐up required in the MDR. It is evident that the successful translation of hydrogels is governed by acquiring high‐quality pre‐clinical and clinical data confirming the device mechanism of action and safety.

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Section: Applicationsmentioning

confidence: 99%

Section: Applicationsmentioning

confidence: 99%

Section: Viscosupplementationmentioning

confidence: 99%

See 1 more Smart Citation

Design and clinical application of injectable hydrogels for musculoskeletal therapy

Øvrebø

Perale

Wojciechowski

et al. 2022

Bioengineering & Transla Med

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“…iPAAG is structurally stable and has been used for various indications such as bulking for stress urinary incontinence and soft tissue augmentation for more than 20 years. iPAAG has also demonstrated promising potential as a treatment for symptomatic OA [ 6 , 7 ].…”

Section: Introductionmentioning

confidence: 99%

“…Upon injection into the joint cavity, iPAAG integrates into the synovial tissue of the inner capsule [ 8 , 9 ]. The non-absorbable, non-biodegradable and non-migratory characteristics of Arthrosamid® provide durable augmentation of the inner joint capsular tissue [ 7 ]. The exact mechanisms of how this provides pain relief in OA patients is being examined.…”

Section: Introductionmentioning

confidence: 99%

Effectiveness and safety of polyacrylamide hydrogel injection for knee osteoarthritis: results from a 12-month follow up of an open-label study

Bliddal,

Beier,

Hartkopp

et al. 2024

J Orthop Surg Res

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Objective There are few effective osteoarthritis (OA) therapies. A novel injectable polyacrylamide hydrogel (iPAAG) previously demonstrated efficacy and safety up to week 26 in an open-label study of knee OA. Here we report longer-term effectiveness and safety data. Methods This multi-centre, open-label study included patients with symptomatic and radiographic knee OA. Primary outcome was WOMAC pain (0–100 scale) at 13 weeks, and patients continued to 26 weeks before entering a further 26-week extension phase. Secondary efficacy outcomes included WOMAC stiffness and function subscales, Patient Global Assessment (PGA) and proportion of OMERACT-OARSI responders. Safety outcomes were adverse events (AEs). Results 49 participants (31 women, mean age 70) received an ultrasound-guided, intra-articular injection of 6 ml iPAAG; 46 completed the extension phase to 52 weeks. There was a significant reduction in the WOMAC pain score from baseline to 52 weeks (− 17.7 points (95% CI − 23.1; − 12.4); p < 0.0001). Similar sustained improvements were observed for WOMAC stiffness (11.0 points; 95% CI − 17.0; − 4.9), physical function (18.0 points; 95% CI − 19.1; − 10.6), and PGA (16.3 points; 95% CI − 23.1; − 9.4). At 52 weeks 62.2% of patients were OMERACT-OARSI responders. From 26 to 52 weeks, 8 adverse effects (AE), including 1 serious AE (cerebrovascular accident) were reported in 5 subjects. None of the new adverse events were thought to be device related. Conclusion This open-label study suggests persistent benefits and safety of iPAAG through 52 weeks after a single injection. Trial registration: Clinicaltrials.gov NCT04179552.

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Development and Characterization of Thermoresponsive Double‐Network Nanocomposite Hydrogel for Bone Tissue Engineering

Indurkar,

Rubenis,

Boccaccini

et al. 2024

Macro Materials & Eng

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In this study, a thermoresponsive double‐network (DN) nanocomposite hydrogel is developed. The primary hydrogel network comprises Pluronic P123, while the secondary network comprises gelatinmethacrylate (GELMA) and polyacrylamide (PAM). A systematic approach is adopted to develop DN hydrogels. Initially, the impact of Pluronic P123 concentrationon the mechanical properties of PAM‐GELMA hydrogel is investigated. Results from the tensile strength and the oscillatory shear tests reveal that an increasing P123 concentration has a marginal effect on the storage modulus while significantly reducing the loss modulus of the PAM‐GELMA hydrogel, thereby improving mechanical properties. Notably, DN3 hydrogel containing 7.5w/v% P123 in PAM‐GELMA exhibits osteoid matrix‐like mechanical properties. To further enhance the mechanical properties, citrate‐containing amorphous calcium phosphate (ACP_CIT) is incorporated in DN3 hydrogel at varying concentrations. At a lower concentration of ACP_CIT (0.75 w/v%), the mechanical properties of DN3‐ACP0.75 hydrogel are notably enhanced. Incorporating ACP_CIT in DN3 hydrogel (DN3‐ACP0.75) decreases creep strain, rapid stress relaxation, and reduced water uptake capacity while maintaining the thermoresponsive behavior. Finally, an in vitro analysis confirms the cytocompatibility of the hydrogels with MC3T3‐E1 cells, indicating the potential use in bone tissue engineering.

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Polyacrylamide hydrogel injection for knee osteoarthritis: results of a 52 week prospective study

Cited by 5 publications

References 0 publications

Design and clinical application of injectable hydrogels for musculoskeletal therapy

Design and clinical application of injectable hydrogels for musculoskeletal therapy

Effectiveness and safety of polyacrylamide hydrogel injection for knee osteoarthritis: results from a 12-month follow up of an open-label study

Development and Characterization of Thermoresponsive Double‐Network Nanocomposite Hydrogel for Bone Tissue Engineering

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