Clinical results of  intradiscal hydrogel  administiration (Gelstixtm) in lumbar degenerative discus disease

doi:10.3906/sag-1901-1

Cited by 4 publications

(1 citation statement)

References 17 publications

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“… 92 For example, GelStix Nucleus Augmentation Device is a modified polyacrylonitrile hydrogel that reconstructs the disc function by increasing hydration and IVD height. Ceylan et al 103 implanted GelStix in 29 patients with IDD and found that the VAS scores were decreased from 7.14 to 2.48 and the ODI scores were decreased from 28.14 to 17.35 after 12 months following treatment. Moreover, another randomized, double‐blind, placebo‐controlled, multicentre study has been conducted to evaluate the efficacy of treatment with the GelStix device in patients with chronic discogenic LBP, which is expected to conclude in August 2021.…”

Section: Hydrogel‐based Biomaterialsmentioning

confidence: 99%

Intradiscal injection for the management of low back pain

Wang

et al. 2021

JOR Spine

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Low back pain (LBP) is a common clinical problem and a major cause of physical disability, imposing a prominent socioeconomic burden. Intervertebral disc degeneration (IDD) has been considered the main cause of LBP. The current treatments have limited efficacy because they cannot address the underlying degeneration. With an increased understanding of the complex pathological mechanism of IDD, various medications and biological reagents have been used for intradiscal injection for the treatment of LBP. There is increasing clinical evidence showing the benefits of these therapies on symptomatic relief and their potential for disc repair and regeneration by targeting the disrupted pathways underlying the cause of the disease. A brief overview of the potential and limitations for these therapies are provided in this review, based on the recent and available data from clinical trials and systematic reviews.Finally, future perspectives are discussed.intervertebral disc degeneration, intradiscal injection, low back pain | INTRODUCTIONLow back pain (LBP) is a common symptom that occurs below the costal margin and above the inferior gluteal fold, which refers to pain, muscle tension, or stiffness. The global prevalence of LBP in 2017 was 7.83%, and 577 million people were affected at any time. 1 In 2019, a systematic review of 13 studies from northern Europe, North America, and Israel reported that the prevalence of LBP ranged between 14% and 20%. 2 A systematic review and meta-analysis revealed that the lifetime prevalence of LBP was 47% in low-, lower-Fu Zhang and Songjuan Wang (shared first authorship) and Zhiyu Zhou and Shaoyu Liu (shared last authorship) contributed equally to this study.

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Section: Hydrogel‐based Biomaterialsmentioning

confidence: 99%

Intradiscal injection for the management of low back pain

Wang

et al. 2021

JOR Spine

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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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Efficacy of the Gelstix nucleus augmentation device for the treatment of chronic discogenic low back pain: protocol for a randomised, sham-controlled, double-blind, multicentre trial

et al. 2022

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IntroductionDiscogenic pain is the cause of pain in 26%–40% of patients with for low back pain. Consensus about treatment of chronic discogenic low back pain is lacking and most treatment alternatives are supported by limited evidence. The percutaneous implantation of hydrogels into the nucleus pulposus represents a promising regenerative intradiscal therapy. The hydrogel ‘GelStix’ is composed primarily of hydrolyzed polyacrylonitrile and acts as a reservoir of hydration, producing increased pressure and improved pH balance, potentially leading to disc preservation. We hypothesise that treatment with GelStix will lead to greater reduction in pain intensity at 6 months post-treatment compared with patients receiving sham treatment.Methods and analysisThis is a parallel group, randomised sham-controlled double-blind, multicentre trial to assess whether the GelStix device is superior to sham in reducing pain intensity in patients with chronic discogenic low back pain. The study will be conducted in two regional hospitals in Europe. Seventy-two participants will be randomised in a 1:1 ratio. The primary outcome will be the change in pain intensity between preoperative baseline and at 6 months postintervention. Secondary outcomes were disability, quality of life, the patient’s global impression of change scale, the use of pain medication and the disc degeneration process assessed by means of MRI. For change in pain intensity, disability, health-related quality of life and disc height, mean values will be compared between groups using linear regression analysis, adjusted for treatment centre.Ethics and disseminationEthics approval was obtained from the Ethics Committee of the Canton Ticino, Switzerland (CE2982) and by the Medical Ethical Committee Arnhem-Nijmegen, the Netherlands (2016-2944). All patients that agree to participate will be asked to sign an informed consent form. Results will be disseminated through international publications in peer-reviewed journals, in addition to international conference presentations.Trial registration numberNCT02763956.Protocol version7.1, 18 November 2020.

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Clinical results of intradiscal hydrogel administiration (Gelstixtm) in lumbar degenerative discus disease

Cited by 4 publications

References 17 publications

Intradiscal injection for the management of low back pain

Intradiscal injection for the management of low back pain

Design and clinical application of injectable hydrogels for musculoskeletal therapy

Efficacy of the Gelstix nucleus augmentation device for the treatment of chronic discogenic low back pain: protocol for a randomised, sham-controlled, double-blind, multicentre trial

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