An Investigator-Initiated, Prospective, Single-Center, Open-Label Clinical Study to Evaluate Safety and Performance of Intra-Articular Hyaluronic Acid (IA-HA) (Biovisc Ortho) in Patients with Osteoarthritis (OA) of the Knee

Ajay Gupta,1 Chethan Channaveera,2 Vijender Anand,1 Satyaranjan Sethi1 1Department of Physical Medicine & Rehabilitation, VMM College and Safdarjang Hospital, New Delhi, 110029, India; 2Department of Physical Medicine & Rehabilitation,AIIMS, Mangalagiri, Andhra Pradesh, 522503, India...

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Autores principales:	Gupta A, Channaveera C, Anand V, Sethi S
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2021
Materias:	osteoarthritis hyaluronic acid intra-articular (ia) viscosupplementation koos Therapeutics. Pharmacology RM1-950
Acceso en línea:	https://doaj.org/article/6b6766d74ad940db9506fc396c9db864
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spelling	oai:doaj.org-article:6b6766d74ad940db9506fc396c9db8642021-12-02T16:58:10ZAn Investigator-Initiated, Prospective, Single-Center, Open-Label Clinical Study to Evaluate Safety and Performance of Intra-Articular Hyaluronic Acid (IA-HA) (Biovisc Ortho) in Patients with Osteoarthritis (OA) of the Knee1179-1438https://doaj.org/article/6b6766d74ad940db9506fc396c9db8642021-05-01T00:00:00Zhttps://www.dovepress.com/an-investigator-initiated-prospective-single-center-open-label-clinica-peer-reviewed-fulltext-article-CPAAhttps://doaj.org/toc/1179-1438Ajay Gupta,1 Chethan Channaveera,2 Vijender Anand,1 Satyaranjan Sethi1 1Department of Physical Medicine & Rehabilitation, VMM College and Safdarjang Hospital, New Delhi, 110029, India; 2Department of Physical Medicine & Rehabilitation,AIIMS, Mangalagiri, Andhra Pradesh, 522503, IndiaCorrespondence: Satyaranjan SethiVMM College and Safdarjang Hospital, New Delhi, 110029, IndiaEmail drsatya.1979@gmail.comObjective: IA-HA is injected into the osteoarthritis knee as a viscosupplementation for therapeutic purposes. This clinical trial was carried out for evaluating the efficacy and safety of Biovisc Ortho IA-HA (20 mg/2 mL) in a 2 mL prefilled syringe.Design: The study was conducted as an open-label, single-center, single-arm clinical trial in India. Patients of knee OA with moderate to severe symptoms for a minimum duration of 3 months were included in the study. Five visits were conducted at weekly intervals and the investigational product was administered at each visit. Two follow-up visits were conducted at 3 and 6 months after the completion of the last injection cycle. The primary outcome variable was change in KOOS pain score from baseline. The secondary outcome variables were analyzed for other KOOS scales and safety of the device.Results: Change in KOOS pain score at 6 months from baseline was 29.71± 15.74 and the change in mean KOOS score for pain was statistically significant (p< 0.0001) for all post-baseline visits. Statistically significant improvement was observed for mean values of efficacy assessments (KOOS) during the study period (6 months) for all the domains evaluated, including pain, joint function and quality of life.Conclusion: Despite being an open, noncomparative study, the safety and efficacy results of IA-HA establish the therapeutic effect of the treatment throughout the study period of 6 months and are safe.Keywords: osteoarthritis, hyaluronic acid, intra-articular, IA, viscosupplementation, KOOSGupta AChannaveera CAnand VSethi SDove Medical Pressarticleosteoarthritishyaluronic acidintra-articular (ia)viscosupplementationkoosTherapeutics. PharmacologyRM1-950ENClinical Pharmacology: Advances and Applications, Vol Volume 13, Pp 73-82 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	osteoarthritis hyaluronic acid intra-articular (ia) viscosupplementation koos Therapeutics. Pharmacology RM1-950
spellingShingle	osteoarthritis hyaluronic acid intra-articular (ia) viscosupplementation koos Therapeutics. Pharmacology RM1-950 Gupta A Channaveera C Anand V Sethi S An Investigator-Initiated, Prospective, Single-Center, Open-Label Clinical Study to Evaluate Safety and Performance of Intra-Articular Hyaluronic Acid (IA-HA) (Biovisc Ortho) in Patients with Osteoarthritis (OA) of the Knee
description	Ajay Gupta,1 Chethan Channaveera,2 Vijender Anand,1 Satyaranjan Sethi1 1Department of Physical Medicine & Rehabilitation, VMM College and Safdarjang Hospital, New Delhi, 110029, India; 2Department of Physical Medicine & Rehabilitation,AIIMS, Mangalagiri, Andhra Pradesh, 522503, IndiaCorrespondence: Satyaranjan SethiVMM College and Safdarjang Hospital, New Delhi, 110029, IndiaEmail drsatya.1979@gmail.comObjective: IA-HA is injected into the osteoarthritis knee as a viscosupplementation for therapeutic purposes. This clinical trial was carried out for evaluating the efficacy and safety of Biovisc Ortho IA-HA (20 mg/2 mL) in a 2 mL prefilled syringe.Design: The study was conducted as an open-label, single-center, single-arm clinical trial in India. Patients of knee OA with moderate to severe symptoms for a minimum duration of 3 months were included in the study. Five visits were conducted at weekly intervals and the investigational product was administered at each visit. Two follow-up visits were conducted at 3 and 6 months after the completion of the last injection cycle. The primary outcome variable was change in KOOS pain score from baseline. The secondary outcome variables were analyzed for other KOOS scales and safety of the device.Results: Change in KOOS pain score at 6 months from baseline was 29.71± 15.74 and the change in mean KOOS score for pain was statistically significant (p< 0.0001) for all post-baseline visits. Statistically significant improvement was observed for mean values of efficacy assessments (KOOS) during the study period (6 months) for all the domains evaluated, including pain, joint function and quality of life.Conclusion: Despite being an open, noncomparative study, the safety and efficacy results of IA-HA establish the therapeutic effect of the treatment throughout the study period of 6 months and are safe.Keywords: osteoarthritis, hyaluronic acid, intra-articular, IA, viscosupplementation, KOOS
format	article
author	Gupta A Channaveera C Anand V Sethi S
author_facet	Gupta A Channaveera C Anand V Sethi S
author_sort	Gupta A
title	An Investigator-Initiated, Prospective, Single-Center, Open-Label Clinical Study to Evaluate Safety and Performance of Intra-Articular Hyaluronic Acid (IA-HA) (Biovisc Ortho) in Patients with Osteoarthritis (OA) of the Knee
title_short	An Investigator-Initiated, Prospective, Single-Center, Open-Label Clinical Study to Evaluate Safety and Performance of Intra-Articular Hyaluronic Acid (IA-HA) (Biovisc Ortho) in Patients with Osteoarthritis (OA) of the Knee
title_full	An Investigator-Initiated, Prospective, Single-Center, Open-Label Clinical Study to Evaluate Safety and Performance of Intra-Articular Hyaluronic Acid (IA-HA) (Biovisc Ortho) in Patients with Osteoarthritis (OA) of the Knee
title_fullStr	An Investigator-Initiated, Prospective, Single-Center, Open-Label Clinical Study to Evaluate Safety and Performance of Intra-Articular Hyaluronic Acid (IA-HA) (Biovisc Ortho) in Patients with Osteoarthritis (OA) of the Knee
title_full_unstemmed	An Investigator-Initiated, Prospective, Single-Center, Open-Label Clinical Study to Evaluate Safety and Performance of Intra-Articular Hyaluronic Acid (IA-HA) (Biovisc Ortho) in Patients with Osteoarthritis (OA) of the Knee
title_sort	investigator-initiated, prospective, single-center, open-label clinical study to evaluate safety and performance of intra-articular hyaluronic acid (ia-ha) (biovisc ortho) in patients with osteoarthritis (oa) of the knee
publisher	Dove Medical Press
publishDate	2021
url	https://doaj.org/article/6b6766d74ad940db9506fc396c9db864
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An Investigator-Initiated, Prospective, Single-Center, Open-Label Clinical Study to Evaluate Safety and Performance of Intra-Articular Hyaluronic Acid (IA-HA) (Biovisc Ortho) in Patients with Osteoarthritis (OA) of the Knee

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