The use of a made-in- Malaysia Hydroxyapatite (HA) granules (GRANUMAS): early clinical results a one year review

This paper is to report on the work that has been performed, in conjunction with a multi-institution research project, toward achieving the production of a locally made bone graft substitute. Hydroxyapatite (HA) granules made from local raw materials have been fabricated using a novel method (Patent...

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Main Authors:	Zulkifly, Ahmad Hafiz, Khalid, Kamarul Ariffin, Zakaria@Mohamad, Zamzuri, Mohd Yusof, Nazri, Che Ahmad, Aminudin
Format:	Conference or Workshop Item
Language:	English
Published:	2007
Subjects:	RA1190 Toxicology RD701 Orthopedics RS Pharmacy and materia medica
Online Access:	http://irep.iium.edu.my/41068/ http://irep.iium.edu.my/41068/ http://irep.iium.edu.my/41068/1/convert-jpg-to-pdf.net_2015-01-31_06-40-33.pdf

id	iium-41068
recordtype	eprints
spelling	iium-410682015-03-13T03:03:55Z http://irep.iium.edu.my/41068/ The use of a made-in- Malaysia Hydroxyapatite (HA) granules (GRANUMAS): early clinical results a one year review Zulkifly, Ahmad Hafiz Khalid, Kamarul Ariffin Zakaria@Mohamad, Zamzuri Mohd Yusof, Nazri Che Ahmad, Aminudin RA1190 Toxicology RD701 Orthopedics RS Pharmacy and materia medica This paper is to report on the work that has been performed, in conjunction with a multi-institution research project, toward achieving the production of a locally made bone graft substitute. Hydroxyapatite (HA) granules made from local raw materials have been fabricated using a novel method (Patent pending No. PI 2004 0748). The granules were characterized both chemically and physically and found to abide by the ASTM F1185-88 (1998) specification that cover the materials requirements for HA intended for use as surgical implants. Biocompatibility studies, involving various cytotoxicity and genotoxicity studies: in vivo animal studies, comprising of acute systemic toxicity, dermal sensitization and primary skin irritation assays and also implantation studies: and a phase 1 clinical trials involving the use of the granules for root socket obliteration in young healthy adults following tooth extraction was performed. Based on the result of these studies, the material was approved for a phase 2 clinical trial. Young adult patients with fractures of the distal end of the radius requiring bone graft usage is voluntarily recruited into this study after fulfilling a set of inclusion and exclusion criteria. An informed consent is acquired prior surgery. Clinical and radiologically observations were made and recorded. Measurements are made and the results were analysed. This presentation represents the preliminary results of patients that have been operated on in 2005. 2007 Conference or Workshop Item PeerReviewed application/pdf en http://irep.iium.edu.my/41068/1/convert-jpg-to-pdf.net_2015-01-31_06-40-33.pdf Zulkifly, Ahmad Hafiz and Khalid, Kamarul Ariffin and Zakaria@Mohamad, Zamzuri and Mohd Yusof, Nazri and Che Ahmad, Aminudin (2007) The use of a made-in- Malaysia Hydroxyapatite (HA) granules (GRANUMAS): early clinical results a one year review. In: Fifth SICOT/SIROT Annual International Conference 2007, 29 August - 1 September 2007, Marrakech, Morocco. http://www.news.sicot.org
repository_type	Digital Repository
institution_category	Local University
institution	International Islamic University Malaysia
building	IIUM Repository
collection	Online Access
language	English
topic	RA1190 Toxicology RD701 Orthopedics RS Pharmacy and materia medica
spellingShingle	RA1190 Toxicology RD701 Orthopedics RS Pharmacy and materia medica Zulkifly, Ahmad Hafiz Khalid, Kamarul Ariffin Zakaria@Mohamad, Zamzuri Mohd Yusof, Nazri Che Ahmad, Aminudin The use of a made-in- Malaysia Hydroxyapatite (HA) granules (GRANUMAS): early clinical results a one year review
description	This paper is to report on the work that has been performed, in conjunction with a multi-institution research project, toward achieving the production of a locally made bone graft substitute. Hydroxyapatite (HA) granules made from local raw materials have been fabricated using a novel method (Patent pending No. PI 2004 0748). The granules were characterized both chemically and physically and found to abide by the ASTM F1185-88 (1998) specification that cover the materials requirements for HA intended for use as surgical implants. Biocompatibility studies, involving various cytotoxicity and genotoxicity studies: in vivo animal studies, comprising of acute systemic toxicity, dermal sensitization and primary skin irritation assays and also implantation studies: and a phase 1 clinical trials involving the use of the granules for root socket obliteration in young healthy adults following tooth extraction was performed. Based on the result of these studies, the material was approved for a phase 2 clinical trial. Young adult patients with fractures of the distal end of the radius requiring bone graft usage is voluntarily recruited into this study after fulfilling a set of inclusion and exclusion criteria. An informed consent is acquired prior surgery. Clinical and radiologically observations were made and recorded. Measurements are made and the results were analysed. This presentation represents the preliminary results of patients that have been operated on in 2005.
format	Conference or Workshop Item
author	Zulkifly, Ahmad Hafiz Khalid, Kamarul Ariffin Zakaria@Mohamad, Zamzuri Mohd Yusof, Nazri Che Ahmad, Aminudin
author_facet	Zulkifly, Ahmad Hafiz Khalid, Kamarul Ariffin Zakaria@Mohamad, Zamzuri Mohd Yusof, Nazri Che Ahmad, Aminudin
author_sort	Zulkifly, Ahmad Hafiz
title	The use of a made-in- Malaysia Hydroxyapatite (HA) granules (GRANUMAS): early clinical results a one year review
title_short	The use of a made-in- Malaysia Hydroxyapatite (HA) granules (GRANUMAS): early clinical results a one year review
title_full	The use of a made-in- Malaysia Hydroxyapatite (HA) granules (GRANUMAS): early clinical results a one year review
title_fullStr	The use of a made-in- Malaysia Hydroxyapatite (HA) granules (GRANUMAS): early clinical results a one year review
title_full_unstemmed	The use of a made-in- Malaysia Hydroxyapatite (HA) granules (GRANUMAS): early clinical results a one year review
title_sort	use of a made-in- malaysia hydroxyapatite (ha) granules (granumas): early clinical results a one year review
publishDate	2007
url	http://irep.iium.edu.my/41068/ http://irep.iium.edu.my/41068/ http://irep.iium.edu.my/41068/1/convert-jpg-to-pdf.net_2015-01-31_06-40-33.pdf
first_indexed	2023-09-18T20:58:50Z
last_indexed	2023-09-18T20:58:50Z
_version_	1777410486261776384

The use of a made-in- Malaysia Hydroxyapatite (HA) granules (GRANUMAS): early clinical results a one year review

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