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Prospective observation of Clostridium histolyticum collagenase for the treatment of Dupuytren’s disease in 788 patients: the Austrian register
INTRODUCTION: Since March 2011, the microbial collagenase of Clostridium histolyticum (Xiapex®, Swedish Orphan Biovitrum AB, Stockholm, Sweden) has become available in the European Union for treatment of Dupuytren’s disease. The purpose of this study was to evaluate potential safety risks of Xiapex®...
Autores principales: | , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Berlin Heidelberg
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6689902/ https://www.ncbi.nlm.nih.gov/pubmed/31317303 http://dx.doi.org/10.1007/s00402-019-03226-3 |
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author | Rohit, Arora Peter, Angermann Paul, Aspalter Anja, Binter Christian, Deml Renate, Danninger Stefan, Gärner Dietmar, Hager Johannes, Jeschke Peter, Kaiser Marco, Keller Martin, Leixnering Maximilian, Neuwirth Christoph, Pezzei Gernot, Schmidle Gerald, Schmölzer Tobias, Steirer Matthias, Wlk Armin, Zadra Markus, Gabl |
author_facet | Rohit, Arora Peter, Angermann Paul, Aspalter Anja, Binter Christian, Deml Renate, Danninger Stefan, Gärner Dietmar, Hager Johannes, Jeschke Peter, Kaiser Marco, Keller Martin, Leixnering Maximilian, Neuwirth Christoph, Pezzei Gernot, Schmidle Gerald, Schmölzer Tobias, Steirer Matthias, Wlk Armin, Zadra Markus, Gabl |
author_sort | Rohit, Arora |
collection | PubMed |
description | INTRODUCTION: Since March 2011, the microbial collagenase of Clostridium histolyticum (Xiapex®, Swedish Orphan Biovitrum AB, Stockholm, Sweden) has become available in the European Union for treatment of Dupuytren’s disease. The purpose of this study was to evaluate potential safety risks of Xiapex® and to contribute to a better understanding for its use. METHODS: A prospective, non-interventional, observational study using Xiapex® for Dupuytren’s disease named XIANIS was conducted between 1.10.2011 and 01.10.2017. Treatment was conducted in accordance to the manufacturer information. Patients were invited for follow-up after 1 week, 1 month, 3 months and 1 year. Demographic data, treatment data, pain levels, anaesthetic application during passive manipulation, subjective function improvement, subjective satisfaction and adverse events were recorded. RESULTS: 788 patients with 814 treatments were included who suffered from Dupuytren’s contracture for a mean of 64 months. The metacarpophalangeal joint was affected in 57% of cases and the PIP joint in 40.8% with a mean contracture of 39° and 56°, respectively. A change in the contracture down to 0°–5° was reported in 66.5% of cases, while 25.5% achieved a partial improvement. The pain during the injection was rated 4.5 and 3.3 during passive manipulation. Adverse events were reported in the majority of treated patients with skin tears being one main common event (26%). Further adverse outcomes were bleeding/hematoma, joint swelling, injection-site swelling, pressure sensitivity, erythema, injection-site pain, peripheral edema, blood blisters, blisters, painless lymphadenopathy, painful lymphadenopathy, axillary pain, arthralgia and sensory abnormality. There were no reported tendon ruptures, anaphylactic reactions or ligament injuries. On 1-year follow-up, 29% showed an increased contracture of a mean of 24° with the need for surgical treatment in 2% of patients. 74% of patients were very satisfied and 72% showed a high functional improvement. CONCLUSION: The injectable collagenase Clostridium histolyticum (Xiapex®) proved to be effective and safe in patients with Dupuytren’s disease. Minor adverse events disappeared within 30 days and the need for surgical treatment within 1 year was very low (2%). No major complications or rare side effects were seen in this prospective observational study. |
format | Online Article Text |
id | pubmed-6689902 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Springer Berlin Heidelberg |
record_format | MEDLINE/PubMed |
spelling | pubmed-66899022019-08-23 Prospective observation of Clostridium histolyticum collagenase for the treatment of Dupuytren’s disease in 788 patients: the Austrian register Rohit, Arora Peter, Angermann Paul, Aspalter Anja, Binter Christian, Deml Renate, Danninger Stefan, Gärner Dietmar, Hager Johannes, Jeschke Peter, Kaiser Marco, Keller Martin, Leixnering Maximilian, Neuwirth Christoph, Pezzei Gernot, Schmidle Gerald, Schmölzer Tobias, Steirer Matthias, Wlk Armin, Zadra Markus, Gabl Arch Orthop Trauma Surg Handsurgery INTRODUCTION: Since March 2011, the microbial collagenase of Clostridium histolyticum (Xiapex®, Swedish Orphan Biovitrum AB, Stockholm, Sweden) has become available in the European Union for treatment of Dupuytren’s disease. The purpose of this study was to evaluate potential safety risks of Xiapex® and to contribute to a better understanding for its use. METHODS: A prospective, non-interventional, observational study using Xiapex® for Dupuytren’s disease named XIANIS was conducted between 1.10.2011 and 01.10.2017. Treatment was conducted in accordance to the manufacturer information. Patients were invited for follow-up after 1 week, 1 month, 3 months and 1 year. Demographic data, treatment data, pain levels, anaesthetic application during passive manipulation, subjective function improvement, subjective satisfaction and adverse events were recorded. RESULTS: 788 patients with 814 treatments were included who suffered from Dupuytren’s contracture for a mean of 64 months. The metacarpophalangeal joint was affected in 57% of cases and the PIP joint in 40.8% with a mean contracture of 39° and 56°, respectively. A change in the contracture down to 0°–5° was reported in 66.5% of cases, while 25.5% achieved a partial improvement. The pain during the injection was rated 4.5 and 3.3 during passive manipulation. Adverse events were reported in the majority of treated patients with skin tears being one main common event (26%). Further adverse outcomes were bleeding/hematoma, joint swelling, injection-site swelling, pressure sensitivity, erythema, injection-site pain, peripheral edema, blood blisters, blisters, painless lymphadenopathy, painful lymphadenopathy, axillary pain, arthralgia and sensory abnormality. There were no reported tendon ruptures, anaphylactic reactions or ligament injuries. On 1-year follow-up, 29% showed an increased contracture of a mean of 24° with the need for surgical treatment in 2% of patients. 74% of patients were very satisfied and 72% showed a high functional improvement. CONCLUSION: The injectable collagenase Clostridium histolyticum (Xiapex®) proved to be effective and safe in patients with Dupuytren’s disease. Minor adverse events disappeared within 30 days and the need for surgical treatment within 1 year was very low (2%). No major complications or rare side effects were seen in this prospective observational study. Springer Berlin Heidelberg 2019-07-17 2019 /pmc/articles/PMC6689902/ /pubmed/31317303 http://dx.doi.org/10.1007/s00402-019-03226-3 Text en © The Author(s) 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. |
spellingShingle | Handsurgery Rohit, Arora Peter, Angermann Paul, Aspalter Anja, Binter Christian, Deml Renate, Danninger Stefan, Gärner Dietmar, Hager Johannes, Jeschke Peter, Kaiser Marco, Keller Martin, Leixnering Maximilian, Neuwirth Christoph, Pezzei Gernot, Schmidle Gerald, Schmölzer Tobias, Steirer Matthias, Wlk Armin, Zadra Markus, Gabl Prospective observation of Clostridium histolyticum collagenase for the treatment of Dupuytren’s disease in 788 patients: the Austrian register |
title | Prospective observation of Clostridium histolyticum collagenase for the treatment of Dupuytren’s disease in 788 patients: the Austrian register |
title_full | Prospective observation of Clostridium histolyticum collagenase for the treatment of Dupuytren’s disease in 788 patients: the Austrian register |
title_fullStr | Prospective observation of Clostridium histolyticum collagenase for the treatment of Dupuytren’s disease in 788 patients: the Austrian register |
title_full_unstemmed | Prospective observation of Clostridium histolyticum collagenase for the treatment of Dupuytren’s disease in 788 patients: the Austrian register |
title_short | Prospective observation of Clostridium histolyticum collagenase for the treatment of Dupuytren’s disease in 788 patients: the Austrian register |
title_sort | prospective observation of clostridium histolyticum collagenase for the treatment of dupuytren’s disease in 788 patients: the austrian register |
topic | Handsurgery |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6689902/ https://www.ncbi.nlm.nih.gov/pubmed/31317303 http://dx.doi.org/10.1007/s00402-019-03226-3 |
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