Cargando…

Clinical assessment of efficacy of poly-L-lactide sternal pin on sternal stability and post-operative pain: a prospective randomized trial in cardiovascular surgery

BACKGROUND: Although the incident rate is low, sternal dislocation and dehiscence due to unstable sternal fixation after cardiovascular surgery could cause potentially lethal complications. Thus, to enforce the stability of closed sternum, the sternal pins have been utilized at surgeon’s discretion....

Descripción completa

Detalles Bibliográficos
Autores principales: Takahara, Shingo, Sasaki, Konosuke, Saito, Takeshi, Sakuma, Kei, Fujiwara, Hidenori, Yoshioka, Ichiro, Kumagai, Kiichiro, Sun, Wenyu, Takase, Kei, Saiki, Yoshikatsu
Formato: Online Artículo Texto
Lenguaje:English
Publicado: AME Publishing Company 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8828521/
https://www.ncbi.nlm.nih.gov/pubmed/35242370
http://dx.doi.org/10.21037/jtd-21-1340
_version_ 1784647865258213376
author Takahara, Shingo
Sasaki, Konosuke
Saito, Takeshi
Sakuma, Kei
Fujiwara, Hidenori
Yoshioka, Ichiro
Kumagai, Kiichiro
Sun, Wenyu
Takase, Kei
Saiki, Yoshikatsu
author_facet Takahara, Shingo
Sasaki, Konosuke
Saito, Takeshi
Sakuma, Kei
Fujiwara, Hidenori
Yoshioka, Ichiro
Kumagai, Kiichiro
Sun, Wenyu
Takase, Kei
Saiki, Yoshikatsu
author_sort Takahara, Shingo
collection PubMed
description BACKGROUND: Although the incident rate is low, sternal dislocation and dehiscence due to unstable sternal fixation after cardiovascular surgery could cause potentially lethal complications. Thus, to enforce the stability of closed sternum, the sternal pins have been utilized at surgeon’s discretion. However, there is no randomized clinical trial to test whether these pins are effective to stabilize a sternum. Hence, this study aimed to examine the clinical efficacy of bioabsorbable poly-L-lactide (PLLA) sternal pins in reinforcing sternal stability and preventing instability of the sternum after full sternotomy. METHODS: We conducted a single institutional, prospective, randomized, single-blinded clinical study involving 100 patients who underwent an initial cardiovascular surgery via sternotomy. Patients were randomly allocated into two groups: with (group P) and without (group N) PLLA sternal pins, at 1:1 ratio from November 2013 to April 2016. Sternal deviation and stability were assessed with postoperative computed tomography (CT) at two postures to put shear stress on the sternum. Additionally, information on patient demographic indices was obtained prospectively, and patient’s pain intensity was assessed with numerical rating scoring system during rehabilitation. Furthermore, propensity score matching was performed for further comparative sub-analysis. RESULTS: Ninety-one patients (43 in group P and 48 in group N) were analyzed using the intention-to-treat method. Group N had a significantly higher proportion of males (P=0.015) and ischemic disease as a primary diagnosis (P=0.040) than group P. Postoperative CT showed that the degree of sternal deviation and stability were comparable between the groups. Similarly, the numerical rating score of pain during rehabilitation showed no difference between the groups. Even after adjusting for patient characteristics using propensity score matching method, no significant differences in sternal gaps, stability, and numerical rating score of pain were observed. Of note, no material-related adverse event such as wound infection was found. CONCLUSIONS: We could not identify the efficacy of the sternal pin in enforcing sternal stability based on CT measurements with mild shear stress on sternum after cardiovascular surgery. Nevertheless, our results with no adverse events might encourage further investigations with a more specific cohort who is susceptible to infection but requires an additional sternal fixation. TRIAL REGISTRATION: This study was registered in University Hospital Medical Information Network Clinical Trial Registry (UMIN000017357).
format Online
Article
Text
id pubmed-8828521
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher AME Publishing Company
record_format MEDLINE/PubMed
spelling pubmed-88285212022-03-02 Clinical assessment of efficacy of poly-L-lactide sternal pin on sternal stability and post-operative pain: a prospective randomized trial in cardiovascular surgery Takahara, Shingo Sasaki, Konosuke Saito, Takeshi Sakuma, Kei Fujiwara, Hidenori Yoshioka, Ichiro Kumagai, Kiichiro Sun, Wenyu Takase, Kei Saiki, Yoshikatsu J Thorac Dis Original Article BACKGROUND: Although the incident rate is low, sternal dislocation and dehiscence due to unstable sternal fixation after cardiovascular surgery could cause potentially lethal complications. Thus, to enforce the stability of closed sternum, the sternal pins have been utilized at surgeon’s discretion. However, there is no randomized clinical trial to test whether these pins are effective to stabilize a sternum. Hence, this study aimed to examine the clinical efficacy of bioabsorbable poly-L-lactide (PLLA) sternal pins in reinforcing sternal stability and preventing instability of the sternum after full sternotomy. METHODS: We conducted a single institutional, prospective, randomized, single-blinded clinical study involving 100 patients who underwent an initial cardiovascular surgery via sternotomy. Patients were randomly allocated into two groups: with (group P) and without (group N) PLLA sternal pins, at 1:1 ratio from November 2013 to April 2016. Sternal deviation and stability were assessed with postoperative computed tomography (CT) at two postures to put shear stress on the sternum. Additionally, information on patient demographic indices was obtained prospectively, and patient’s pain intensity was assessed with numerical rating scoring system during rehabilitation. Furthermore, propensity score matching was performed for further comparative sub-analysis. RESULTS: Ninety-one patients (43 in group P and 48 in group N) were analyzed using the intention-to-treat method. Group N had a significantly higher proportion of males (P=0.015) and ischemic disease as a primary diagnosis (P=0.040) than group P. Postoperative CT showed that the degree of sternal deviation and stability were comparable between the groups. Similarly, the numerical rating score of pain during rehabilitation showed no difference between the groups. Even after adjusting for patient characteristics using propensity score matching method, no significant differences in sternal gaps, stability, and numerical rating score of pain were observed. Of note, no material-related adverse event such as wound infection was found. CONCLUSIONS: We could not identify the efficacy of the sternal pin in enforcing sternal stability based on CT measurements with mild shear stress on sternum after cardiovascular surgery. Nevertheless, our results with no adverse events might encourage further investigations with a more specific cohort who is susceptible to infection but requires an additional sternal fixation. TRIAL REGISTRATION: This study was registered in University Hospital Medical Information Network Clinical Trial Registry (UMIN000017357). AME Publishing Company 2022-01 /pmc/articles/PMC8828521/ /pubmed/35242370 http://dx.doi.org/10.21037/jtd-21-1340 Text en 2022 Journal of Thoracic Disease. All rights reserved. https://creativecommons.org/licenses/by-nc-nd/4.0/Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.
spellingShingle Original Article
Takahara, Shingo
Sasaki, Konosuke
Saito, Takeshi
Sakuma, Kei
Fujiwara, Hidenori
Yoshioka, Ichiro
Kumagai, Kiichiro
Sun, Wenyu
Takase, Kei
Saiki, Yoshikatsu
Clinical assessment of efficacy of poly-L-lactide sternal pin on sternal stability and post-operative pain: a prospective randomized trial in cardiovascular surgery
title Clinical assessment of efficacy of poly-L-lactide sternal pin on sternal stability and post-operative pain: a prospective randomized trial in cardiovascular surgery
title_full Clinical assessment of efficacy of poly-L-lactide sternal pin on sternal stability and post-operative pain: a prospective randomized trial in cardiovascular surgery
title_fullStr Clinical assessment of efficacy of poly-L-lactide sternal pin on sternal stability and post-operative pain: a prospective randomized trial in cardiovascular surgery
title_full_unstemmed Clinical assessment of efficacy of poly-L-lactide sternal pin on sternal stability and post-operative pain: a prospective randomized trial in cardiovascular surgery
title_short Clinical assessment of efficacy of poly-L-lactide sternal pin on sternal stability and post-operative pain: a prospective randomized trial in cardiovascular surgery
title_sort clinical assessment of efficacy of poly-l-lactide sternal pin on sternal stability and post-operative pain: a prospective randomized trial in cardiovascular surgery
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8828521/
https://www.ncbi.nlm.nih.gov/pubmed/35242370
http://dx.doi.org/10.21037/jtd-21-1340
work_keys_str_mv AT takaharashingo clinicalassessmentofefficacyofpolyllactidesternalpinonsternalstabilityandpostoperativepainaprospectiverandomizedtrialincardiovascularsurgery
AT sasakikonosuke clinicalassessmentofefficacyofpolyllactidesternalpinonsternalstabilityandpostoperativepainaprospectiverandomizedtrialincardiovascularsurgery
AT saitotakeshi clinicalassessmentofefficacyofpolyllactidesternalpinonsternalstabilityandpostoperativepainaprospectiverandomizedtrialincardiovascularsurgery
AT sakumakei clinicalassessmentofefficacyofpolyllactidesternalpinonsternalstabilityandpostoperativepainaprospectiverandomizedtrialincardiovascularsurgery
AT fujiwarahidenori clinicalassessmentofefficacyofpolyllactidesternalpinonsternalstabilityandpostoperativepainaprospectiverandomizedtrialincardiovascularsurgery
AT yoshiokaichiro clinicalassessmentofefficacyofpolyllactidesternalpinonsternalstabilityandpostoperativepainaprospectiverandomizedtrialincardiovascularsurgery
AT kumagaikiichiro clinicalassessmentofefficacyofpolyllactidesternalpinonsternalstabilityandpostoperativepainaprospectiverandomizedtrialincardiovascularsurgery
AT sunwenyu clinicalassessmentofefficacyofpolyllactidesternalpinonsternalstabilityandpostoperativepainaprospectiverandomizedtrialincardiovascularsurgery
AT takasekei clinicalassessmentofefficacyofpolyllactidesternalpinonsternalstabilityandpostoperativepainaprospectiverandomizedtrialincardiovascularsurgery
AT saikiyoshikatsu clinicalassessmentofefficacyofpolyllactidesternalpinonsternalstabilityandpostoperativepainaprospectiverandomizedtrialincardiovascularsurgery