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Effect of Early vs Delayed Surgical Treatment on Motor Recovery in Incomplete Cervical Spinal Cord Injury With Preexisting Cervical Stenosis: A Randomized Clinical Trial
IMPORTANCE: The optimal management for acute traumatic cervical spinal cord injury (SCI) is unknown. OBJECTIVE: To determine whether early surgical decompression results in better motor recovery than delayed surgical treatment in patients with acute traumatic incomplete cervical SCI associated with...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
American Medical Association
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8579238/ https://www.ncbi.nlm.nih.gov/pubmed/34751757 http://dx.doi.org/10.1001/jamanetworkopen.2021.33604 |
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author | Chikuda, Hirotaka Koyama, Yurie Matsubayashi, Yoshitaka Ogata, Toru Ohtsu, Hiroshi Sugita, Shurei Sumitani, Masahiko Kadono, Yuho Miura, Toshiki Tanaka, Sakae Akiyama, Toru Ando, Kei Anno, Masato Azuma, Seiichi Endo, Kenji Endo, Toru Fujiyoshi, Takayuki Furuya, Takeo Hayashi, Hiroyuki Higashikawa, Akiro Hiyama, Akihiko Horii, Chiaki Iimoto, Seiji Iizuka, Yoichi Ikuma, Hisanori Imagama, Shiro Inokuchi, Koichi Inoue, Hirokazu Inoue, Tomoo Ishii, Keisuke Ishii, Masayoshi Ito, Takui Itoi, Akira Iwamoto, Kohei Iwasaki, Motoki Kaito, Takashi Kato, Tsuyoshi Katoh, Hiroyuki Kawaguchi, Yoshiharu Kawano, Osamu Kimura, Atsushi Kobayashi, Kazuyoshi Koda, Masao Komatsu, Miki Kumagai, Gentaro Maeda, Takeshi Makino, Takahiro Mannoji, Chikato Masuda, Kazuhiro Masuda, Keisuke Matsumoto, Koji Matsumoto, Morio Matsunaga, Shunji Matsuyama, Yukihiro Mieda, Tokue Miyoshi, Kota Mochida, Joji Moridaira, Hiroshi Motegi, Hiroyuki Nakagawa, Yukihiro Nohara, Yutaka Oae, Kazunori Ogawa, Shinji Okazaki, Rentaro Okuda, Akinori Onishi, Eijiro Ono, Atsushi Oshima, Masashi Oshita, Yusuke Saita, Kazuo Sasao, Yutaka Sato, Kimiaki Sawakami, Kimihiko Seichi, Atsushi Seki, Shoji Shigematsu, Hideki Suda, Kota Takagi, Yasutaka Takahashi, Masahito Takahashi, Ryosuke Takasawa, Eiji Takenaka, Shota Takeshita, Katsushi Takeshita, Yujiro Tokioka, Takamitsu Tokuhashi, Yasuaki Tonosu, Juichi Uei, Hiroshi Wada, Kanichiro Watanabe, Masahiko Yahata, Tadashi Yamada, Kei Yasuda, Taketoshi Yasui, Keigo Yoshii, Toshitaka |
author_facet | Chikuda, Hirotaka Koyama, Yurie Matsubayashi, Yoshitaka Ogata, Toru Ohtsu, Hiroshi Sugita, Shurei Sumitani, Masahiko Kadono, Yuho Miura, Toshiki Tanaka, Sakae Akiyama, Toru Ando, Kei Anno, Masato Azuma, Seiichi Endo, Kenji Endo, Toru Fujiyoshi, Takayuki Furuya, Takeo Hayashi, Hiroyuki Higashikawa, Akiro Hiyama, Akihiko Horii, Chiaki Iimoto, Seiji Iizuka, Yoichi Ikuma, Hisanori Imagama, Shiro Inokuchi, Koichi Inoue, Hirokazu Inoue, Tomoo Ishii, Keisuke Ishii, Masayoshi Ito, Takui Itoi, Akira Iwamoto, Kohei Iwasaki, Motoki Kaito, Takashi Kato, Tsuyoshi Katoh, Hiroyuki Kawaguchi, Yoshiharu Kawano, Osamu Kimura, Atsushi Kobayashi, Kazuyoshi Koda, Masao Komatsu, Miki Kumagai, Gentaro Maeda, Takeshi Makino, Takahiro Mannoji, Chikato Masuda, Kazuhiro Masuda, Keisuke Matsumoto, Koji Matsumoto, Morio Matsunaga, Shunji Matsuyama, Yukihiro Mieda, Tokue Miyoshi, Kota Mochida, Joji Moridaira, Hiroshi Motegi, Hiroyuki Nakagawa, Yukihiro Nohara, Yutaka Oae, Kazunori Ogawa, Shinji Okazaki, Rentaro Okuda, Akinori Onishi, Eijiro Ono, Atsushi Oshima, Masashi Oshita, Yusuke Saita, Kazuo Sasao, Yutaka Sato, Kimiaki Sawakami, Kimihiko Seichi, Atsushi Seki, Shoji Shigematsu, Hideki Suda, Kota Takagi, Yasutaka Takahashi, Masahito Takahashi, Ryosuke Takasawa, Eiji Takenaka, Shota Takeshita, Katsushi Takeshita, Yujiro Tokioka, Takamitsu Tokuhashi, Yasuaki Tonosu, Juichi Uei, Hiroshi Wada, Kanichiro Watanabe, Masahiko Yahata, Tadashi Yamada, Kei Yasuda, Taketoshi Yasui, Keigo Yoshii, Toshitaka |
collection | PubMed |
description | IMPORTANCE: The optimal management for acute traumatic cervical spinal cord injury (SCI) is unknown. OBJECTIVE: To determine whether early surgical decompression results in better motor recovery than delayed surgical treatment in patients with acute traumatic incomplete cervical SCI associated with preexisting canal stenosis but without bone injury. DESIGN, SETTING, AND PARTICIPANTS: This multicenter randomized clinical trial was conducted in 43 tertiary referral centers in Japan from December 2011 through November 2019. Patients aged 20 to 79 years with motor-incomplete cervical SCI with preexisting canal stenosis (American Spinal Injury Association [ASIA] Impairment Scale C; without fracture or dislocation) were included. Data were analyzed from September to November 2020. INTERVENTIONS: Patients were randomized to undergo surgical treatment within 24 hours after admission or delayed surgical treatment after at least 2 weeks of conservative treatment. MAIN OUTCOMES AND MEASURES: The primary end points were improvement in the mean ASIA motor score, total score of the spinal cord independence measure, and the proportion of patients able to walk independently at 1 year after injury. RESULTS: Among 72 randomized patients, 70 patients (mean [SD] age, 65.1 [9.4] years; age range, 41-79 years; 5 [7%] women and 65 [93%] men) were included in the full analysis population (37 patients assigned to early surgical treatment and 33 patients assigned to delayed surgical treatment). Of these, 56 patients (80%) had data available for at least 1 primary outcome at 1 year. There was no significant difference among primary end points for the early surgical treatment group compared with the delayed surgical treatment group (mean [SD] change in ASIA motor score, 53.7 [14.7] vs 48.5 [19.1]; difference, 5.2; 95% CI, −4.2 to 14.5; P = .27; mean [SD] SCIM total score, 77.9 [22.7] vs 71.3 [27.3]; P = .34; able to walk independently, 21 of 30 patients [70.0%] vs 16 of 26 patients [61.5%]; P = .51). A mixed-design analysis of variance revealed a significant difference in the mean change in ASIA motor scores between the groups (F(1,49) = 4.80; P = .03). The early surgical treatment group, compared with the delayed surgical treatment group, had greater motor scores than the delayed surgical treatment group at 2 weeks (mean [SD] score, 34.2 [18.8] vs 18.9 [20.9]), 3 months (mean [SD] score, 49.1 [15.1] vs 37.2 [20.9]), and 6 months (mean [SD] score, 51.5 [13.9] vs 41.3 [23.4]) after injury. Adverse events were common in both groups (eg, worsening of paralysis, 6 patients vs 6 patients; death, 3 patients vs 3 patients). CONCLUSIONS AND RELEVANCE: These findings suggest that among patients with cervical SCI, early surgical treatment produced similar motor regain at 1 year after injury as delayed surgical treatment but showed accelerated recovery within the first 6 months. These exploratory results suggest that early surgical treatment leads to faster neurological recovery, which requires further validation. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01485458; umin.ac.jp/ctr Identifier: UMIN000006780 |
format | Online Article Text |
id | pubmed-8579238 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | American Medical Association |
record_format | MEDLINE/PubMed |
spelling | pubmed-85792382021-11-23 Effect of Early vs Delayed Surgical Treatment on Motor Recovery in Incomplete Cervical Spinal Cord Injury With Preexisting Cervical Stenosis: A Randomized Clinical Trial Chikuda, Hirotaka Koyama, Yurie Matsubayashi, Yoshitaka Ogata, Toru Ohtsu, Hiroshi Sugita, Shurei Sumitani, Masahiko Kadono, Yuho Miura, Toshiki Tanaka, Sakae Akiyama, Toru Ando, Kei Anno, Masato Azuma, Seiichi Endo, Kenji Endo, Toru Fujiyoshi, Takayuki Furuya, Takeo Hayashi, Hiroyuki Higashikawa, Akiro Hiyama, Akihiko Horii, Chiaki Iimoto, Seiji Iizuka, Yoichi Ikuma, Hisanori Imagama, Shiro Inokuchi, Koichi Inoue, Hirokazu Inoue, Tomoo Ishii, Keisuke Ishii, Masayoshi Ito, Takui Itoi, Akira Iwamoto, Kohei Iwasaki, Motoki Kaito, Takashi Kato, Tsuyoshi Katoh, Hiroyuki Kawaguchi, Yoshiharu Kawano, Osamu Kimura, Atsushi Kobayashi, Kazuyoshi Koda, Masao Komatsu, Miki Kumagai, Gentaro Maeda, Takeshi Makino, Takahiro Mannoji, Chikato Masuda, Kazuhiro Masuda, Keisuke Matsumoto, Koji Matsumoto, Morio Matsunaga, Shunji Matsuyama, Yukihiro Mieda, Tokue Miyoshi, Kota Mochida, Joji Moridaira, Hiroshi Motegi, Hiroyuki Nakagawa, Yukihiro Nohara, Yutaka Oae, Kazunori Ogawa, Shinji Okazaki, Rentaro Okuda, Akinori Onishi, Eijiro Ono, Atsushi Oshima, Masashi Oshita, Yusuke Saita, Kazuo Sasao, Yutaka Sato, Kimiaki Sawakami, Kimihiko Seichi, Atsushi Seki, Shoji Shigematsu, Hideki Suda, Kota Takagi, Yasutaka Takahashi, Masahito Takahashi, Ryosuke Takasawa, Eiji Takenaka, Shota Takeshita, Katsushi Takeshita, Yujiro Tokioka, Takamitsu Tokuhashi, Yasuaki Tonosu, Juichi Uei, Hiroshi Wada, Kanichiro Watanabe, Masahiko Yahata, Tadashi Yamada, Kei Yasuda, Taketoshi Yasui, Keigo Yoshii, Toshitaka JAMA Netw Open Original Investigation IMPORTANCE: The optimal management for acute traumatic cervical spinal cord injury (SCI) is unknown. OBJECTIVE: To determine whether early surgical decompression results in better motor recovery than delayed surgical treatment in patients with acute traumatic incomplete cervical SCI associated with preexisting canal stenosis but without bone injury. DESIGN, SETTING, AND PARTICIPANTS: This multicenter randomized clinical trial was conducted in 43 tertiary referral centers in Japan from December 2011 through November 2019. Patients aged 20 to 79 years with motor-incomplete cervical SCI with preexisting canal stenosis (American Spinal Injury Association [ASIA] Impairment Scale C; without fracture or dislocation) were included. Data were analyzed from September to November 2020. INTERVENTIONS: Patients were randomized to undergo surgical treatment within 24 hours after admission or delayed surgical treatment after at least 2 weeks of conservative treatment. MAIN OUTCOMES AND MEASURES: The primary end points were improvement in the mean ASIA motor score, total score of the spinal cord independence measure, and the proportion of patients able to walk independently at 1 year after injury. RESULTS: Among 72 randomized patients, 70 patients (mean [SD] age, 65.1 [9.4] years; age range, 41-79 years; 5 [7%] women and 65 [93%] men) were included in the full analysis population (37 patients assigned to early surgical treatment and 33 patients assigned to delayed surgical treatment). Of these, 56 patients (80%) had data available for at least 1 primary outcome at 1 year. There was no significant difference among primary end points for the early surgical treatment group compared with the delayed surgical treatment group (mean [SD] change in ASIA motor score, 53.7 [14.7] vs 48.5 [19.1]; difference, 5.2; 95% CI, −4.2 to 14.5; P = .27; mean [SD] SCIM total score, 77.9 [22.7] vs 71.3 [27.3]; P = .34; able to walk independently, 21 of 30 patients [70.0%] vs 16 of 26 patients [61.5%]; P = .51). A mixed-design analysis of variance revealed a significant difference in the mean change in ASIA motor scores between the groups (F(1,49) = 4.80; P = .03). The early surgical treatment group, compared with the delayed surgical treatment group, had greater motor scores than the delayed surgical treatment group at 2 weeks (mean [SD] score, 34.2 [18.8] vs 18.9 [20.9]), 3 months (mean [SD] score, 49.1 [15.1] vs 37.2 [20.9]), and 6 months (mean [SD] score, 51.5 [13.9] vs 41.3 [23.4]) after injury. Adverse events were common in both groups (eg, worsening of paralysis, 6 patients vs 6 patients; death, 3 patients vs 3 patients). CONCLUSIONS AND RELEVANCE: These findings suggest that among patients with cervical SCI, early surgical treatment produced similar motor regain at 1 year after injury as delayed surgical treatment but showed accelerated recovery within the first 6 months. These exploratory results suggest that early surgical treatment leads to faster neurological recovery, which requires further validation. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01485458; umin.ac.jp/ctr Identifier: UMIN000006780 American Medical Association 2021-11-09 /pmc/articles/PMC8579238/ /pubmed/34751757 http://dx.doi.org/10.1001/jamanetworkopen.2021.33604 Text en Copyright 2021 The OSCIS investigators. JAMA Network Open. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the CC-BY License. |
spellingShingle | Original Investigation Chikuda, Hirotaka Koyama, Yurie Matsubayashi, Yoshitaka Ogata, Toru Ohtsu, Hiroshi Sugita, Shurei Sumitani, Masahiko Kadono, Yuho Miura, Toshiki Tanaka, Sakae Akiyama, Toru Ando, Kei Anno, Masato Azuma, Seiichi Endo, Kenji Endo, Toru Fujiyoshi, Takayuki Furuya, Takeo Hayashi, Hiroyuki Higashikawa, Akiro Hiyama, Akihiko Horii, Chiaki Iimoto, Seiji Iizuka, Yoichi Ikuma, Hisanori Imagama, Shiro Inokuchi, Koichi Inoue, Hirokazu Inoue, Tomoo Ishii, Keisuke Ishii, Masayoshi Ito, Takui Itoi, Akira Iwamoto, Kohei Iwasaki, Motoki Kaito, Takashi Kato, Tsuyoshi Katoh, Hiroyuki Kawaguchi, Yoshiharu Kawano, Osamu Kimura, Atsushi Kobayashi, Kazuyoshi Koda, Masao Komatsu, Miki Kumagai, Gentaro Maeda, Takeshi Makino, Takahiro Mannoji, Chikato Masuda, Kazuhiro Masuda, Keisuke Matsumoto, Koji Matsumoto, Morio Matsunaga, Shunji Matsuyama, Yukihiro Mieda, Tokue Miyoshi, Kota Mochida, Joji Moridaira, Hiroshi Motegi, Hiroyuki Nakagawa, Yukihiro Nohara, Yutaka Oae, Kazunori Ogawa, Shinji Okazaki, Rentaro Okuda, Akinori Onishi, Eijiro Ono, Atsushi Oshima, Masashi Oshita, Yusuke Saita, Kazuo Sasao, Yutaka Sato, Kimiaki Sawakami, Kimihiko Seichi, Atsushi Seki, Shoji Shigematsu, Hideki Suda, Kota Takagi, Yasutaka Takahashi, Masahito Takahashi, Ryosuke Takasawa, Eiji Takenaka, Shota Takeshita, Katsushi Takeshita, Yujiro Tokioka, Takamitsu Tokuhashi, Yasuaki Tonosu, Juichi Uei, Hiroshi Wada, Kanichiro Watanabe, Masahiko Yahata, Tadashi Yamada, Kei Yasuda, Taketoshi Yasui, Keigo Yoshii, Toshitaka Effect of Early vs Delayed Surgical Treatment on Motor Recovery in Incomplete Cervical Spinal Cord Injury With Preexisting Cervical Stenosis: A Randomized Clinical Trial |
title | Effect of Early vs Delayed Surgical Treatment on Motor Recovery in Incomplete Cervical Spinal Cord Injury With Preexisting Cervical Stenosis: A Randomized Clinical Trial |
title_full | Effect of Early vs Delayed Surgical Treatment on Motor Recovery in Incomplete Cervical Spinal Cord Injury With Preexisting Cervical Stenosis: A Randomized Clinical Trial |
title_fullStr | Effect of Early vs Delayed Surgical Treatment on Motor Recovery in Incomplete Cervical Spinal Cord Injury With Preexisting Cervical Stenosis: A Randomized Clinical Trial |
title_full_unstemmed | Effect of Early vs Delayed Surgical Treatment on Motor Recovery in Incomplete Cervical Spinal Cord Injury With Preexisting Cervical Stenosis: A Randomized Clinical Trial |
title_short | Effect of Early vs Delayed Surgical Treatment on Motor Recovery in Incomplete Cervical Spinal Cord Injury With Preexisting Cervical Stenosis: A Randomized Clinical Trial |
title_sort | effect of early vs delayed surgical treatment on motor recovery in incomplete cervical spinal cord injury with preexisting cervical stenosis: a randomized clinical trial |
topic | Original Investigation |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8579238/ https://www.ncbi.nlm.nih.gov/pubmed/34751757 http://dx.doi.org/10.1001/jamanetworkopen.2021.33604 |
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effectofearlyvsdelayedsurgicaltreatmentonmotorrecoveryinincompletecervicalspinalcordinjurywithpreexistingcervicalstenosisarandomizedclinicaltrial AT sawakamikimihiko effectofearlyvsdelayedsurgicaltreatmentonmotorrecoveryinincompletecervicalspinalcordinjurywithpreexistingcervicalstenosisarandomizedclinicaltrial AT seichiatsushi effectofearlyvsdelayedsurgicaltreatmentonmotorrecoveryinincompletecervicalspinalcordinjurywithpreexistingcervicalstenosisarandomizedclinicaltrial AT sekishoji effectofearlyvsdelayedsurgicaltreatmentonmotorrecoveryinincompletecervicalspinalcordinjurywithpreexistingcervicalstenosisarandomizedclinicaltrial AT shigematsuhideki effectofearlyvsdelayedsurgicaltreatmentonmotorrecoveryinincompletecervicalspinalcordinjurywithpreexistingcervicalstenosisarandomizedclinicaltrial AT sudakota effectofearlyvsdelayedsurgicaltreatmentonmotorrecoveryinincompletecervicalspinalcordinjurywithpreexistingcervicalstenosisarandomizedclinicaltrial AT takagiyasutaka effectofearlyvsdelayedsurgicaltreatmentonmotorrecoveryinincompletecervicalspinalcordinjurywithpreexistingcervicalstenosisarandomizedclinicaltrial AT takahashimasahito effectofearlyvsdelayedsurgicaltreatmentonmotorrecoveryinincompletecervicalspinalcordinjurywithpreexistingcervicalstenosisarandomizedclinicaltrial AT takahashiryosuke effectofearlyvsdelayedsurgicaltreatmentonmotorrecoveryinincompletecervicalspinalcordinjurywithpreexistingcervicalstenosisarandomizedclinicaltrial AT takasawaeiji effectofearlyvsdelayedsurgicaltreatmentonmotorrecoveryinincompletecervicalspinalcordinjurywithpreexistingcervicalstenosisarandomizedclinicaltrial AT takenakashota effectofearlyvsdelayedsurgicaltreatmentonmotorrecoveryinincompletecervicalspinalcordinjurywithpreexistingcervicalstenosisarandomizedclinicaltrial AT takeshitakatsushi effectofearlyvsdelayedsurgicaltreatmentonmotorrecoveryinincompletecervicalspinalcordinjurywithpreexistingcervicalstenosisarandomizedclinicaltrial AT takeshitayujiro effectofearlyvsdelayedsurgicaltreatmentonmotorrecoveryinincompletecervicalspinalcordinjurywithpreexistingcervicalstenosisarandomizedclinicaltrial AT tokiokatakamitsu effectofearlyvsdelayedsurgicaltreatmentonmotorrecoveryinincompletecervicalspinalcordinjurywithpreexistingcervicalstenosisarandomizedclinicaltrial AT tokuhashiyasuaki effectofearlyvsdelayedsurgicaltreatmentonmotorrecoveryinincompletecervicalspinalcordinjurywithpreexistingcervicalstenosisarandomizedclinicaltrial AT tonosujuichi effectofearlyvsdelayedsurgicaltreatmentonmotorrecoveryinincompletecervicalspinalcordinjurywithpreexistingcervicalstenosisarandomizedclinicaltrial AT ueihiroshi effectofearlyvsdelayedsurgicaltreatmentonmotorrecoveryinincompletecervicalspinalcordinjurywithpreexistingcervicalstenosisarandomizedclinicaltrial AT wadakanichiro effectofearlyvsdelayedsurgicaltreatmentonmotorrecoveryinincompletecervicalspinalcordinjurywithpreexistingcervicalstenosisarandomizedclinicaltrial AT watanabemasahiko effectofearlyvsdelayedsurgicaltreatmentonmotorrecoveryinincompletecervicalspinalcordinjurywithpreexistingcervicalstenosisarandomizedclinicaltrial AT yahatatadashi effectofearlyvsdelayedsurgicaltreatmentonmotorrecoveryinincompletecervicalspinalcordinjurywithpreexistingcervicalstenosisarandomizedclinicaltrial AT yamadakei effectofearlyvsdelayedsurgicaltreatmentonmotorrecoveryinincompletecervicalspinalcordinjurywithpreexistingcervicalstenosisarandomizedclinicaltrial AT yasudataketoshi effectofearlyvsdelayedsurgicaltreatmentonmotorrecoveryinincompletecervicalspinalcordinjurywithpreexistingcervicalstenosisarandomizedclinicaltrial AT yasuikeigo effectofearlyvsdelayedsurgicaltreatmentonmotorrecoveryinincompletecervicalspinalcordinjurywithpreexistingcervicalstenosisarandomizedclinicaltrial AT yoshiitoshitaka effectofearlyvsdelayedsurgicaltreatmentonmotorrecoveryinincompletecervicalspinalcordinjurywithpreexistingcervicalstenosisarandomizedclinicaltrial |