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Randomized Controlled Trial
. 2021 Nov 1;4(11):e2133604.
doi: 10.1001/jamanetworkopen.2021.33604.

Effect of Early vs Delayed Surgical Treatment on Motor Recovery in Incomplete Cervical Spinal Cord Injury With Preexisting Cervical Stenosis: A Randomized Clinical Trial

OSCIS investigators; Hirotaka Chikuda  1 , Yurie Koyama  2 , Yoshitaka Matsubayashi  3 , Toru Ogata  4 , Hiroshi Ohtsu  5 , Shurei Sugita  6 , Masahiko Sumitani  7 , Yuho Kadono  8 , Toshiki Miura  9 , Sakae Tanaka  3 , Toru Akiyama  10 , Kei Ando  11 , Masato Anno  12 , Seiichi Azuma  13 , Kenji Endo  14 , Toru Endo  15 , Takayuki Fujiyoshi  16 , Takeo Furuya  17 , Hiroyuki Hayashi  18 , Akiro Higashikawa  19 , Akihiko Hiyama  20 , Chiaki Horii  12 , Seiji Iimoto  21 , Yoichi Iizuka  1 , Hisanori Ikuma  22 , Shiro Imagama  11 , Koichi Inokuchi  23 , Hirokazu Inoue  24 , Tomoo Inoue  22 , Keisuke Ishii  12 , Masayoshi Ishii  25 , Takui Ito  26 , Akira Itoi  27 , Kohei Iwamoto  22 , Motoki Iwasaki  28 , Takashi Kaito  29 , Tsuyoshi Kato  30 , Hiroyuki Katoh  20 , Yoshiharu Kawaguchi  31 , Osamu Kawano  32 , Atsushi Kimura  24 , Kazuyoshi Kobayashi  11 , Masao Koda  17 , Miki Komatsu  21 , Gentaro Kumagai  33 , Takeshi Maeda  32 , Takahiro Makino  29 , Chikato Mannoji  34 , Kazuhiro Masuda  35 , Keisuke Masuda  36 , Koji Matsumoto  37 , Morio Matsumoto  38 , Shunji Matsunaga  39 , Yukihiro Matsuyama  40 , Tokue Mieda  1 , Kota Miyoshi  41 , Joji Mochida  20 , Hiroshi Moridaira  42 , Hiroyuki Motegi  34 , Yukihiro Nakagawa  15 , Yutaka Nohara  42 , Kazunori Oae  23 , Shinji Ogawa  43 , Rentaro Okazaki  13 , Akinori Okuda  36 , Eijiro Onishi  44 , Atsushi Ono  33 , Masashi Oshima  37 , Yusuke Oshita  45 , Kazuo Saita  10 , Yutaka Sasao  46 , Kimiaki Sato  47 , Kimihiko Sawakami  26 , Atsushi Seichi  3 , Shoji Seki  31 , Hideki Shigematsu  36 , Kota Suda  21 , Yasutaka Takagi  18 , Masahito Takahashi  48 , Ryosuke Takahashi  27 , Eiji Takasawa  1 , Shota Takenaka  29 , Katsushi Takeshita  24 , Yujiro Takeshita  41 , Takamitsu Tokioka  49 , Yasuaki Tokuhashi  37 , Juichi Tonosu  19 , Hiroshi Uei  37 , Kanichiro Wada  33 , Masahiko Watanabe  20 , Tadashi Yahata  23 , Kei Yamada  47 , Taketoshi Yasuda  31 , Keigo Yasui  21 , Toshitaka Yoshii  30
Affiliations
Randomized Controlled Trial

Effect of Early vs Delayed Surgical Treatment on Motor Recovery in Incomplete Cervical Spinal Cord Injury With Preexisting Cervical Stenosis: A Randomized Clinical Trial

OSCIS investigators et al. JAMA Netw Open. .

Erratum in

  • Error in Figure 3.
    [No authors listed] [No authors listed] JAMA Netw Open. 2021 Dec 1;4(12):e2143306. doi: 10.1001/jamanetworkopen.2021.43306. JAMA Netw Open. 2021. PMID: 34910157 Free PMC article. No abstract available.

Abstract

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 (F1,49 = 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.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Matsubayashi reported receiving personal fees from Stryker outside the submitted work. Dr Ohtsu reported receiving personal fees from EPS International Consulting outside the submitted work. Dr Sumitani reported receiving grants from Shionogi & Co, Heartfelt, Nipro, and Pfizer; personal fees from Nippon Zoki Pharmaceutical, Daiichi-Sankyo, Mundipharma, Eisai MSD, and GlaxoSmithKline; and donations from Eisai and Fureasu outside the submitted work. Dr Katoh reported receiving grants from the Japanese Ministry of Health, Labour, and Welfare during the conduct of the study. Dr M. Matsumoto reported receiving grants from Nuvasive and Medtronic outside the submitted work. Dr Matsunaga reported receiving grants from the Japanese Ministry of Health, Labour, and Welfare during the conduct of the study. Dr Wada reported receiving grants from the Japanese Ministry of Health, Labour, and Welfare during the conduct of the study. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Enrollment and Randomization of Participants
Patients with any of the primary end points are presented as with data available. ASIA indicates American Spinal Injury Association.
Figure 2.
Figure 2.. Mean ASIA Motor Score During the Study Period, According to Treatment Group
ASIA indicates American Spinal Injury Association; error bars, 95% CIs.
Figure 3.
Figure 3.. Mean ASIA Motor Score During the Study Period, Among Patients With or Without Central Cord Syndrome
ASIA indicates American Spinal Injury Association; error bars, 95% CIs.
See this image and copyright information in PMC

References

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