Kazuyoshi Kobayashi, Yuho Kadono, Hiroshi Uei, Takeo Furuya, Chiaki Horii, Yasuaki Tokuhashi, Yurie Koyama, Yukihiro Matsuyama, Akinori Okuda, Koichi Inokuchi, Toru Akiyama, Osamu Kawano, Chikato Mannoji, Tokue Mieda, Masato Anno, Masashi Oshima, Koji Matsumoto, Ryosuke Takahashi, Shota Takenaka, Atsushi Ono, Hiroshi Moridaira, Keisuke Ishii, Katsushi Takeshita, Akihiko Hiyama, Hirokazu Inoue, Tomoo Inoue, Yasutaka Takagi, Takamitsu Tokioka, Shurei Sugita, Taketoshi Yasuda, Tadashi Yahata, Kei Ando, Hiroyuki Hayashi, Kota Miyoshi, Eiji Takasawa, Shinji Ogawa, Takeshi Maeda, Yoshitaka Matsubayashi, Takui Ito, Hiroyuki Motegi, Kimihiko Sawakami, Tsuyoshi Kato, Morio Matsumoto, Motoki Iwasaki, Sakae Tanaka, Takayuki Fujiyoshi, Seiji Iimoto, Yusuke Oshita, Yukihiro Nakagawa, Juichi Tonosu, Masahiko Watanabe, Masao Koda, Seiichi Azuma, Shoji Seki, Yutaka Nohara, Yujiro Takeshita, Masahito Takahashi, Kota Suda, Hideki Shigematsu, Kimiaki Sato, Keisuke Masuda, Miki Komatsu, Takashi Kaito, Hirotaka Chikuda, Keigo Yasui, Yoshiharu Kawaguchi, Kenji Endo, Akiro Higashikawa, Hisanori Ikuma, Akira Itoi, Kanichiro Wada, Kazunori Oae, Masayoshi Ishii, Atsushi Kimura, Atsushi Seichi, Takahiro Makino, Hiroshi Ohtsu, Joji Mochida, Toshitaka Yoshii, Rentaro Okazaki, Toru Endo, Kazuo Saita, Shiro Imagama, Eijiro Onishi, Kei Yamada, Kohei Iwamoto, Toru Ogata, Yutaka Sasao, Hiroyuki Katoh, Masahiko Sumitani, Toshiki Miura, Kazuhiro Masuda, Shunji Matsunaga, Yoichi Iizuka, and Gentaro Kumagai
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