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

被引:69
作者
Chikuda, Hirotaka [1 ]
Koyama, Yurie [2 ]
Matsubayashi, Yoshitaka [3 ]
Ogata, Toru [4 ]
Ohtsu, Hiroshi [5 ]
Sugita, Shurei [6 ]
Sumitani, Masahiko [7 ]
Kadono, Yuho [8 ]
Miura, Toshiki [9 ]
Tanaka, Sakae [3 ]
Akiyama, Toru [10 ]
Ando, Kei [11 ]
Anno, Masato [12 ]
Azuma, Seiichi [13 ]
Endo, Kenji [14 ]
Endo, Toru [15 ]
Fujiyoshi, Takayuki [16 ]
Furuya, Takeo [17 ]
Hayashi, Hiroyuki [18 ]
Higashikawa, Akiro [19 ]
Hiyama, Akihiko [20 ]
Horii, Chiaki [12 ]
Iimoto, Seiji [21 ]
Iizuka, Yoichi [1 ]
Ikuma, Hisanori [22 ]
Imagama, Shiro [11 ]
Inokuchi, Koichi [23 ]
Inoue, Hirokazu
Inoue, Tomoo [22 ,24 ]
Ishii, Keisuke [12 ,25 ]
Ishii, Masayoshi
Ito, Takui [26 ]
Itoi, Akira [27 ]
Iwamoto, Kohei [22 ]
Iwasaki, Motoki [28 ]
Kaito, Takashi [29 ]
Kato, Tsuyoshi [30 ]
Katoh, Hiroyuki [20 ]
Kawaguchi, Yoshiharu [31 ]
Kawano, Osamu [32 ]
Kimura, Atsushi [24 ]
Kobayashi, Kazuyoshi [11 ]
Koda, Masao [17 ]
Komatsu, Miki [21 ]
Kumagai, Gentaro [33 ]
Maeda, Takeshi [32 ]
Makino, Takahiro [29 ]
Mannoji, Chikato [34 ]
Masuda, Kazuhiro [35 ]
Masuda, Keisuke [36 ]
机构
[1] Gunma Univ, Dept Orthopaed Surg, 3-39-22 Showa Machi, Maebashi, Gunma 3718511, Japan
[2] Kitasato Univ, Sch Nursing, Sagamihara, Kanagawa, Japan
[3] Univ Tokyo, Dept Orthopaed Surg, Tokyo, Japan
[4] Univ Tokyo, Dept Rehabil Med, Tokyo, Japan
[5] Natl Ctr Global Hlth & Med, Tokyo, Japan
[6] Komagome Hosp, TokyoMetropolitan Canc & Infect Dis Ctr, Tokyo, Japan
[7] Univ Tokyo Hosp, Dept Pain & Palliat Med, Tokyo, Japan
[8] Saitama Med Univ, Moroyama, Saitama, Japan
[9] JR Tokyo Gen Hosp, Tokyo, Japan
[10] Jichi Med Univ, Saitama Med Ctr, Saitama, Japan
[11] Nagoya Univ Hosp, Nagoya, Aichi, Japan
[12] Tokyo Metropolitan Bokutoh Hosp, Tokyo, Japan
[13] Japanese Red Cross Saitama Hosp, Saitama, Japan
[14] Tokyo Med Univ, Tokyo, Japan
[15] Wakayama Med Univ Hosp, Wakayama, Japan
[16] Kimitsu Chuo Hosp, Kisarazu, Japan
[17] Chiba Univ Hosp, Chiba, Japan
[18] Tonami Gen Hosp, Tonami, Toyama, Japan
[19] Kanto Rosai Hosp, Kawasaki, Kanagawa, Japan
[20] Tokai Univ Hosp, Isehara, Kanagawa, Japan
[21] Hokkaido Spinal Cord Injury Ctr, Bibai, Hokkaido, Japan
[22] Kagawa Prefectural Cent Hosp, Takamatsu, Kagawa, Japan
[23] Saitama Med Univ, Saitama Med Ctr, Kawagoe, Saitama, Japan
[24] Jichi Med Univ Hosp, Shimotsuke, Tochigi, Japan
[25] Kansai Rosai Hosp, Amagasaki, Hyogo, Japan
[26] Niigata City Gen Hosp, Niigata, Japan
[27] Juntendo Univ, Shizuoka Hosp, Izunokuni, Japan
[28] Osaka Rosai Hosp, Sakai, Osaka, Japan
[29] Osaka Univ Hosp, Suita, Osaka, Japan
[30] Tokyo Med & Dent Univ Hosp, Tokyo, Japan
[31] Toyama Univ Hosp, Toyama, Japan
[32] Spinal Injuries Ctr, Iizuka, Fukuoka, Japan
[33] Hirosaki Univ Hosp, Hirosaki, Aomori, Japan
[34] Chiba Aoba Municipal Hosp, Chiba, Japan
[35] Tokyo Metropolitan Tama Med Ctr, Tokyo, Japan
[36] Nara Med Univ Hosp, Kashihara, Nara, Japan
[37] Nihon Univ Itabashi Hosp, Tokyo, Japan
[38] Keio Univ Hosp, Tokyo, Japan
[39] Imakiire Gen Hosp, Kagoshima, Japan
[40] Hamamatsu Univ Hosp, Hamamatsu, Shizuoka, Japan
[41] Yokohama Rosai Hosp, Yokohama, Kanagawa, Japan
[42] Dokkyo Med Univ Hosp, Mibu, Tochigi, Japan
[43] Sendai Med Ctr, Sendai, Miyagi, Japan
[44] Kurashiki Cent Hosp, Kurashiki, Okayama, Japan
[45] Showa Univ, Northern Yokohama Hosp, Yokohama, Kanagawa, Japan
[46] St Marianna Univ Hosp, Kawasaki, Kanagawa, Japan
[47] Kurume Univ Hosp, Kurume, Fukuoka, Japan
[48] Univ Tokyo, Dept Orthopaed Surg, Tokyo, Japan
[49] Kyorin Univ Hosp, Tokyo, Japan
[50] Kochi Hlth Sci Ctr, Kochi, Japan
关键词
ICCP PANEL; DECOMPRESSION; GUIDELINES; SURGERY; CONDUCT; CRITERIA;
D O I
10.1001/jamanetworkopen.2021.33604
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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,F-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.
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