Please wait a minute...
Journal of Neurorestoratology  2018, Vol. 6 Issue (1): 165-170    doi: 10.26599/JNR.2018.9040016
Clinical Trial Design     
Multicenter, randomized, double-blind placebo-control intramedullary decompression for acute complete spinal cord contusion injury
Lin Chen1, Yaping Feng2, Yuqi Zhang1,(✉), Hongyun Huang3,4,(✉), Xiaodong Guo5
1 Department of Neurorestoratology, Neurosurgery Center, Tsinghua University Yuquan Hospital, Beijing, China
2 Department of Neurosurgery, the 920th Hospital of the PLA Joint Logistics Support Force, Kunming, China
3 Institute of Neurorestoratology, General Hospital of Chinese People’s Armed Police Forces, Beijing, China
4 Beijing Hongtianji Neuroscience Academy, Beijing, China
5 Department of Orthopaedics, Union Hospital, Tongji Medical College, Huazhong University of Science & Technology, China
Download: PDF (641 KB)      HTML
Export: BibTeX | EndNote (RIS)      

Abstract  Introduction:

Spinal cord injury is one of the main causes of severe neurological trauma and disability. Intramedullary decompression of acute spinal cord contusion in acute phase is one of the important therapeutic exploration methods. Due to the lack of multicenter, randomized, double-blind, placebo-controlled clinical studies, true effect of this treatment remains controversial.

Objective of the study:

This design of the study is to explore the safety and neurorestorative effects of intramedullary decompression for acute complete spinal cord contusion injury.

Design of the study:

We design the prospective, multicenter, randomized, double- blind placebo-controlled trial (MRDPT) for acute (less than 24 hours after injury) spinal cord contusion injury. Sixty patients with acute complete spinal cord contusion injury (20 in cervical 4 to thoracic 1, 20 in thoracic 2 to thoracic 9, and 20 in thoracic 10 to lumbar vertebra 1) are selected according to the selected conditions. All patients receive conventional treatments such as reduction and fixation of spinal fractures and/or spinal spondylolisthesis, bone external decompression relieves spinal cord compression. At the same time, group A (n = 30, 10 of each segment group) undergoes intramedullary decompression surgery and group B (n = 30) does not undergo intramedullary decompression. All relevant functional changes before, after, and during the follow-up period are recorded to ensure objective evaluation of the results of the treatment.

Ethics and dissemination:

The clinical study protocol and consent form were approved by China Branch of International Association of Neurorestoratology and the ethics committees of the hospitals which join this trial. Registration No. of this study is ChiCTR1800020458. Findings will be published in peer-reviewed journals.

Key wordsintramedullary decompression surgery      complete acute spinal cord contusion injury      protocol      multicenter      RCT clinical trial     
Received: 15 November 2018      Published: 30 December 2018
Corresponding Authors: Yuqi Zhang,Hongyun Huang   
Cite this article:

Lin Chen, Yaping Feng, Yuqi Zhang, Hongyun Huang, Xiaodong Guo. Multicenter, randomized, double-blind placebo-control intramedullary decompression for acute complete spinal cord contusion injury. Journal of Neurorestoratology, 2018, 6: 165-170.

URL:     OR

[1]   Eckert MJ, Martin MJ. Trauma: Spinal cord injury. Surg Clin North Am. 2017, 97(5): 1031-1045.
[2]   Kumar R, Lim J, Mekary RA, et al. Traumatic spinal injury: Global epidemiology and worldwide volume. World Neurosurg. 2018, 113: e345-e363.
[3]   Gazdic M, Volarevic V, Harrell CR, et al. Stem cells therapy for spinal cord injury. Int J Mol Sci. 2018, 19(4): E1039.
[4]   Huang H, Young W, Chen L, et al. Clinical cell therapy guidelines for neurorestoration (IANR/CANR 2017). Cell Transplant. 2018, 27(2): 310-324.
[5]   Fox IK, Miller AK, Curtin CM. Nerve and tendon transfer surgery in cervical spinal cord injury: individualized choices to optimize function. Top Spinal Cord Inj Rehabil. 2018, 24(3): 275-287.
[6]   Yozbatiran N, Keser Z, Davis M, et al. Transcranial direct current stimulation (tDCS) of the primary motor cortex and robot-assisted arm training in chronic incomplete cervical spinal cord injury: A proof of concept sham-randomized clinical study. Neuro Rehabilitation. 2016, 39(3): 401-411
[7]   Ajiboye AB, Willett FR, Young DR, et al. Restoration of reaching and grasping movements through brain-controlled muscle stimulation in a person with tetraplegia: a proof-of- concept demonstration. Lancet. 2017, 389(10081): 1821-1830.
[8]   Lebedev MA, Nicolelis MA. Brain-machine interfaces: from basic science to neuroprostheses and neurorehabilitation. Physiol Rev. 2017, 97(2): 767-837.
[9]   Galanda M, Nádvorník P, Fr?hlich J. Surgical treatment of spasticity in spinal cord injuries (critical comments on longitudinal myelotomy). Bratisl Lek Listy. 1974, 61(5): 589-594.
[10]   Yamada S, Perot PL Jr, Ducker TB, et al. Myelotomy for control of mass spasms in paraplegia. J Neurosurg. 1976, 45(6): 683-691.
[11]   Borovich B, Peyser E, Gruskiewicz J. Acute central and intermediate cervical cord injury. Neurochirurgia (Stuttg). 1978, 21(3): 77-84.
[12]   Wu G, Zhao L. Field Surgery. Shanghai Scientific and Technologic Press, 1981.
[13]   Tachibana S, Okada K, Ohwada T, et al. Posterior longitudinal myelotomy as a surgical treatment of acute cervical spinal cord injury. No Shinkei Geka. 1984, 12(2): 183-188.
[14]   Koyanagi I, Iwasaki Y, Isu T, et al. Myelotomy for acute cervical cord injury. Report of four cases. Neurol Med Chir (Tokyo). 1989, 29(4): 302-306.
[15]   Cao XJ, Feng SQ, Fu CF, et al. Repair, protection and regeneration of spinal cord injury. Neural Regeneration Research 2015, 10(12): 1953-1975.
[16]   Qu YZ, Luo Z, Guo XD, et al. The durotomy or myelotomy for the spinal cord extensive swelling with/without intramedullary hemorrhage. Chinese Journal of Orthopaedics 2015, 35(7): 707-713.
[17]   Zhu H, Feng YP, Young W, et al. Early neurosurgical intervention of spinal cord contusion: an analysis of 30 cases. Chin Med J (Engl). 2008, 121(24): 2473-2478.
[18]   Kim M, Hong SK, Jeon SR, et al. Early (≤ 48 Hours) versus Late (>48 Hours) surgery in spinal cord injury: Treatment outcomes and risk factors for spinal cord injury. World Neurosurg. 2018, 118: e513-e525.
[19]   Sewell MD, Vachhani K, Alrawi A, et al. Results of early and late surgical decompression and stabilization for acute traumatic cervical spinal cord injury in patients with concomitant chest injuries. World Neurosurg. 2018, 118: e161-e165.
[20]   Ahuja CS, Schroeder GD, Vaccaro AR, et al. Spinal cord injury-what are the controversies? J Orthop Trauma. 2017, 31(): S7-S13.
[21]   Tykocki T, Poniatowski ?, Czy? M, et al. Intraspinal pressure monitoring and extensive duroplasty in the acute phase of traumatic spinal cord injury: A systematic review. World Neurosurg. 2017, 105: 145-152.
[22]   Huang H, Sun T, Chen L, et al. Consensus of clinical neurorestorative progresses in patients with complete chronic spinal cord injury. Cell Transplant. 2014, 23: S1-13.
[23]   Feng Y, Sun T, Chen L, et al. Clinical therapeutic guideline for neurorestoration in spinal cord injury (Chinese version 2016). J Neurorestoratology 2017, 5: 73-83.
No related articles found!