Optimal treatment for Spinal Cord Injury associated with cervical canal Stenosis (OSCIS): a study protocol for a randomized controlled trial comparing early versus delayed surgery

Trials

Yoshiaki Toyama³  Morio Matsumoto³  Yurie Koyama⁴  Masahiko Sumitani⁵  Shurei Sugita⁴  Toru Ogata¹  Hiroshi Ohtsu²  Hirotaka Chikuda⁴ 

[1] Rehabilitation for the Movement Functions, Research Institute, National Rehabilitation Center for Persons with Disabilities, Saitama 359-8555, Japan;Department of Clinical Trial Data Management, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan;Department of Orthopaedic Surgery, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku, Tokyo 160-0016, Japan;Department of Orthopaedic Surgery, Faculty of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan;Department of Medical Engineering, Faculty of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan

关键词: Bone injury;    Spinal fracture;    Spondylosis;    Ossification of the posterior longitudinal ligament;    Canal stenosis;    Timing;    Surgery;    Spinal cord injury;   

Others  :  1093282
DOI  :  10.1186/1745-6215-14-245

 received in 2013-04-27, accepted in 2013-07-31,  发布年份 2013

【 摘 要 】

Background

The optimal management of acute cervical spinal cord injury (SCI) associated with preexisting canal stenosis remains to be established. The objective of this study is to examine whether early surgical decompression (within 24 hours after admission) would result in greater improvement in motor function compared with delayed surgery (later than two weeks) in cervical SCI patients presenting with canal stenosis, but without bony injury.

Methods/design

OSCIS is a randomized, controlled, parallel-group, assessor-blinded, multicenter trial. We will recruit 100 cervical SCI patients who are admitted within 48 hours of injury (aged 20 to 79 years; without fractures or dislocations; American Spinal Injury Association (ASIA) grade C; preexisting spinal canal stenosis). Patients will be enrolled from 36 participating hospitals across Japan and randomly allocated in a 1:1 ratio to either early surgical decompression (within 24 hours after admission) or delayed surgery following at least two weeks of conservative treatment. The primary outcomes include: 1) the change from baseline to one year in the ASIA motor score; 2) the total score of the Spinal Cord Independence Measure and 3) the proportion of patients who are able to walk without human assistance. The secondary outcomes are: 1) the health-related quality of life as measured by the Medical Outcomes Study Short Form 36 and the EuroQol 5 Dimension; 2) the Neuropathic Pain Symptom Inventory and 3) the walking status as evaluated with the Walking Index for Spinal Cord Injury II. The analysis will be on an intention-to-treat basis. The primary analysis will be a comparison of the primary and secondary outcomes one year after the injury.

Discussion

The results of this study will provide evidence of the potential benefit of early surgical decompression compared to the current ‘watch and wait’ strategy.

Trial registration

UMIN000006780; NCT01485458

【 授权许可】

   
2013 Chikuda et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Chikuda H, Yasunaga H, Takeshita K, Horiguchi H, Kawaguchi H, Ohe K, Fushimi K, Tanaka S: Mortality and morbidity after high-dose methylprednisolone treatment in patients with acute cervical spinal cord injury: a propensity-matched analysis using a nationwide administrative database. Emerg Med J 2013.
• [2]Pouw MH, van Middendorp JJ, van Kampen A, Curt A, van de Meent H, Hosman AJ: Diagnostic criteria of traumatic central cord syndrome. Part 3: descriptive analyses of neurological and functional outcomes in a prospective cohort of traumatic motor incomplete tetraplegics. Spinal Cord 2011, 49:614-622.
• [3]Burns SP, Golding DG, Rolle WA Jr, Graziani V, Ditunno JF Jr: Recovery of ambulation in motor-incomplete tetraplegia. Arch Phys Med Rehabil 1997, 78:1169-1172.
• [4]Foo D: Spinal cord injury in forty-four patients with cervical spondylosis. Paraplegia 1986, 24:301-306.
• [5]Cadotte DW, Fehlings M: Role of early decompression for spinal cord injury. In Controversies in spine surgery: best evidence recommendations. Edited by Vaccaro A, Eck J. New York: Thiema; 2010:86-92.
• [6]Lenehan B, Fisher CG, Vaccaro A, Fehlings M, Aarabi B, Dvorak MF: The urgency of surgical decompression in acute central cord injuries with spondylosis and without instability. Spine (Phila Pa 1976) 2010, 35:S180-186.
• [7]Kawano O, Ueta T, Shiba K, Iwamoto Y: Outcome of decompression surgery for cervical spinal cord injury without bone and disc injury in patients with spinal cord compression: a multicenter prospective study. Spinal Cord 2010, 48:548-553.
• [8]Chikuda H, Seichi A, Takeshita K, Matsunaga S, Watanabe M, Nakagawa Y, Oshima K, Sasao Y, Tokuhashi Y, Nakahara S, et al.: Acute cervical spinal cord injury complicated by preexisting ossification of the posterior longitudinal ligament: a multicenter study. Spine (Phila Pa 1976) 2011, 36:1453-1458.
• [9]Steinmets MP, Anderson PA, Patel R, Resnick DK: Anatomy and pathophysiology of spinal cord injury. In Atlas of spine trauma: adult and pediatric. Edited by Kim DH, Ludwig SC, Vaccaro A, Chang J. Philadelphia, Pennsylvania: Saunders; 2008:11-20.
• [10]Vaccaro AR, Daugherty RJ, Sheehan TP, Dante SJ, Cotler JM, Balderston RA, Herbison GJ, Northrup BE: Neurologic outcome of early versus late surgery for cervical spinal cord injury. Spine (Phila Pa 1976) 1997, 22:2609-2613.
• [11]La Rosa G, Conti A, Cardali S, Cacciola F, Tomasello F: Does early decompression improve neurological outcome of spinal cord injured patients? Appraisal of the literature using a meta-analytical approach. Spinal Cord 2004, 42:503-512.
• [12]Fehlings MG, Vaccaro A, Wilson JR, Singh A, Cadotte WD, Harrop JS, Aarabi B, Shaffrey C, Dvorak M, Fisher C, et al.: Early versus delayed decompression for traumatic cervical spinal cord injury: results of the Surgical Timing in Acute Spinal Cord Injury Study (STASCIS). PLoS One 2012, 7:e32037.
• [13]Vale FL, Burns J, Jackson AB, Hadley MN: Combined medical and surgical treatment after acute spinal cord injury: results of a prospective pilot study to assess the merits of aggressive medical resuscitation and blood pressure management. J Neurosurg 1997, 87:239-246.
• [14]Bracken MB, Shepard MJ, Collins WF, Holford TR, Young W, Baskin DS, Eisenberg HM, Flamm E, Leo-Summers L, Maroon J, et al.: A randomized, controlled trial of methylprednisolone or naloxone in the treatment of acute spinal-cord injury. Results of the Second National Acute Spinal Cord Injury Study. N Engl J Med 1990, 322:1405-1411.
• [15]Ito Y, Sugimoto Y, Tomioka M, Kai N, Tanaka M: Does high dose methylprednisolone sodium succinate really improve neurological status in patient with acute cervical cord injury?: a prospective study about neurological recovery and early complications. Spine (Phila Pa 1976) 2009, 34:2121-2124.
• [16]Bluvshtein V, Front L, Itzkovich M, Aidinoff E, Gelernter I, Hart J, Biering-Soerensen F, Weeks C, Laramee MT, Craven C, et al.: SCIM III is reliable and valid in a separate analysis for traumatic spinal cord lesions. Spinal Cord 2011, 49:292-296.
• [17]Catz A, Itzkovich M, Agranov E, Ring H, Tamir A: SCIM - spinal cord independence measure: a new disability scale for patients with spinal cord lesions. Spinal Cord 1997, 35:850-856.
• [18]Itzkovich M, Gelernter I, Biering-Sorensen F, Weeks C, Laramee MT, Craven BC, Tonack M, Hitzig SL, Glaser E, Zeilig G, et al.: The Spinal Cord Independence Measure (SCIM) version III: reliability and validity in a multi-center international study. Disabil Rehabil 2007, 29:1926-1933.
• [19]Fukuhara S, Bito S, Green J, Hsiao A, Kurokawa K: Translation, adaptation, and validation of the SF-36 Health Survey for use in Japan. J Clin Epidemiol 1998, 51:1037-1044.
• [20]Ware JE Jr, Sherbourne CD: The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992, 30:473-483.
• [21]The EuroQol Group: EuroQol - a new facility for the measurement of health-related quality of life. Health Policy 1990, 16:199-208.
• [22]Bouhassira D, Attal N, Fermanian J, Alchaar H, Gautron M, Masquelier E, Rostaing S, Lanteri-Minet M, Collin E, Grisart J, et al.: Development and validation of the Neuropathic Pain Symptom Inventory. Pain 2004, 108:248-257.
• [23]Dittuno PL, Ditunno JF Jr: Walking index for spinal cord injury (WISCI II): scale revision. Spinal Cord 2001, 39(12):654-656.
• [24]Tator CH: Review of treatment trials in human spinal cord injury: issues, difficulties, and recommendations. Neurosurgery 2006, 59:957-982.