Assessment of Surgical Techniques for Treating Cervical Spondylotic Myelopathy
NCT ID: NCT00285337
Last Updated: 2017-11-01
Study Results
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Basic Information
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COMPLETED
321 participants
OBSERVATIONAL
2005-12-31
2007-11-30
Brief Summary
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Secondary aims are to quantify the amount of change pre and post-surgery concerning the same outcome measures; to determine if there are differences in outcomes between posterior surgical techniques (i.e. laminectomy with fusion or laminoplasty) and examine the relationship between baseline MRI and baseline and follow-up neurological and functional outcomes.
Detailed Description
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A variety of surgical approaches and procedures are available, and the optimal choice of treatment remains controversial. Surgical procedures designed to decompress the spinal cord and, in some cases, stabilize the spine have been shown to be successful, but there is a persistent percentage of patients who do not improve with surgical intervention.3 Additionally, the potential complications of surgery for CSM may depend on the various methods of surgical management. Historically, cervical laminectomy, a posterior approach, had been regarded as the standard surgical treatment of CSM. However, over the past 20 years, it has been increasingly recognized that laminectomy without fusion is not appropriate for all patients and may result in instability and deformity. Because of the instability caused by laminectomies, alternate surgical approaches such as anterior approaches to the spine and laminoplasty have been developed, and have gained increasing popularity over the years.3 A range of factors must be considered when deciding which surgical technique to use. Surgeons are often challenged with determining the most appropriate technique because there is limited information about whether there is a difference between surgical procedures in terms of clinical and radiographic outcomes, in postoperative complication rates and in functional and quality of life outcomes. Methods of treatment include conservative and surgical management. Among surgically managed patients, an anterior or posterior approach may be employed. Among those managed posteriorly, laminoplasty or laminectomy with fusion are common surgical techniques. With several standards of care available for this population, a better understanding of the corresponding positive and negative outcomes with respect to clinical and patient-centered outcomes is warranted.
Conditions
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Keywords
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Interventions
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Laminectomy and Laminoplasty
Posterior versus anterior approach to laminectomy and laminoplasty
Eligibility Criteria
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Inclusion Criteria
* and one or more of the following signs: corticospinal distribution motor deficits, athropy of hand intrinsic muscles, hyperflexia, positive Hoffman sign, upgoing plantar responses, lower limb spasticity, broad based unstable gait
Exclusion Criteria
* previous surgery for CSM
* Active infection
* Neoplastic disease
* Rheumatoid arthritis
* Ankylosing spondylitis
* Trauma
* Concomitant lumbar stenosis
* Not referred for surgical consultation
* Participating in other trials or unlikely to attend follow-ups
ALL
Yes
Sponsors
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AOSpine North America
INDUSTRY
AOSpine North America Research Network
NETWORK
Responsible Party
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Principal Investigators
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Michael Fehlings, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Toronto
Locations
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Spine Education and Research Institute
Thornton, Colorado, United States
Emory University
Atlanta, Georgia, United States
Indianda Spine Group
Indianapolis, Indiana, United States
Kansas University Medical Center
Kansas City, Kansas, United States
John Hopkins University
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
New England Baptist Hospital
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Thomas Jefferson University and Rothman Institure Orthopaedics
Philadelphia, Pennsylvania, United States
Universty of Utah
Salt Lake City, Utah, United States
University Of Virginia
Charlottesville, Virginia, United States
Harborview Medical Center
Seattle, Washington, United States
University of Toronto
Toronto, Ontario, Canada
Countries
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References
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Fehlings MG, Smith JS, Kopjar B, Arnold PM, Yoon ST, Vaccaro AR, Brodke DS, Janssen ME, Chapman JR, Sasso RC, Woodard EJ, Banco RJ, Massicotte EM, Dekutoski MB, Gokaslan ZL, Bono CM, Shaffrey CI. Perioperative and delayed complications associated with the surgical treatment of cervical spondylotic myelopathy based on 302 patients from the AOSpine North America Cervical Spondylotic Myelopathy Study. J Neurosurg Spine. 2012 May;16(5):425-32. doi: 10.3171/2012.1.SPINE11467. Epub 2012 Feb 10.
Fehlings MG, Jha NK, Hewson SM, Massicotte EM, Kopjar B, Kalsi-Ryan S. Is surgery for cervical spondylotic myelopathy cost-effective? A cost-utility analysis based on data from the AOSpine North America prospective CSM study. J Neurosurg Spine. 2012 Sep;17(1 Suppl):89-93. doi: 10.3171/2012.6.AOSPINE111069.
Karadimas SK, Gatzounis G, Fehlings MG. Pathobiology of cervical spondylotic myelopathy. Eur Spine J. 2015 Apr;24 Suppl 2:132-8. doi: 10.1007/s00586-014-3264-4. Epub 2014 Mar 14.
Wilson JR, Fehlings MG, Kalsi-Ryan S, Shamji MF, Tetreault LA, Rhee JM, Chapman JR. Diagnosis, heritability, and outcome assessment in cervical myelopathy: a consensus statement. Spine (Phila Pa 1976). 2013 Oct 15;38(22 Suppl 1):S76-7. doi: 10.1097/BRS.0b013e3182a7f4bf.
Fehlings MG, Wilson JR, Yoon ST, Rhee JM, Shamji MF, Lawrence BD. Symptomatic progression of cervical myelopathy and the role of nonsurgical management: a consensus statement. Spine (Phila Pa 1976). 2013 Oct 15;38(22 Suppl 1):S19-20. doi: 10.1097/BRS.0b013e3182a7f4de.
Kalsi-Ryan S, Karadimas SK, Fehlings MG. Cervical spondylotic myelopathy: the clinical phenomenon and the current pathobiology of an increasingly prevalent and devastating disorder. Neuroscientist. 2013 Aug;19(4):409-21. doi: 10.1177/1073858412467377. Epub 2012 Nov 30.
Shamji MF, Ames CP, Smith JS, Rhee JM, Chapman JR, Fehlings MG. Myelopathy and spinal deformity: relevance of spinal alignment in planning surgical intervention for degenerative cervical myelopathy. Spine (Phila Pa 1976). 2013 Oct 15;38(22 Suppl 1):S147-8. doi: 10.1097/BRS.0b013e3182a7f521.
Lawrence BD, Shamji MF, Traynelis VC, Yoon ST, Rhee JM, Chapman JR, Brodke DS, Fehlings MG. Surgical management of degenerative cervical myelopathy: a consensus statement. Spine (Phila Pa 1976). 2013 Oct 15;38(22 Suppl 1):S171-2. doi: 10.1097/BRS.0b013e3182a7f4ff.
Liu S, Lafage R, Smith JS, Protopsaltis TS, Lafage VC, Challier V, Shaffrey CI, Radcliff K, Arnold PM, Chapman JR, Schwab FJ, Massicotte EM, Yoon ST, Fehlings MG, Ames CP. Impact of dynamic alignment, motion, and center of rotation on myelopathy grade and regional disability in cervical spondylotic myelopathy. J Neurosurg Spine. 2015 Dec;23(6):690-700. doi: 10.3171/2015.2.SPINE14414. Epub 2015 Aug 28.
Arnold PM, Fehlings MG, Kopjar B, Yoon ST, Massicotte EM, Vaccaro AR, Brodke DS, Shaffrey CI, Smith JS, Woodard EJ, Banco RJ, Chapman JR, Janssen ME, Bono CM, Sasso RC, Dekutoski MB, Gokaslan ZL. Mild diabetes is not a contraindication for surgical decompression in cervical spondylotic myelopathy: results of the AOSpine North America multicenter prospective study (CSM). Spine J. 2014 Jan;14(1):65-72. doi: 10.1016/j.spinee.2013.06.016. Epub 2013 Aug 24.
Fehlings MG, Wilson JR, Kopjar B, Yoon ST, Arnold PM, Massicotte EM, Vaccaro AR, Brodke DS, Shaffrey CI, Smith JS, Woodard EJ, Banco RJ, Chapman JR, Janssen ME, Bono CM, Sasso RC, Dekutoski MB, Gokaslan ZL. Efficacy and safety of surgical decompression in patients with cervical spondylotic myelopathy: results of the AOSpine North America prospective multi-center study. J Bone Joint Surg Am. 2013 Sep 18;95(18):1651-8. doi: 10.2106/JBJS.L.00589.
Tetreault LA, Kopjar B, Vaccaro A, Yoon ST, Arnold PM, Massicotte EM, Fehlings MG. A clinical prediction model to determine outcomes in patients with cervical spondylotic myelopathy undergoing surgical treatment: data from the prospective, multi-center AOSpine North America study. J Bone Joint Surg Am. 2013 Sep 18;95(18):1659-66. doi: 10.2106/JBJS.L.01323.
Karpova A, Arun R, Kalsi-Ryan S, Massicotte EM, Kopjar B, Fehlings MG. Do quantitative magnetic resonance imaging parameters correlate with the clinical presentation and functional outcomes after surgery in cervical spondylotic myelopathy? A prospective multicenter study. Spine (Phila Pa 1976). 2014 Aug 15;39(18):1488-97. doi: 10.1097/BRS.0000000000000436.
Fehlings MG, Barry S, Kopjar B, Yoon ST, Arnold P, Massicotte EM, Vaccaro A, Brodke DS, Shaffrey C, Smith JS, Woodard E, Banco RJ, Chapman J, Janssen M, Bono C, Sasso R, Dekutoski M, Gokaslan ZL. Anterior versus posterior surgical approaches to treat cervical spondylotic myelopathy: outcomes of the prospective multicenter AOSpine North America CSM study in 264 patients. Spine (Phila Pa 1976). 2013 Dec 15;38(26):2247-52. doi: 10.1097/BRS.0000000000000047.
Kopjar B, Tetreault L, Kalsi-Ryan S, Fehlings M. Psychometric properties of the modified Japanese Orthopaedic Association scale in patients with cervical spondylotic myelopathy. Spine (Phila Pa 1976). 2015 Jan 1;40(1):E23-8. doi: 10.1097/BRS.0000000000000648.
Arvin B, Kalsi-Ryan S, Karpova A, Mercier D, Furlan JC, Massicotte EM, Fehlings MG. Postoperative magnetic resonance imaging can predict neurological recovery after surgery for cervical spondylotic myelopathy: a prospective study with blinded assessments. Neurosurgery. 2011 Aug;69(2):362-8. doi: 10.1227/NEU.0b013e31821a418c.
Furlan JC, Kalsi-Ryan S, Kailaya-Vasan A, Massicotte EM, Fehlings MG. Functional and clinical outcomes following surgical treatment in patients with cervical spondylotic myelopathy: a prospective study of 81 cases. J Neurosurg Spine. 2011 Mar;14(3):348-55. doi: 10.3171/2010.10.SPINE091029. Epub 2011 Jan 14.
Singh A, Tetreault L, Fehlings MG, Fischer DJ, Skelly AC. Risk factors for development of cervical spondylotic myelopathy: results of a systematic review. Evid Based Spine Care J. 2012 Aug;3(3):35-42. doi: 10.1055/s-0032-1327808.
Skelly AC, Hashimoto RE, Norvell DC, Dettori JR, Fischer DJ, Wilson JR, Tetreault LA, Fehlings MG. Cervical spondylotic myelopathy: methodological approaches to evaluate the literature and establish best evidence. Spine (Phila Pa 1976). 2013 Oct 15;38(22 Suppl 1):S9-18. doi: 10.1097/BRS.0b013e3182a7ebbf.
Yoon ST, Raich A, Hashimoto RE, Riew KD, Shaffrey CI, Rhee JM, Tetreault LA, Skelly AC, Fehlings MG. Predictive factors affecting outcome after cervical laminoplasty. Spine (Phila Pa 1976). 2013 Oct 15;38(22 Suppl 1):S232-52. doi: 10.1097/BRS.0b013e3182a7eb55.
Fehlings MG, Tetreault LA, Wilson JR, Skelly AC. Cervical spondylotic myelopathy: current state of the art and future directions. Spine (Phila Pa 1976). 2013 Oct 15;38(22 Suppl 1):S1-8. doi: 10.1097/BRS.0b013e3182a7e9e0.
Kalsi-Ryan S, Singh A, Massicotte EM, Arnold PM, Brodke DS, Norvell DC, Hermsmeyer JT, Fehlings MG. Ancillary outcome measures for assessment of individuals with cervical spondylotic myelopathy. Spine (Phila Pa 1976). 2013 Oct 15;38(22 Suppl 1):S111-22. doi: 10.1097/BRS.0b013e3182a7f499.
Shamji MF, Massicotte EM, Traynelis VC, Norvell DC, Hermsmeyer JT, Fehlings MG. Comparison of anterior surgical options for the treatment of multilevel cervical spondylotic myelopathy: a systematic review. Spine (Phila Pa 1976). 2013 Oct 15;38(22 Suppl 1):S195-209. doi: 10.1097/BRS.0b013e3182a7eb27.
Smith JS, Lafage V, Ryan DJ, Shaffrey CI, Schwab FJ, Patel AA, Brodke DS, Arnold PM, Riew KD, Traynelis VC, Radcliff K, Vaccaro AR, Fehlings MG, Ames CP. Association of myelopathy scores with cervical sagittal balance and normalized spinal cord volume: analysis of 56 preoperative cases from the AOSpine North America Myelopathy study. Spine (Phila Pa 1976). 2013 Oct 15;38(22 Suppl 1):S161-70. doi: 10.1097/BRS.0b013e3182a7eb9e.
Karadimas SK, Erwin WM, Ely CG, Dettori JR, Fehlings MG. Pathophysiology and natural history of cervical spondylotic myelopathy. Spine (Phila Pa 1976). 2013 Oct 15;38(22 Suppl 1):S21-36. doi: 10.1097/BRS.0b013e3182a7f2c3.
Karpova A, Arun R, Davis AM, Kulkarni AV, Massicotte EM, Mikulis DJ, Lubina ZI, Fehlings MG. Predictors of surgical outcome in cervical spondylotic myelopathy. Spine (Phila Pa 1976). 2013 Mar 1;38(5):392-400. doi: 10.1097/BRS.0b013e3182715bc3.
Karpova A, Arun R, Davis AM, Kulkarni AV, Mikulis DJ, Sooyong C, Rabin D, Craciunas S, Smith SR, Hansen MA, George J, Fehlings MG. Reliability of quantitative magnetic resonance imaging methods in the assessment of spinal canal stenosis and cord compression in cervical myelopathy. Spine (Phila Pa 1976). 2013 Feb 1;38(3):245-52. doi: 10.1097/BRS.0b013e3182672307.
Karpova A, Arun R, Cadotte DW, Davis AM, Kulkarni AV, O'Higgins M, Fehlings MG. Assessment of spinal cord compression by magnetic resonance imaging--can it predict surgical outcomes in degenerative compressive myelopathy? A systematic review. Spine (Phila Pa 1976). 2013 Jul 15;38(16):1409-21. doi: 10.1097/BRS.0b013e31829609a0.
Tetreault LA, Dettori JR, Wilson JR, Singh A, Nouri A, Fehlings MG, Brodt ED, Jacobs WB. Systematic review of magnetic resonance imaging characteristics that affect treatment decision making and predict clinical outcome in patients with cervical spondylotic myelopathy. Spine (Phila Pa 1976). 2013 Oct 15;38(22 Suppl 1):S89-110. doi: 10.1097/BRS.0b013e3182a7eae0.
Tetreault L, Nouri A, Singh A, Fawcett M, Nater A, Fehlings MG. An Assessment of the Key Predictors of Perioperative Complications in Patients with Cervical Spondylotic Myelopathy Undergoing Surgical Treatment: Results from a Survey of 916 AOSpine International Members. World Neurosurg. 2015 May;83(5):679-90. doi: 10.1016/j.wneu.2015.01.021. Epub 2015 Feb 12.
Tetreault LA, Cote P, Kopjar B, Arnold P, Fehlings MG; AOSpine North America and International Clinical Trial Research Network. A clinical prediction model to assess surgical outcome in patients with cervical spondylotic myelopathy: internal and external validations using the prospective multicenter AOSpine North American and international datasets of 743 patients. Spine J. 2015 Mar 1;15(3):388-97. doi: 10.1016/j.spinee.2014.12.145. Epub 2014 Dec 27.
Tetreault LA, Karpova A, Fehlings MG. Predictors of outcome in patients with degenerative cervical spondylotic myelopathy undergoing surgical treatment: results of a systematic review. Eur Spine J. 2015 Apr;24 Suppl 2:236-51. doi: 10.1007/s00586-013-2658-z. Epub 2013 Feb 6.
Mohanty C, Massicotte EM, Fehlings MG, Shamji MF. Association of preoperative cervical spine alignment with spinal cord magnetic resonance imaging hyperintensity and myelopathy severity: analysis of a series of 124 cases. Spine (Phila Pa 1976). 2015 Jan 1;40(1):11-6. doi: 10.1097/BRS.0000000000000670.
Nouri A, Tetreault L, Cote P, Zamorano JJ, Dalzell K, Fehlings MG. Does Magnetic Resonance Imaging Improve the Predictive Performance of a Validated Clinical Prediction Rule Developed to Evaluate Surgical Outcome in Patients With Degenerative Cervical Myelopathy? Spine (Phila Pa 1976). 2015 Jul 15;40(14):1092-100. doi: 10.1097/BRS.0000000000000919.
Nouri A, Tetreault L, Singh A, Karadimas SK, Fehlings MG. Degenerative Cervical Myelopathy: Epidemiology, Genetics, and Pathogenesis. Spine (Phila Pa 1976). 2015 Jun 15;40(12):E675-93. doi: 10.1097/BRS.0000000000000913.
Nouri A, Tetreault L, Zamorano JJ, Dalzell K, Davis AM, Mikulis D, Yee A, Fehlings MG. Role of magnetic resonance imaging in predicting surgical outcome in patients with cervical spondylotic myelopathy. Spine (Phila Pa 1976). 2015 Feb 1;40(3):171-8. doi: 10.1097/BRS.0000000000000678.
Singh A, Tetreault L, Casey A, Laing R, Statham P, Fehlings MG. A summary of assessment tools for patients suffering from cervical spondylotic myelopathy: a systematic review on validity, reliability and responsiveness. Eur Spine J. 2015 Apr;24 Suppl 2:209-28. doi: 10.1007/s00586-013-2935-x. Epub 2013 Sep 5.
Liu S, Tetreault L, Fehlings MG, Challier V, Smith JS, Shaffrey CI, Arnold PM, Scheer JK, Chapman JR, Kopjar B, Protopsaltis TS, Lafage V, Schwab F, Massicotte EM, Yoon ST, Ames CP. Novel Method Using Baseline Normalization and Area Under the Curve to Evaluate Differences in Outcome Between Treatment Groups and Application to Patients With Cervical Spondylotic Myelopathy Undergoing Anterior Versus Posterior Surgery. Spine (Phila Pa 1976). 2015 Dec;40(24):E1299-304. doi: 10.1097/BRS.0000000000001152.
Bak AB, Moghaddamjou A, Arnold PM, Harrop JS, Fehlings MG. Chronic pain after decompression for degenerative cervical myelopathy: a pooled trajectory analysis of individual participant data. Pain. 2025 Oct 15. doi: 10.1097/j.pain.0000000000003828. Online ahead of print.
Wong R, Alvi MA, Quddusi AI, Fehlings MG. Role of Neck Pain in Defining Clinical Trajectories of Outcomes in Patients With Degenerative Cervical Myelopathy: Results of a Novel Machine Learning Algorithm. Global Spine J. 2025 May 10:21925682251341263. doi: 10.1177/21925682251341263. Online ahead of print.
Pedro KM, Alvi MA, Hejrati N, Moghaddamjou A, Fehlings MG. Elderly Patients Show Substantial Improvement in Health-Related Quality of Life After Surgery for Degenerative Cervical Myelopathy Despite Medical Frailty: An Ambispective Analysis of a Multicenter, International Data Set. Neurosurgery. 2024 Jan 10. doi: 10.1227/neu.0000000000002818. Online ahead of print.
Merali ZG, Witiw CD, Badhiwala JH, Wilson JR, Fehlings MG. Using a machine learning approach to predict outcome after surgery for degenerative cervical myelopathy. PLoS One. 2019 Apr 4;14(4):e0215133. doi: 10.1371/journal.pone.0215133. eCollection 2019.
Other Identifiers
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06-CSM-03
Identifier Type: -
Identifier Source: org_study_id