NCT00285337

Brief Summary

The primary purpose of this study is to compare anterior and posterior surgical approach in treatment of CSM in terms of surgical complications and neurological, functional, disease-specific and quality of life outcomes measures. 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
321

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2005

Geographic Reach
2 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2006

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

November 1, 2017

Status Verified

October 1, 2017

First QC Date

February 1, 2006

Last Update Submit

October 30, 2017

Conditions

Keywords

MyelopathyLaminectomyLaminoplastyDecompression of Spinal CordCervical Spondylosis

Outcome Measures

Primary Outcomes (2)

  • Clinical and radiological outcomes, functional status and general health related quality of life between anterior vs. posterior approach

    12 months

  • Compare the rate of complications between operative patients managed with anterior vs. posterior approaches 6,12 and 24 months following surgery

    24 months

Secondary Outcomes (1)

  • Compare the outcome of operative treatment at baseline and 6, 12 and 24 months using Nurick score, 30m walk test, mJOA score, NDI and SF-36

    24 months

Interventions

Posterior versus anterior approach to laminectomy and laminoplasty

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergo surgery for symptomatic cervical spondylotic myelopathy with one or or more of the following symptoms: Numb clumsy hands, impairment of gait, bilateral arm parasthesia, L'Hermitte's phenomena
  • 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

You may not qualify if:

  • Asymptomatic cervical spondylotic myelopathy
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Spine Education and Research Institute

Thornton, Colorado, 80229, United States

Location

Emory University

Atlanta, Georgia, 30329, United States

Location

Indianda Spine Group

Indianapolis, Indiana, 46260, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

John Hopkins University

Baltimore, Maryland, 21287, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

New England Baptist Hospital

Boston, Massachusetts, 02120, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Thomas Jefferson University and Rothman Institure Orthopaedics

Philadelphia, Pennsylvania, 19107, United States

Location

Universty of Utah

Salt Lake City, Utah, 84108, United States

Location

University Of Virginia

Charlottesville, Virginia, 22908, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

University of Toronto

Toronto, Ontario, M5T 2S8, Canada

Location

Related Publications (42)

  • 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.

    PMID: 22324802BACKGROUND
  • 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.

    PMID: 22985375BACKGROUND
  • 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.

    PMID: 24626958BACKGROUND
  • 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.

    PMID: 23963010BACKGROUND
  • 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.

    PMID: 23963011BACKGROUND
  • 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.

    PMID: 23204243BACKGROUND
  • 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.

    PMID: 23963013BACKGROUND
  • 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.

    PMID: 23963012BACKGROUND
  • 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.

    PMID: 26315953BACKGROUND
  • 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;16(1):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.

MeSH Terms

Conditions

Spinal Cord DiseasesSpondylosis

Interventions

LaminectomyLaminoplasty

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System DiseasesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Orthopedic ProceduresTherapeuticsDecompression, SurgicalSurgical Procedures, OperativeNeurosurgical Procedures

Study Officials

  • Michael Fehlings, MD, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2006

First Posted

February 2, 2006

Study Start

December 1, 2005

Study Completion

November 1, 2007

Last Updated

November 1, 2017

Record last verified: 2017-10

Locations