Cervical Spondylotic Myelopathy Surgical Trial

NCT02076113 | Active Not Recruiting Results DMC

• 2 other identifiers: LCID: 2013-085CE-1304-6173
• Study Type: interventional
• Target: 269
• Locations: 2 countries
• Sites: 16

Brief Summary

The purpose of the study is to determine the optimal surgical approach (ventral vs dorsal) for patients with multi-level cervical spondylotic myelopathy (CSM). There are no established guidelines for the management of patients with CSM, which represents the most common cause of spinal cord injury and dysfunction in the US and in the world. This study aims to test the hypothesis that ventral surgery is associated with superior Short Form-36 physical component Score (SF-36 PCS) outcome at one year follow-up compared to dorsal approaches and that both ventral and dorsal surgery improve symptoms of spinal cord dysfunction measured using the modified Japanese Orthopedic Association Score (mJOA). A secondary hypothesis is that health resource utilization for ventral surgery, dorsal fusion, and laminoplasty surgery are different. A third hypothesis is that cervical sagittal balance post-operatively is a significant predictor of SF-36 PCS outcome.

Conditions

Cervical Spondylosis With Myelopathy

Keywords

cervical spondylotic myelopathy; degenerative cervical spondylosis; spinal fusion

Outcome Measures

Primary Outcomes (1)

• Measurement of Change in Short Form 36 (SF 36) Physical Component Score (PCS) From Baseline to 1 Year and 2 Year

  Standardized measure of patient's functional health and well being as reported by the patient. The SF-36 physical component summary (PCS) scores range from 0 to 100, with higher scores representing better quality of life.

  1 year and 2 year

Secondary Outcomes (9)

• Short Form-36 (SF-36) Physical Component Summary (PCS) Score

  Pre-operative, 1 year and 2 year

• Oswestry Neck Disability Index (NDI)

  Pre-operative, 1 year and 2 year

• EuroQol-5D

  Pre-operative, 1 year and 2 year

• Modified Japanese Orthopedic Association Score mJOA

  Pre-operative and 1 year

• Sagittal Balance Measurements

  1 year

Other Outcomes (1)

• Short Form-36 (SF-36) Physical Component Summary (PCS) Score by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty

  Pre-operative, 1 year and 2 year

Study Arms (2)

Ventral

ACTIVE COMPARATOR

Ventral Decompression with Fusion

Procedure: Ventral (Front) decompression with Fusion

Dorsal

ACTIVE COMPARATOR

Dorsal Decompression with Fusion or Dorsal Laminoplasty

Procedure: Dorsal (Back) Decompression with Fusion; Procedure: Dorsal (back) Laminoplasty

Interventions

Ventral (Front) decompression with Fusion PROCEDURE

Ventral decompression and fusion will be performed using a multi-level discectomy (including partial or single level corpectomy) with fusion and plating. Allograft will be used at each disc space and all compressive osteophytes will be removed using the operating microscope. Fixation will be performed with rigid, semi-constrained, or dynamic titanium plates to optimize fusion and minimize complications.

Also known as: Anterior Cervical Discectomy and Fusion (ACDF)

Ventral

Dorsal (Back) Decompression with Fusion PROCEDURE

Dorsal decompression and fusion will be performed using midline cervical laminectomy with the application of lateral mass screws and rods for rigid fixation. All surgeons will use local bone and allograft as needed to perform a lateral mass fusion, which typically will include one level rostral to the levels decompressed.

Also known as: Posterior decompression and fusion

Dorsal

Dorsal (back) Laminoplasty PROCEDURE

Laminoplasty will be performed using an open-door approach with the application of plates and screws at each treated level. Ceramic or allograft laminar spacers (surgeon's choice) can be used with plates and screws to expand the canal diameter.

Dorsal

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CSM (≥2 levels of spinal cord compression from C3 to C7)
• Present with ≥2 of the following symptoms/signs: clumsy hands, gait disturbance, hyperreflexia, up going toes, bladder dysfunction.

You may not qualify if:

• C2-C7 kyphosis\>5º (measured in standing neutral cervical spine radiograph),
• Segmental kyphotic deformity (defined by ≥3 osteophytes extending dorsal to a C2-C7 dorsal-caudal line measured on cervical spine CT),
• Structurally significant ossification of posterior longitudinal ligament (OPLL - measured on cervical spine CT),
• Previous cervical spine surgery
• Significant active health-related co-morbidity (Anesthesia Class IV or higher).

Sponsors & Collaborators

• Lahey Clinic: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (16)

University of California- San Francisco

San Francisco, California, 94143, United States

Location

Emory

Atlanta, Georgia, 30329, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

Location

Washington University School of Medicine- St. Louis

St Louis, Missouri, 63110, United States

Location

Rutgers-New Jersey Medical School

Newark, New Jersey, 07103, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Columbia

New York, New York, 10032, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44106, United States

Location

MetroHealth

Cleveland, Ohio, 44109, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Utah Health Sciences

Salt Lake City, Utah, 84132, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

University Health Network-University of Toronto

Toronto, Ontario, M5T2S8, Canada

Location

Related Publications (6)

• Ghogawala Z, Martin B, Benzel EC, Dziura J, Magge SN, Abbed KM, Bisson EF, Shahid J, Coumans JV, Choudhri TF, Steinmetz MP, Krishnaney AA, King JT Jr, Butler WE, Barker FG 2nd, Heary RF. Comparative effectiveness of ventral vs dorsal surgery for cervical spondylotic myelopathy. Neurosurgery. 2011 Mar;68(3):622-30; discussion 630-1. doi: 10.1227/NEU.0b013e31820777cf.

  PMID: 21164373 BACKGROUND

• Ghogawala Z, Coumans JV, Benzel EC, Stabile LM, Barker FG 2nd. Ventral versus dorsal decompression for cervical spondylotic myelopathy: surgeons' assessment of eligibility for randomization in a proposed randomized controlled trial: results of a survey of the Cervical Spine Research Society. Spine (Phila Pa 1976). 2007 Feb 15;32(4):429-36. doi: 10.1097/01.brs.0000255068.94058.8a.

  PMID: 17304133 BACKGROUND

• Ghogawala Z, Benzel EC, Heary RF, Riew KD, Albert TJ, Butler WE, Barker FG 2nd, Heller JG, McCormick PC, Whitmore RG, Freund KM, Schwartz JS. Cervical spondylotic myelopathy surgical trial: randomized, controlled trial design and rationale. Neurosurgery. 2014 Oct;75(4):334-46. doi: 10.1227/NEU.0000000000000479.

  PMID: 24991714 BACKGROUND

• Roguski M, Benzel EC, Curran JN, Magge SN, Bisson EF, Krishnaney AA, Steinmetz MP, Butler WE, Heary RF, Ghogawala Z. Postoperative cervical sagittal imbalance negatively affects outcomes after surgery for cervical spondylotic myelopathy. Spine (Phila Pa 1976). 2014 Dec 1;39(25):2070-7. doi: 10.1097/BRS.0000000000000641.

  PMID: 25419682 BACKGROUND

• Ghogawala Z, Terrin N, Dunbar MR, Breeze JL, Freund KM, Kanter AS, Mummaneni PV, Bisson EF, Barker FG 2nd, Schwartz JS, Harrop JS, Magge SN, Heary RF, Fehlings MG, Albert TJ, Arnold PM, Riew KD, Steinmetz MP, Wang MC, Whitmore RG, Heller JG, Benzel EC. Effect of Ventral vs Dorsal Spinal Surgery on Patient-Reported Physical Functioning in Patients With Cervical Spondylotic Myelopathy: A Randomized Clinical Trial. JAMA. 2021 Mar 9;325(10):942-951. doi: 10.1001/jama.2021.1233.

  PMID: 33687463 BACKGROUND

• Miranda SP, Whitmore RG, Kanter A, Mummaneni PV, Bisson EF, Barker FG 2nd, Harrop J, Magge SN, Heary RF, Fehlings MG, Albert TJ, Arnold PM, Riew KD, Steinmetz MP, Wang MC, Heller JG, Benzel EC, Ghogawala Z. Patients May Return to Work Sooner After Laminoplasty: Occupational Outcomes of the Cervical Spondylotic Myelopathy Surgical Trial. Neurosurgery. 2025 Jan 1;96(1):131-141. doi: 10.1227/neu.0000000000003048. Epub 2024 Jun 24.

  PMID: 38912784 DERIVED

Related Links

• Patient Centered Outcomes Research Institute

MeSH Terms

Interventions

Decompression; Gene Fusion; Laminoplasty

Intervention Hierarchy (Ancestors)

Therapeutics; Pressure; Mechanical Phenomena; Physical Phenomena; Recombination, Genetic; Genetic Phenomena; Orthopedic Procedures; Neurosurgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Zoher Ghogawala, MD
• Organization: Lahey Hospital & Medical Center

zoher.ghogawala@lahey.org

781-744-8984

Study Officials

• Zoher Ghogawala, MD

  Lahey Clinic, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2014
• First Posted: March 3, 2014
• Study Start: April 1, 2014
• Primary Completion: March 30, 2018
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 20, 2026
• Results First Posted: July 20, 2021

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available after publication of the trial's primary results.
• Access Criteria: Researchers whose proposed use of data has been approved with a signed data use agreement.

Locations

CA (1); US (15)