Cervical Spondylosis With MyelopathyNCT02076113
Cervical Spondylotic Myelopathy Surgical Trial
A study testing Ventral (Front) decompression with Fusion, Dorsal (Back) Decompression with Fusion and Dorsal (back) Laminoplasty in people with Cervical Spondylosis With Myelopathy, run by Lahey Clinic at 16 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Cervical Spondylosis With Myelopathy
- What is being tested?
- Ventral (Front) decompression with Fusion, Dorsal (Back) Decompression with Fusion and Dorsal (back) Laminoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 269 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 1 Apr 2014to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
United States15 sites
Emory
Atlanta, Georgia, 30329
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
Cleveland Clinic Foundation
Cleveland, Ohio, 44106
MetroHealth
Cleveland, Ohio, 44109
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of Wisconsin
Madison, Wisconsin, 53792
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Hospital for Special Surgery
New York, New York, 10021
Columbia
New York, New York, 10032
Rutgers-New Jersey Medical School
Newark, New Jersey, 07103
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
University of Utah Health Sciences
Salt Lake City, Utah, 84132
University of California- San Francisco
San Francisco, California, 94143
Washington University School of Medicine- St. Louis
St Louis, Missouri, 63110
Canada1 site
University Health Network-University of Toronto
Toronto, Ontario, M5T2S8
About this study
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.
Read the detailed description
Patients' images will be transmitted electronically (without identifying information) to a group of 15 CSM surgeon investigators for their expert opinion. They will provide their opinion on surgical strategy. Equipoise for randomization will be established using this spinal experts network polling mechanism.
If randomized, the patient will be randomized to one of the two treatment approaches - either Ventral (front) (treatment A) or Dorsal (back) (treatment B) approach. If randomized to treatment A (front surgery), the patient will receive decompression/fusion from the front of the neck. If randomized to treatment B (dorsal/back surgery), then the patient and their surgeon will select which posterior procedure they will receive (either dorsal decompression/fusion or dorsal laminoplasty).
Treatment A: Decompression/fusion from the front of the neck.
Treatment B: Dorsal/posterior neck surgery (one of the two surgical procedures listed below):
Dorsal decompression/fusion or dorsal laminoplasty (no fusion)
Functional outcomes will be determined using well-known quantitative scales (SF-36, Oswestry Neck Disability Index (NDI), mJOA, and EuroQol-5D). These instruments will be administered pre-op, 3 months, 6 months, and at 1 year. Additionally, functional outcomes instruments (SF-36, Oswestry Neck Disability Index, and EuroQol-5D) will be collected annually at years 2,3,4 and 5.
Pre-op imaging will include a cervical MRI and cervical CT as well as cervical flexion/extension films and standing cervical-thoracic-lumbar-sacral x-ray . A cervical MRI will be performed at 3 months. At 1 year (randomized patients only) will undergo cervical flexion/ extension xrays and standing cervical-thoracic-lumbar-sacral x-ray . A cervical CT will be performed only if the Oswestry NDI score is > 30.
- Conditions
- Cervical Spondylosis With Myelopathy
- Being tested
- Ventral (Front) decompression with Fusion, Dorsal (Back) Decompression with Fusion, Dorsal (back) Laminoplasty
- Keywords
- cervical spondylotic myelopathy, degenerative cervical spondylosis, spinal fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventral (Front) decompression with FusionProcedure or surgery
Also called Anterior Cervical Discectomy and Fusion (ACDF)
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.
Dorsal (Back) Decompression with FusionProcedure or surgery
Also called Posterior decompression and fusion
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.
Dorsal (back) LaminoplastyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Ventral | Active comparator | Ventral Decompression with Fusion Receives: Procedure: Ventral (Front) decompression with Fusion |
| Dorsal | Active comparator | Dorsal Decompression with Fusion or Dorsal Laminoplasty Receives: Procedure: Dorsal (Back) Decompression with Fusion; Procedure: Dorsal (back) Laminoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year and 2 year
Secondary outcomes (9)
Short Form-36 (SF-36) Physical Component Summary (PCS) Score
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. A typical patient with cervical myelopathy who is being recommended surgery would have a score between 30 and 40.
Measured: Pre-operative, 1 year and 2 year
Oswestry Neck Disability Index (NDI)
Standard instrument for measuring self-rated disability secondary to neck pain. The NDI ranges from 0 to 100, with lower scores representing less disability. A typical patient with moderate neck pain and disability would have a score between 20 and 40.
Measured: Pre-operative, 1 year and 2 year
EuroQol-5D
Standardized measure of health related quality of life. For the EQ-5D score, 0 indicates death and 1 indicates a perfect health state. EQ-5D scores between 0.6 and 0.7 represent a moderate but significant reduction in overall health-related quality of life.
Measured: Pre-operative, 1 year and 2 year
Modified Japanese Orthopedic Association Score mJOA
Short instrument for the functional assessment of patients. The scale ranges from 0 to 17, with higher scores representing less dysfunction due to myelopathy. A typical patient with moderate cervical myelopathy has an mJOA score between 12 and 14.
Measured: Pre-operative and 1 year
Sagittal Balance Measurements
Sagittal vertical axis was measured at 1 year postoperatively.
Measured: 1 year
Cumulative Health Resource Utilization Over 1 Year by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
Patient diary capturing out of pocket health utilization related to cervical surgery. The cumulative health resource utilization over 1-year is reported for the 'as treated' cohorts. Patients reported diagnostic imaging (MRI, x-ray, or CT), along with physical therapy and ongoing (at 1 year) physical therapy, opioid use and ongoing (at 1 year) opioid use, along with appointments with physicians. Data was collected at 1, 3, and 6 months and 1 year after surgery. The data presented is accumulative over the 1 year after surgery.
Measured: Within 1 year of surgery
Number of Participants With Continued Full or Part Time Work Status at Each Follow Up Time Point by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
Work status was recorded for all patients (working full-time; working part-time; not working, unable to work; not working, but able to work; or retired) at each follow-up through 1 year.
Measured: Pre-operative, 1, 3 and 6 months and 1 year
Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction.
Measured: Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Number of Participants With Unresolved Swallowing Difficulty (Complication) at 3 Months
Dysphagia is considered swallowing difficulty. Difficulty swallowing that resolved within 3 months was considered a minor complication, while prolonged (on going after 3 months) dysphagia was considered a major complication.
Measured: 3 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study start1 Apr 2014
- Primary completion30 Mar 2018
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cervical Spondylosis With MyelopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lahey Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Zoher Ghogawala, MD, Principal investigator, Lahey Clinic, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02076113
- Sponsor's protocol ID
- LCID: 2013-085
- Other IDs
- CE-1304-6173
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2014
- Last updated
- 20 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Deidentified data will be available after publication of the trial's primary outcome results. Requests can be emailed to zoher.ghogawala@lahey.org.
Publications
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.
PubMed 21164373Ghogawala 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.
PubMed 17304133Ghogawala 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.
PubMed 24991714Roguski 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.
PubMed 25419682Ghogawala 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.
PubMed 33687463Whitmore RG, Miranda SP, Bydon M, Dholakia R, Moriarty JP, Borah BJ, Kanter AS, Mummaneni PV, Bisson EF, Harrop JS, Magge SN, Heary RF, Fehlings MG, Albert TJ, Arnold PM, Riew KD, Steinmetz MP, Benzel EC, Wang MC, Heller JG, Ghogawala Z. Cost-Effectiveness of Anterior and Posterior Surgical Approaches for Cervical Spondylotic Myelopathy: An Economic Evaluation of a Randomized Clinical Trial. Neurosurgery. 2026 Nov 3. doi: 10.1227/neu.0000000000004268. Online ahead of print.
PubMed 42975416Miranda 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.
PubMed 38912784
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Spondylotic Myelopathy Surgical Trial
- ClinicalTrials.gov ID
- NCT02076113
- Acronym / sponsor ID
- LCID: 2013-085
- Conditions
- Cervical Spondylosis With Myelopathy
- Keywords
- cervical spondylotic myelopathy, degenerative cervical spondylosis, spinal fusion
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 269 participants (actual)
- Lead sponsor
- Lahey ClinicUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 3 Mar 2014 (estimated)
- Results
- Posted 20 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients' images will be transmitted electronically (without identifying information) to a group of 15 CSM surgeon investigators for their expert opinion. They will provide their opinion on surgical strategy. Equipoise for randomization will be established using this spinal experts network polling mechanism.
If randomized, the patient will be randomized to one of the two treatment approaches - either Ventral (front) (treatment A) or Dorsal (back) (treatment B) approach. If randomized to treatment A (front surgery), the patient will receive decompression/fusion from the front of the neck. If randomized to treatment B (dorsal/back surgery), then the patient and their surgeon will select which posterior procedure they will receive (either dorsal decompression/fusion or dorsal laminoplasty).
Treatment A: Decompression/fusion from the front of the neck.
Treatment B: Dorsal/posterior neck surgery (one of the two surgical procedures listed below):
Dorsal decompression/fusion or dorsal laminoplasty (no fusion)
Functional outcomes will be determined using well-known quantitative scales (SF-36, Oswestry Neck Disability Index (NDI), mJOA, and EuroQol-5D). These instruments will be administered pre-op, 3 months, 6 months, and at 1 year. Additionally, functional outcomes instruments (SF-36, Oswestry Neck Disability Index, and EuroQol-5D) will be collected annually at years 2,3,4 and 5.
Pre-op imaging will include a cervical MRI and cervical CT as well as cervical flexion/extension films and standing cervical-thoracic-lumbar-sacral x-ray . A cervical MRI will be performed at 3 months. At 1 year (randomized patients only) will undergo cervical flexion/ extension xrays and standing cervical-thoracic-lumbar-sacral x-ray . A cervical CT will be performed only if the Oswestry NDI score is > 30.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ventral | Active comparator | Procedure: Ventral (Front) decompression with FusionVentral Decompression with Fusion |
| Dorsal | Active comparator | Procedure: Dorsal (Back) Decompression with Fusion, Procedure: Dorsal (back) LaminoplastyDorsal Decompression with Fusion or Dorsal Laminoplasty |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ventral (Front) decompression with FusionAlso: Anterior Cervical Discectomy and Fusion (ACDF)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. | Procedure or surgery | Ventral |
| Dorsal (Back) Decompression with FusionAlso: Posterior decompression and fusionDorsal 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. | Procedure or surgery | Dorsal |
| Dorsal (back) LaminoplastyLaminoplasty 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. | Procedure or surgery | Dorsal |
Primary outcome
Measurement of Change in Short Form 36 (SF 36) Physical Component Score (PCS) From Baseline to 1 Year and 2 Year
Time frame: 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.
9 secondary outcomes
Short Form-36 (SF-36) Physical Component Summary (PCS) Score
Time frame: Pre-operative, 1 year and 2 year
Oswestry Neck Disability Index (NDI)
Time frame: Pre-operative, 1 year and 2 year
EuroQol-5D
Time frame: Pre-operative, 1 year and 2 year
Modified Japanese Orthopedic Association Score mJOA
Time frame: Pre-operative and 1 year
Sagittal Balance Measurements
Time frame: 1 year
Cumulative Health Resource Utilization Over 1 Year by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
Time frame: Within 1 year of surgery
Number of Participants With Continued Full or Part Time Work Status at Each Follow Up Time Point by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
Time frame: Pre-operative, 1, 3 and 6 months and 1 year
Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
Time frame: Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Number of Participants With Unresolved Swallowing Difficulty (Complication) at 3 Months
Time frame: 3 months, 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21164373Ghogawala 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.
- Background: PubMed 17304133Ghogawala 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.
- Background: PubMed 24991714Ghogawala 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.
- Background: PubMed 25419682Roguski 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.
- Background: PubMed 33687463Ghogawala 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.
- Derived from this study: PubMed 42975416Whitmore RG, Miranda SP, Bydon M, Dholakia R, Moriarty JP, Borah BJ, Kanter AS, Mummaneni PV, Bisson EF, Harrop JS, Magge SN, Heary RF, Fehlings MG, Albert TJ, Arnold PM, Riew KD, Steinmetz MP, Benzel EC, Wang MC, Heller JG, Ghogawala Z. Cost-Effectiveness of Anterior and Posterior Surgical Approaches for Cervical Spondylotic Myelopathy: An Economic Evaluation of a Randomized Clinical Trial. Neurosurgery. 2026 Nov 3. doi: 10.1227/neu.0000000000004268. Online ahead of print.
- Derived from this study: PubMed 38912784Miranda 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.
- Patient Centered Outcomes Research InstituteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Deidentified data will be available after publication of the trial's primary outcome results. Requests can be emailed to zoher.ghogawala@lahey.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zoher Ghogawala, MD principal investigator
Lahey Clinic, Inc.
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventral (Front) decompression with Fusion, Dorsal (Back) Decompression with Fusion and Dorsal (back) Laminoplasty in people with Cervical Spondylosis With Myelopathy, run by Lahey Clinic at 16 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Change in Short Form 36 (SF 36) Physical Component Score (PCS) From Baseline to 1 Year and 2 Year (time frame: 1 year and 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02076113, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.