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ACTIVE NOT RECRUITING NA

Cervical Spondylotic Myelopathy Surgical Trial

NCT02076113 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • PROCEDURE Ventral (Front) decompression with Fusion
  • PROCEDURE Dorsal (Back) Decompression with Fusion
  • PROCEDURE Dorsal (back) Laminoplasty

Study Locations (16)

New York

  • Hospital for Special Surgery — New York
  • Columbia — New York

Ohio

  • Cleveland Clinic Foundation — Cleveland
  • MetroHealth — Cleveland

Pennsylvania

  • Thomas Jefferson University Hospital — Philadelphia
  • University of Pittsburgh Medical Center — Pittsburgh

Wisconsin

  • University of Wisconsin — Madison
  • Medical College of Wisconsin — Milwaukee

California

  • University of California- San Francisco — San Francisco

Georgia

  • Emory — Atlanta

Kansas

  • University of Kansas Medical Center — Kansas City

Massachusetts

  • Lahey Hospital and Medical Center — Burlington

Trial Details

FieldValue
Enrollment Target 269 participants
Start Date 2014-04-01
Est. Completion 2026-12-30
Phase NA

Sponsor

Lahey Clinic

17 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02076113

The ClinicalTrials.gov registry entry for NCT02076113 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 269 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lahey Clinic, which has 17 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Cervical Spondylosis With Myelopathy appearing as the primary indexed condition, and to 3 interventions — of which Ventral (Front) decompression with Fusion is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02076113 reports 16 study locations spanning 12 distinct geographic areas — top geographies include New York, Ohio, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02076113 about?

NCT02076113 is a clinical study titled "Cervical Spondylotic Myelopathy Surgical Trial". 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 an...

What is the current status of trial NCT02076113?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 269 participants. The study started on 2014-04-01. Estimated completion is 2026-12-30.

What conditions does trial NCT02076113 study?

This clinical trial studies the following conditions: Cervical Spondylosis With Myelopathy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02076113?

The interventions under investigation include: Ventral (Front) decompression with Fusion (PROCEDURE), Dorsal (Back) Decompression with Fusion (PROCEDURE), Dorsal (back) Laminoplasty (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02076113?

This trial is sponsored by Lahey Clinic, which has 17 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02076113 being conducted?

This trial has 16 study locations across California, Georgia, Kansas, Massachusetts, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial