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NCT02076113 · ClinicalTrials.gov registry record · NA
Cervical Spondylotic Myelopathy Surgical Trial
A NA study of Cervical Spondylosis With Myelopathy, sponsored by Lahey Clinic.
- Active
- Registry status
- NA
- Development phase
- 269
- Enrollment target
- 16
- Study locations
NCT02076113 is a NA study of Cervical Spondylosis With Myelopathy that is active but no longer recruiting, run by Lahey Clinic. The registered enrollment target is 269 participants. The trial reports 16 study locations across 12 states.
The verdict
NCT02076113, a NA study of Cervical Spondylosis With Myelopathy, is active but no longer recruiting, sponsored by Lahey Clinic.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 269 participants
- Enrollment target
- 16
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 269 participants |
| Start Date | 2014-04-01 |
| Est. Completion | 2026-12-30 |
| Phase | NA |
Interested in This Trial?
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, categorized as NA. 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 43 total studies on file at ClinicalTrials.gov.
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.
NCT02076113 reports 16 study locations spanning 12 distinct geographic areas - top geographies include New York, Ohio, Pennsylvania.
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.
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).
Who is sponsoring clinical trial NCT02076113?
This trial is sponsored by Lahey Clinic, which has 43 total clinical trials registered on ClinicalTrials.gov.
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.
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