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Stand-Alone Cage Verus Anterior Plating for Anterior Cervical Discectomy and Fusion.

NCT03312192 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-09-16

No results posted yet for this study

Summary

The purpose of this study is to compare the clinical results between two different techniques for ACDF: 1. Stand-alone ACDF, which means the placement of an interbody device (cage) without anterior fixation or plating; 2. ACDF with and interbody cage and anterior plating for fixation. Both of these procedures are commonly performed at Rush with unclear advantage of one procedure over the other. Both have been associated with good to excellent clinical outcomes. The devices used in this study are approved by the Food and Drug Administration (FDA).

Conditions

  • Degenerative Disc Disease
  • Cervical Spine Degeneration

Interventions

DEVICE

Interbody Cage

Anterior cervical discectomy and fusion with interbody cage placement

DEVICE

Interbody Cage and Anterior Plating

Anterior cervical discectomy and fusion with interbody cage placement and anterior plating

Sponsors & Collaborators

  • Rush University Medical Center

    lead OTHER

Principal Investigators

  • Kern Singh, MD · Rush University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-17
Primary Completion
2020-12-31
Completion
2020-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03312192 on ClinicalTrials.gov