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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Patients undergoing a primary 1- to 2-level ACDF.
(a) Diagnosis: myelopathy, radiculopathy, myeloradiculopathy, stenosis, herniated nucleus pulposus, degenerative disc disease, spondylosis, osteophytic complexes, and foraminal stenosis.
  • - Patients able to provide informed consent.

Exclusion Criteria:

- Cervical spine trauma

Trial Details

Trial ID:

This trial id was obtained from, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Rush University Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Kern Singh, MD
Principal Investigator Affiliation Rush University Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Enrolling by invitation
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Degenerative Disc Disease, Cervical Spine Degeneration
Additional Details

Anterior cervical discectomy and fusion (ACDF) is one the most common procedures performed by spine surgeons. Although ACDF with autologous bone graft and anterior plating is commonly performed, this procedure may be associated with postoperative dysphagia, significant costs and adjacent segment pathology. To address these concerns, a number of surgeons have opted to utilize an interbody cage in a stand-alone fashion with good to excellent results. However, the published data is limited and currently there in no consensus among spine surgeons regarding the best technique to achieve fusion and improve clinical outcomes in patients with degenerative disc disease in the cervical spine.

Arms & Interventions


Active Comparator: Plate and Cage

ACDF with interbody cage and anterior plating.

Active Comparator: Stand Alone Cage

ACDF with stand alone interbody cage without anterior plating


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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Rush University Medical Center, Chicago, Illinois



Rush University Medical Center

Chicago, Illinois, 60612