Official title: Prospective Randomized Controlled Trail of the Effects of Steroids on Swallowing, Airway and Arthrodesis Related to Myulti-Level Anterior Cervical Reconstruction

Anterior cervical discectomy and fusion with or without decompression is a well-established surgical treatment for spine patients with the appropriate indications. Anterior approach involves some retraction that affect the midline structures of the anterior neck. Irritation and swelling may result, leading to postoperative dysphagia and the less common but critically important occurrence of postoperative airway compromise. Steroids given intraoperatively may reduce the incidence of these adverse outcomes by reducing the degree of swelling within the anterior neck subsequent to local surgical tissue trauma.

The investigators hypothesize that the use of steroids intraoperatively provides a significant benefit to the patient, in terms of reduced incidence of dysphagia and airway compromise.

Conditions: Swallowing
Being tested: Decadron, Saline
Keywords: anterior, cervical, fusion, swallowing, Swallowing after anterior cervical discectomy and fusion, Bony fusion rates post anterior cervical discectomy and fusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DecadronDrug
Decadron will be given at a dose of 0.2 mg/kg intraoperatively, followed by Decadron 4 mg. every 6 hours for 24 hours.
SalineDrug
Placebo saline will be given intraoperatively as well as 4 doses every 6 hours for 24 hours.

Study groups in NCT01065961
Study group	Role	What they receive
Decadron	Active comparator	Subject will be given Decadron 0.2mg/kg intraoperatively. This dose will be followed by 4 mg. every 6 hours for the first 24 hours. Receives: Drug: Decadron
Saline	Placebo comparator	subject will be given a blinded dose of placebo saline intraoperatively followed by placebo doses every 6 hours for 24 hours. Receives: Drug: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

subjects will demonstrate good bony fusion
Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2008Nov 2016

First posted10 Feb 2010 (estimated)
Study startNov 2008
Primary completionNov 2016 (estimated)
Study completionNov 2016 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SwallowingStudies 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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 200 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01065961
Sponsor's protocol ID: D-01
Status last verified: Nov 2008
First submitted: 9 Feb 2010
Last updated: 10 Feb 2010
Results posted: No
Data monitoring committee: No

Publications

Jeyamohan SB, Kenning TJ, Petronis KA, Feustel PJ, Drazin D, DiRisio DJ. Effect of steroid use in anterior cervical discectomy and fusion: a randomized controlled trial. J Neurosurg Spine. 2015 Aug;23(2):137-43. doi: 10.3171/2014.12.SPINE14477. Epub 2015 May 1.
PubMed 25932600

Want to know more?

Darryl DiRisio, MD

518 262-5088

dirisi@mail.amc.edu

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Swallowing trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Randomized Controlled Trail of the Effects of Steroids on Swallowing, Airway and Arthrodesis Related to Myulti-Level Anterior Cervical Reconstruction
ClinicalTrials.gov ID: NCT01065961
Acronym / sponsor ID: D-01
Conditions: Swallowing
Keywords: anterior, cervical, fusion, swallowing, Swallowing after anterior cervical discectomy and fusion, Bony fusion rates post anterior cervical discectomy and fusion
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 200 participants (estimated)
Lead sponsor: Albany Medical CollegeUniversity, hospital or other
Study start: Nov 2008
Primary completion: Nov 2016 (estimated)
Study completion: Nov 2016 (estimated)
First posted: 10 Feb 2010 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The investigators hypothesize that the use of steroids intraoperatively provides a significant benefit to the patient, in terms of reduced incidence of dysphagia and airway compromise.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Decadron	Active comparator	Drug: DecadronSubject will be given Decadron 0.2mg/kg intraoperatively. This dose will be followed by 4 mg. every 6 hours for the first 24 hours.
Saline	Placebo comparator	Drug: Salinesubject will be given a blinded dose of placebo saline intraoperatively followed by placebo doses every 6 hours for 24 hours.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

18 years of age or greater
Cervical spondylosis requiring surgical treatment at 2 or more motion segments
Ventrally - approachable vertebral levels

Key exclusion criteria (8 listed)

Minors (under 18 years old)
Pregnant women
Patients currently taking steroids
Patients requiring surgical treatment at only one segment
Comatose or incapacitated patients who cannot consent to participate

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
DecadronDecadron will be given at a dose of 0.2 mg/kg intraoperatively, followed by Decadron 4 mg. every 6 hours for 24 hours.	Drug	Decadron
SalinePlacebo saline will be given intraoperatively as well as 4 doses every 6 hours for 24 hours.	Drug	Saline

Primary outcome

subjects will demonstrate good bony fusion
Time frame: one year

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2010.
Derived from this study: PubMed 25932600Jeyamohan SB, Kenning TJ, Petronis KA, Feustel PJ, Drazin D, DiRisio DJ. Effect of steroid use in anterior cervical discectomy and fusion: a randomized controlled trial. J Neurosurg Spine. 2015 Aug;23(2):137-43. doi: 10.3171/2014.12.SPINE14477. Epub 2015 May 1.

Related trials for Swallowing

RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Recruiting
taVNS in Infants Severe Dysphagia
Dysphagia, Swallowing Disorders
Not yet recruitingPhase 2
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Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux

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.

Darryl DiRisio, MD contact

518 262-5088

dirisi@mail.amc.edu

Margaret Czerwinski, BSN, RN contact

518 262-0034

czerwim@mail.amc.edu

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Decadron and Saline in people with Swallowing, run by Albany Medical College at 1 site in United States.

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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 10 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Darryl DiRisio, MD (518 262-5088, dirisi@mail.amc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

subjects will demonstrate good bony fusion (time frame: one 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 NCT01065961, which also lists 1 linked publication.

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 10 Feb 2010.