NCT02539394

Brief Summary

The purpose of this study is to determine what effect intraoperative topical steroids have on reducing swallowing difficulty following Anterior Cervical Discectomy and Fusion surgery.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 3, 2015

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2021

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

July 10, 2023

Completed
Last Updated

July 10, 2023

Status Verified

June 1, 2023

Enrollment Period

5.3 years

First QC Date

August 27, 2015

Results QC Date

February 27, 2023

Last Update Submit

June 16, 2023

Conditions

Cervical Disc HerniationCervical Degenerative Disc DiseaseCervical Spondylotic MyelopathyDysphagiaOsteoarthritis of Cervical Spine

Keywords

Anterior Cervical Discectomy and FusionDysphagiaACDF

Outcome Measures

Primary Outcomes (10)

  • Degree of Dysphagia Patients Experience (Burden)

    SWAL-QOL survey - Burden domain Score ranges between 0 and 100 (worst-best)

    Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

  • Degree of Dysphagia Patients Experience (Eating Desire)

    SWAL-QOL survey - Eating desire domain Score ranges between 0 and 100 (worst-best)

    Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

  • Degree of Dysphagia Patients Experience (Eating Duration)

    SWAL-QOL survey - Eating duration domain Score ranges between 0 and 100 (worst-best)

    Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

  • Degree of Dysphagia Patients Experience (Food Selection)

    SWAL-QOL survey - Food Selection domain Score ranges between 0 and 100 (worst-best)

    Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

  • Degree of Dysphagia Patients Experience (Communication)

    SWAL-QOL survey - Communication domain Score ranges between 0 and 100 (worst-best)

    Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

  • Degree of Dysphagia Patients Experience (Fear Swallow)

    SWAL-QOL survey - Fear swallow domain Score ranges between 0 and 100 (worst-best)

    Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

  • Degree of Dysphagia Patients Experience (Social)

    SWAL-QOL survey - Social domain Score ranges between 0 and 100 (worst-best)

    Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

  • Degree of Dysphagia Patients Experience (Mental)

    SWAL-QOL survey - Mental domain Score ranges between 0 and 100 (worst-best)

    Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

  • Degree of Dysphagia Patients Experience (Sleep)

    SWAL-QOL survey - Sleep domain Score ranges between 0 and 100 (worst-best)

    Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

  • Degree of Dysphagia Patients Experience (Fatigue)

    SWAL-QOL survey - Fatigue domain Score ranges between 0 and 100 (worst-best)

    Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

Secondary Outcomes (10)

  • Patient Reported Swallowing Difficulty Over 1 Year

    Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

  • Patients' Bazaz Dysphagia Score - Liquid

    Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

  • Patients' Bazaz Dysphagia Score - Solid

    Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

  • Patients' Neck Disability

    Pre-Op, Week 4-6, 3 Months, 6 Months, 12 Months

  • Patients' Pain Scores on the Visual Analog Scale - Neck Pain

    Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

  • +5 more secondary outcomes

Study Arms (2)

Treatment

EXPERIMENTAL

Procedure: Anterior Cervical Discectomy and Fusion. The treatment arm will receive 40 mg of Methylprednisolone Acetate delivered with a Hemostatic Matrix Kit prior to closure.

Drug: Methylprednisolone AcetateOther: Hemostatic Matrix Kit

Control

PLACEBO COMPARATOR

Procedure: Anterior Cervical Discectomy and Fusion. The control group will receive only a Hemostatic Matrix Kit prior to closure.

Other: Hemostatic Matrix Kit

Interventions

Methylprednisolone AcetateDRUG

Methylprednisolone Acetate is a corticosteroid known to reduce swelling and inflammation.

Also known as: Depo-Medrol
Treatment
Hemostatic Matrix KitOTHER

Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.

ControlTreatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient \> 18 years undergoing a 2-4 level Anterior Cervical Discectomy and Fusion

You may not qualify if:

  • Patients undergoing revision surgery
  • Pediatric patients
  • Trauma patients with cervical spine fractures
  • Patients with cancer
  • Patients with active infection
  • Patients with a known allergy to Methylprednisolone Acetate
  • Patients who refuse to participate
  • Non English speakers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Methylprednisolone Acetate

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

MethylprednisolonePrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Catherine Himo Gang
Organization
HospitalSS
gangh@hss.edu
917-260-4603

Study Officials

  • Todd Albert, MD

    Hospital for Special Surgery, New York

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2015

First Posted

September 3, 2015

Study Start

August 1, 2015

Primary Completion

November 12, 2020

Study Completion

November 12, 2021

Last Updated

July 10, 2023

Results First Posted

July 10, 2023

Record last verified: 2023-06