NCT03311425

Brief Summary

The purpose of this study is to determine if the incidence and duration of postoperative dysphagia are improved in the participants receiving a local injection of methylprednisolone with systemic dexamethasone when compared to those receiving the usual systemic dexamethasone.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2014

Longer than P75 for phase_3

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, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 17, 2017

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2019

Completed
Last Updated

November 20, 2020

Status Verified

November 1, 2020

Enrollment Period

2.9 years

First QC Date

October 9, 2017

Last Update Submit

November 18, 2020

Conditions

Dysphagia

Keywords

Anterior cervical discectomy and fusionprevertebral swellingswallowingmethylprednisoloneintraoperative steroid

Outcome Measures

Primary Outcomes (1)

  • Change from baseline SWAL-QOL survey at 3 months

    In the postoperative period, patients will be asked to complete the SWAL-QOL survey at the 3 month follow up office visit. This will be compared to preoperative scores. Each survey is scored out of 100 with minimum score of 20 indicating severe dysphagia and 100 indicating no dysphagia/normal swallowing. As such, a greater decrease in SWAL-QOL score from preoperative (baseline) to 3 month visit indicates greater postoperative swallowing difficulty.

    3 months

Secondary Outcomes (2)

  • Change from Baseline Prevertebral Soft Tissue Swelling at 3 months

    3 months

  • Adverse Events

    1 year

Study Arms (2)

Local Depomedrol plus IV dexamethasone

ACTIVE COMPARATOR

Local intraoperative application of methylprednisolone (Depomedrol) plus standard systemic (IV) dexamethasone

Drug: MethylprednisoloneDrug: Dexamethasone

IV dexamethasone

PLACEBO COMPARATOR

Intraoperative systemic (IV) steroid (dexamethasone) only.

Drug: Dexamethasone

Interventions

MethylprednisoloneDRUG

Application of 40mg Depomedrol (methylprednisolone acetate) suspension into the retropharyngeal space prior to incision closure

Local Depomedrol plus IV dexamethasone
DexamethasoneDRUG

Administration of 10mg Dexamethasone IV intraoperatively

IV dexamethasoneLocal Depomedrol plus IV dexamethasone

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing a primary 1- to 3-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

You may not qualify if:

  • Allergies or other contraindications to medicines in the protocol including:
  • (a) Existing history gastrointestinal bleeding
  • Existing history of dysphagia
  • Current Smokers
  • Cervical spine trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (18)

  • Caspar W, Barbier DD, Klara PM. Anterior cervical fusion and Caspar plate stabilization for cervical trauma. Neurosurgery. 1989 Oct;25(4):491-502. doi: 10.1097/00006123-198910000-00001.

    PMID: 2797387BACKGROUND

  • Saunders RL, Bernini PM, Shirreffs TG Jr, Reeves AG. Central corpectomy for cervical spondylotic myelopathy: a consecutive series with long-term follow-up evaluation. J Neurosurg. 1991 Feb;74(2):163-70. doi: 10.3171/jns.1991.74.2.0163.

    PMID: 1988583BACKGROUND

  • Stewart M, Johnston RA, Stewart I, Wilson JA. Swallowing performance following anterior cervical spine surgery. Br J Neurosurg. 1995;9(5):605-9. doi: 10.1080/02688699550040882.

    PMID: 8561932BACKGROUND

  • Martin RE, Neary MA, Diamant NE. Dysphagia following anterior cervical spine surgery. Dysphagia. 1997 Winter;12(1):2-8; discussion 9-10. doi: 10.1007/pl00009513.

    PMID: 8997826BACKGROUND

  • Schneeberger AG, Boos N, Schwarzenbach O, Aebi M. Anterior cervical interbody fusion with plate fixation for chronic spondylotic radiculopathy: a 2- to 8-year follow-up. J Spinal Disord. 1999 Jun;12(3):215-20; discussion 221.

    PMID: 10382774BACKGROUND

  • Frempong-Boadu A, Houten JK, Osborn B, Opulencia J, Kells L, Guida DD, Le Roux PD. Swallowing and speech dysfunction in patients undergoing anterior cervical discectomy and fusion: a prospective, objective preoperative and postoperative assessment. J Spinal Disord Tech. 2002 Oct;15(5):362-8. doi: 10.1097/00024720-200210000-00004.

    PMID: 12394659BACKGROUND

  • Bazaz R, Lee MJ, Yoo JU. Incidence of dysphagia after anterior cervical spine surgery: a prospective study. Spine (Phila Pa 1976). 2002 Nov 15;27(22):2453-8. doi: 10.1097/00007632-200211150-00007.

    PMID: 12435974BACKGROUND

  • Smith-Hammond CA, New KC, Pietrobon R, Curtis DJ, Scharver CH, Turner DA. Prospective analysis of incidence and risk factors of dysphagia in spine surgery patients: comparison of anterior cervical, posterior cervical, and lumbar procedures. Spine (Phila Pa 1976). 2004 Jul 1;29(13):1441-6. doi: 10.1097/01.brs.0000129100.59913.ea.

    PMID: 15223936BACKGROUND

  • Yue WM, Brodner W, Highland TR. Persistent swallowing and voice problems after anterior cervical discectomy and fusion with allograft and plating: a 5- to 11-year follow-up study. Eur Spine J. 2005 Sep;14(7):677-82. doi: 10.1007/s00586-004-0849-3. Epub 2005 Feb 4.

    PMID: 15692825BACKGROUND

  • Lee JY BR, Furey CG, ., et al. Dysphagia after anterior cervical spine surgery: Pathophysiology, incidence, and prevention. Cervical Spine Research Society 2007.

    BACKGROUND

  • Lee MJ, Bazaz R, Furey CG, Yoo J. Risk factors for dysphagia after anterior cervical spine surgery: a two-year prospective cohort study. Spine J. 2007 Mar-Apr;7(2):141-7. doi: 10.1016/j.spinee.2006.02.024. Epub 2007 Jan 22.

    PMID: 17321961BACKGROUND

  • Riley LH 3rd, Skolasky RL, Albert TJ, Vaccaro AR, Heller JG. Dysphagia after anterior cervical decompression and fusion: prevalence and risk factors from a longitudinal cohort study. Spine (Phila Pa 1976). 2005 Nov 15;30(22):2564-9. doi: 10.1097/01.brs.0000186317.86379.02.

    PMID: 16284596BACKGROUND

  • Lee MJ, Bazaz R, Furey CG, Yoo J. Influence of anterior cervical plate design on Dysphagia: a 2-year prospective longitudinal follow-up study. J Spinal Disord Tech. 2005 Oct;18(5):406-9. doi: 10.1097/01.bsd.0000177211.44960.71.

    PMID: 16189451BACKGROUND

  • Vaidya R, Carp J, Sethi A, Bartol S, Craig J, Les CM. Complications of anterior cervical discectomy and fusion using recombinant human bone morphogenetic protein-2. Eur Spine J. 2007 Aug;16(8):1257-65. doi: 10.1007/s00586-007-0351-9. Epub 2007 Mar 27.

    PMID: 17387522BACKGROUND

  • Riley LH 3rd, Vaccaro AR, Dettori JR, Hashimoto R. Postoperative dysphagia in anterior cervical spine surgery. Spine (Phila Pa 1976). 2010 Apr 20;35(9 Suppl):S76-85. doi: 10.1097/BRS.0b013e3181d81a96.

    PMID: 20407354BACKGROUND

  • Pedram M, Castagnera L, Carat X, Macouillard G, Vital JM. Pharyngolaryngeal lesions in patients undergoing cervical spine surgery through the anterior approach: contribution of methylprednisolone. Eur Spine J. 2003 Feb;12(1):84-90. doi: 10.1007/s00586-002-0495-6. Epub 2002 Dec 4.

    PMID: 12592551BACKGROUND

  • Nam TW, Lee DH, Shin JK, Goh TS, Lee JS. Effect of intravenous dexamethasone on prevertebral soft tissue swelling after anterior cervical discectomy and fusion. Acta Orthop Belg. 2013 Apr;79(2):211-5.

    PMID: 23821974BACKGROUND

  • Haws BE, Khechen B, Narain AS, Hijji FY, Bohl DD, Massel DH, Mayo BC, Ahn J, Singh K. Impact of local steroid application on dysphagia following an anterior cervical discectomy and fusion: results of a prospective, randomized single-blind trial. J Neurosurg Spine. 2018 Jul;29(1):10-17. doi: 10.3171/2017.11.SPINE17819. Epub 2018 Apr 20.

    PMID: 29676673DERIVED

MeSH Terms

Conditions

Deglutition Disorders

Interventions

MethylprednisoloneDexamethasone

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Kern Singh, MD

    Rush University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Orthopaedic Surgery

Study Record Dates

First Submitted

October 9, 2017

First Posted

October 17, 2017

Study Start

August 1, 2014

Primary Completion

June 27, 2017

Study Completion

July 20, 2019

Last Updated

November 20, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share