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Effect of Local Intraoperative Steroid on Dysphagia After ACDF

NCT ID: NCT03311425

Last Updated: 2020-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-01

Study Completion Date

2019-07-20

Brief Summary

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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.

Detailed Description

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Postoperative dysphagia is a known complication of anterior cervical spinal fusion (ACF) surgery with a published incidence that ranges from 1.7% to 50.3%.1-9 The pathophysiology of post-operative dysphagia is not fully understood and is subject to further study. Postoperative dysphagia has been reported to improve with time with a mean incidence of 19.8% at 6 months, 16.8% at 12 months, and 12.9% at 24 months after ACDF. The investigator's standard of practice is to provide 10mg of dexamethasone IV intraoperatively in order to reduce postoperative prevertebral soft tissue swelling. Despite the growing popularity of ACDF procedures, there is a lack of clear evidence supporting the utilization of perioperative corticosteroids in the setting of an ACDF.

Conditions

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Dysphagia

Keywords

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Anterior cervical discectomy and fusion prevertebral swelling swallowing methylprednisolone intraoperative steroid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Local Depomedrol plus IV dexamethasone

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

Group Type ACTIVE_COMPARATOR

Methylprednisolone

Intervention Type DRUG

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

Dexamethasone

Intervention Type DRUG

Administration of 10mg Dexamethasone IV intraoperatively

IV dexamethasone

Intraoperative systemic (IV) steroid (dexamethasone) only.

Group Type PLACEBO_COMPARATOR

Dexamethasone

Intervention Type DRUG

Administration of 10mg Dexamethasone IV intraoperatively

Interventions

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Methylprednisolone

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

Intervention Type DRUG

Dexamethasone

Administration of 10mg Dexamethasone IV intraoperatively

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Allergies or other contraindications to medicines in the protocol including:

(a) Existing history gastrointestinal bleeding
* Existing history of dysphagia
* Current Smokers
* Cervical spine trauma
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rush University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Kern Singh

Professor of Orthopaedic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kern Singh, MD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

References

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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.

Reference Type BACKGROUND
PMID: 2797387 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1988583 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8561932 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8997826 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10382774 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12394659 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12435974 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15223936 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15692825 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 17321961 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16284596 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16189451 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17387522 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20407354 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12592551 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23821974 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29676673 (View on PubMed)

Other Identifiers

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13092002

Identifier Type: -

Identifier Source: org_study_id