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Effect of Local Intraoperative Steroid on Dysphagia After ACDF

Primary Purpose

Dysphagia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Methylprednisolone
Dexamethasone
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dysphagia focused on measuring Anterior cervical discectomy and fusion, prevertebral swelling, swallowing, methylprednisolone, intraoperative steroid

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Local Depomedrol plus IV dexamethasone

    IV dexamethasone

    Arm Description

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

    Intraoperative systemic (IV) steroid (dexamethasone) only.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Change from Baseline Prevertebral Soft Tissue Swelling at 3 months
    Prevertebral soft tissue swelling will be measured utilizing the standard of practice plain lateral radiographs that are obtained at the 3 month postoperative follow up office visit.The area of the prevertebral soft tissue density will be measured from the caudal border of C1 to the cranial end plate of C7 with a digital measuring instrument. These measurements will be compared to the preoperative measurements obtained utilizing the preoperative lateral plain radiographs which are also standard of practice.
    Adverse Events
    Any perioperative or postoperative adverse events will be recorded and evaluated between cohorts

    Full Information

    First Posted
    October 9, 2017
    Last Updated
    November 18, 2020
    Sponsor
    Rush University Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03311425
    Brief Title
    Effect of Local Intraoperative Steroid on Dysphagia After ACDF
    Official Title
    The Effects of Intraoperative Local and Systemic Corticosteroid Administration on Postoperative Dysphagia After Anterior Cervical Fusion
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1, 2014 (Actual)
    Primary Completion Date
    June 27, 2017 (Actual)
    Study Completion Date
    July 20, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rush University Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dysphagia
    Keywords
    Anterior cervical discectomy and fusion, prevertebral swelling, swallowing, methylprednisolone, intraoperative steroid

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    140 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Local Depomedrol plus IV dexamethasone
    Arm Type
    Active Comparator
    Arm Description
    Local intraoperative application of methylprednisolone (Depomedrol) plus standard systemic (IV) dexamethasone
    Arm Title
    IV dexamethasone
    Arm Type
    Placebo Comparator
    Arm Description
    Intraoperative systemic (IV) steroid (dexamethasone) only.
    Intervention Type
    Drug
    Intervention Name(s)
    Methylprednisolone
    Intervention Description
    Application of 40mg Depomedrol (methylprednisolone acetate) suspension into the retropharyngeal space prior to incision closure
    Intervention Type
    Drug
    Intervention Name(s)
    Dexamethasone
    Intervention Description
    Administration of 10mg Dexamethasone IV intraoperatively
    Primary Outcome Measure Information:
    Title
    Change from baseline SWAL-QOL survey at 3 months
    Description
    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.
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Change from Baseline Prevertebral Soft Tissue Swelling at 3 months
    Description
    Prevertebral soft tissue swelling will be measured utilizing the standard of practice plain lateral radiographs that are obtained at the 3 month postoperative follow up office visit.The area of the prevertebral soft tissue density will be measured from the caudal border of C1 to the cranial end plate of C7 with a digital measuring instrument. These measurements will be compared to the preoperative measurements obtained utilizing the preoperative lateral plain radiographs which are also standard of practice.
    Time Frame
    3 months
    Title
    Adverse Events
    Description
    Any perioperative or postoperative adverse events will be recorded and evaluated between cohorts
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kern Singh, MD
    Organizational Affiliation
    Rush University Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    2797387
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    1988583
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    8561932
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    8997826
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    10382774
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    12394659
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    12435974
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    15223936
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    15692825
    Citation
    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.
    Results Reference
    background
    Citation
    Lee JY BR, Furey CG, ., et al. Dysphagia after anterior cervical spine surgery: Pathophysiology, incidence, and prevention. Cervical Spine Research Society 2007.
    Results Reference
    background
    PubMed Identifier
    17321961
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    16284596
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    16189451
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    17387522
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    20407354
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    12592551
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23821974
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    29676673
    Citation
    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.
    Results Reference
    derived

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    Effect of Local Intraoperative Steroid on Dysphagia After ACDF

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