Effect of Local Intraoperative Steroid on Dysphagia After ACDF

• ClinicalTrials.gov Identifier: NCT03311425
• Recruitment Status: Active, not recruiting
• First Posted: October 17, 2017
• Last Update Posted: March 26, 2019
• Sponsor: Rush University Medical Center
• Information provided by (Responsible Party): Kern Singh, Rush University Medical Center

Tracking Information

• First Submitted Date: October 9, 2017
• First Posted Date: October 17, 2017
• Last Update Posted Date: March 26, 2019
• Actual Study Start Date: August 1, 2014
• Actual Primary Completion Date: June 27, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 16, 2017)

Change from baseline SWAL-QOL survey at 3 months [ Time Frame: 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.

Original Primary Outcome Measures (submitted: October 11, 2017)

Change from baseline SWAL-QOL survey at 3 months [ Time Frame: 3 months ]

In the postoperative period, patients will be asked to complete the SWAL-QOL survey at the 3 month follow up office visit.

• Change History: Complete list of historical versions of study NCT03311425 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: October 11, 2017)

• Change from Baseline Prevertebral Soft Tissue Swelling at 3 months [ Time Frame: 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 [ Time Frame: 1 year ]
  Any perioperative or postoperative adverse events will be recorded and evaluated between cohorts

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Prevention
• Condition: Dysphagia

Intervention

• Drug: Methylprednisolone
  Application of 40mg Depomedrol (methylprednisolone acetate) suspension into the retropharyngeal space prior to incision closure
• Drug: Dexamethasone
  Administration of 10mg Dexamethasone IV intraoperatively

Study Arms

• Active Comparator: Local Depomedrol plus IV dexamethasone
  Local intraoperative application of methylprednisolone (Depomedrol) plus standard systemic (IV) dexamethasone
  Interventions:

  • Drug: Methylprednisolone
  • Drug: Dexamethasone
• Placebo Comparator: IV dexamethasone
  Intraoperative systemic (IV) steroid (dexamethasone) only.
  Intervention: Drug: Dexamethasone

Publications *

• Caspar W, Barbier DD, Klara PM. Anterior cervical fusion and Caspar plate stabilization for cervical trauma. Neurosurgery. 1989 Oct;25(4):491-502.
• 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.
• Stewart M, Johnston RA, Stewart I, Wilson JA. Swallowing performance following anterior cervical spine surgery. Br J Neurosurg. 1995;9(5):605-9.
• Martin RE, Neary MA, Diamant NE. Dysphagia following anterior cervical spine surgery. Dysphagia. 1997 Winter;12(1):2-8; discussion 9-10.
• 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.
• 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.
• 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.
• 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.
• 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. Epub 2005 Feb 4.
• Lee JY BR, Furey CG, ., et al. Dysphagia after anterior cervical spine surgery: Pathophysiology, incidence, and prevention. Cervical Spine Research Society 2007.
• 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. Epub 2007 Jan 22.
• 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.
• 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.
• 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. Epub 2007 Mar 27.
• 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. Review.
• 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. Epub 2002 Dec 4.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: October 11, 2017): 104
• Original Actual Enrollment: Same as current
• Estimated Study Completion Date: September 13, 2020
• Actual Primary Completion Date: June 27, 2017 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03311425
• Other Study ID Numbers: 13092002
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Kern Singh, Rush University Medical Center
• Study Sponsor: Rush University Medical Center
• Collaborators: Not Provided

Investigators

• Principal Investigator: Kern Singh, MD; Rush University Medical Center

• PRS Account: Rush University Medical Center
• Verification Date: March 2019