Effect of Local Steroid Application on a Cervical Plate Versus Intravenous Steroids on Dysphagia Following Anterior Cervical Discectomy and Fusion (ACDF)

NCT02577991 | Completed Results

• 1 other identifier: STU00085674
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Local application of steroids in ACDF surgery will lead to decreased incidence of dysphagia compared to intravenous steroids or a control group

Conditions

Cervical Spine

Outcome Measures

Primary Outcomes (5)

• Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op

  Outcome measure used to measure the incidence and severity of postoperative trouble swallowing. Summative score of 10 questions (range 0-40) with each question scored 0-4 with higher scores indicating greater severity/frequency of difficulty or disability reported by the patient for the indicated activity; EAT-10 \>3 = dysphagia \& EAT-10 \>15 = severe dysphagia

  baseline, post op day 1, post op 2 weeks, post op 6 weeks, post op 3 months, post op 6 months, and post op 1 year.

• Percentage of Patients Reporting Abnormal Vocal Handicap Measured by the VHI-10 From Baseline Through 1 Year Post-Op

  Outcome measure used to measure the incidence and severity of postoperative trouble with hoarseness of voice; summative score of 10 questions (range 0-40) with each question scored 0-4 with higher scores indicating greater severity/frequency of disability or handicap reported by the patient. Reported as a percentage of patients in each group reporting an 'abnormal' VHI-10 score defined as a summative score \>11

  baseline, post op day 1, post op 2 weeks, post op 6 weeks, post op 3 months, post op 6 months, and post op 1 year.

• Neck Disability Index (NDI) Mean Percentage Score From Baseline Through 1 Year Post Op

  Outcome measure used to measure for neck pain that includes personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Summative scores for 10 questions (range 0-50) with each question scored 0-5 where higher scores for each question indicates greater extent of disability/difficulty for the associated activity. Reported as a mean percentage + standard deviation of difficulty/disability experienced by the patient.

  Obtained at baseline, post op day 1, post op 2 weeks, post op 6 weeks, post op 3 months, post op 6 months, and post op 1 year

• Median Visual Analog Scale Pain Score for Patients From Baseline Through 1 Year Post Op

  Most commonly utilized pain scale; scored 0-10 with higher values indicating increased severity of pain experienced by the patient

  Obtained at baseline, post op day 1, post op 2 weeks, post op 6 weeks, post op 3 months, post op 6 months, and post op 1 year; analyzed for all time points through 6 months post op

• Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score

  Outcome measure used to measure the incidence and severity of postoperative trouble swallowing

  Evaluated at baseline, post op day 1, post op 2 weeks, post op 6 weeks, post op 3 months, post op 6 months, and post op 1 year

Study Arms (3)

Control group

NO INTERVENTION

No steroid

IV steroid

EXPERIMENTAL

10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate

Drug: Decadron

Local steroid

EXPERIMENTAL

40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate

Drug: Triamcinolone

Interventions

Decadron DRUG

10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate

IV steroid

Triamcinolone DRUG

40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate

Local steroid

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients undergoing ACDF (single or multi-level) for the treatment of cervical radiculopathy or myelopathy
• All subjects must have given signed, informed consent prior to registration on study.

You may not qualify if:

• Patients undergoing revision surgery, any operations for trauma, infection, tumor
• Patients with general metabolic diseases such as rheumatoid arthritis, diabetes, chronic heart and renal diseases.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Medicine Department of Orthopaedic Surgery

Chicago, Illinois, 60611, United States

Location

Related Publications (6)

• Fountas KN, Kapsalaki EZ, Nikolakakos LG, Smisson HF, Johnston KW, Grigorian AA, Lee GP, Robinson JS Jr. Anterior cervical discectomy and fusion associated complications. Spine (Phila Pa 1976). 2007 Oct 1;32(21):2310-7. doi: 10.1097/BRS.0b013e318154c57e.

  PMID: 17906571 BACKGROUND

• Sanfilippo JA Jr, Lim MR, Jacoby SM, Laterra R, Harrop JS, Vaccaro AR, Hilibrand AS, Anderson DG, Albert TJ. "Normal" prevertebral soft tissue swelling following elective anterior cervical decompression and fusion. J Spinal Disord Tech. 2006 Aug;19(6):399-401. doi: 10.1097/00024720-200608000-00004.

  PMID: 16891973 BACKGROUND

• 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: 12592551 BACKGROUND

• Lee SH, Kim KT, Suk KS, Park KJ, Oh KI. Effect of retropharyngeal steroid on prevertebral soft tissue swelling following anterior cervical discectomy and fusion: a prospective, randomized study. Spine (Phila Pa 1976). 2011 Dec 15;36(26):2286-92. doi: 10.1097/BRS.0b013e318237e5d0.

  PMID: 22020609 BACKGROUND

• McAfee PC, Cappuccino A, Cunningham BW, Devine JG, Phillips FM, Regan JJ, Albert TJ, Ahrens JE. Lower incidence of dysphagia with cervical arthroplasty compared with ACDF in a prospective randomized clinical trial. J Spinal Disord Tech. 2010 Feb;23(1):1-8. doi: 10.1097/BSD.0b013e31819e2ab8.

  PMID: 20051917 BACKGROUND

• Belafsky PC, Mouadeb DA, Rees CJ, Pryor JC, Postma GN, Allen J, Leonard RJ. Validity and reliability of the Eating Assessment Tool (EAT-10). Ann Otol Rhinol Laryngol. 2008 Dec;117(12):919-24. doi: 10.1177/000348940811701210.

  PMID: 19140539 BACKGROUND

MeSH Terms

Interventions

Calcium Dobesilate; Triamcinolone

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Surabhi Bhatt
• Organization: Northwestern University Department of Orthopaedic Surgery

surabhi.bhatt@nm.org

312-472-6024

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 12, 2015
• First Posted: October 16, 2015
• Study Start: February 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: May 30, 2019
• Results First Posted: May 30, 2019

Record last verified: 2019-05

Locations

US (1)