Cervical Spine Clinical Trial
Official title:
A Prospective, Randomized Controlled Trial on the Effect of Local Steroid Application on a Cervical Plate Versus Intravenous Steroids on Dysphagia Following Anterior Cervical Discectomy and Fusion (ACDF)
NCT number | NCT02577991 |
Other study ID # | STU00085674 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 2014 |
Est. completion date | June 2017 |
Verified date | May 2019 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Local application of steroids in ACDF surgery will lead to decreased incidence of dysphagia compared to intravenous steroids or a control group
Status | Completed |
Enrollment | 80 |
Est. completion date | June 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Northwestern Medicine Department of Orthopaedic Surgery | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Northwestern University |
United States,
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View 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. Epub 2002 Dec 4. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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. | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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