The Impact of Local Steroid Application on Dysphagia following an Anterior Cervical Discectomy and Fusion: Preliminary Results of a Prospectively, Randomized, Single Blind Trial

OBJECTIVEIntraoperative local steroid application has been theorized to reduce swelling and improve swallowing in the immediate period following anterior cervical discectomy and fusion (ACDF). Therefore, the purpose of this study was to quantify the impact of intraoperative local steroid application on patient-reported swallow function and swelling after ACDF.METHODSA prospective, randomized single-blind controlled trial was conducted. A priori power analysis determined that 104 subjects were needed to detect an 8-point difference in the Quality of Life in Swallowing Disorders (SWAL-QOL) questionnaire score. One hundred four patients undergoing 1- to 3-level ACDF procedures for degenerative spinal pathology were randomized to Depo-Medrol (DEPO) or no Depo-Medrol (NODEPO) cohorts. Prior to surgical closure, patients received 1 ml of either Depo-Medrol (DEPO) or saline (NODEPO) applied to a Gelfoam carrier at the surgical site. Patients were blinded to the application of steroid or saline following surgery. The SWAL-QOL questionnaire was administered both pre- and postoperatively. A ratio of the prevertebral swelling distance to the anteroposterior diameter of each vertebral body level was calculated at the involved levels ± 1 level by using pre- and postoperative lateral radiographs. The ratios of all levels were averaged and multiplied by 100 to obtain a swelling index. An air index was calculated in the same manner but using the tracheal air window diameter in place of the prevertebral swelling distance. Statistical analysis was performed using the Student t-test and chi-square analysis. Statistical significance was set at p < 0.05.RESULTSOf the 104 patients, 55 (52.9%) were randomized to the DEPO cohort and 49 (47.1%) to the NODEPO group. No differences in baseline patient demographics or preoperative characteristics were demonstrated between the two cohorts. Similarly, estimated blood loss and length of hospitalization did not differ between the cohorts. Neither was there a difference in the mean change in the scaled total SWAL-QOL score, swelling index, and air index between the groups at any time point. Furthermore, no complications were observed in either group (retropharyngeal abscess or esophageal perforation).CONCLUSIONSThe results of this prospective, randomized single-blind study did not demonstrate an impact of local intraoperative steroid application on patient-reported swallowing function or swelling following ACDF. Neither did the administration of Depo-Medrol lead to an earlier hospital discharge than that in the NODEPO cohort. These results suggest that intraoperative local steroid administration may not provide an additional benefit to patients undergoing ACDF procedures.■ CLASSIFICATION OF EVIDENCE Type of question: therapeutic; study design: randomized controlled trial; evidence: Class I.Clinical trial registration no.: NCT03311425 (clinicaltrials.gov)

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Faculty Opinions recommendation of The safety of addition of nitrous oxide to general anaesthesia in at-risk patients having major non-cardiac surgery (ENIGMA-II): a randomised, single-blind trial.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.718540124.793503374 ◽

2015 ◽

Author(s):

John Augoustides ◽

Sophia Cisler ◽

Elizabeth Valentine

Keyword(s):

At Risk ◽

Nitrous Oxide ◽

Cardiac Surgery ◽

General Anaesthesia ◽

Blind Trial ◽

Risk Patients ◽

Single Blind ◽

Single Blind Trial

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Faculty Opinions recommendation of The safety of addition of nitrous oxide to general anaesthesia in at-risk patients having major non-cardiac surgery (ENIGMA-II): a randomised, single-blind trial.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.718540124.793502113 ◽

2014 ◽

Author(s):

Peter Nagele

Keyword(s):

At Risk ◽

Nitrous Oxide ◽

Cardiac Surgery ◽

General Anaesthesia ◽

Blind Trial ◽

Risk Patients ◽

Single Blind ◽

Single Blind Trial

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Faculty Opinions recommendation of Drug-eluting stents in elderly patients with coronary artery disease (SENIOR): a randomised single-blind trial.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.732060494.793539280 ◽

2017 ◽

Author(s):

Paulus Kirchhof

Keyword(s):

Coronary Artery Disease ◽

Coronary Artery ◽

Elderly Patients ◽

Drug Eluting Stents ◽

Blind Trial ◽

Drug Eluting ◽

Artery Disease ◽

Single Blind ◽

Single Blind Trial

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Nonunion Rates After Anterior Cervical Discectomy and Fusion: Comparison of Polyetheretherketone vs Structural Allograft Implants

Neurosurgery ◽

10.1093/neuros/nyab079 ◽

2021 ◽

Author(s):

Won Hyung A Ryu ◽

Dominick Richards ◽

Mena G Kerolus ◽

Adewale A Bakare ◽

Ryan Khanna ◽

...

Keyword(s):

Smoking Status ◽

Posterior Instrumentation ◽

Patient Reported Outcome ◽

Anterior Cervical Discectomy ◽

Successful Outcome ◽

Cervical Discectomy ◽

Structural Allograft ◽

Modifiable Factors ◽

Patient Reported ◽

The Impact

Abstract BACKGROUND Although advances in implant materials, such as polyetheretherketone (PEEK), have been developed aimed to improve outcome after anterior cervical discectomy and fusion (ACDF), it is essential to confirm whether these changes translate into clinically important sustained benefits. OBJECTIVE To compare the radiographic and clinical outcomes of patients undergoing up to 3-level ACDF with PEEK vs structural allograft implants. METHODS In this cohort study, radiographic and symptomatic nonunion rates were compared in consecutive patients who underwent 1 to 3 level ACDF with allograft or PEEK implant. Prospectively collected clinical data and patient-reported outcome (PRO) scores were compared between the allograft and PEEK groups. Regression analysis was performed to determine the predictors of nonunion. RESULTS In total, 194 of 404 patients met the inclusion criteria (79% allograft vs 21% PEEK). Preoperative demographic variables were comparable between the 2 groups except for age. The rate of radiographic nonunion was higher with PEEK implants (39% vs 27%, P = .0035). However, a higher proportion of nonunion in the allograft cohort required posterior instrumentation (14% vs 3%, P = .039). Patients with multilevel procedures and PEEK implants had up to 5.8 times the risk of radiographic nonunion, whereas younger patients, active smokers, and multilevel procedures were at higher risk of symptomatic nonunion. CONCLUSION Along with implant material, factors such as younger age, active smoking status, and the number of operated levels were independent predictors of fusion failure. Given the impact of nonunion on PRO, perioperative optimization of modifiable factors and surgical planning are essential to ensure a successful outcome.

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