This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Effect of Intravenous Corticosteroid Injections on Dysphagia After Cervical Spine Surgery (NCT02266797), a randomized phase 3 study. The primary outcome is Intravenous Corticosteroids Effect on Post-operative Dysphagia.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02266797 |
| Phase | Phase 3 |
| Condition | Dysphagia After Anterior Cervical Decompression and Fusion of the Spine |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 4 |
| Arms in the primary outcome | n/a |
| Lead sponsor | NYU Langone Health |
| Results posted | Yes |
2. Clinical Question
Population
Patients undergoing anterior cervical spine surgery were the intended study population. The condition of interest was dysphagia after anterior cervical decompression and fusion. The registry reports enrollment of 4, but does not provide the primary-outcome data for the enrolled population; it attributes their unavailability to premature halting of the study.
Intervention
The intervention was intravenous dexamethasone, a corticosteroid. The planned regimen began before the incision, with subsequent doses 8 and 16 hours after the first dose. The first dose was 0.3 mg/kg and each subsequent dose was 0.15 mg/kg.
Comparator
The comparison group was to receive intravenous physiological saline. This is the placebo-controlled comparison described in the registry record. The record does not give enough primary-outcome information to compare the groups’ dysphagia outcomes.
Primary question
The study asked whether perioperative intravenous corticosteroids affected postoperative dysphagia after anterior cervical spine surgery. Dysphagia severity was to be assessed with questionnaires and a postoperative swallow evaluation; a videofluoroscopic swallow study could also be performed if recommended by the swallowing expert. The stated primary-outcome timeframe was 12 months. No primary-outcome result is reported in the registry record.
3. Trial Design
The registry describes a randomized, triple-masked, parallel-group, placebo-controlled Phase 3 study sponsored by NYU Langone Health. The planned comparison was intravenous dexamethasone versus intravenous saline in patients undergoing anterior cervical spine surgery. The record lists the study as terminated and reports enrollment of 4. Its start is recorded as 2013-11, and its primary completion date as 2015-09-01.
The dexamethasone regimen was described as a first dose before the incision, followed by doses 8 and 16 hours after the first dose. The first dose was 0.3 mg/kg, and each subsequent dose was 0.15 mg/kg. The saline group was to receive intravenous physiological saline. Although the registry identifies the study as randomized and triple-masked, further details about how the allocation sequence was generated, concealed, or implemented are not reported in the registry record. The identities of the parties included in masking are also not reported in the registry record.
The registry names postoperative dysphagia as the primary outcome and gives a 12-month timeframe. It also lists secondary questions concerning aspiration, postoperative nausea, radicular pain, and surgical outcomes such as fusion rates. The record does not include primary-outcome data, and it lists no analysis entries. It does not report why the study was terminated or provide a detailed account of the conduct of the trial. Therefore, the design features identify the intended comparison, but the registry record does not support a numerical estimate of the treatment-group difference.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Dexamethasone | Saline |
|---|---|---|
| STARTED | 1 | 3 |
| COMPLETED | 1 | 2 |
| NOT COMPLETED | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: Data not available due to premature halting of study
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Dexamethasone | Saline | Total |
|---|---|---|---|---|
| Participants analysed | 1 | 3 | 4 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 1 | 3 | 4 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Female | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Male | Participants | 1 | 3 | 4 |
| Region of Enrollment: United States | participants | 1 | 3 | 4 |
6. Primary Endpoint
The registry lists the primary outcome as Intravenous Corticosteroids Effect on Post-operative Dysphagia, measured over 12 months.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint concerned the severity of dysphagia after anterior cervical spine surgery. The planned assessment included dysphagia questionnaires and a postoperative swallow evaluation by a licensed swallowing expert. If that expert recommended further assessment, a videofluoroscopic swallow study could be performed. The registry gives a primary-outcome timeframe of 12 months, while the described swallow evaluation was to occur two weeks after surgery.
Dysphagia is the outcome of interest because the study was designed to examine swallowing problems after the specified surgery and whether the assigned study treatment affected their development or severity. Combining questionnaire information with an expert evaluation could capture reported symptoms as well as findings from an assessment of swallowing. A videofluoroscopic study was described as conditional on the expert’s recommendation, rather than as an assessment for every participant. The registry does not state the questionnaire instruments, scoring rules, definition of a clinically important change, or method for combining assessment components. It reports that primary-outcome data were unavailable because the study halted prematurely. No endpoint values, treatment-group comparison, or measure of precision are reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record does not report a numerical primary-outcome result. It states that dysphagia data were unavailable because the study halted prematurely. Consequently, the record does not establish the direction or size of any difference between dexamethasone and saline for postoperative dysphagia. It also gives no primary-outcome estimate, confidence interval, or p value. Those omissions prevent an assessment of how precisely the intended treatment comparison was estimated.
Enrollment was 4, but that figure does not substitute for an outcome comparison. Without outcome values, group-specific dysphagia results, or a reported analysis, enrollment alone cannot show whether the groups differed. The registry’s listed safety counts are a separate kind of information and cannot be used to infer the primary endpoint. They describe adverse-event reporting, not dysphagia severity.
The study’s randomized and masked design describes how the trial was intended to compare treatments. Those design features do not produce an interpretable treatment estimate when the primary outcome is unavailable. Nor does the record explain why the trial was terminated, whether there were changes to its conduct, or whether any unregistered analyses were performed. Such details are not reported in the registry record and should not be inferred from the termination status.
The registry lists secondary questions about aspiration, postoperative nausea, radicular pain, and surgical outcomes, including fusion rates. It does not provide results for these questions in the record. The record lists six outcome measures, but an outcome list is not evidence that results were collected or analyzed. It also lists no analysis entries. The posted information therefore supports a description of the study’s aims and planned assessments, but not conclusions about observed treatment differences.
In general, an estimate describes the observed contrast between groups, while a confidence interval indicates the range of values compatible with the data under the analysis assumptions. Neither can be interpreted without a reported estimate and its uncertainty. Because the registry supplies neither for the primary endpoint, the precision of the intended comparison cannot be evaluated. The absence of a reported result should not be treated as evidence that the treatments were equivalent or that no difference existed.
9. Statistical Methods Explained
The registry identifies a randomized, triple-masked, parallel-group comparison of dexamethasone and saline. These labels describe the planned trial structure, not the statistical analysis used to estimate an outcome. The registry record does not report an analysis method, and it lists no analysis entries. The primary endpoint is described through multiple assessment components and a stated 12-month timeframe, but no single numerical comparison is reported.
What does randomization contribute?
In general, randomization assigns participants to treatment groups using a chance-based process. When implemented as planned, it aims to make the groups comparable with respect to factors that could influence outcomes, including factors that were not measured. That aim depends on the actual allocation process and on the availability of outcome data. The record labels this study randomized, but details of sequence generation and allocation concealment are not reported in the registry record. With primary-outcome data unavailable, randomization cannot be used to recover a treatment contrast from the enrollment figure alone.
What does masking mean for interpretation?
In general, masking is intended to limit the influence of knowledge about assigned treatment on care, outcome assessment, or reporting. The registry labels the study triple-masked, but does not specify which roles were masked or describe how masking was maintained. The saline comparator is identified as intravenous physiological saline. These design descriptions may be relevant to how the trial was intended to reduce bias, but they do not establish that masking was successful or permit evaluation of a treatment effect.
How should the endpoint be understood statistically?
The planned dysphagia assessment included questionnaires and an evaluation by a licensed swallowing expert two weeks after surgery. A videofluoroscopic swallow study was to be conducted if the expert recommended it. The registry gives 12 months as the primary-outcome timeframe. These details describe a set of intended observations, but the record does not report the scales, scoring procedures, outcome definition, or rules for summarizing the assessment components. Without those details and observed results, it is not possible to identify a specific estimand or reproduce a comparison from the record.
In general, an estimand is the precise treatment contrast a trial intends to quantify for a defined population, outcome, and time point. Clear specification matters when an endpoint has more than one component or assessment occasion. The registry’s primary outcome is not reduced to a single comparison, and no numerical endpoint estimate is reported. This limits interpretation beyond the broad question of whether the study intended to assess dysphagia after surgery.
What can a confidence interval or p value tell readers?
In general, a confidence interval conveys uncertainty around an estimate under the assumptions of the analysis. A p value describes how compatible the observed data are with a specified null hypothesis and model; it does not measure the size or clinical importance of an effect. Either quantity must be interpreted alongside the underlying estimate, the outcome definition, and the analysis plan. No primary-outcome estimate, confidence interval, or p value is reported in the registry record, so none can be interpreted for this comparison.
Can planning calculations replace trial results?
General sample-size calculations can illustrate the number of participants per arm that might be needed under stated assumptions, such as a target power, significance level, allocation scheme, and effect size. They are planning illustrations, not observed results and not evidence that a trial had a particular probability of detecting an effect. The registry record does not report a trial-specific statistical plan or sample-size justification. Because the primary outcome is unavailable and no numerical observed effect is reported in the record, no planning calculation can serve as an estimate of what the treatment comparison showed.
For interpretation, the key statistical distinction is between a trial design and an analyzed result. The design describes the intended allocation and outcome assessment; an analysis requires observed outcome data and a stated approach to comparison. Here, the registry describes the former but does not report the latter for the primary endpoint. The record therefore supports methodological description, not a reconstructed treatment estimate.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists the primary dysphagia outcome and secondary questions about aspiration, postoperative nausea, radicular pain, and surgical outcomes such as fusion rates. It also reports six outcome measures. When a study evaluates multiple outcomes or assessment components, general statistical practice must address how the questions will be prioritized and how the chance of false-positive findings will be considered. The registry record does not report a multiplicity strategy, a hierarchy among the secondary outcomes, or an adjustment method. No outcome-specific analyses are listed, so the record does not permit assessment of how multiplicity was handled in practice.
The primary outcome includes questionnaires and a swallow evaluation, with videofluoroscopic assessment conditional on expert recommendation. The registry does not report rules for handling differing assessment availability, combining components, or choosing among time points. These are relevant because outcome definitions and assessment procedures affect which observations enter a comparison. The record also does not describe its missing-data methods, including how incomplete questionnaires or unevaluated participants would have been handled. It reports that primary-outcome data were unavailable because the study halted prematurely.
The analysis populations are not reported in the registry record. It does not state whether an intention-to-treat, per-protocol, or other population was specified, nor how participants with incomplete follow-up would be treated. The record lists no analysis entries. These limitations mean readers cannot determine which participants were intended to contribute to an outcome estimate, whether missingness was examined, or whether the planned handling of multiple outcomes was prespecified. These details should not be inferred from the randomized design or from the registry’s outcome list.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Dexamethasone | 0 | 1 | 0.0% |
| Saline | 0 | 3 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Dexamethasone | 0 of 1 |
| Saline | 0 of 3 |
The registry lists serious adverse events and other adverse events separately for the dexamethasone and saline groups. For dexamethasone, 1 participant was listed as at risk for serious adverse events and 0 as affected; for other adverse events, 1 was listed as at risk and 0 as affected. For saline, 3 were listed as at risk for serious adverse events and 0 as affected; for other adverse events, 3 were listed as at risk and 0 as affected. The registry lists no serious adverse-event terms.
These figures are counts in the registry’s adverse-event record. They should be read with their listed at-risk groups, rather than as rates or as a complete description of safety. The record does not report the basis for the different at-risk counts, a detailed adverse-event collection period, or a statistical comparison of safety between groups. The death fields are not reported in the registry record. A zero affected count in the listed groups does not establish that an event could not occur, and these safety entries do not answer the primary dysphagia question. Given the study’s enrollment of 4 and lack of primary-outcome data, the adverse-event counts are limited descriptive information, not a basis for broad safety conclusions.
12. What the Result Does, and Does Not, Mean
The registry documents an intended randomized, masked comparison of intravenous dexamethasone with saline for dysphagia after anterior cervical spine surgery. It describes the dexamethasone dosing schedule, the planned dysphagia assessments, and a 12-month primary-outcome timeframe. It also records that the study was terminated and that primary-outcome data were unavailable because it halted prematurely. These registry entries describe the research question and the limits of the posted results.
The record does not show whether dysphagia severity was lower, higher, or similar between the treatment groups. It does not report an effect estimate or a measure of uncertainty, and it gives no basis for evaluating statistical significance or clinical importance. Enrollment of 4 does not reveal the outcome distribution or establish what the randomized comparison would have shown. The absence of reported primary results is not evidence of no treatment difference.
The registry also does not report results for the listed secondary questions about aspiration, nausea, radicular pain, or surgical outcomes. The adverse-event entries describe zero affected participants in the at-risk groups recorded for each category, but these counts are limited to the registry’s entries and do not supply the missing dysphagia result. They should not be treated as an overall evaluation of treatment safety.
In general, randomized design can support a fair comparison when allocation and follow-up are carried out as intended and when outcomes are measured and analyzed. The record does not include the outcome data or analysis details needed to judge those conditions for this study. The defensible conclusion is therefore about the state of the evidence in the registry: the intended question is clear, but the posted record does not provide an answer to it.
13. Why This Trial Matters Statistically
This study is statistically notable because its randomized and masked design is paired with an unavailable primary outcome. A trial’s design can specify a useful comparison, but statistical interpretation depends on observed outcomes and an analysis that makes the comparison explicit. Here, the registry describes both treatment strategies and the planned dysphagia assessments, yet reports no primary-outcome data because the study halted prematurely.
The record also illustrates why enrollment alone is not an outcome result. A participant count cannot show the direction, magnitude, or precision of a treatment contrast. Without group-specific dysphagia results, readers cannot assess whether the planned questionnaires and swallowing evaluations yielded a discernible difference. Nor can they distinguish a small, imprecise estimate from a larger estimate when no estimate is reported.
The endpoint itself raises general analysis considerations: it involves questionnaires, expert assessment, a conditional videofluoroscopic study, and a stated 12-month timeframe. For a result to be interpreted, a clear outcome definition and rules for summarizing these assessments would matter. The registry does not report those statistical details, or an analysis plan that explains how multiple outcomes would be handled.
For clinical researchers and biostatisticians, the record is a reminder to separate intended methods from reported evidence. Randomization and masking are important design properties, but they do not compensate for missing outcome results. Clear reporting of termination, analysis populations, missing-data handling, outcome definitions, and estimates with uncertainty would be needed to make the intended comparison assessable. The registry record leaves these questions unresolved.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The central limitation is that the registry reports no primary-outcome data, attributing their unavailability to premature halting of the study. As a result, the intended treatment comparison cannot be estimated or assessed for precision. The record lists enrollment of 4 but does not provide group-specific primary-outcome observations, participant flow, or follow-up completion information.
The registry does not report why the study was terminated, whether any changes were made to its planned conduct, or whether results were analyzed outside the registry. It also does not give a statistical analysis plan, a sample-size justification, a specified analysis population, or methods for handling missing outcome data. No primary-outcome estimate, confidence interval, or p value appears in the record. The design labels alone do not answer these questions.
The outcome description leaves important measurement details unspecified: the questionnaire instruments and scoring, the rule for defining dysphagia severity, and how the expert evaluation and conditional videofluoroscopic study would contribute to a summary. The registry states a 12-month timeframe and describes a two-week postoperative swallow evaluation, but does not explain the relationship between these assessment points in a statistical analysis. Multiplicity procedures for the listed outcomes are also not reported in the registry record.
Finally, safety information is limited to the listed affected and at-risk counts. The record does not report death counts, detailed event terms, or a statistical safety comparison. These limitations constrain interpretation to the study’s intended design and the specific registry entries; they do not establish what the full trial data may or may not contain.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Effect of Intravenous Corticosteroid Injections on Dysphagia After Cervical Spine Surgery — NCT02266797.
- Registry record last updated 2018-10-25; status last verified 2018-09.
- Results first posted 2016-03-14.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry describes a Phase 3, randomized, triple-masked, parallel-group, placebo-controlled study sponsored by NYU Langone Health. It compared a planned intravenous dexamethasone regimen with intravenous saline for dysphagia after anterior cervical spine surgery. The first dexamethasone dose was 0.3 mg/kg before incision, followed by 0.15 mg/kg doses 8 and 16 hours after the first dose.
The primary outcome was dysphagia severity, assessed through questionnaires and a postoperative swallow evaluation, with videofluoroscopic assessment if recommended. The stated timeframe was 12 months. The record reports enrollment of 4 and a terminated status. It states that primary-outcome data were unavailable because the study halted prematurely and lists no analysis entries. Secondary questions concerned aspiration, postoperative nausea, radicular pain, and surgical outcomes. The posted record therefore describes the trial’s aim and design but does not report a numerical primary-outcome comparison.