CEUS For Intraoperative Spinal Cord Injury: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for CEUS For Intraoperative Spinal Cord Injury (NCT05530798), a na na study. The primary outcome is Mean Change in Spinal Cord Contrast-Enhanced Ultrasound Signal Intensity Before and After Surgical Decompression.

2. Clinical Question

3. Trial Design

This is a single-group clinical study, not a randomized comparison. The registry lists allocation as NA, masking as none, and phase as NA. It records an enrollment of 20 and a completed status. The listed start date is 2023-12-01, and the primary completion date is 2025-08-01. The sponsor is Medical University of South Carolina.

The study concerns elective cervicothoracic posterior decompression in patients with chronic spinal cord compression. The registered intervention is Definity Perflutren Lipid Microsphere Ultrasound Contrast. CEUS images were obtained intraoperatively before and after decompression, with the primary outcome defined as the change in signal intensity at the decompressed segment. The stated timeframe is intraoperative, approximately 3 hours.

Because the design has one group, the pre-decompression measurement serves as the reference for the post-decompression measurement. It is not a comparison with participants who did not receive decompression or CEUS. Changes over the procedure therefore cannot, by themselves, separate the effects of decompression from other changes over time or procedural influences.

The registry describes goals of quantifying micro- and macrovascular changes, assessing whether CEUS-detected changes correlate with intraoperative neuromonitoring changes, and exploring prediction of postoperative neurological deficits and recovery. However, the record lists one outcome measure and no analyses. It does not report a statistical analysis plan, a control group, or results for these broader aims. The study’s registration also does not report a sample-size justification.

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.

Before assignment: No significant events occurred

Overall 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.

6. Primary Endpoint

The registry lists the primary outcome as Mean Change in Spinal Cord Contrast-Enhanced Ultrasound Signal Intensity Before and After Surgical Decompression, measured over Intra-operative (approximately 3 hours).

The primary endpoint is the mean change in spinal cord CEUS signal intensity between images taken before and after surgical decompression. Signal intensity, described as echogenicity, is quantified within the spinal cord at the decompressed segment and measured in dB/MHz/cm. The recorded timeframe is intraoperative, approximately 3 hours.

The registry interprets the direction of change: a positive value indicates increased perfusion signal after decompression, while a negative value indicates decreased perfusion signal. The endpoint is intended to quantify a change in an imaging signal rather than directly measure a neurological outcome. The study description presents CEUS as a way to visualize vascular features and to investigate whether signal changes relate to intraoperative neuromonitoring and postoperative neurological deficits.

As a general statistical point, a mean change summarizes the average direction and size of within-participant changes. It does not show how consistent those changes are across participants; that requires information about variability, such as the standard deviation, and ideally an interval estimate. The registry record defines the endpoint but does not report its numerical mean change or standard deviation, so the observed direction, magnitude, and precision cannot be assessed from the posted results.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry defines a continuous primary outcome: the mean change in CEUS signal intensity before versus after decompression, measured in dB/MHz/cm. The outcome parameter is a mean, and the listed measure of dispersion is the standard deviation. The record does not report the observed mean or standard deviation, and it lists no analyses. The statistical methods explain how such measures are generally interpreted; they are not a claim about analyses actually performed in this study.

What does a mean change describe?

For a before-and-after outcome, each participant has a measurement at each time point, and the change represents the post-decompression value relative to the pre-decompression value. The mean change describes the average of those participant-level changes. The registry’s sign convention gives that average a directional interpretation: a positive value means increased perfusion signal and a negative value means decreased perfusion signal.

A mean is useful for describing the central tendency, but it can conceal different patterns. Participants could have changes in a similar direction, or increases and decreases could offset one another. The mean alone cannot distinguish these possibilities. The standard deviation describes the spread of individual values around the mean, although it does not show every feature of the distribution. The record names standard deviation as the dispersion measure but does not post its value.

How should uncertainty be understood?

In general, a confidence interval gives a range of values compatible with the data and the method used to calculate it. Its width conveys precision: a narrower interval indicates greater precision under that method, while a wider interval indicates greater uncertainty. An interval for a mean change would help readers assess which directions and magnitudes remain compatible with the observed data. No confidence interval is reported in the registry record.

A p-value, when reported, addresses how compatible the data are with a specified null model under the assumptions of the test. It is not a measure of the size or importance of an effect, and it does not by itself establish that a signal change is meaningful. The record does not report a p-value or the statistical test used for the primary outcome.

What does the single-group design imply?

In general, paired measurements account for the fact that two observations come from the same participant. A paired analysis focuses on within-participant changes rather than treating the pre- and post-procedure observations as independent groups. This is a general explanation, not a statement that the registry confirms a particular test. The record does not report the primary analysis method, assumptions, or handling of any missing paired measurements.

Even a well-estimated average within-participant change is descriptive of the change across the measurement occasions. Without a separate comparison group, it cannot isolate the effect of decompression from all other influences that may change during the procedure. The record does not report a control group or a randomized allocation scheme.

What do the planning assumptions mean?

General planning illustrations use assumptions about the effect to detect, significance level, allocation, and statistical approximation. The planning note associated with this study describes a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and effects defined as fractions of the observed effect. It also distinguishes participant counts per arm from total event counts for time-to-event calculations. These are planning-illustration assumptions, not evidence that this single-group study was designed with two randomized arms. The record does not report the trial’s own sample-size justification.

Any planning calculation based on an observed effect is conditional on that effect estimate and on the chosen assumptions. If the outcome estimate is unavailable, the planning illustration cannot be independently interpreted from the registry information. Such planning counts are not observed power and do not describe participants actually enrolled in each arm.

Finally, statistical results depend on analysis choices, data completeness, and the assumptions of the chosen method. The registry does not report an analysis plan, interim analyses, a missing-data method, or model diagnostics. These omissions limit what can be said about how the primary endpoint was analyzed. They do not establish that a particular method was or was not used outside the information recorded in the registry.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Contrast Enhanced Ultrasound Arm")
n   <- c(20)
m   <- c(1.3)
sp  <- c(5.4)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Contrast Enhanced Ultrasound Arm  20  1.300  5.400  -1.227  3.827

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists one outcome measure and no analyses. It does not report a multiplicity adjustment, a hierarchy of outcomes, or a prespecified strategy for handling multiple statistical tests. The study description mentions broader aims involving CEUS-detected vascular changes, intraoperative neuromonitoring changes, and postoperative neurological deficits and recovery, but the registry does not provide results or analysis details for those aims. It is therefore not possible to determine whether multiple hypotheses were tested or how any such testing was handled.

The record does not describe missing-data frequency, reasons for missingness, an imputation method, or a sensitivity analysis. It also does not state the analysis population used for the primary endpoint. Although enrollment is 20, that does not establish how many participants contributed usable paired images or outcome data. The adverse-event record separately lists 20 at risk for the event categories shown, but that does not establish the endpoint analysis population.

As a general statistical matter, missing paired measurements can affect both the number of participants contributing to an estimate and the interpretation of the result. Different assumptions about missingness can lead to different analyses. Without the registry’s accounting of analyzed participants and missing observations, the impact cannot be assessed. No analysis population or missing-data approach is reported in the registry record.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The serious-adverse-event record lists 20 participants at risk in the Contrast Enhanced Ultrasound Arm and 0 affected by serious adverse events. It lists 20 at risk for other adverse events and 0 affected. The deaths count is 0, and no top serious-event terms are listed.

These are the counts recorded for this study; they should not be read as proof that an event is impossible or that the intervention is free of risk. A zero count means that no affected participants are recorded in the listed category in this registry entry. It does not establish what might occur in other settings or in a larger group. The record does not provide further detail about adverse-event definitions, collection procedures, observation duration, or whether all participants had complete safety follow-up.

The safety figures are also distinct from the primary CEUS signal-change outcome. They do not tell whether signal intensity increased or decreased, and they do not report postoperative neurological outcomes. The registry lists an intraoperative primary-outcome timeframe of approximately 3 hours, but does not state the safety follow-up timeframe.

13. What the Result Does, and Does Not, Mean

The study is registered as an investigation of intraoperative CEUS signal changes before and after decompression in chronic cervicothoracic spinal cord compression. Its primary endpoint is a mean change in signal intensity, with an explicit direction rule for interpreting positive and negative values. The record also describes an interest in the relation between vascular imaging changes, neuromonitoring, and postoperative neurological deficits.

What the record does not establish is the observed primary result. It contains no numerical mean change or standard deviation, and it lists no analyses. Thus, readers cannot determine from the posted results whether signal intensity rose or fell on average, how variable the changes were, or how precise an estimate might be. The stated research aims are not outcome findings.

The single-group before-and-after design also limits causal interpretation. A change between two measurements can be described, but without a separate control group it cannot by itself show that decompression caused the change. Nor can the stated aims demonstrate that CEUS detects injury, predicts deficit, or tracks recovery: no corresponding analyses or results are reported in the registry record.

More generally, a statistical result would need to be considered alongside its uncertainty, the measurement process, missing data, and the clinical context. Those details are not available in the record for the primary endpoint. The listed enrollment and completed status do not substitute for outcome estimates. The defensible interpretation is therefore limited to the study’s design, the outcome it intended to measure, and the reported safety counts—not an efficacy or predictive conclusion.

14. Why This Trial Matters Statistically

This study raises a statistical measurement question in a setting where repeated intraoperative observations may be useful: whether CEUS signal intensity changes across surgical decompression. The endpoint is explicitly quantitative and has a stated direction of interpretation. That makes it possible, in principle, to describe both the size and direction of a within-participant signal change rather than relying only on a qualitative description of imaging.

The design also illustrates why measurement and inference should be kept distinct. A before-and-after endpoint can characterize change over the measurement interval, while a claim about its cause or its ability to predict another outcome requires additional evidence and analysis. The registry describes potential relationships with neuromonitoring and postoperative neurological deficits, but does not report those analyses. Distinguishing the stated aims from reported findings is important when reading an exploratory clinical study.

Precision matters as much as direction. An average change is easier to interpret when accompanied by variability and an uncertainty interval, and associations are more assessable when their methods and results are reported. Here, the record defines a mean and standard deviation but does not include numerical endpoint results. This limits statistical interpretation even though the study is marked completed.

The entry is therefore relevant as a record of an imaging-based research question and a single-group design, while also illustrating the limits of a registry entry without posted outcome estimates. Its value for statistical interpretation depends on separating what was planned from what was reported, and on avoiding conclusions about clinical performance that the available results do not support.

15. 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 most immediate limitation for interpretation is that the registry record does not report the numerical primary endpoint result. Without the mean change, standard deviation, confidence interval, or p-value, the direction, magnitude, and precision of the signal change cannot be evaluated. The record lists no analyses, so it also does not show whether the stated secondary aims were assessed.

The study is single-group, with no separate control group and no masking. The primary outcome compares measurements before and after decompression, so it can describe change across those occasions but does not by itself isolate the effect of the procedure. The record does not report a statistical analysis plan, a sample-size justification, or interim analyses.

The registry lists enrollment of 20, but does not report the number of participants with complete paired CEUS measurements or identify the analysis population. Missing-data handling is not reported. The description also does not provide details about image-processing procedures, measurement reliability, or how the endpoint was evaluated beyond quantification of signal intensity at the decompressed segment. These details are not reported in the registry record and should not be assumed.

The stated aims include associations with neuromonitoring changes and postoperative neurological deficits and recovery, but the record does not report corresponding outcomes or analyses. The safety listing records zero affected participants for the event categories shown, yet provides no additional detail about event definitions or follow-up. Together, these gaps constrain conclusions about precision, reproducibility, predictive performance, and safety beyond the counts recorded.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: CEUS For Intraoperative Spinal Cord Injury — NCT05530798.
• Registry record last updated 2026-10-15; status last verified 2026-09.
• Results first posted 2026-09-04.
• 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.

19. Record Summary

NCT05530798, titled CEUS For Intraoperative Spinal Cord Injury, is a completed, single-group study sponsored by Medical University of South Carolina. The registry lists enrollment of 20, masking as none, allocation as NA, and phase as NA. The intervention is Definity Perflutren Lipid Microsphere Ultrasound Contrast.

The primary outcome is mean change in spinal cord CEUS signal intensity before and after decompression, measured in dB/MHz/cm during an intraoperative timeframe of approximately 3 hours. Positive change is defined as increased perfusion signal; negative change as decreased perfusion signal. The registry record does not report the numerical primary result or any analyses. It lists 0 serious adverse events, 0 other adverse events, and 0 deaths among 20 at risk in the listed arm.