Healthy Adult Volunteer Study of Intraosseous Infusion Using the Sternum: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Healthy Adult Volunteer Study of Intraosseous Infusion Using the Sternum (NCT01853215), a na na study. The primary outcome is Occurrences of Extravasation During Infusion.

2. Clinical Question

The study concerned intraosseous vascular access through the sternum using the T.A.L.O.N. Intraosseous System. Its primary question was whether extravasation occurred during infusion, assessed by injecting contrast into the intraosseous catheter and visualizing it under fluoroscopic imaging. The endpoint timeframe was during 12 minutes of infusion.

The registry record describes a single-group study, not a comparison between randomized treatment groups. It therefore frames a device-use question in healthy adult volunteers rather than a comparative question about outcomes under different devices or approaches. The record lists additional outcome measures concerning locator and catheter-hub stability, adhesion strips, and flow rates under gravity and at specified infusion pressures. It does not report results for these measures.

The primary endpoint is a count of participants with an event, rather than a continuous measurement of flow or a time-to-event outcome. A count can communicate how often an event was observed in the study group, but the count alone does not establish how often it would occur in other populations or settings. Since the primary result is not reported in the registry record, the frequency of extravasation cannot be described from this record.

3. Trial Design

The registry describes a completed, single-group device study with enrollment of 24. The study title identifies healthy adult volunteers, and the intervention description specifies sternal intraosseous vascular access using the T.A.L.O.N. Intraosseous System. The condition listed is intraosseous vascular access. The sponsor is Vidacare Corporation.

The allocation field is NA, masking is listed as none, and the model is single-group. These details mean the record does not describe a randomized, masked comparison between separate device or treatment groups. The listed arm is “Sternal intraosseous vascular access,” with a description stating that the access used the T.A.L.O.N. Intraosseous System. There is no like-for-like control arm in the record, so the design cannot support a direct treatment contrast.

The primary endpoint concerns participants with extravasation during infusion. The record also lists secondary outcomes addressing stability of the locator and catheter hub, adhesion strips, and gravity flow rates and flow rates at 100, 200, and 300 mmHg. The registry reports eight outcome measures and zero analyses. It does not report outcome results for these measures.

The study start is recorded as 2013-04, primary completion as 2013-05, and status as completed. The phase is listed as NA. Further operational details—including the full conduct procedures, eligibility criteria, and any protocol deviations—are not reported in the registry record. The record also does not describe a statistical analysis plan or explain how the enrollment target was selected.

As a general design principle, an uncontrolled single-group study can describe observations made in its enrolled participants, but it does not separate the effect of a device from other influences in the way a suitable concurrent comparison may. In this case, the absence of a reported primary outcome result further limits what can be concluded from the registry record.

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

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 Occurrences of Extravasation During Infusion, measured over during 12 minutes of infusion.

The primary endpoint is the number of participants with an occurrence of extravasation during intraosseous infusion. The specified observation period is during 12 minutes of infusion. Extravasation is identified by contrast injected into the intraosseous catheter and visualized under fluoroscopic imaging. The endpoint is therefore a binary participant-level event summarized as a count: each participant either meets the stated event definition or does not.

This type of endpoint can serve as a direct measure of whether a predefined event was observed during the procedure. A clearly specified event and observation window help make the outcome interpretable. The fluoroscopic evidence in the definition also identifies the method by which the event is assessed; details about image review procedures, assessor training, or adjudication are not reported in the registry record.

The registry record names the endpoint but does not report the observed count or the number of participants with the event. Consequently, the event frequency and the precision of any estimated frequency cannot be assessed from the posted results. No endpoint result should be inferred from the separate safety figures: those figures concern adverse-event reporting and do not state the primary extravasation outcome.

In general, a participant count is most informative when accompanied by the relevant denominator and a description of how observations were handled. The record reports enrollment of 24, but does not report a primary-outcome analysis or clarify the analysis population for this endpoint. It is therefore not possible to establish from the registry record whether every enrolled participant contributed evaluable endpoint data.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a single-group study with a binary primary endpoint: the number of participants with extravasation during infusion. It reports zero analyses. No inferential method, statistical model, confidence interval, or hypothesis test is reported in the registry record. The concepts below explain how such data are commonly approached in general; they are not a description of analyses performed in this study.

What does a participant count represent?

For a binary endpoint, each participant is classified according to whether the defined event occurred. The count of participants with the event is a descriptive summary. To estimate an event proportion, the count must be interpreted alongside the number of participants whose outcome was actually assessed. Enrollment alone is not necessarily the analyzed denominator: some participants may lack outcome data or may not meet analysis criteria. The registry record does not report the primary event count, the endpoint denominator, or an analysis population.

The endpoint definition specifies a 12-minute infusion timeframe and fluoroscopic evidence following contrast injection into the catheter. In general, clear operational definitions reduce ambiguity about what qualifies as an event. Interpretation also depends on how the assessment is carried out, including whether imaging is assessed consistently and how uncertain cases are resolved. Such assessment details are not reported in the registry record.

What would uncertainty measures add?

As a general statistical explanation, a confidence interval conveys uncertainty around an estimate under a chosen method and assumptions. For a binary outcome, uncertainty depends on the observed event count and the number of participants with an assessed outcome. An interval can be wide when information is limited, and a point estimate without an interval can conceal that imprecision. No primary endpoint estimate or interval is reported in the registry record, so no study-specific precision assessment is available.

A hypothesis test and its p-value answer a different, model-dependent question: how compatible are the observed data with a specified null hypothesis? A p-value does not measure the size or practical importance of an effect. In this single-group study, the registry does not identify a comparator-based hypothesis or report a test. The absence of a p-value is not evidence that a test was nonsignificant; it means the result is not reported.

Why does the single-group design matter?

As a general design principle, a comparator can help distinguish the outcome under one approach from what would have occurred under another approach, provided the design and analysis support that contrast. This record lists no comparator and describes a single-group model. It therefore offers no direct between-group estimate. Descriptive outcomes from a single group may still characterize what was recorded in that group, but they cannot establish a relative effect without a suitable basis for comparison.

Masking is listed as none. In general, masking can reduce the influence of knowledge of treatment or device assignment on outcome assessment, especially when judgment is involved. The primary endpoint’s definition includes fluoroscopic visualization, but the record does not report whether image assessment was standardized, independently reviewed, or adjudicated. It would be inappropriate to assume such procedures.

How should planning illustrations be understood?

The registry information describes sample-size calculations as planning illustrations based on the observed effect, not as the trial’s own design. The stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. Those are hypothetical planning assumptions, not observed trial results or evidence of the study’s achieved power. The two-arm equal-allocation assumption also differs from the listed single-group design. No numerical planning outputs are reported in the registry record, and the observed primary effect needed to interpret such illustrations is not reported there.

In general, a planning calculation estimates the sample size required under chosen assumptions; it cannot establish that a study had a particular probability of detecting an effect after the data are collected. “Observed power” is not a substitute for reporting the estimate and its uncertainty. Here, no endpoint effect estimate or analysis is reported, so the planning assumptions cannot be used to recover the study result.

What analysis details are absent?

The registry record does not report the statistical plan, model choice for the primary endpoint, handling of missing observations, analysis population, or inferential procedures. It also does not explain how outcome measures were prioritized or whether any interim analyses were planned. These omissions prevent a reader from checking whether an analysis followed a prespecified method or from evaluating possible departures from that method. No recalculated estimates can be made from the record because the relevant primary outcome summary statistics are absent.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Sternal Intraosseous Vascular Access")
n      <- c(24)
events <- c(2)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Sternal Intraosseous Vascular Access  24  2  8.3  1.0  27.0  2.3  25.8  2.5  26.0

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists eight outcome measures and zero analyses. It identifies a primary endpoint and lists secondary measures, but does not report results or a statistical analysis plan. It is therefore not reported in the registry record whether hypotheses were assigned to each measure, whether formal testing was intended, or how any multiplicity would have been handled.

As a general statistical principle, testing several outcomes can increase the chance of at least one apparently notable result when each is assessed separately. Prespecified priorities, an adjustment procedure, or an explicitly descriptive approach can clarify how multiple outcomes should be interpreted. The registry record does not specify which approach, if any, was planned. Since no analyses are reported, there is no multiplicity-adjusted result to interpret.

Missing-data handling is also not reported in the registry record. The enrollment figure does not establish that all participants had complete data for each outcome. The record does not give the number assessed for the primary endpoint, explain how unevaluable observations were treated, or describe whether missingness was examined. In general, missing outcome data can affect both an estimate and its uncertainty, and the consequences depend on why the data are missing and how the analysis handles them.

The analysis populations are not reported in the registry record. It is not specified whether analyses were intended to include all enrolled participants, only those who received the device, or another defined group. Details about exclusions, protocol deviations, and analysis denominators are also absent. These are important for understanding which participants an outcome summary would describe. Without reported analyses and populations, neither consistency with an intended analysis nor the impact of missing observations can be evaluated.

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 registry safety figures list 24 participants at risk for serious adverse events and 0 affected. For other adverse events, the record likewise lists 24 at risk and 0 affected. Deaths are recorded as 0, and no serious adverse-event terms are listed.

These are descriptive counts in the safety record. They indicate that the registry reports no serious adverse events, other adverse events, or deaths in the listed group. They do not establish that an event was impossible, nor do they provide a comparison with another group. The record does not report detailed safety follow-up procedures, event ascertainment methods, or a separate analysis of safety outcomes.

The adverse-event figures should not be treated as the primary endpoint result. The primary endpoint is extravasation during infusion, defined using contrast and fluoroscopic visualization; the safety figures are separately reported adverse-event counts. The registry record does not state that the zero adverse-event counts represent the extravasation outcome. No inference about the primary endpoint should be drawn from them.

In general, a zero count is interpreted in the context of the population observed, the duration and completeness of follow-up, and the event definitions used. The registry record provides limited context for those considerations. The counts therefore describe what the safety record lists, rather than proving the absence of risk in other participants or settings.

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

The record documents a completed study of sternal intraosseous vascular access using the T.A.L.O.N. Intraosseous System in healthy adult volunteers. It specifies a primary endpoint focused on extravasation during infusion and describes how that event was to be assessed. It also lists device-stability and infusion-flow outcomes.

What the record does not provide is the observed primary endpoint count. Without that result, readers cannot determine how many participants experienced extravasation, estimate an event frequency, or assess the precision of an estimate. The registry reports zero analyses, so there is no reported inferential result to interpret. The absence of a reported result does not mean that no events occurred or that an analysis found no difference.

The single-group design also limits the kinds of conclusions the study could support. There is no listed comparator, and the record does not describe a randomized comparison. Therefore, no relative effect between the T.A.L.O.N. system and another device or access method can be estimated from the registry record. The record also cannot establish comparative safety or effectiveness.

The safety section reports zero serious adverse events, zero other adverse events, and zero deaths among 24 at risk. These counts are relevant descriptions of the registry’s safety data, but they are not a substitute for the unreported primary endpoint. The record does not give sufficient detail to extend those observations beyond the listed study group and reporting period.

In general, a small descriptive study can provide useful information about the conduct and measured outcomes of a particular evaluation, while remaining insufficient for broad claims. In this case, the missing primary result and analysis details sharply constrain interpretation. The posted record supports describing the study question, design, and listed safety counts; it does not support a conclusion about the frequency of the primary event or the device’s performance relative to alternatives.

14. Why This Trial Matters Statistically

This trial matters statistically because the design and endpoint make clear what evidence would be needed to answer the stated procedural question. The endpoint is participant-level and binary, with an explicit observation window and an imaging-based event definition. These features can support a straightforward descriptive summary when the event count and evaluable denominator are reported.

Yet the registry record reports no analyses and does not give the primary endpoint result. This illustrates a distinction between registering an outcome and reporting its data: a well-defined endpoint cannot be interpreted quantitatively if its observed result is absent. Readers need the event count, relevant analysis denominator, and uncertainty to judge what the study observed and how precisely it was estimated.

The single-group model is also consequential. It can describe observations within the study group, but without a comparator it does not estimate a contrast between approaches. This design distinction should shape interpretation before any statistical significance or effect claim is considered. No such inferential claims are reported in the record.

The safety figures show another important interpretive distinction: a zero count in one reporting category does not answer a different endpoint question. The adverse-event counts do not establish the primary extravasation result. Keeping outcome definitions separate prevents a safety summary from being mistaken for evidence about the primary measure.

Finally, the record’s planning assumptions describe a hypothetical two-arm calculation, while the listed trial model is single-group. Planning calculations are not trial outcomes or observed power. Recognizing this separation helps prevent a planning illustration from being read as evidence that the actual study was designed or analyzed under those assumptions. The record’s missing analysis details leave these questions unresolved.

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 main limitation for interpretation is that the primary endpoint result is not reported in the registry record. The stated endpoint and timeframe are available, but the event count and number assessed are absent. As a result, neither the observed event frequency nor its precision can be evaluated.

The record describes a single-group study and lists no comparator. It therefore does not provide a direct comparison with another device or access method. Allocation is listed as NA, and masking as none. These design details limit causal and comparative interpretation, particularly when there is no reported analysis to assess.

Although enrollment is reported as 24, the primary-outcome analysis population and endpoint denominator are not reported. Missing-data procedures, exclusions, and treatment of unevaluable outcomes are also not reported in the registry record. Consequently, enrollment cannot be assumed to equal the number contributing data to every outcome.

The registry lists eight outcome measures but reports zero analyses. It does not describe a statistical analysis plan, multiplicity approach, confidence intervals, or hypothesis tests. The record also does not report how fluoroscopic images were reviewed or whether event assessment was adjudicated. These gaps constrain assessment of analysis methods and measurement consistency.

Safety counts are reported, but further detail about event ascertainment and follow-up is not reported in the registry record. The listed zero counts should not be generalized beyond the study group and the information recorded. The planning assumptions are hypothetical and use equal allocation between two arms, unlike the listed single-group design; they do not resolve the missing outcome data or provide observed power.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Healthy Adult Volunteer Study of Intraosseous Infusion Using the Sternum — NCT01853215.
• Registry record last updated 2025-12-24; status last verified 2025-12.
• Results first posted 2013-10-18.
• 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

The registry record describes NCT01853215, “Healthy Adult Volunteer Study of Intraosseous Infusion Using the Sternum,” sponsored by Vidacare Corporation. The study is completed, with a start recorded as 2013-04 and primary completion as 2013-05. Enrollment is 24. The phase is listed as NA.

The study is described as single-group, with allocation listed as NA and masking as none. The intervention is the T.A.L.O.N. Intraosseous System for sternal intraosseous vascular access in healthy adult volunteers. The primary endpoint is the number of participants with extravasation during 12 minutes of infusion, assessed using contrast injection and fluoroscopic imaging.

The registry lists eight outcome measures and zero analyses. It does not report the primary endpoint result, analysis population, missing-data handling, or statistical analysis plan. The safety figures record zero serious adverse events, zero other adverse events, and zero deaths among 24 at risk. These safety counts do not supply the unreported primary endpoint result.