Effects of Using the Duracore Splinting Device on Patient Outcomes Related to Chest Trauma: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Effects of Using the Duracore Splinting Device on Patient Outcomes Related to Chest Trauma (NCT04909463), a randomized na study. The primary outcome is FVC Change.

2. Clinical Question

3. Trial Design

The registry describes a randomized, single-masked, parallel-group study of a chest splinting device for patients with rib fractures. Its title identifies the device as the Duracore splinting device. The study was sponsored by CommonSpirit Health and is marked as terminated. The registry gives the study start as 2020-12-04 and the primary completion date as 2021-07-30. It records enrollment of 8 participants and notes that early termination followed the COVID-19 pandemic.

The four listed groups separate participants by fracture laterality and device assignment: unilateral fractures with no device, unilateral fractures with the device, bilateral fractures with no device, and bilateral fractures with the device. The registry lists outcome data for the two unilateral groups only. One participant contributed to the unilateral no-device group and two to the unilateral device group; the bilateral groups have no participants recorded for this endpoint. The record does not report further detail about the randomization procedure, masking procedures, or allocation concealment.

The primary outcome is FVC change, measured in liters, with the registry specifying a mean and standard deviation. The stated timeframe is 3 days of consistent measuring and a final measurement 24 hours prior to expected discharge. Secondary outcomes listed include length of stay, time to ambulation, injury severity score, day of admission, and vital capacity measurement via incentive spirometry. The registry lists 8 outcome measures, but the number of analyses posted is 0. It does not report the intended statistical analysis plan, sample-size justification, or additional details about study procedures.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Eight participants were enrolled before early termination of the study due to the COVID-19 pandemic. Three participants contributed data for this outcome measure. Two participants were assigned to the Unilateral Rib Fractures with Device Intervention group and one participant to the Unilateral Rib Fractures without Device group. Five participants withdrew early or were discharged without providing complete outcome data. Results are summarized only for participants who contributed data.

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.

Population: lack of available subjects due to the covid19 pandemic

6. Primary Endpoint

The registry lists the primary outcome as FVC Change, measured over 3 days of consistent measuring and a final measurement 24 hours prior to expected discharge.

The primary endpoint is change in forced vital capacity, or FVC, measured in liters. FVC is a measure of the volume of air that can be forcibly exhaled after a full inhalation. As a general clinical measurement, it can describe pulmonary function; in this study, the registry uses it to assess lung capacity over time among patients with rib fractures who did or did not receive the splinting device.

The registry describes repeated measurement over 3 days of consistent measuring, followed by a final measurement 24 hours prior to expected discharge. A change endpoint is intended to capture how a measurement shifts during a defined period, rather than only recording a single value. For a comparison to be interpretable, the definitions of the starting value, later values, and direction of change need to be clear. The registry’s description does not specify the formula used to define the change or how measurements at different time points were combined.

The posted endpoint summaries are means with standard deviations. They show a mean FVC change of 0.06 liters in the unilateral no-device group and 0.34 liters in the unilateral device group. These summaries represent only one participant and two participants, respectively. The small numbers limit how well the means characterize each group, and the record does not provide a comparative analysis or confidence interval. The values therefore describe the posted observations but do not, on their own, establish a precise difference between groups.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry characterizes the primary measure as continuous and reports a mean with a standard deviation for each group. A continuous outcome can take values along a scale, such as FVC measured in liters. A mean describes the arithmetic center of observed values, while the standard deviation describes how dispersed those observations are around the mean. These statistics are descriptive: they summarize the observations available, but they do not by themselves quantify uncertainty about a comparison between groups.

What does the standard deviation tell the reader?

As a general statistical concept, a standard deviation is a measure of spread among individual observations. A small standard deviation can indicate that observations are close to their mean, but it must be interpreted in light of the number of observations. Here, the unilateral no-device result is based on one participant and has a reported standard deviation of 0.0. That value cannot establish that FVC change is consistent among the broader population; there is only one observation in that group. The unilateral device result is based on two participants and has a standard deviation of 0.33. With such limited data, this is also an unstable estimate of variability.

Why is a group comparison not available?

A comparative analysis would ordinarily quantify the difference between groups and its uncertainty, using a method suited to the endpoint and trial design. The registry reports no analyses and indicates that values are missing or not estimable for a two-arm comparison of this continuous endpoint. It does not provide a confidence interval or p-value for the primary outcome. No analysis method, adjustment, or model is reported in the registry record. As a result, the descriptive group means should not be mistaken for a tested treatment contrast.

A confidence interval is, in general, a range calculated from data and a statistical method to express uncertainty around an estimate. It helps readers assess the precision of a group contrast. No confidence interval for the FVC comparison is reported. Without an interval or another comparative analysis, the precision of a difference between the two observed group means cannot be evaluated from the registry results. A numerical difference could be calculated from the displayed means, but that would not substitute for a prespecified analysis or an uncertainty estimate.

How should the design and analysis be distinguished?

The study is recorded as randomized, single-masked, and parallel-group. Those labels describe features of the planned design, but the registry record does not explain the specific randomization or masking procedures. The fact that a study is randomized does not remove the uncertainty caused by very few endpoint observations, nor does it create a comparative result when no analysis is posted. Interpretation depends both on how the trial was designed and on what data and analyses are available.

The endpoint is described as FVC change over time, but the registry record does not report the calculation used to form that change or the analysis of repeated measurements. It is therefore not possible to determine whether the recorded summaries represent a particular visit, an average across visits, or another summary of repeated measurements. The registry’s stated measurement timeframe is 3 days of consistent measuring and a final measurement 24 hours prior to expected discharge; this describes intended timing, not a reported analysis method.

What do the planning illustrations represent?

General sample-size planning uses assumptions about the effect a future study aims to detect, the significance level, allocation, and statistical method. The registry’s planning description states a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; it describes effects as fractions of the observed effect. Such figures are planning illustrations, not observed outcomes and not evidence that this trial had a particular probability of detecting an effect. The record does not report the study’s own sample-size justification. With only three participants contributing to the primary endpoint, planning values based on the observed effect should be treated cautiously, because the observed estimate is itself highly uncertain.

Over-dispersion is a general concern when observed data are more variable than a model assumes. For a continuous endpoint, an inaccurate estimate of spread can affect standard errors and confidence intervals. In this study the group sizes are too small to characterize variability reliably, and the registry does not report a model or comparative uncertainty calculation. The main statistical limitation is therefore not a choice among competing reported methods; it is the absence of a posted comparative analysis and the sparse outcome data available for describing the groups.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 8 outcome measures and names five secondary outcomes: length of stay, time to ambulation, injury severity score, day of admission, and vital capacity measurement via incentive spirometry. It reports 0 analyses. The record does not describe which outcomes were formally tested, whether any outcomes were prioritized beyond identifying FVC change as primary, or whether an adjustment for multiple comparisons was planned or used.

As a general statistical issue, examining several outcomes can increase the chance of finding an apparently notable result by chance if each is tested separately. A prespecified analysis plan can clarify how multiple outcomes are handled. No such plan is reported in the registry record, so readers cannot determine whether or how multiplicity was addressed. The listed secondary outcomes should not be treated as evidence of completed statistical tests.

Eight participants enrolled before early termination due to the COVID-19 pandemic, while three participants contributed data to the primary FVC outcome. The registry does not explain why the remaining enrolled participants did not contribute to that endpoint, or whether their data were unavailable, incomplete, or otherwise excluded. Missing-data methods and reasons for missing observations are not reported in the registry record.

The registry does not describe the analysis population, such as whether analyses were intended to follow randomized assignment or include only participants with observed measurements. It also does not report an approach to incomplete repeated measurements. Consequently, the posted endpoint counts should be understood as the participants contributing to that specific outcome, not as a complete account of all randomized participants or the planned analysis population.

11. 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 reports zero serious adverse events among those at risk in each listed group, and zero deaths in each group. It also records zero other adverse events among those at risk. The listed groups are unilateral rib fractures with no device, unilateral rib fractures with the device, bilateral rib fractures with no device, and bilateral rib fractures with the device. The numbers at risk are 3, 4, 1, and 0, respectively, for both serious and other adverse events.

These figures are counts recorded in the registry. A zero recorded event count means that no events of that category are posted for the listed group during the reported study period; it does not show that the true risk is zero. The group sizes are small, and one listed group has no participants at risk. The adverse-event denominators also do not match the primary endpoint contributing counts, and the registry does not explain the difference.

The record lists no serious adverse event terms. It does not provide additional detail about event definitions, follow-up duration for safety, or how events were collected. The figures therefore describe the posted safety counts, but they do not establish comparative safety or rule out uncommon events.

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

The main result is that the registry posts FVC change summaries for three participants in the unilateral rib fracture groups: one participant without device intervention and two with device intervention. Their respective mean changes are 0.06 liters and 0.34 liters. These values describe the observations recorded for those participants. They do not amount to a precise estimate of the difference between the device and no-device groups.

The study’s randomized, single-masked, parallel-group design identifies a comparative research question, but the registry reports no analysis for the primary endpoint. It gives no confidence interval or p-value for a group contrast. The uncertainty around any comparison is therefore not quantified in the posted primary results. With very few participants contributing and no bilateral participants recorded for this endpoint, the summaries cannot support a robust conclusion for the broader study population or for each of the four listed groups.

The values also do not establish whether the device changes FVC in a particular direction. The registry calls the measure FVC change but does not specify how change was calculated or coded. The summary statistics should not be interpreted as showing that the device works or does not work. They are incomplete descriptive results from an early-terminated study, not a definitive answer to the clinical question.

The safety counts show zero serious adverse events, zero other adverse events, and zero deaths in the posted group records. Given the small numbers at risk and the absence of additional safety-method detail, these observations cannot rule out adverse events or provide a reliable comparison of safety between groups.

In practical statistical terms, the record documents what was observed for a small subset of enrolled participants and identifies important gaps in comparative estimation. It does not establish a treatment effect, its precision, or its clinical importance. Additional outcome data and a reported analysis would be needed to address those questions; the registry does not report such evidence for this trial.

13. Why This Trial Matters Statistically

This trial illustrates why a randomized design and a comparative question do not guarantee an interpretable comparative result. The registry identifies a randomized, single-masked, parallel-group study, yet only three participants contributed to the primary FVC outcome and no analysis is posted. The group means remain descriptive, and the precision of a contrast cannot be assessed from the available primary results.

It also illustrates the importance of separating enrollment from endpoint contribution. The registry records eight enrolled participants, but the primary outcome includes three. Those counts answer different questions: enrollment describes the study’s recorded size, while endpoint contribution describes the participants represented in the primary summaries. The record does not explain the difference, making transparent accounting of participant flow and missing measurements especially important.

The four listed groups distinguish fracture laterality as well as device assignment, but primary outcome data appear only in the two unilateral groups. This limits what can be learned about the bilateral groups and underscores the need to read subgroup summaries in light of their actual data. A mean and standard deviation can look complete as a summary format, even when there are too few observations to support a stable estimate.

Finally, early termination due to the COVID-19 pandemic and the absence of a reported analysis plan leave uncertainty about what could be answered as intended. The record does not report a sample-size justification or analysis strategy. These are not minor details: they help readers understand whether a study was designed and analyzed to estimate a meaningful contrast. The trial is statistically instructive because it makes the distinction between recorded observations and reliable comparative evidence especially clear.

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 most direct limitation is the very small number of participants contributing to the primary outcome: one in the unilateral no-device group and two in the unilateral device group. The summaries are consequently sensitive to the observations of individual participants and provide little basis for estimating group variability. The reported standard deviation of 0.0 in the one-participant group should not be read as evidence that responses are uniform in the population.

The registry records eight participants enrolled before early termination due to the COVID-19 pandemic, but only three contributed data to the primary FVC outcome. The reasons the other enrolled participants are not represented in the endpoint summaries are not reported in the registry record. Participant flow, the extent of missing measurements, and any methods for handling incomplete data are not described.

Although four groups are listed, outcome data are posted only for the two unilateral groups. There are no primary endpoint observations listed for either bilateral group. The registry therefore cannot provide a four-group comparison or show whether any observed pattern differs by fracture laterality. The brief primary outcome population description is incomplete in the record, so details beyond the listed group summaries should not be inferred.

The endpoint description does not specify how FVC change was calculated from the repeated measurements. No comparative estimate, confidence interval, p-value, or statistical analysis method is posted. The registry also does not report a sample-size justification, a detailed analysis plan, analysis populations, or a multiplicity approach. These gaps limit interpretation of both the primary endpoint and the listed secondary outcomes.

Finally, the adverse-event counts are sparse, and further safety definitions and collection methods are not reported. Zero posted events cannot establish absence of risk. Together, early termination, few endpoint observations, incomplete reporting, and no posted analysis prevent precise conclusions about comparative outcomes.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Effects of Using the Duracore Splinting Device on Patient Outcomes Related to Chest Trauma — NCT04909463.
• Registry record last updated 2025-05-14; status last verified 2025-04.
• Results first posted 2025-05-14.
• 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.

18. Record Summary

The registry describes a randomized, single-masked, parallel-group study of the Duracore splinting device in patients with rib fractures. It records 8 participants enrolled and early termination due to the COVID-19 pandemic. The primary endpoint is mean change in FVC, measured in liters over the stated period of 3 days of consistent measuring and a final measurement 24 hours prior to expected discharge.

Three participants contributed to the primary endpoint: one in the unilateral no-device group and two in the unilateral device group. The posted mean changes are 0.06 liters and 0.34 liters, respectively. No primary comparative analysis is posted, and the bilateral groups have no participants recorded for this outcome. The registry lists five secondary outcomes, 8 outcome measures, and 0 analyses. Safety records list zero serious adverse events, other adverse events, and deaths in the groups. The small endpoint counts and missing comparative analysis mean the posted results are descriptive and imprecise.