Safety and Efficacy Study of the Treatment of Humerus Fractures: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Safety and Efficacy Study of the Treatment of Humerus Fractures (NCT02394080), a na na study. The primary outcome is Normal Radiographic Fracture Healing.

2. Clinical Question

The central statistical question is descriptive: how many participants met the registry’s radiographic definition at the stated follow-up? A count can describe the observed outcome in the analyzed participants, but it does not by itself estimate what would have happened to the same participants under another treatment. The record identifies no comparator group, so there is no within-trial treatment contrast for the primary outcome.

The study’s stated purpose was to collect safety and performance data for PBSS when used to stabilize and align acute humerus fractures. Other listed outcomes concern radiographic healing, pain, function, mobility, and range of motion. Those measures broaden the clinical description, but their existence does not establish that results were reported for each one. The primary outcome count and its statistical uncertainty are not reported in the registry record.

3. Trial Design

NCT02394080 is a completed, single-group study sponsored by IlluminOss Medical, Inc. The registry lists enrollment of 44 and the intervention as the Photodynamic Bone Stabilization System. The study’s official title describes it as a CE Marking Study of the system for humerus fractures; its brief summary says the purpose was to collect safety and performance data in acute humerus fractures.

The record identifies allocation as NA, masking as none, and the model as single group. These design features matter when interpreting the results: there is no randomized allocation or blinded comparison reported, and the study does not supply a concurrent control group for estimating a treatment contrast. The registry record does not report a comparator or an alternative arm.

The intervention is described as an inflatable, thin-walled polyethylene terephthalate balloon mounted on an insertion catheter. The system is designed to deliver monomer cement to the fracture site via the medullary canal. This is a description of the device and its intended delivery approach, not evidence about the magnitude of benefit or risk.

The study start is listed as 2015-02, and primary completion as 2017-05. Its status is completed. These dates describe the registry record’s study timeline; they do not establish when each participant was assessed or how long each individual was followed beyond the stated primary-outcome timeframe.

Enrollment is not interchangeable with the number analyzed for a particular outcome. The primary population is described as the Intent-to-Treat Population, subjects with a valid assessment. The number with a valid primary assessment is not reported in the registry record, so the enrollment figure should not be treated as the primary-outcome denominator.

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: Intent-to-Treat Population, subjects with a valid assessment

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: Intent-to-Treat Population (n=33)- all patients who met eligibility criteria, provided ICF, underwent surgery, and have successful implantation of the IlluminOss PBSS into the intramedullary canal. Modified intent to treat (n=44)- all patients who provided ICF, underwent surgery, and have successful implantation of the IlluminOss PBSS into the intramedullary canal

6. Primary Endpoint

The registry lists the primary outcome as Normal Radiographic Fracture Healing, measured over 180 days.

The primary endpoint is titled Normal Radiographic Fracture Healing. It is a count of participants, assessed at 180 days. The registry definition is “Two of four cortices or two of four views demonstrating bridging on standard radiographs.” In other words, the endpoint classifies radiographic findings against a specified threshold and records how many participants meet that threshold.

A binary endpoint turns an assessment into categories, such as meeting or not meeting the stated criterion. Reporting a count can make the observed frequency of a defined finding clear. The definition also makes explicit what radiographic evidence qualifies as normal healing for this endpoint. It should not be treated as a direct measure of every aspect of recovery: the record lists separate measures for pain, function, mobility, and range of motion.

General statistical context: a binary outcome is often described by the number meeting the criterion together with the number assessed, and may also be expressed as a proportion with an interval indicating uncertainty. The registry record identifies the endpoint and the population as subjects with a valid assessment, but the outcome count, denominator, proportion, and uncertainty interval are not reported in the registry record. Without those results, the endpoint definition alone does not establish how frequently the criterion was met.

The 180-day timeframe is the endpoint’s stated assessment period. The record does not describe the radiograph review process, assessor training, or procedures for resolving disagreements; those details are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is binary: each participant either meets the stated radiographic criterion or does not, assuming an assessment can be classified. The registry describes the outcome as a count of participants and defines normal healing as bridging on two of four cortices or two of four views. That definition is the basis for classification; it is not itself a statistical result. The count and denominator needed to describe the observed frequency are not reported in the registry record.

What does a count tell the reader?

A count reports how many observations fall into a category. For a binary outcome, the count is most interpretable alongside the number assessed, because the same count can represent different frequencies in different-sized groups. A proportion expresses the count relative to the assessed group. General statistical context: a confidence interval around a proportion describes uncertainty about the underlying frequency compatible with the observed data and the chosen method. It does not show the range of individual participant outcomes, and it does not remove limitations in the design or data collection. The primary outcome count, denominator, proportion, and confidence interval are not reported in the registry record.

What does the single-group design allow?

A single-group study can describe the outcomes observed in the enrolled group, provided the outcome data are available. It does not estimate a randomized treatment difference, because there is no randomized comparator group. General statistical context: randomization supports a comparison by assigning participants to groups through a chance process; without that comparison, differences from an external reference may reflect differences in population, care, assessment, or follow-up as well as treatment. No external reference or comparative analysis is reported in the registry record.

Allocation is listed as NA, masking as none, and the model as single group. These design labels should not be converted into assumptions about how assessments were performed or how participants were selected. Details such as assessor blinding, radiograph reading procedures, and the handling of protocol deviations are not reported in the registry record.

How should statistical uncertainty be understood?

General statistical context: an estimate based on a finite group varies from sample to sample, so an interval estimate is useful for conveying precision. A narrower interval generally indicates greater precision under the model used, while a wider interval indicates more uncertainty. An interval is not a guarantee that the true value lies within it, and its interpretation depends on the assumptions and calculation method. No interval or primary-outcome estimate is reported in the registry record, so the precision of the primary result cannot be evaluated.

The record lists a sample-size planning illustration based on a stated fraction of the observed effect, a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It also specifies that the effect to detect is the stated fraction of the observed effect. Such illustrations are planning calculations, not observed results and not evidence of observed power. The record does not report that these were the study’s own design assumptions or sample-size justification; the study’s sample-size justification is not reported in the registry record.

The planning illustration assumes two arms even though this trial is listed as single-group. Its equal-allocation comparison is therefore a hypothetical planning framework, not the trial’s actual allocation. The illustration’s numerical sample-size outputs are not reported in the registry record. No conclusion about the study’s achieved power should be drawn from a planning calculation.

Why can over-dispersion matter?

General statistical context: over-dispersion occurs when the observed variability is greater than a statistical model expects. If a model assumes less variability than the data contain, its uncertainty estimates may be too small, and tests may appear more precise than warranted. Whether over-dispersion is relevant depends on the outcome and model. The primary endpoint is a participant count with a binary classification, but the registry record does not report a statistical model or a dispersion assessment. It is therefore not possible to say whether an over-dispersion adjustment was considered or used.

More broadly, the registry lists one analysis but does not report the analysis method, test, model, confidence-interval method, or any adjustment for covariates. These methods are not reported in the registry record. The outcome and design alone do not justify inferring a particular statistical procedure. Any interpretation of precision or statistical significance would require the actual result and the method used to produce it.

Finally, the primary population is described as the Intent-to-Treat Population with a valid assessment. The label does not resolve how participants without a valid assessment were treated in practice. General statistical context: missing outcome data can affect both the analyzed denominator and the interpretation of an estimate, especially if the likelihood of missingness is related to outcome status. The registry record does not report the amount, reasons, or handling of missing primary-outcome data, so the direction or size of any effect on the result cannot be determined.

10. Multiplicity, Missing Data and Analysis Populations

The registry reports ten outcome measures and one analysis. It lists the primary endpoint of normal radiographic fracture healing and eight secondary outcome categories: complete radiographic healing, normal radiographic healing, pain VAS, DASH Score, Constant Shoulder Score, pain on palpation, return to pre-fracture mobility, and range of motion. The registry record does not explain the relationship between the total number of outcome measures and the listed outcome categories.

When a study evaluates multiple outcomes, the chance of at least one apparently notable result can increase if each is tested separately. General statistical context: multiplicity procedures can control the error rate across a family of tests, while prespecifying a primary endpoint can identify the main question. The registry record does not report whether any multiplicity adjustment was used, how outcomes were grouped for testing, or whether secondary outcomes were considered exploratory. The statistical analysis plan is not reported in the registry record.

The primary analysis population is described as the Intent-to-Treat Population, subjects with a valid assessment. This wording identifies a qualification but does not state how many participants had valid assessments or how missing outcomes were handled. Enrollment of 44 does not establish the number analyzed for the primary endpoint. The number of missing or invalid assessments, reasons for missingness, imputation methods, and sensitivity analyses are not reported in the registry record.

General statistical context: missing-data methods rely on assumptions about why measurements are missing. A complete-case analysis uses observed assessments but can be biased if the participants with observed results differ systematically from those without them. Imputation or sensitivity analyses can explore alternative assumptions, but their suitability depends on the data and analysis plan. No specific method can be attributed to this trial from the registry information.

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 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: implant site reaction (6.1%), myocardial infarction (3.0%), ileus (3.0%), device dislocation (3.0%), device extrusion (3.0%).

For the PBSS group, the registry lists 33 participants at risk and 14 affected for serious adverse events. It lists 33 at risk and 14 affected for other adverse events. The record also lists four deaths. These are separate registry entries; it does not explain whether the deaths overlap with the serious adverse-event count or how they were classified.

The listed serious adverse-event terms and percentages are: Implant site reaction, 6.1%; Myocardial infarction, 3.0%; Ileus, 3.0%; Device dislocation, 3.0%; Device extrusion, 3.0%; and Sudden cardiac death, 3.0%. The registry does not clarify whether each percentage is based on participants or events, nor does the entry establish whether terms can overlap for an individual participant. Those details are not reported in the registry record.

These safety figures are descriptive. There is no comparator group in this single-group study, so the counts do not provide a comparative risk estimate. The registry entries alone also do not establish that a particular event was caused by the device or the procedure. The record does not report further detail on event timing, severity grading, relatedness assessment, or how the listed events were adjudicated.

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

The registry record establishes that a completed, single-group study evaluated PBSS for acute humerus fractures and defined normal radiographic healing at 180 days using a specific radiographic criterion. It also reports enrollment and selected safety counts. These registry entries describe the study’s scope and some recorded safety information, but they do not supply the primary healing result.

The number meeting the primary criterion, the number with a valid assessment, and an estimate of uncertainty are not reported in the registry record. Without these results, readers cannot assess the observed frequency of normal radiographic healing or its precision. The missing result should not be interpreted as a negative result, a positive result, or evidence of no effect.

Even if a primary count were available, a single-group design would remain descriptive rather than a randomized comparison. The registry lists no comparator, so it cannot show how outcomes would differ under another treatment or under no device. General statistical context: an observed outcome in one group can reflect multiple influences, and a treatment effect requires an appropriate comparative framework and assumptions. The design does not support attributing any observed healing or adverse event solely to PBSS.

The safety entries report participants at risk and affected for serious and other adverse events, selected serious-event terms with percentages, and deaths. They do not by themselves establish event causality, comparative safety, or the balance of benefits and harms. The denominator basis for the term-specific percentages and overlap among categories are not reported in the registry record.

The secondary outcome list indicates that the study considered several aspects of healing, pain, function, mobility, and motion. However, their results and analysis details are not reported in the registry record. The listed measures should not be mistaken for findings. The record supports a description of the design and outcomes that were named, but not conclusions about efficacy, comparative performance, or clinical benefit.

13. Why This Trial Matters Statistically

This study is statistically important to interpret as a single-group device study rather than as a comparative trial. Its design determines what kinds of claims the data could support: descriptive outcomes within the enrolled group are distinct from estimates of differences between treatments. The registry lists no comparator and no randomized allocation, so the study does not supply a randomized treatment contrast.

The primary endpoint is defined in concrete radiographic terms and has a stated assessment timeframe of 180 days. This is useful for identifying what the study intended to count. At the same time, an endpoint definition is not a result. The primary count, denominator, and uncertainty are not reported in the registry record, leaving the central outcome impossible to quantify from the posted information.

The difference between enrollment and analysis population is also consequential. The record reports enrollment of 44 but specifies that the primary population comprises subjects with a valid assessment. Because the number assessed is not reported, enrollment cannot be used as a substitute denominator. This illustrates why outcome counts need to be read alongside the analyzed population and missing-data handling.

The safety entries likewise require careful interpretation. Counts of participants at risk and affected provide some descriptive context, but the absence of a comparator and incomplete detail on event denominators and overlap restricts what can be inferred. Separating reported counts from causal or comparative claims is a central part of sound statistical reading.

Finally, the registry lists multiple outcomes but does not report how multiplicity was handled or provide the results for the listed secondary measures. A clear distinction between planned measures, available findings, and analysis methods helps prevent readers from treating a list of outcomes as evidence that those outcomes were achieved.

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 primary limitation for interpretation is that the primary endpoint result is not reported in the registry record. Without the count meeting the radiographic criterion, its denominator, or an uncertainty estimate, the central outcome cannot be evaluated quantitatively.

The study is single-group, with no comparator listed, and allocation is recorded as NA. It therefore does not provide a randomized like-for-like comparison. Any observed outcome, if reported, would describe the study group rather than establish a comparative treatment effect. Masking is recorded as none; the record does not specify whether outcome assessors were masked or how radiographs were reviewed.

Enrollment of 44 is reported, but the primary population requires a valid assessment. The number assessed, the amount and reasons for missing data, and their handling are not reported in the registry record. This prevents confirmation of the primary analysis denominator and limits assessment of possible selection from missing outcome data.

The record lists ten outcome measures and one analysis, but does not describe the statistical analysis plan, tests, models, interval methods, or multiplicity procedures. Results for the secondary outcomes are not reported in the registry record. The study’s sample-size justification is not reported in the registry record; planning illustrations do not establish the study’s original design rationale or observed power.

For safety, the record lists at-risk and affected counts, deaths, and selected serious-event terms with percentages. It does not clarify percentage denominators, whether events are counted by participant or event, overlap among terms, event timing, or relatedness. These limitations restrict interpretation of the safety entries and preclude causal or comparative conclusions from the registry information alone.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Safety and Efficacy Study of the Treatment of Humerus Fractures — NCT02394080.
• Registry record last updated 2026-07-15; status last verified 2026-05.
• Results first posted 2026-07-15.
• 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

NCT02394080 is a completed, single-group study sponsored by IlluminOss Medical, Inc., with enrollment of 44. It evaluated the Photodynamic Bone Stabilization System for acute humerus fractures. The record lists no comparator, allocation as NA, and no masking.

The primary outcome is normal radiographic fracture healing at 180 days, defined as bridging on two of four cortices or two of four views. Its analysis population is described as the Intent-to-Treat Population with a valid assessment. The primary outcome count, denominator, and uncertainty are not reported in the registry record.

The registry lists ten outcome measures and one analysis, alongside secondary measures related to radiographic healing, pain, function, mobility, and range of motion. It also reports safety counts for the PBSS group, selected serious adverse-event terms, and four deaths. The record does not provide a comparative treatment effect or enough detail to establish event causality.