Post Treatment Comparison Intramedullary Nail vs. Nonoperative Treatment: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Post Treatment Comparison Intramedullary Nail vs. Nonoperative Treatment (NCT01975467), a registered phase not stated study. The primary outcome is DASH Score.

2. Clinical Question

3. Trial Design

This was a post-market clinical study of displaced midshaft clavicle fractures. Its stated objective was to compare results 1-3 years after treatment with internal fixation using the Sonoma Orthopedic Products CRx™ and results after nonoperative management, such as a sling. The registry record lists a device intervention and describes a nonoperative control group and an intramedullary nail test group. It does not give a randomized allocation procedure; the record specifically notes that allocation is not stated and that the arms are not a like-for-like control comparison.

The recorded enrollment is 9. The study status is TERMINATED, and the primary outcome population is described as “Terminated due to low enrollment.” The record gives a start date of 2013-10 and a primary completion date of 2014-06. These registry entries establish the study's recorded status and timing, but do not show how many enrolled subjects received each treatment, completed follow-up, or contributed to an outcome assessment.

The primary outcome was DASH Score at “One time point,” with assessment described for subjects 1-3 years post-treatment. Range of Motion and Strength is listed as a secondary outcome. The study objective also refers to patient-related functional outcomes and patient satisfaction, but the registry record does not provide additional outcome definitions or results for these measures. It records two outcome measures and zero analyses.

The registry record does not describe a protocol for allocation, concealment, blinding, follow-up procedures, or the timing of assessments beyond the primary outcome's stated timeframe. Details of any planned statistical model, adjustment variables, sample-size justification, or interim analyses are not reported in the registry record. The sample-size assumptions described for planning illustrations are not evidence of the study's design or of a completed analysis.

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

Analysis population for the primary outcome, as defined in the registry: Terminated due to low enrollment

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 DASH Score, measured over One time point.

The primary endpoint is DASH Score. The registry describes it as an evaluation of fracture outcome “utilizing the DASH instrument for function” in subjects 1-3 years post-treatment. The listed timeframe is “One time point.” The record does not specify a unit, the score's parameterization, or a measure of dispersion, and it does not state the precise assessment date for each subject.

As general context, a functional outcome measure can capture aspects of a participant's reported ability that are not represented by a clinical measurement alone. A score can then be summarized to describe the observed responses in a study group and, where data permit, compared across groups. The registry's stated purpose for the DASH instrument is assessment of function; further details about the particular scoring procedure are not reported in the registry record.

The outcome is relevant to the study's stated objective because the comparison concerns results after two forms of treatment, and function is an explicitly named area of interest. However, the endpoint's presence in a registry entry is not itself a result. No group-level DASH scores, treatment contrast, uncertainty interval, or statistical test are reported. Consequently, neither the direction nor the magnitude nor the precision of any between-group difference can be described from the posted results.

The registry record also does not report how missing DASH assessments were handled, whether the score was analyzed as a continuous measure, or what population was included in the analysis. Those omissions prevent a full assessment of how the intended functional outcome was translated into an analysis.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record names a primary outcome and a secondary outcome but does not report an analysis method or an analysis result. It records zero analyses. This means that no inferential procedure can be attributed to the posted results: there is no reported treatment contrast, model, standard error, confidence interval, or p-value. The discussion below explains general statistical concepts that would matter when interpreting a treatment comparison; it does not describe methods that the record says were used.

What does an outcome estimate contribute?

General statistical context: an outcome estimate reduces the observed data to a quantity relevant to the study question. For a two-group question, an estimate might describe each group's outcome or a contrast between groups. The contrast's definition matters. A difference in group averages, a comparison of distributions, or another summary answers a different statistical question. The registry record gives no DASH scores and does not specify a summary measure or contrast, so the estimand—the exact quantity intended to be estimated—is not reported in the registry record.

Even a numerical estimate needs uncertainty information. A confidence interval is a range generated by a statistical procedure to convey uncertainty around an estimate under its assumptions. Wider intervals generally indicate less precision, while narrower intervals indicate greater precision. An interval does not guarantee that the true value lies within it, and it does not correct for bias from an unsuitable comparison or missing data. No interval is reported for DASH Score, range of motion, or strength in this study.

What can a significance test establish?

General statistical context: a p-value evaluates how unusual the data would be under a specified null hypothesis and statistical model. Its interpretation depends on the analysis plan, the data, and assumptions such as appropriate measurement and independent observations. A small p-value is not a measure of effect size, and a large p-value does not establish equivalence or prove that groups are the same. The posted results contain no p-value, so no significance conclusion is available. In particular, the planning significance level of 0.05 is an assumption for an illustration; it is not a trial result or a reported decision rule for the study's analysis.

A test is only one part of interpretation. The estimated magnitude, uncertainty, design, and quality of the measurements also matter. Here, the primary outcome estimate and the analysis population are absent, and allocation is not stated. A significance test cannot repair limitations in the way groups were formed or establish that a group contrast reflects treatment rather than other differences.

Why does allocation matter?

General statistical context: random allocation, when used and properly implemented, is intended to reduce systematic differences between groups at the point of assignment. An observational or otherwise nonrandom comparison can be affected by confounding if factors related to treatment choice also relate to outcomes. The registry record does not state allocation and flags the arms as not a like-for-like control comparison. It does not describe baseline characteristics or adjustment methods. Therefore, the extent of group comparability and any handling of confounding are not reported in the registry record.

Adjustment can account for measured covariates under an appropriate model, but it cannot automatically eliminate unmeasured confounding. The choice of variables and model should be justified in advance and reported transparently. No adjusted or unadjusted estimate is posted, and no covariate list or modeling specification is reported. It would be inappropriate to infer that adjustment was or was not performed beyond the record's statement that it lists zero analyses.

What do the planning assumptions mean?

The record's sample-size assumptions describe a planning illustration using a two-sided significance level of 0.05, equal allocation between the arms, and a normal approximation. They also state that the effect to detect is a stated fraction of the observed effect. These assumptions describe an illustration, not a documented design justification for this trial. The record does not report a protocol-based sample-size calculation, the target enrollment, or the rationale for selecting a clinically important effect. Sample-size illustrations are planning aids and are never observed power.

Planning calculations depend on the effect size, variability, allocation, significance level, and desired power, among other assumptions. If an assumed effect is uncertain or overly optimistic, the resulting planning figures may not represent a realistic future study. In this case, the registry record does not present the primary outcome estimate on which the described observed-effect illustration would be based. The basis for that input cannot be independently reviewed from the posted results. No planning figure changes the fact that the current record supplies no outcome comparison.

What is the role of measurement and variability?

General statistical context: an outcome's distribution and measurement properties influence which summaries and methods are appropriate. A continuous score may be summarized in different ways depending on its distribution and the clinical question. Unusual values, skewness, limited ranges, or clustering can affect standard methods and uncertainty estimates. Over-dispersion—variation greater than a model expects—can make conventional uncertainty estimates too small if it is ignored. These are general considerations, not reported features of this study: the record gives no DASH values, distribution summaries, unit, or dispersion measure from which to assess them.

Range of motion and strength are named as secondary outcomes, but their definitions, units, assessment methods, and group summaries are not reported in the registry record. Without those details, readers cannot evaluate the scale of measurement, consistency of assessment, or suitability of any statistical method. The record also does not state whether measurements were taken by blinded assessors.

10. Multiplicity, Missing Data and Analysis Populations

The record names DASH Score as the primary outcome and Range of Motion and Strength as a secondary outcome. The study objective also mentions patient-related functional outcomes and patient satisfaction. It records two outcome measures and zero analyses. It does not identify how the objective's various outcomes relate to the registry's listed outcome measures, which comparisons were planned, or how outcome definitions were prioritized beyond naming DASH Score as primary.

General statistical context: when many outcomes, time points, or comparisons are tested, the chance of at least one apparently notable result can increase. A prespecified multiplicity strategy can address that issue, for example by controlling error across a defined family of tests or by specifying a hierarchy. The registry record does not report a multiplicity plan, and it does not provide results with which to assess whether multiple comparisons were conducted. No correction method should be assumed.

The primary outcome's timeframe is “One time point,” and its description refers to subjects 1-3 years post-treatment. The record does not specify how assessments within that interval were selected or whether all subjects were assessed at a common time. The timing and number of assessments for secondary outcomes are not reported in the registry record.

Missing-data handling and analysis populations are also not described. The record does not say how many subjects had an observed DASH Score, whether any subjects were excluded from an analysis, or how incomplete follow-up was treated. It does not define an intention-to-treat, per-protocol, or other analysis population. Those details matter because an analysis limited to subjects with available measurements can differ from one based on a broader target population, particularly when missingness relates to treatment or outcome. No imputation approach, sensitivity analysis, or explanation of missingness is reported in the registry record.

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

The registry record establishes that a post-market study was registered to compare post-treatment outcomes for displaced midshaft clavicle fractures managed with an intramedullary nail or nonoperative treatment. It records enrollment of 9 and a TERMINATED status, with termination attributed to low enrollment in the primary outcome population description. It also identifies DASH Score as the primary outcome and Range of Motion and Strength as a secondary outcome.

Those details do not constitute an estimate of treatment effect. No group-level primary outcome values, treatment contrast, uncertainty interval, or statistical test are reported. The record therefore does not show whether the observed functional outcomes favored either group, how large any difference might have been, or how precisely a difference could be estimated. It cannot support a conclusion that the treatments had the same or different outcomes.

The record also does not establish that the groups were comparable. Allocation is not stated, and the registry explicitly cautions that the arms are not a like-for-like control comparison. If a group difference had been reported, the design information would still require careful consideration of selection and other differences between subjects. With no outcome estimate, the potential influence of such differences cannot be evaluated.

The adverse-event entries should not be interpreted as evidence that no events occurred. Each group has zero recorded at-risk subjects and zero affected subjects for serious and other events; death counts are null. Those entries do not provide a usable denominator for assessing event occurrence. The record does not report an interpretable comparative safety analysis.

General statistical context: absence of a reported difference is not the same as evidence of no difference. Establishing that outcomes are sufficiently similar would require a defined comparison and an analysis precise enough to rule out differences that matter under a prespecified criterion. No such estimate or criterion is reported. The appropriate reading is limited: the study's intended comparison is documented, but its posted results do not answer the clinical or statistical question.

12. Why This Trial Matters Statistically

This study matters statistically because its registry record illustrates the distinction between a registered comparison and an interpretable result. The stated question is concrete: compare post-treatment outcomes after intramedullary nail fixation with outcomes after nonoperative management of displaced midshaft clavicle fractures. The record identifies a primary functional endpoint, but does not report the numerical outcome or any analysis. A clearly stated question cannot substitute for the data and estimates needed to answer it.

The low enrollment and terminated status are central to the record's interpretation. The recorded enrollment is 9, and the primary outcome population is described as terminated due to low enrollment. Such information signals that the intended analysis may not have been completed, but it does not disclose the specific number assessed, the availability of outcome measurements, or the reason no analyses are posted. Those details would be needed to distinguish an uncollected outcome from an unreported analysis.

The comparison also highlights how design affects interpretation. Allocation is not stated, and the registry cautions that the arms are not a like-for-like control comparison. Statistical adjustment, even if undertaken, would not by itself ensure comparability. Readers need clear information about treatment assignment, participant characteristics, missing data, and the analysis population to understand what a group contrast represents.

Finally, planning assumptions should be separated from study findings. An illustration based on an observed effect, equal allocation, a normal approximation, and a significance level of 0.05 concerns planning under stated assumptions. It does not demonstrate that the trial had adequate power, establish an effect, or replace a result. The registry record supplies no primary estimate against which to assess the effect underlying that illustration.

13. 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 is the absence of posted outcome results. Although the registry names DASH Score as the primary endpoint and Range of Motion and Strength as a secondary outcome, it records zero analyses and does not report group summaries, a contrast, or uncertainty. The primary outcome population is identified as terminated due to low enrollment, so the record does not establish that the intended comparison was completed.

Enrollment is recorded as 9, but group-specific enrollment, follow-up, and outcome availability are not reported in the registry record. This prevents assessment of the data contributing to any potential outcome analysis. The record also gives no participant characteristics, so the extent to which the treatment groups differed at baseline cannot be evaluated.

Allocation is not stated. The registry flags the arms as not a like-for-like control comparison, which limits the causal interpretation of a treatment comparison even if outcome estimates were available. The record does not describe allocation procedures, treatment selection, baseline adjustment, or other methods for addressing differences between groups.

Outcome reporting is limited. The DASH Score is described as an evaluation of function at one time point, but the record does not report the unit, score summary, dispersion, assessment details, or missing-data approach. It does not provide definitions or results for the secondary outcome, and the relation between the listed outcomes and the broader objective's references to patient satisfaction and patient-related functional outcomes is unclear.

Safety information is also not interpretable as event incidence: both groups have zero at-risk counts and zero affected counts, while death counts are null. Finally, the registry record does not report a statistical analysis plan, multiplicity strategy, sample-size justification, or interim analyses. These gaps constrain both the assessment of the study's methods and the conclusions that can be drawn from its posted results.

14. Related Tutorials

15. Related Statistical Calculators

16. Sources

• ClinicalTrials.gov: Post Treatment Comparison Intramedullary Nail vs. Nonoperative Treatment — NCT01975467.
• Registry record last updated 2016-12-28; status last verified 2016-11.
• Results first posted 2016-12-28.
• 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.

17. Record Summary

NCT01975467 is a post-market clinical study titled “Post Treatment Comparison Intramedullary Nail vs. Nonoperative Treatment.” Its official title describes 1-3 year follow-up of displaced midshaft fractures treated with an intramedullary nail versus nonoperative treatment. The sponsor is Sonoma Orthopedic Products, Inc.; the recorded start is 2013-10, and the primary completion date is 2014-06.

The study lists CRx as a device intervention, with a test group treated using an intramedullary nail and a control group treated with a sling. The primary outcome is DASH Score at one time point, intended to evaluate function 1-3 years post-treatment. Range of Motion and Strength is listed as a secondary outcome. Enrollment is recorded as 9, and status is TERMINATED due to low enrollment.

The record lists two outcome measures and zero analyses. It reports no primary outcome estimate or statistical comparison. Allocation is not stated, and the registry notes that the arms are not a like-for-like control comparison. The posted record therefore documents the intended study question and status but does not provide results with which to evaluate the treatment comparison.