Observational Study on JuniOrtho Plating System for Deformities and Fractures Treatment in Lower Limb: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Observational Study on JuniOrtho Plating System for Deformities and Fractures Treatment in Lower Limb (NCT05245617), a registered phase not stated study. The primary outcome is Percentage (%) of Subjects With at Least One Serious/Not Serious Adverse Event Certainly Related or Possibly Related to JPS (ADEs).

2. Clinical Question

The study asks how the JuniOrtho Plating System performs, and what safety events are observed, when used in pediatric and adult patients with lower-limb conditions. It is a post-market clinical follow-up study, intended to collect clinical data after the device entered the European market. Its focus is descriptive: the record does not describe a randomized treatment comparison or a like-for-like control group.

The registry record lists an enrollment of 30 and a completed status. It also names satisfactory bone consolidation and maintained bone-correction alignment as secondary outcomes. Those aims provide context for the follow-up, but the reported record does not include numerical results for them. The study can describe observed outcomes among its treated patients; without a control group, it cannot establish how those outcomes compare with another treatment or with what would otherwise have happened.

3. Trial Design

This is a single-center, observational post-market clinical follow-up study of the JuniOrtho Plating System. The stated purpose is to collect real-world clinical data on device performance and safety, supporting the post-market evaluation of the system. The registry record lists Orthofix s.r.l. as sponsor and reports an enrollment of 30. The study status is completed, with a start date of 2022-11-16 and a primary completion date of 2024-04-19.

The treatment group is described as JPS-treated patients. The brief description of the intended population includes pediatric patients, excluding newborns, and small-stature adult patients. The conditions listed are deformity, congenital defect, and trauma. The named intervention is the JuniOrtho Plating System. More detailed eligibility criteria and the complete arm description are not reported in the registry record.

The primary outcome is a percentage of subjects experiencing at least one serious or non-serious adverse event that the investigator judges certainly or possibly related to the device. Its stated timeframe is up to 18 months from surgery, at device removal. The record also lists outcomes concerning satisfactory bone consolidation and maintenance of bone-correction alignment, each according to the investigator's opinion. Four outcome measures are listed overall, but the other outcome details are not reported in the registry record.

No randomized comparison is described, and allocation is not stated. The record therefore supports a descriptive account of outcomes in the treated group, rather than a causal comparison between assigned treatments. The statistical analysis plan, missing-data procedures, analysis populations, and interim-analysis details are not reported in the registry record. Although the outcome definition names a confidence interval, the method used to calculate it is not reported.

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:

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 Percentage (%) of Subjects With at Least One Serious/Not Serious Adverse Event Certainly Related or Possibly Related to JPS (ADEs), measured over Up to 18 months from surgery (at device removal).

The primary endpoint is the percentage of subjects with at least one serious or non-serious adverse event that the investigator considers certainly or possibly related to the JuniOrtho Plating System. The specified follow-up is up to 18 months from surgery, at device removal. In this endpoint, the key unit is the subject: someone with multiple qualifying events still meets the stated criterion of having at least one. The endpoint is intended to describe device-related safety during the defined follow-up period.

A percentage is a proportion expressed on a percentage scale. In general, its interpretation depends on both the number of subjects meeting the endpoint and the number assessed for it. The registry record does not report those endpoint-specific values, a point estimate, or a numerical confidence interval. It names a 95.2% confidence interval as the dispersion measure, but does not provide interval limits or explain the calculation method. Consequently, the stated endpoint cannot be quantified or assessed for precision from the registry record.

The endpoint also depends on investigator judgments about whether an event is certainly or possibly related to the device. That attribution is part of the outcome definition, not an independently verified causal conclusion in the record. The registry record does not report how these judgments were made or whether they were reviewed by another party. The endpoint is therefore best understood as a planned measure of attributed adverse events, with its numerical result and attribution procedures not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

In general, a proportion endpoint counts the subjects who satisfy a stated event definition and relates that count to the subjects assessed. Here, the definition requires at least one serious or non-serious adverse event judged certainly or possibly related to the device. Because the endpoint is expressed as a percentage of subjects, it is not the same as a count of every adverse event: a subject can meet the definition through one or more qualifying events. The registry record does not report the endpoint numerator or denominator, so the proportion cannot be reconstructed.

What would a confidence interval communicate?

In general, a confidence interval describes the statistical uncertainty around an estimate under a specified method and assumptions. A narrower interval indicates greater precision under that method; a wider interval indicates less precision. It does not remedy limitations in the study design, such as the absence of a control group, and it does not account automatically for bias in outcome recording or participant selection. The registry record names a 95.2% confidence interval for the primary endpoint, but gives neither the interval nor the calculation method. Its precision therefore cannot be evaluated from the posted results.

For a binary outcome, interval methods can differ, particularly when there are few subjects or when the estimated proportion is near a boundary. General methods may use different approximations or exact procedures, and their coverage and width can differ. The registry record does not identify which method was used, so it would be inappropriate to infer one from the confidence-level label. No recalculated estimate is available because the primary endpoint summary statistics are not reported.

How should the adverse-event counts be understood?

The adverse-event record gives separate serious and other-event entries for the treated group, each with 30 at risk, alongside affected entries of 2 and 4, respectively. These are descriptive fields. The record does not define whether the affected values count subjects or events, describe possible overlap between categories, or state whether these entries use the primary endpoint's relatedness criterion. They should not be treated as a substitute for the primary endpoint estimate. The listed serious-event terms and their 3.3% values are also descriptive entries; further detail about coding, attribution, or overlap is not reported in the registry record.

General statistical interpretation distinguishes an event count from a participant-level risk. Event counts can include repeated events in the same subject, while a participant-level endpoint counts each qualifying subject according to the endpoint definition. Without a clear definition of the adverse-event fields and their denominators, those quantities should not be interchanged. The registry record does not report a time-to-event analysis, event rates, or exposure-adjusted estimates.

What does the design permit statistically?

In general, an observational cohort can describe outcomes among people who received an intervention, but an uncontrolled cohort cannot by itself distinguish the effect of the intervention from other explanations. Differences in baseline health, condition severity, clinical decisions, and follow-up can affect observed outcomes. The registry record describes a single-center observational study and does not report a like-for-like control group or allocation process. It therefore supports descriptive interpretation, not a randomized treatment-effect estimate.

The record says there are no reported analyses. It does not specify an analysis model, adjustment for patient characteristics, handling of repeated events, or a plan for subgroup analyses. The title of the primary endpoint indicates investigator-assessed relatedness, but the record does not report blinding, adjudication, or procedures for resolving uncertain attribution. These omissions make it difficult to assess how consistently the endpoint would be classified.

How do planning assumptions differ from study results?

General sample-size planning estimates ask how many participants per arm might be needed for a chosen statistical design and target effect. The stated planning assumptions use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect defined as a fraction of the observed effect. These are planning illustrations, not a description of the study's observational design. In particular, planning for two arms does not create a control group in this study. Such estimates are not observed power, and no sample-size illustration values are reported in the registry record. The record also specifies that time-to-event planning uses total events, whereas other planning outputs use participants per arm.

In general, planning based on an effect observed in a small or uncontrolled study can be sensitive to uncertainty in that effect. Choosing a smaller target effect changes the planning question; it does not establish what effect a later study will observe. These considerations concern design planning rather than the interpretation of this study's unreported primary result.

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("JPS Treated Patients")
n      <- c(30)
events <- c(1)
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  JPS Treated Patients  30  1  3.3  0.1  17.2  0.6  16.7  0.8  16.7

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists four outcome measures, including the primary adverse-event endpoint and outcomes concerning bone consolidation and maintained correction alignment. It does not report a multiplicity strategy, such as whether the analysis would adjust for assessing multiple outcomes or define a hierarchy among them. Without such information, the degree to which multiple outcome testing was planned or controlled is not reported in the registry record. Numerical secondary-outcome results are also not reported.

Missing-data handling is not reported in the registry record. It does not state how participants without a recorded assessment, those lost to follow-up, or those with incomplete adverse-event information were handled. The endpoint is defined over follow-up up to 18 months from surgery at device removal, but the record does not give the number assessed at that point, completeness of follow-up, or any method for addressing incomplete observation. The enrollment figure alone does not establish how many participants contributed to each outcome.

Analysis populations are not reported in the registry record. The record does not specify whether analyses were based on all enrolled patients, those who received the device, those with available follow-up, or another defined group. It also does not describe exclusions from the analysis set. No interim analyses or statistical analysis plan are reported. These gaps limit assessment of how outcome denominators were chosen and whether missing observations or multiple assessments could affect interpretation. The absence of these details does not itself indicate a particular analysis practice; it means the registry record does not document one.

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 4% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: delayed union, nonunion, malunion (3.3%), events caused by anesthesia and surgery (3.3%), loosening of the implant and loss of fixation (3.3%).

The adverse-event entries for JPS-treated patients list 30 at risk for serious adverse events, with 2 in the affected field, and 30 at risk for other adverse events, with 4 in the affected field. The registry record does not define those affected fields in enough detail to determine whether they count subjects or events, or whether the categories overlap. They should therefore be read as recorded entries, not converted into a new percentage or combined into a total.

The primary endpoint is narrower in one respect and broader in another: it concerns serious or non-serious events that the investigator judges certainly or possibly related to the device, and it asks whether a subject had at least one such event. The adverse-event entries are not explicitly said to use that same relatedness rule. The primary endpoint's numerical result is not reported in the registry record, so these safety entries cannot be used as its replacement.

Three serious-event terms are listed, each at 3.3%: delayed union, nonunion, malunion; events caused by anesthesia and surgery; and loosening of the implant and loss of fixation. The registry record does not report their event narratives, timing, overlap, or attribution status. These entries describe what is recorded, but do not establish whether an event was caused by the device.

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

The record describes a completed observational follow-up of the JuniOrtho Plating System, with safety and clinical performance as its central aims. It identifies the primary endpoint and follow-up timeframe, and it lists selected adverse-event entries. Those details help explain what the study was designed to observe. However, the primary endpoint's percentage and confidence interval are not reported, and numerical findings for the secondary outcomes are not reported in the registry record.

Accordingly, the posted information does not quantify the frequency of the primary endpoint or show how precisely it was estimated. A confidence-interval label alone is not enough to determine either the estimate or its uncertainty. The adverse-event affected entries and serious-event terms provide limited descriptive information, but their definitions and relationship to the primary endpoint are not fully documented. The record does not support combining them, converting them into other measures, or treating them as a complete account of all safety outcomes.

Even if an observed outcome percentage were available, an uncontrolled observational study would describe the treated cohort rather than establish what would have occurred under another treatment or no treatment. Patient characteristics, condition severity, surgical care, and follow-up can contribute to outcomes. The record describes no like-for-like control comparison, and allocation is not stated. Investigator judgments of relatedness are part of the endpoint definition, but do not, by themselves, demonstrate causation.

The listed secondary outcomes are based on investigator opinion, and their numerical results are not reported. The record also does not document missing-data procedures, analysis populations, or multiplicity handling. These omissions matter because they affect how outcomes are classified, which observations contribute to estimates, and how multiple outcomes are interpreted. They should be treated as unavailable information, not as evidence that any particular procedure was or was not used.

In short, the registry record establishes the study context, design, and intended outcome questions, alongside a limited set of adverse-event entries. It does not provide the numerical primary result needed to judge its frequency or precision, and it does not provide a comparative estimate. The record therefore supports a cautious descriptive reading, not a conclusion about a treatment effect.

14. Why This Trial Matters Statistically

This study illustrates a statistical distinction that matters in post-market device evaluation: defining an outcome is not the same as reporting its result. The registry record specifies a participant-level adverse-event endpoint, a relatedness criterion, and a follow-up window. Yet it does not report the endpoint percentage or its confidence interval. Without those values, readers cannot quantify the outcome or assess its statistical precision.

It also shows why adverse-event summaries need clear definitions. The record lists serious and other adverse-event affected entries, as well as serious-event terms. But it does not explain whether the affected fields count subjects or events, whether categories overlap, or whether the entries reflect the primary endpoint's relatedness criterion. Statistical interpretation depends on matching the numerator and denominator to the exact question being asked; unclear definitions make apparently similar figures non-interchangeable.

The observational design is another important consideration. A treated cohort can contribute useful descriptions of outcomes in clinical use, but without a control comparison it cannot isolate a device effect from differences in patients, conditions, care, or follow-up. A planning illustration that assumes equal allocation between two arms is not evidence that such a comparison occurred. Nor is a sample-size projection an observed result or observed power.

Finally, the record does not report methods for missing data, analysis populations, or multiplicity. These are not minor presentation details: they inform which observations an estimate represents and how much confidence to place in a set of outcome findings. Their absence makes the limits of interpretation part of the statistical reading. The study's post-market purpose is clear, while the posted numerical evidence remains incomplete for evaluating its primary endpoint.

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 study is described as observational and single center, with no like-for-like control comparison. This limits interpretation to outcomes recorded among JPS-treated patients. Allocation is not stated, and the record does not describe a comparator group, so it cannot support a direct treatment contrast. Potential differences in patient characteristics, condition severity, surgical care, and follow-up cannot be separated from device-associated outcomes using the information reported.

The primary endpoint result is not reported. The registry record identifies its definition and names a 95.2% confidence interval, but provides neither the point estimate nor interval limits. It also does not report the statistical method used to calculate the interval. The listed adverse-event entries do not resolve this gap because their relationship to the primary endpoint is not specified.

The record describes investigator-assessed relatedness for the primary endpoint and investigator opinion for the secondary outcomes. It does not report assessment procedures, adjudication, or whether outcome assessors were blinded. Definitions of the serious and other adverse-event affected fields, potential overlap among categories, and event-level details are not reported in the registry record. These omissions constrain interpretation of the safety entries.

Enrollment is reported as 30, but the registry record does not report outcome-specific denominators, follow-up completeness, missing-data handling, or analysis populations. Numerical results for bone consolidation and maintained alignment are also not reported. Multiplicity procedures, interim analyses, and a statistical analysis plan are not reported in the registry record. The brief description of the intended population and arm is incomplete, so further eligibility and treatment details cannot be characterized from this record.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Observational Study on JuniOrtho Plating System for Deformities and Fractures Treatment in Lower Limb — NCT05245617.
• Registry record last updated 2026-01-30; status last verified 2026-01.
• Results first posted 2026-01-08.
• 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

NCT05245617 is a completed, single-center observational post-market clinical follow-up study of the JuniOrtho Plating System, sponsored by Orthofix s.r.l. It reports an enrollment of 30, a start date of 2022-11-16, and a primary completion date of 2024-04-19. The study concerns lower-limb deformities and fractures in pediatric patients, excluding newborns, and small-stature adult patients.

The primary endpoint is the percentage of subjects experiencing at least one serious or non-serious adverse event judged certainly or possibly related to the device, up to 18 months from surgery at device removal. The registry record does not report its numerical estimate or confidence interval. It lists serious and other adverse-event affected entries and three serious-event terms at 3.3% each, but does not fully define how these entries relate to the primary endpoint.

Secondary outcomes concern satisfactory bone consolidation and maintained bone-correction alignment, according to investigator opinion; their numerical results are not reported. Missing-data methods, analysis populations, multiplicity procedures, and a statistical analysis plan are not reported in the registry record. The design supports descriptive interpretation, not a controlled comparison.