Opioid Free and Therapy Minimized Advantages Using HANA Table for Total Hip Arthroplasty: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Opioid Free and Therapy Minimized Advantages Using HANA Table for Total Hip Arthroplasty (NCT03790306), a registered phase not stated study. The primary outcome is Pre-operative Narcotic Use.

2. Clinical Question

3. Trial Design

NCT03790306 is a completed study sponsored by St. Elizabeth Medical Center, Utica, NY. The registry record gives a start date of 2019-01-15, a primary completion date of 2020-01-24, and enrollment of 207. Its title and brief summary focus on anterior approach total hip arthroplasty performed using the HANA table, alongside education, pain protocols, and recovery tools. The record does not provide enough information to characterize the study design in greater detail.

The registry record does not state an allocation method and identifies the study as not being a randomized comparison. It also notes that arms are not a like-for-like control comparison. A defined comparator, allocation process, or basis for comparing groups is not reported in the registry record. Accordingly, the described study should not be read as a randomized treatment comparison.

The primary endpoint is pre-operative narcotic use. Listed secondary outcomes include numeric pain scores, sleep quality, adherence to the prescribed post-operative recovery protocol, hospital length of stay, and return to work and driving 6 weeks after surgery. The record lists 9 outcome measures but 0 analyses. Results for these outcomes and their analysis populations are not reported in the registry record.

The brief summary describes a goal of examining whether the approach can be carried out with little, if any, opioid need, in the context of the stated care components. That goal is not itself an observed result. The specific protocol, eligibility criteria, follow-up procedures, and statistical plan are not reported in 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 Pre-operative Narcotic Use, measured over Pre-operatively.

The primary endpoint is titled “Pre-operative Narcotic Use.” Its description says it is the percentage of patients who used opioids pre-operatively, while the outcome is specified as a participant count. These descriptions indicate that the endpoint concerns whether participants used opioids before surgery, rather than the amount of opioid medication used after surgery. The count and percentage observed for this endpoint are not reported in the registry record.

As a general statistical concept, a binary outcome records whether each participant meets a defined condition, such as reporting pre-operative opioid use, or does not. A count can describe how many participants fall into the condition category. To interpret such a count as a percentage, the denominator and the rules for determining use must also be clear. The registry record does not report the endpoint count, its denominator for analysis, or operational details such as the time window and source used to establish pre-operative use.

This endpoint can describe the cohort’s pre-surgical opioid-use status, but it does not directly measure post-operative consumption, pain relief, recovery, or whether an intervention changed opioid use. Those questions would require outcome definitions and results that are not reported in the registry record. The primary endpoint’s title alone does not establish whether it was assessed as a baseline characteristic, an outcome, or both in the analysis.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record gives the primary outcome as a participant count and describes the intended measure as the percentage of patients who used opioids pre-operatively. This is a binary-outcome framework: participants are classified according to whether the specified event or condition is present. A count describes the number classified as having the condition. A proportion or percentage additionally requires a denominator, generally the number of participants whose outcome status is available and eligible for the calculation. Neither the primary count nor an analysis denominator is reported in the registry record.

As a general statistical concept, defining the outcome precisely is essential. Researchers need rules for what qualifies as opioid use, the period in which use is assessed, and how the information is collected. They also need to specify how uncertain or missing reports are handled. These details affect which participants are classified as having the endpoint. The registry record does not report these operational definitions or the method used to ascertain pre-operative use. The endpoint label should therefore not be taken as evidence that a particular definition or data source was used.

A confidence interval is a general tool for expressing the precision of an estimate. For a binary outcome, an interval around a proportion can indicate how much uncertainty remains about the underlying frequency in a population, conditional on the sampling and modeling assumptions. An interval is not a guarantee that the true value lies within its limits, and it does not by itself address bias, missing data, or differences between participants. No primary outcome estimate or confidence interval is reported in the registry record, so its precision cannot be evaluated.

The record lists 9 outcome measures and 0 analyses. An outcome measure is not the same as an analysis: an outcome can be registered without a result being posted, and a list of outcomes does not establish which statistical tests or models were used. The statistical plan, including any covariate adjustment, subgroup analysis, or handling of repeated measurements, is not reported in the registry record. No statistical test or model should be inferred from the outcome titles.

The registry record includes a generic sample-size planning illustration based on an observed effect, a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It describes the effect to detect as a stated fraction of the observed effect. For time-to-event outcomes, the illustration concerns total events; for other outcomes, it concerns participants per arm. These are planning assumptions, not a report of the trial’s design rationale or an observed result. The registry record does not report a trial-specific sample-size justification, the observed effect used for planning, or calculated participant targets. Since a comparator and allocation approach are not stated and the record identifies no like-for-like control comparison, an equal-allocation illustration should not be mistaken for a description of the enrolled study.

As a general concept, over-dispersion occurs when variation in the data exceeds what a statistical model assumes. It matters because a model that understates variation can produce uncertainty intervals that are too narrow and tests that appear more conclusive than warranted. For a simple binary outcome, the choice of model depends on the design, sampling structure, and question being asked. The registry record does not report a model, evidence of over-dispersion, or a need for an over-dispersion adjustment; no such feature can be attributed to this analysis.

For a non-randomized or otherwise non-comparative study, descriptive summaries can characterize the participants and their recorded outcomes. They do not, on their own, separate the effect of a procedure or care pathway from other explanations, such as participant selection, differences in care, or changes over time. Here, the allocation method is not stated, and the record flags that arms are not a like-for-like control comparison. The registry record does not provide a comparative estimate or analysis that addresses these concerns.

Recalculated results, when available, are simple unadjusted recalculations from posted summary statistics and are not a substitute for the sponsor’s own analysis. No such recalculation is reported for this record. The posted record also does not include a sponsor analysis for the primary endpoint. Consequently, there is no numerical outcome estimate to recalculate or compare with a sponsor-reported 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("THR With HANA Table")
n      <- c(207)
events <- c(30)
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  THR With HANA Table  207  30  14.5  10.0  20.0  10.3  19.9  10.4  19.9

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists 9 outcome measures, including the primary pre-operative narcotic-use endpoint and secondary outcomes concerning pain scores, sleep quality, recovery-protocol adherence, hospital length of stay, and return to work and driving 6 weeks after surgery. It reports 0 analyses. The order of testing, any designation of confirmatory outcomes beyond the listed primary endpoint, and any adjustment for multiple testing are not reported in the registry record.

As a general statistical concept, examining many outcomes can increase the chance that at least one result appears notable by chance. Multiplicity methods can control or otherwise account for this issue, but the method depends on the study objectives and analysis plan. The registry record does not state whether multiplicity was considered or adjusted for. Without posted outcome analyses, the implications of multiplicity cannot be assessed for this study.

Missing-data methods and analysis populations are also not reported in the registry record. The record does not state how participants with missing outcome values, incomplete follow-up, or protocol deviations were handled. It does not identify an intention-to-treat, per-protocol, or other analysis population for the primary or secondary outcomes. Enrollment of 207 should not be treated as the denominator for every analysis in the absence of those details.

As a general concept, missing outcomes can affect both the estimate and its precision, particularly when the likelihood of missingness is related to participant characteristics or outcomes. Transparent reporting would identify the number contributing to each outcome and explain how absent values were handled. Those details, along with a multiplicity plan and analysis-population definitions, are not reported in the registry record.

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 5% reporting threshold.

The safety record lists the “THR With HANA Table” group with 207 participants at risk for serious adverse events and 0 participants affected. It also lists 207 at risk and 0 affected for other adverse events, and 0 deaths. These figures describe the events recorded in the registry safety record; they do not supply a detailed event narrative or event-specific breakdown.

As a general statistical concept, observing zero recorded events does not establish that the true risk is zero. The interpretation depends on how events were defined, how completely they were collected, and the length and completeness of follow-up. Those details are not reported in the registry record. The record also does not report a comparison group suitable for estimating a relative safety difference.

The figures should therefore be read narrowly: no serious adverse events, other adverse events, or deaths are listed in the posted safety counts for this group. They do not establish the absence of every possible complication, nor do they establish that the procedure or associated care components caused or prevented an event.

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

The registry record establishes the study’s stated focus: anterior approach total hip arthroplasty using the HANA table, together with education, pain protocols, and recovery tools. It identifies pre-operative narcotic use as the primary endpoint and lists other intended outcomes related to pain, sleep, adherence, hospital stay, and return to work and driving. It also records enrollment of 207 and a completed status.

What the record does not establish is the observed pre-operative opioid-use count or percentage. Although the brief summary describes an aim of little, if any, opioid need, the record does not report a post-operative opioid-use result. It also does not report numerical results for the listed secondary outcomes. The stated aim cannot be substituted for measured outcomes.

The absence of a reported comparator and the registry’s explicit note that this is not a randomized comparison limit conclusions about cause and effect. Even if outcome values were available, a descriptive result from a group would not by itself show that the HANA table, a pain protocol, education, or recovery tools produced the outcome. The record does not report an analysis that separates the contribution of any individual component.

As a general concept, statistical evidence requires both an estimate and information about its uncertainty, along with an appropriate design and analysis for the question. Those elements are not reported for the primary endpoint in this registry record. The safety counts are also limited to the events recorded and lack reported follow-up details. The appropriate interpretation is therefore a description of registered aims, outcomes, enrollment, and posted safety counts—not a conclusion about clinical benefit, lack of benefit, or comparative safety.

14. Why This Trial Matters Statistically

This study is statistically relevant because its stated goal concerns opioid use in the context of a surgical approach and a bundle of associated care components, while the registered primary endpoint is pre-operative narcotic use. Keeping the endpoint’s timing and meaning distinct from the study aim is important: a measure of use before surgery is not a measure of opioid consumption after surgery. The registry record does not report results that connect these questions.

The record also illustrates why a study’s design and comparator matter. It does not state an allocation method and explicitly cautions that the arms are not a like-for-like control comparison. A planned or observed difference between non-equivalent groups, if one were reported, could reflect differences in participants or care as well as the intervention under consideration. No comparative analysis is posted to address that issue.

Outcome reporting is central to statistical interpretation. The record lists 9 outcome measures but 0 analyses, so readers can identify the topics of interest without being able to assess their observed values, uncertainty, or analysis methods. The lack of reported denominators and missing-data handling further prevents assessment of how many participants contributed to each outcome.

Finally, the adverse-event counts show why safety figures need context. Zero recorded events is a factual count in the registry record, but without event definitions and follow-up information it cannot establish a zero underlying risk. The study’s statistical importance lies in these interpretive distinctions: registered intent, observed data, analysis, and causal evidence are different things, and the record does not report them all.

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 interpreting this specific record is the absence of posted results for the primary endpoint. The record names pre-operative narcotic use and describes a percentage, but it does not report the participant count, percentage, or analysis denominator. It also does not report post-operative opioid use, despite the brief summary’s stated aim concerning opioid need.

The study design is incompletely described. Allocation is not stated, and the registry record cautions that the arms are not a like-for-like control comparison. A comparator and its characteristics are not reported. This prevents a supported between-group interpretation and limits any causal claim about the HANA table or the accompanying care components.

The record does not report eligibility criteria, participant characteristics, endpoint definitions, data-collection procedures, follow-up completeness, or the statistical analysis plan. Missing-data methods, analysis populations, and multiplicity procedures are also not reported in the registry record. These omissions make it difficult to judge outcome ascertainment, precision, and the potential for bias.

Although 207 participants were enrolled, the number contributing data to each outcome is not reported. The record lists 9 outcome measures but 0 analyses, leaving no posted outcome estimates or uncertainty intervals to assess. Safety reporting is similarly limited: 0 serious adverse events, 0 other adverse events, and 0 deaths are listed, but definitions and follow-up duration are not reported. These limitations constrain interpretation of both effectiveness-related outcomes and safety.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Opioid Free and Therapy Minimized Advantages Using HANA Table for Total Hip Arthroplasty — NCT03790306.
• Registry record last updated 2020-11-10; status last verified 2020-10.
• Results first posted 2020-03-17.
• 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

NCT03790306 is a completed study sponsored by St. Elizabeth Medical Center, Utica, NY, concerning anterior approach total hip arthroplasty using the HANA table. The registry record reports enrollment of 207, a start date of 2019-01-15, and a primary completion date of 2020-01-24.

The primary endpoint is pre-operative narcotic use, described as the percentage of participants who used opioids before surgery. Secondary outcomes include pain scores, sleep quality, recovery-protocol adherence, hospital length of stay, and return to work and driving 6 weeks after surgery. The registry record lists 9 outcome measures and 0 analyses.

No primary or secondary outcome results, comparator, allocation method, statistical analysis plan, or analysis-population details are reported in the registry record. The safety record lists 0 serious adverse events, 0 other adverse events, and 0 deaths among the recorded group.