Fast Track Total Knee Arthroplasty: Local Infiltration Analgesia vs Femoral Nerve Block: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Fast Track Total Knee Arthroplasty: Local Infiltration Analgesia vs Femoral Nerve Block (NCT01966263), a randomized phase 4 study. The primary outcome is Stair Climbing Task (SCT).

2. Clinical Question

The registry states that the trial aimed to determine whether either anesthetic technique was better for achieving optimal functional outcome after one year in people receiving total knee arthroplasty within a fast-track rehabilitation protocol. The posted primary outcome is the SCT, expressed as a mean time in seconds. The comparison is therefore between group averages on a functional task, not a direct measure of pain relief or a general measure of every aspect of recovery.

The posted results compare 36 participants in the LIA group with 37 in the FNB group for the primary outcome. The registry also lists the Timed Up and Go Test and Six Minute Walking Test as secondary outcomes. Those measures offer additional views of mobility, but the primary statistical question remains the one-year SCT comparison. A difference in group means is an estimate of the average contrast; it does not describe every participant’s result or establish that one technique is preferable for an individual.

3. Trial Design

The registry record describes NCT01966263 as a completed, randomized, parallel-group phase 4 trial. Enrollment is listed as 80. The study started in 2013-11, and primary completion is listed as 2014-11. The sponsor is Sint Maartenskliniek. The condition is arthroplasty, replacement, knee.

Participants were assigned to LIA or FNB. The record identifies the study as single masked, but which people were masked and how masking was implemented are not reported in the registry record. The two groups received different anesthetic procedures: LIA involving infiltration of knee tissues, or FNB with a catheter. The descriptions in the registry explain the general techniques but do not provide a complete procedural protocol in the available record.

The primary outcome was the Stair Climbing Task, assessed at one year and reported as a mean with standard deviation in seconds. The registry describes the task as assessing the ability to ascend and descend a flight of stairs, as well as lower-extremity strength, power, and balance. Two secondary outcomes are listed at one year: the Timed Up and Go Test, measured in seconds, and the Six Minute Walking Test, measured in meters.

Outcome counts are not identical across all measures. For the primary outcome, the posted group counts are 36 for LIA and 37 for FNB. The secondary outcome counts are also reported separately, with the walking-test group counts differing from those for the other outcomes. The registry notes some outcome-specific exclusions and withdrawal, but the complete accounting of participants at each stage and the full analysis-population definition are not reported in the registry record. The original sample-size justification and detailed statistical analysis plan are also 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

Analysis population for the primary outcome, as defined in the registry: One patient from group FNB was excluded due to revision surgery of the knee; one patient from group FNB withdrew from follow up due to the development of a malignancy. One patient in group FNB and three patients in group LIA were excluded due to TKA of the contralateral knee. In group LIA one patient withdrew from follow up due to the development of a severe eye disorder requiring intensive treatment. One patient from group FNB was unable to perform the 6MWT due to severe backache.

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 Stair Climbing Task (SCT), measured over one year.

The primary endpoint is the Stair Climbing Task (SCT) at one year after total knee arthroplasty. The registry defines the task as measuring the ability to ascend and descend a flight of stairs and as assessing lower-extremity strength, power, and balance. Results are reported as mean time in seconds with standard deviations.

Using a timed functional task provides a concrete way to compare average performance between the randomized groups. Because time is the recorded unit, the outcome reflects how long completion takes; it is not itself a direct measure of pain, quality of life, or the full range of recovery experiences. A group mean can also conceal variation between participants, which is why the standard deviations are relevant alongside the means.

For this trial, the posted means are 14.3 seconds for LIA and 13.8 seconds for FNB. The comparison is expressed as the FNB mean minus the LIA mean, giving a mean difference of -0.5 seconds. The reported interval for that difference extends from -3.27 to 2.27 seconds. These estimates describe the observed group averages and uncertainty around their contrast. They do not establish how clinically meaningful a particular difference would be; a threshold for meaningful change is not reported in the registry record.

The one-year assessment aligns with the stated objective of comparing functional outcome after a year. The registry does not report whether additional SCT assessments were collected at other times or how the one-year time point was selected as the primary assessment.

7. Results Posted in the Registry

• Femoral Nerve Block (FNB): mean 13.80 versus 14.30 on control; difference -0.50 (95% CI -3.27 to 2.27), standardized effect d = -0.08; z-test p = 0.723.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Timed Up and Go Test (TUG)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Femoral Nerve Block (FNB): mean 7.60 versus 7.80 on control; difference -0.20 (95% CI -0.93 to 0.53), standardized effect d = -0.13; z-test p = 0.592.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Femoral Nerve Block (FNB) and the control. The interval gives the range of effects that remain compatible with the data.

Six Minute Walking Test (6MWT)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Femoral Nerve Block (FNB): mean 505.00 versus 489.00 on control; difference 16.00 (95% CI -19.93 to 51.93), standardized effect d = 0.21; z-test p = 0.383.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Femoral Nerve Block (FNB) and the control. The interval gives the range of effects that remain compatible with the data.

The two secondary outcomes add measures of mobility alongside the primary stair-climbing assessment. Taken together, the posted comparisons do not show a consistent, statistically clear separation between LIA and FNB. Their point estimates differ in direction across measures, while the reported intervals include zero. This pattern does not establish that the groups are the same; rather, the estimates remain uncertain and do not provide a clear secondary-outcome signal.

The secondary outcomes relate to the primary result by broadening the functional picture. The SCT concerns stair ascent and descent and is the stated primary endpoint. TUG and 6MWT assess other aspects of mobility, using different tasks and measurement scales. Agreement across outcomes could provide supportive context, while disagreement might reflect different functional domains or sampling variability. In this record, secondary results do not resolve the uncertainty in the primary SCT comparison.

These analyses carry less weight than the primary outcome for confirmatory interpretation. The registry lists two secondary outcomes, and the posted comparisons are unadjusted. When multiple outcomes are examined, the chance of observing at least one apparently notable result can rise; multiplicity procedures are one way to address that issue. Whether an adjustment was prespecified or performed is not reported in the registry record. Without that information, secondary findings should be treated as supportive or exploratory, not as independent proof of an overall treatment effect.

The secondary results also have outcome-specific counts. The TUG comparison uses 36 LIA and 37 FNB observations, while the 6MWT comparison uses 36 in each group. These counts and the measurement units matter when interpreting the estimates, but they do not explain why the counts differ. The full reasons for missing or excluded observations, and the handling of those observations in the analyses, are not reported in the registry record.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Timed Up and Go Test (TUG)
• Six Minute Walking Test (6MWT)

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous: each participant’s SCT result is a time in seconds. The registry reports a mean and standard deviation for each group, and the comparison is a mean difference. The displayed contrast is defined as the FNB group mean minus the LIA group mean. A negative value therefore means the observed FNB group mean was numerically lower; the sign alone does not establish whether the difference matters to patients or clinicians.

What does a mean difference describe?

In general, a mean difference compares the average values in two groups on the original measurement scale. It is expressed in the same units as the outcome, which makes the primary SCT contrast interpretable in seconds. It does not show how much the groups overlap, describe the result for a typical individual, or indicate whether a difference is important. The group standard deviations describe spread around each group mean and help convey how variable participants’ results were.

How should the interval be read?

A confidence interval gives a range of values compatible with the observed data under the statistical method used. In general, a narrower interval indicates greater precision, while a wider interval indicates greater uncertainty about the effect’s size. The primary SCT interval is -3.27 to 2.27 seconds and includes zero. This means the posted estimate does not rule out no average difference, and it also remains compatible with contrasts in either direction. The confidence level and the full procedure used to construct the interval are not reported in the registry record, so those details should not be assumed.

What does the p-value contribute?

The unadjusted p-value for the primary contrast is 0.723. In general, a p-value describes how unusual the observed data, or data more extreme, would be under a specified null hypothesis and statistical model. It is not the probability that the null hypothesis is true, and it does not measure the size or importance of an effect. It should be interpreted alongside the estimated difference and interval, rather than as a stand-alone decision rule. The registry record does not identify a multiplicity adjustment for the reported p-values.

Why do standard deviations and sample counts matter?

The LIA and FNB primary-outcome means are based on 36 and 37 participants, with standard deviations of 7.1 and 4.7 seconds. In general, estimates of group means become more precise when there is more information and less variability, although precision also depends on the analysis method and study design. The observed counts are outcome-specific. They should not be confused with the total enrollment, because not every enrolled participant necessarily contributes to every posted outcome.

For the secondary outcomes, the same basic framework applies: means and standard deviations summarize each group, and the mean difference expresses the contrast in the original units. TUG is measured in seconds, while 6MWT is measured in meters. The trial record lists unadjusted comparisons but does not report a model specification or any covariate-adjusted estimates. Detailed methods for handling missing observations, protocol deviations, or the outcome-specific exclusions are not fully reported.

What does over-dispersion mean in general?

Over-dispersion is a general concern in analyses of count data when the observed variation is greater than expected under a model’s assumptions. It can make standard errors too small if ignored. The outcomes in this trial are continuous measurements summarized by means and standard deviations, not count outcomes, so over-dispersion is not the central issue for the reported comparisons. More generally, an analysis should use methods suited to the outcome type and observed data structure; the precise modeling choices for this trial are not reported in the registry record.

The sample-size illustrations use the observed effect as a planning reference and make assumptions stated with those figures: a two-sided significance level of 0.05, equal allocation, and a normal approximation. They are not a reconstruction of the trial’s original planning. The registry record does not report the original sample-size justification, its target effect, or its assumptions. General planning estimates depend strongly on the effect size selected, the outcome’s variability, and the desired power.

11. Confidence Intervals and Precision

The primary SCT mean difference is -0.5 seconds, with a reported confidence interval from -3.27 to 2.27 seconds. The interval crosses zero: the data are compatible with no average difference as well as with a negative or positive contrast. Its span is important because it shows that the point estimate alone does not pin down the effect precisely. The p-value of 0.723 is consistent with the interval’s failure to distinguish the observed contrast from zero under the reported unadjusted comparison.

Precision is not the same as correctness or clinical importance. A confidence interval describes uncertainty under the method used, but it does not account automatically for every possible source of bias, missing data, measurement error, or analysis choice. The confidence level and interval-construction method are not reported in the registry record. Interpretation should therefore focus on the stated bounds without assuming unreported details.

The primary group standard deviations, 7.1 seconds for LIA and 4.7 seconds for FNB, show that participant outcomes varied within each group. Variation and the number of observations both affect how precisely a group contrast can be estimated. With posted primary counts of 36 and 37, the estimated contrast remains uncertain. A mean difference near zero is not enough to establish that any true difference must also be near zero.

For the secondary measures, the posted intervals also cross zero. This broad pattern indicates that the estimates do not sharply distinguish a group contrast from no difference. It does not imply equal precision across outcomes: each measure has its own scale, variability, and number of observations. No clinically important difference threshold is reported for the SCT or secondary measures, so statistical precision cannot by itself answer whether a possible difference would matter in practice.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are participants per arm for 80% power and participants per arm for 90% power. These are not total event counts: the outcomes are continuous, and the displayed planning quantities refer to participants in each of two arms. In general, the 80% power column represents a planning target under which the assumed effect would be detected at the stated significance level in 80% of repeated studies; the 90% column uses a higher detection probability under the same planning framework.

The stated assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, a normal approximation, and an effect to detect equal to the stated fraction of the observed effect. The figures are planning illustrations computed from the observed effect, not the original design assumptions; the original sample-size justification is not reported in the registry record. These estimates are not observed power.

For example, planning for 100% of the observed SCT effect gives 2,264 participants per arm for 80% power and 3,031 participants per arm for 90% power. Planning for 75% of that observed effect gives 4,025 participants per arm for 80% power and 5,388 participants per arm for 90% power. The analogous figures for 50% of the observed effect are 9,055 and 12,122 participants per arm. Across these rows, smaller effects require more participants because a smaller group contrast is harder to distinguish from random variation.

These values should not be read as recommendations for a future study or as evidence that the current trial was adequately or inadequately planned. They depend on the observed estimate and the stated simplifying assumptions, and do not incorporate unreported design features or a clinically selected target effect. The curve should be understood in the same planning context: it illustrates how required sample size changes with the effect being targeted, not what the completed trial’s power was.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -0.500; pooled standard deviation σ = 6.004.
2. n = 2 × (1.96 + 0.842)² × 6.004² / -0.500² = 2,263.7, rounded up to 2,264 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -0.5                      # observed difference in means
sigma <- 6.00421213651564                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(1966263)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 2,264 (80% power), 3,031 (90% power)
 75% of observed effect: n per arm = 4,025 (80% power), 5,388 (90% power)
 50% of observed effect: n per arm = 9,055 (80% power), 12,122 (90% power)
power.t.test: 2264.6 
Simulated power at n = 2,264 per arm: 0.800 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The registry identifies one primary endpoint and two secondary outcomes. The primary endpoint is the one-year Stair Climbing Task; the secondary measures are TUG and 6MWT. Keeping this distinction in view matters because a primary outcome ordinarily carries the principal confirmatory question, while secondary outcomes may provide additional context.

Multiplicity arises when several statistical comparisons are made. In general, performing more tests can increase the chance that at least one result appears noteworthy through random variation. Statistical plans may address this with adjustments or by defining a hierarchy of outcomes and tests. Whether the trial prespecified an adjustment, a testing hierarchy, or another multiplicity strategy is not reported in the registry record. The posted comparisons are unadjusted, so the secondary p-values should not be interpreted as if they were multiplicity-controlled evidence.

The record lists outcome-specific exclusions and a withdrawal for the primary outcome: one FNB participant was excluded due to knee revision surgery, one FNB participant withdrew from follow-up due to development of a malignancy, and one FNB participant and three LIA participants were excluded due to total knee arthroplasty of the contralateral knee. The primary outcome description also begins to identify another LIA exclusion but is incomplete in the registry record. The posted analysis counts therefore need to be understood in the context of exclusions and follow-up, while the full participant flow is not reported in the registry record.

The complete missing-data method is not reported. In particular, the record does not say whether missing outcomes were imputed, whether a complete-case analysis was used, or how sensitivity to missing observations was assessed. The exact analysis population and whether the primary comparison followed an intention-to-treat approach are also not reported in the registry record. These details affect how directly the results can be interpreted as estimates of the randomized-group contrast.

The record does not report a full statistical analysis plan, interim analyses, or a prespecified clinical threshold for an important difference. Those omissions do not invalidate the posted summary statistics, but they limit assessment of whether outcome selection, exclusions, and analysis choices were planned before results were known.

15. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

The registry reports serious adverse events for 40 participants at risk in each group. The number affected by a serious adverse event is 0 for LIA and 0 for FNB. For other adverse events, 40 participants are listed at risk in each group and 0 are listed as affected in either group.

These entries describe what was posted for the defined at-risk groups; they should not be read as proof that no adverse event of any kind occurred. The record does not provide serious adverse event terms, and the serious-event term list is empty. Death counts are not reported in the registry record. The event definitions, collection procedures, and duration of safety surveillance are not reported in the registry record, so the scope of these figures cannot be fully assessed from the posted information.

Zero reported events in the listed groups is a summary of the registry entries, not a comparative safety analysis. The counts do not establish that the procedures have identical safety profiles or that rare events are excluded. Safety interpretation depends on complete event ascertainment and adequate follow-up, details that are not available in the registry record.

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

The posted primary result is an estimated mean difference of -0.5 seconds on the one-year SCT, with a confidence interval from -3.27 to 2.27 seconds and an unadjusted p-value of 0.723. The estimate is numerically in the direction of a lower average SCT time in the FNB group, but the interval includes zero and allows contrasts in both directions. The result therefore does not provide clear statistical evidence of a difference between the group means.

This does not prove that the techniques are equivalent. Equivalence requires a prespecified range of differences considered acceptably small and an analysis designed to test that question. Neither an equivalence margin nor an equivalence analysis is reported in the registry record. Likewise, the result does not show that either approach is better for every participant, or address outcomes that were not measured or posted.

The trial’s stated objective concerns functional outcome after one year within a fast-track rehabilitation protocol. The SCT, TUG, and 6MWT provide specific functional measures, not a complete account of recovery. The registry does not report a threshold for clinical importance, so the practical meaning of possible differences cannot be judged from statistical estimates alone. It also does not report the full analysis plan or complete missing-data methods.

The safety entries list no affected participants for serious or other adverse events in the groups at risk, but the event terms and surveillance details are not reported. Those entries should be treated as registry reporting, not as proof that the procedures have indistinguishable safety or that uncommon events cannot occur.

Overall, the posted data describe group averages and uncertainty in a relatively small set of outcome observations. They support a cautious statement: the observed primary contrast is close to zero, but its uncertainty does not establish the absence of a potentially meaningful difference. No treatment recommendation follows from these statistics alone.

17. Why This Trial Matters Statistically

This trial is statistically instructive because the reported primary estimate is close to zero while its interval remains wide enough to include contrasts in both directions. A point estimate alone can make a comparison look settled; the interval shows why uncertainty needs to remain part of the interpretation. The result illustrates the difference between failing to find clear evidence of a group difference and demonstrating equivalence.

It also highlights the importance of matching the statistical question to the clinical question. The registry describes an objective of comparing functional outcome after one year, and the SCT is the designated primary measure. A mean difference in seconds answers a focused question about average stair-task time. It does not automatically answer whether any observed difference matters, whether one technique is preferable for every participant, or whether outcomes beyond those measured differ.

The outcome-specific sample counts and exclusions are another useful reminder that total enrollment and analysis counts are not interchangeable. Primary and secondary measures can have different numbers of observations, and the reasons and methods behind those differences affect interpretation. Here, the registry provides some exclusion information but not a complete participant-flow or missing-data account.

Finally, the secondary outcomes illustrate why a set of unadjusted tests should be interpreted as a whole rather than selecting an isolated result. The record lists multiple functional outcomes but does not report a multiplicity strategy. That limits confirmatory claims from secondary comparisons. Together, these features make precision, outcome hierarchy, and transparent analysis reporting central to understanding what the posted findings can support.

18. 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.

Several limitations specific to this trial constrain interpretation. The registry record does not report the original sample-size justification, target effect, or design assumptions, so the reason for enrolling 80 participants cannot be assessed from the posted information. Planning illustrations based on observed effects do not answer whether the trial was designed to detect a clinically important difference.

The primary-outcome sample counts are 36 for LIA and 37 for FNB, below the total enrollment of 80. The record describes some outcome-specific exclusions and a withdrawal, including knee revision surgery, contralateral total knee arthroplasty, and development of a malignancy, but the full participant flow and the complete analysis population are not reported. The primary outcome description is incomplete after beginning to identify an additional LIA exclusion.

The statistical analysis plan, exact missing-data handling, and any covariate adjustment are not reported in the registry record. The record identifies the study as single masked but does not identify who was masked. The confidence-interval level and construction method are also not stated. These gaps limit assessment of potential bias and of the assumptions behind the posted estimates.

There is no reported threshold for a clinically important difference on the SCT or secondary outcomes, and no equivalence or non-inferiority margin is reported. Multiplicity handling for the primary and secondary outcomes is not reported. The safety record gives zero affected participants in the listed groups but does not provide event terms or surveillance details; death counts are not reported. These limitations do not change the posted numerical results, but they narrow the conclusions that can responsibly be drawn from them.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Fast Track Total Knee Arthroplasty: Local Infiltration Analgesia vs Femoral Nerve Block — NCT01966263.
• Registry record last updated 2023-01-25; status last verified 2022-04.
• Results first posted 2023-01-25.
• 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.

22. Record Summary

NCT01966263 is a completed randomized, parallel-group phase 4 trial comparing local infiltration analgesia with femoral nerve block for people undergoing total knee arthroplasty within a fast-track rehabilitation protocol. Enrollment is listed as 80. The primary outcome is the Stair Climbing Task at one year.

The posted primary means are 14.3 seconds for LIA and 13.8 seconds for FNB. The mean difference is -0.5 seconds, with a reported confidence interval from -3.27 to 2.27 seconds and an unadjusted p-value of 0.723. The interval includes zero, so the posted comparison does not establish a clear difference in average SCT time.

The registry also posts TUG and 6MWT results. Multiplicity handling, the complete analysis plan, original sample-size assumptions, and full missing-data methods are not reported in the registry record. The posted findings should be interpreted as estimates with uncertainty, not as proof of equivalence or a treatment recommendation.