Efficacy and Safety of RTX-GRT7039 in Adult Subjects With Knee Osteoarthritis: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Efficacy and Safety of RTX-GRT7039 in Adult Subjects With Knee Osteoarthritis (NCT05248386), a randomized phase 3 study. The primary outcome is Least Squares Mean (Standard Error) [LS-mean (SE)] Change From Baseline in WOMAC Pain Subscale Score at Week 12.

2. Clinical Question

The clinical question concerns whether the groups had different average changes in knee pain over the primary assessment period. The registry describes a randomized, double-blind, placebo-controlled, parallel-group Phase III trial in adults with knee osteoarthritis pain despite standard of care. Randomization supports a between-group comparison, while placebo injections provide a comparison under the same general injection procedure. The outcome is not simply a score at Week 12: it is the change from baseline, compared between groups using least-squares means. The posted primary estimates are -2.959 for RTX-GRT7039 and -2.847 for placebo. The calculated unadjusted contrast is -0.112, with a confidence interval that includes zero. These estimates describe the registry results; they do not by themselves establish a clinically important difference, or establish that the groups are equivalent. The record does not report a threshold for clinical importance.

3. Trial Design

This was a completed, randomized, quadruple-masked, parallel-group, placebo-controlled Phase III trial sponsored by Grünenthal GmbH. The registry describes it as a multi-site clinical trial. Participants were assigned to RTX-GRT7039 or matching placebo, delivered by intra-articular injection. The double-blind treatment period was 52 weeks, during which the intervention description specifies repeated injections. The record lists enrollment as 469 and reports outcome groups of 234 for RTX-GRT7039 and 232 for placebo; the registry does not explain the relationship between the enrollment figure and the numbers reported for this outcome.

The trial began on 2022-08-26, had primary completion on 2024-11-18, and is listed as completed. The primary endpoint was change from baseline in WOMAC pain at Week 12. Other posted outcomes include WOMAC pain at Week 26 and Week 52 and WOMAC physical function at Week 12, Week 26, and Week 52. The record lists six outcome measures overall. It does not provide details of the randomization procedure, allocation concealment, the identities of the groups covered by quadruple masking, injection scheduling, site locations, or any protocol deviations in the record summarized.

Randomization and masking are design features intended to reduce bias in treatment assignment and outcome assessment. A parallel-group design compares groups assigned to different interventions rather than having each participant receive both interventions. Placebo control offers a comparison with an injection matching the active intervention. These design features support interpretation of a between-group contrast, but do not resolve questions about missing data, analysis populations, or statistical multiplicity when those details are not reported. The registry record does not report the original sample-size justification or detailed statistical analysis plan.

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.

Population: Reporting groups (Full Analysis Set \[FAS\] and Safety Analysis Set \[SAS\]) corresponds to all subjects with an Investigational medicinal product (IMP) administration or matching placebo (including incomplete administrations): FAS - based on treatment as randomized (i.e. as planned); SAF - based on treatment received.

6. Primary Endpoint

The registry lists the primary outcome as Least Squares Mean (Standard Error) [LS-mean (SE)] Change From Baseline in WOMAC Pain Subscale Score at Week 12, measured over Baseline up to Week 12.

The primary endpoint is the least-squares mean change from baseline to Week 12 in the WOMAC pain subscale score for the index knee. The registry describes the scale as an 11-point numeric rating scale, from 0 = no pain to 10 = pain as bad as you can imagine. The subscale consists of 5 questions, and the score is averaged over the number of questions. The endpoint is expressed as a score on a scale, rather than as a count of events or a time-to-event outcome.

Change from baseline focuses on how the score shifts over the assessment period, while the between-group contrast asks whether average change differs between the randomized groups. Least-squares means are model-based group means; the record does not describe the model used to obtain them. This type of outcome is used to summarize a continuous measure across participants, retaining information about degree of change rather than reducing the outcome to categories such as improved or not improved. The posted values are negative in both groups, indicating decreases in the pain scores from baseline as represented by the outcome. The contrast, rather than either group’s change alone, is the relevant quantity for comparing the randomized interventions. The registry record does not report a threshold for a clinically important difference on this scale.

7. Results Posted in the Registry

• RTX-GRT7039: mean -2.96 versus -2.85 on control; difference -0.11 (95% CI -0.53 to 0.30), standardized effect d = -0.05; z-test p = 0.598.

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.

LS-mean (SE) Change From Baseline in WOMAC Pain Subscale Score at Week 26

• 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 errors.
• Result:
  • RTX-GRT7039: mean -2.56 versus -2.60 on control; difference 0.03 (95% CI -0.40 to 0.46), standardized effect d = 0.01; z-test p = 0.880.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between RTX-GRT7039 and the control. The interval gives the range of effects that remain compatible with the data.

LS-mean (SE) Change From Baseline in WOMAC Pain Subscale Score at Week 52

• 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 errors.
• Result:
  • RTX-GRT7039: mean -2.69 versus -2.82 on control; difference 0.14 (95% CI -0.36 to 0.64), standardized effect d = 0.05; z-test p = 0.590.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between RTX-GRT7039 and the control. The interval gives the range of effects that remain compatible with the data.

LS-mean (SE) Change From Baseline in WOMAC Physical Function Subscale Score at Week 12

• 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 errors.
• Result:
  • RTX-GRT7039: mean -2.80 versus -2.74 on control; difference -0.06 (95% CI -0.45 to 0.33), standardized effect d = -0.03; z-test p = 0.754.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between RTX-GRT7039 and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes cover WOMAC pain at Week 26 and Week 52, and WOMAC physical function at Week 12, Week 26, and Week 52. Across the posted comparisons, the estimates are close to zero relative to their confidence intervals, and the intervals include zero. The overall pattern does not show a clearly separated average change between the randomized groups across these listed assessments. This broadly aligns with the primary Week 12 pain comparison, whose unadjusted interval also includes zero.

The secondary measures extend the clinical description beyond the primary pain assessment: they consider pain at later assessments and physical function over the listed follow-up periods. Their pattern should not be treated as independent confirmation of the primary result. Pain outcomes at different times are related measures, and pain and physical function can also be related. A collection of tests increases the opportunity for apparently notable results to arise through chance if each is considered separately.

The registry record does not report multiplicity adjustment, a hierarchy among the secondary outcomes, or a complete set of reported analyses. The comparisons are unadjusted recalculations from posted summaries. Unadjusted secondary results therefore carry less inferential weight than a prespecified primary analysis with a documented testing strategy. In particular, a secondary result should not be selected in isolation to make a broader claim about efficacy or duration of effect. The overall pattern is useful context, but the registry record does not provide the analysis details needed for strong confirmatory interpretation of these outcomes.

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

• LS-mean (SE) Change From Baseline in WOMAC Pain Subscale Score at Week 26
• LS-mean (SE) Change From Baseline in WOMAC Pain Subscale Score at Week 52
• LS-mean (SE) Change From Baseline in WOMAC Physical Function Subscale Score at Week 12
• LS-mean (SE) Change From Baseline in WOMAC Physical Function Subscale Score at Week 26
• LS-mean (SE) Change From Baseline in WOMAC Physical Function Subscale Score at Week 52

9. Statistical Interpretation

10. Statistical Methods Explained

The posted primary outcome is continuous: WOMAC pain is reported as a score, and the group summaries are least-squares means with standard errors. The comparison of interest is the mean change in the RTX-GRT7039 group relative to the mean change in the placebo group. The direction of the contrast depends on the stated order. With RTX-GRT7039 minus placebo, a negative value means the estimated change was more negative in the RTX-GRT7039 group. Since a lower pain score represents less pain on the described scale, direction must be considered alongside the size and uncertainty of the estimate.

What does a least-squares mean represent?

A least-squares mean is generally a model-based estimate of a group mean. It may account for terms included in a statistical model, unlike a simple arithmetic average. The registry record does not report the model specification, covariates, or assumptions used to produce these estimates. The posted group values can therefore be described as least-squares means, but the details of their adjustment cannot be reconstructed from the record.

What does the standard error describe?

A standard error describes the precision of an estimated mean: it reflects how much the estimate would vary across repeated samples under the statistical framework used. It is not the spread of individual participants’ scores. The Week 12 standard errors are 0.15 in both groups. Standard errors help quantify uncertainty around the reported group means and can contribute to an uncertainty interval for a comparison. The standard error alone does not describe the range of individual outcomes or establish the clinical importance of a difference.

How should the between-group estimate be read?

The primary recalculated contrast is -0.112, with a 95% confidence interval from -0.528 to 0.304. The point estimate is the single best estimate under the calculation used, while the interval shows a range of values compatible with the data and its assumptions. Because the interval crosses zero, it includes no average difference as well as values in either direction. This is a reason to avoid treating the point estimate as a precise or conclusive treatment effect. A confidence interval does not assign probabilities to individual values inside it, and it is not a guarantee that the true value lies within the interval.

What does an unadjusted p-value tell us?

The primary unadjusted recalculated p-value is 0.598. In general, a p-value measures how unusual results at least as incompatible with a null hypothesis would be under that hypothesis and the test assumptions. It is not the probability that the null hypothesis is true, the probability that the result is due to chance, or a measure of the size or importance of an effect. The record does not report adjustment for multiple comparisons. Thus, this p-value should be understood as an unadjusted calculation rather than as a multiplicity-controlled result.

What is the role of the approximate pooled standard deviation?

The recalculated comparisons include an approximate pooled standard deviation, marked as approximate in the record. A standard deviation describes variation among individual measurements, whereas a standard error describes uncertainty in an estimated mean. Over-dispersion is general statistical terminology for variability greater than a model assumes; when it occurs, standard errors and tests based on an under-dispersed model can be misleading. The registry record does not report an over-dispersion assessment or a model diagnosing this issue. The approximate pooled standard deviation is useful as a standardized description of the contrast, but it is not an additional trial-reported endpoint and should not be mistaken for a raw patient-level distribution.

What can be inferred from the posted calculations?

The recalculated contrasts use the posted group means and standard errors as summary statistics. They are simple, unadjusted re-calculations rather than an alternative to a prespecified model-based analysis. The record does not provide individual-level data, the analysis model, missing-data handling, analysis population definitions, or a sponsor-reported inferential analysis. Those omissions limit how far the recalculations can be used to reproduce the original statistical approach. The group estimates and uncertainty calculations are best read as descriptive evidence about the reported outcome, with the caveat that the original modeling details are not available in the registry record.

11. Confidence Intervals and Precision

The primary contrast is -0.112, with a 95% confidence interval from -0.528 to 0.304. The interval is wide enough to include zero and values in both directions. It therefore conveys uncertainty about whether the average change differed between groups, as well as the direction and size of contrasts compatible with the posted summaries. The point estimate alone would obscure that uncertainty.

A confidence interval is a range produced by a method that, under its assumptions and across repeated comparable samples, would contain the true parameter at its stated coverage rate. It is not a range containing a stated proportion of individual participant scores. Nor does it mean that there is a 95% probability that the true difference lies within this particular interval. Its interpretation depends on the calculation and assumptions. Here, the interval is associated with an unadjusted recalculation from posted summary statistics, not a reported adjusted sponsor analysis.

The interval’s inclusion of zero means the summaries are compatible with no average between-group difference. It does not prove equivalence, because the registry record does not report an equivalence margin or a noninferiority design. The confidence limits also should not be interpreted as a clinical importance range: the record does not identify a threshold for meaningful change on the WOMAC pain scale. Precision is therefore statistical, not a direct judgment of clinical relevance.

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, not total events. They are illustrative calculations based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The assumed effect to detect is listed as 100%, 75%, or 50% of the observed effect. The original trial’s own sample-size assumptions and justification are not reported in the registry record.

The 80% power column represents the number of participants per arm that the planning calculation estimates would be needed to have an 80% chance of detecting the specified effect under its assumptions, if that effect were present. The 90% power column uses a higher target chance of detection and therefore generally requires more participants per arm. These are design-planning quantities; power is not a probability that the trial’s conclusion is correct. The figures are not observed power.

Smaller effects are harder to distinguish from random variation, so the planning calculation requires more participants per arm as the target effect becomes smaller. For the primary Week 12 outcome, the illustrated values are especially large because the observed contrast is small relative to its variability. The illustrations should not be interpreted as a recommendation for a future study without a separate design assessment. They do not incorporate details absent from the registry record, such as its original analysis model, missing-data approach, or any allowance for multiplicity or attrition. Their purpose is to show how the participant requirement changes under the stated assumptions and different fractions of the observed effect, not to reconstruct the trial’s actual design process.

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 = -0.112; pooled standard deviation σ = 2.290.
2. n = 2 × (1.96 + 0.842)² × 2.290² / -0.112² = 6,560.7, rounded up to 6,561 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 <- -0.112                      # observed difference in means
sigma <- 2.289671806779                     # 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(5248386)
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 = 6,561 (80% power), 8,783 (90% power)
 75% of observed effect: n per arm = 11,664 (80% power), 15,614 (90% power)
 50% of observed effect: n per arm = 26,243 (80% power), 35,132 (90% power)
power.t.test: 6561.6 
Simulated power at n = 6,561 per arm: 0.803 (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 record lists one primary outcome and five secondary outcomes, including pain and physical function at multiple assessment times. Testing several outcomes can increase the chance of at least one apparently unusual result when each test is judged separately. Statistical plans often address this multiplicity by specifying an outcome hierarchy, adjusting significance thresholds, or using another prespecified strategy. The registry record does not report whether any such strategy was planned or applied. The posted recalculated p-values are unadjusted and should not be read as multiplicity-controlled evidence.

The record does not report the statistical analysis plan, model specification, analysis populations, or detailed handling of missing outcome data. For a longitudinal trial, these details matter because the reported means may depend on which participants contribute observations and on the assumptions used for unavailable measurements. Methods such as imputation or likelihood-based analysis are general options, but the record does not state which, if any, were used. The reason for missing data, the amount of missingness, and sensitivity analyses are also not reported in the registry record.

The trial is described as randomized and masked, but those design features do not answer how participants were included in each analysis or whether all randomized participants were analyzed as assigned. The registry record does not specify an intention-to-treat, per-protocol, or safety population for these outcomes. It also does not describe deviations from treatment, adherence, or whether the least-squares means account for baseline score or other covariates. These omissions do not invalidate the posted summaries, but they limit independent assessment of the assumptions behind the estimates and their generalizability to all randomized participants.

No reported analyses are listed for the secondary outcomes. That means the registry record does not display a detailed inferential analysis for those outcomes; it does not establish that no analyses were performed elsewhere. The absence of methods and analysis-population details is an important limit on interpreting both primary and secondary comparisons.

15. Safety Results

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

Deaths

Other (non-serious) adverse events

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

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: osteoarthritis (1.7%), hypertension (0.9%), spinal pain (0.9%), lymphoma (0.4%), femoral neck fracture (0.4%).

The registry reports serious adverse events affecting 17 in the RTX-GRT7039 group and 14 in the placebo group. The group counts at risk are 234 and 232, respectively. These are posted serious adverse event figures; no rate has been calculated from them. The registry also reports zero deaths in each group. Separately, other adverse events affected 53 in the RTX-GRT7039 group and 40 in the placebo group. The record does not describe the seriousness criteria, event ascertainment details, exposure-adjusted analyses, or a causal assessment for the reported events.

The serious adverse event terms listed include Osteoarthritis at 1.7%, Hypertension at 0.9%, Spinal pain at 0.9%, Lymphoma at 0.4%, Femoral neck fracture at 0.4%, and Fall at 0.4%. The registry listing does not provide enough context in the posted record to attribute these terms to a particular group or to establish that an event was caused by an intervention. Counts and percentages describe reported safety observations; differences between groups are not, by themselves, evidence of causation. These figures should be read alongside the limitations in event definitions and follow-up reporting, rather than as a complete safety assessment.

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

The primary result describes average change in WOMAC pain over baseline to Week 12 in the two randomized groups. The group estimates were -2.959 for RTX-GRT7039 and -2.847 for placebo; the unadjusted recalculated contrast was -0.112, with a 95% confidence interval from -0.528 to 0.304. This interval includes zero and spans values in either direction. Thus, the posted summaries do not establish a clear between-group difference at the primary assessment. They also do not demonstrate that the interventions are equivalent, since an equivalence margin and corresponding analysis are not reported.

The result is specific to the endpoint, assessment time, groups, and statistical summaries in the registry record. It does not by itself answer whether a change is important to patients, because the record does not give a threshold for clinically important change. It also does not settle questions about later outcomes, individual response, duration beyond the listed assessments, or the balance of benefits and harms. The secondary outcomes offer related context, but their unadjusted status and the absence of a reported multiplicity strategy limit confirmatory interpretation.

The trial’s randomized, masked, placebo-controlled design provides a structured basis for comparing the assigned groups. However, full interpretation also depends on the analysis model, handling of missing measurements, analysis populations, and other methods that are not reported in the registry record. The safety counts are descriptive and do not establish whether any event was caused by treatment. The posted results should therefore be understood as estimates with uncertainty and reporting limitations, not as medical advice or as a definitive verdict about treatment efficacy or safety.

17. Why This Trial Matters Statistically

This trial illustrates why the contrast between randomized groups is more informative than interpreting each group’s change in isolation. Both groups had negative mean changes in the primary pain score, but the comparative question is whether those changes differed. The recalculated contrast is close to zero and uncertain, with an interval that includes values in both directions. That distinction is central to interpreting controlled trials: improvement within a group does not itself show that the assigned intervention outperformed its comparator.

The results also demonstrate the value of reporting uncertainty alongside a point estimate. A single contrast can appear exact, but its confidence interval communicates the range of compatible effects under the calculation’s assumptions. Here, that range does not support a precise directional conclusion. The secondary outcomes show a related challenge: multiple measures and time points can create many opportunities for interpretation, making a prespecified multiplicity plan important. Such a plan is not reported in the registry record.

Finally, statistical significance, precision, and clinical importance are distinct questions. The record’s unadjusted calculations address an inferential comparison, while the registry does not report a clinical importance threshold or detailed model and missing-data methods. Separating these questions helps prevent a p-value or an individual outcome from carrying more meaning than the underlying evidence 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 trial-specific reporting gaps limit interpretation. The registry record gives least-squares means and standard errors but does not describe the model used to estimate them, the covariates included, or the assumptions behind the analysis. It also does not report the primary analysis population, how missing outcome measurements were handled, or sensitivity analyses. These details could affect the estimates and the uncertainty around them.

The record lists multiple secondary outcomes but does not provide a multiplicity strategy or reported analyses for those outcomes. The displayed comparisons are unadjusted recalculations from the posted summaries, so they should not be treated as a complete confirmatory analysis. No clinically important difference threshold is reported for the WOMAC pain or physical function scores. The record also does not provide details of outcome completion at each assessment, adherence, treatment discontinuation, or protocol deviations.

For safety, the registry reports affected counts and selected serious-event terms, but does not give event-level narratives, group attribution for the listed terms, causal assessments, or exposure-adjusted comparisons in the posted record. The enrollment figure and the outcome-specific group sizes are both recorded, but their relationship is not explained. These reporting limitations do not alter the values as posted, but they constrain independent assessment of the trial’s analysis and the scope of conclusions that can be drawn from the registry record.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Efficacy and Safety of RTX-GRT7039 in Adult Subjects With Knee Osteoarthritis — NCT05248386.
• Registry record last updated 2026-03-18; status last verified 2026-02.
• Results first posted 2025-08-12.
• 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

The registry record describes a completed, randomized, quadruple-masked, parallel-group, placebo-controlled Phase III trial of intra-articular RTX-GRT7039 in adults with knee osteoarthritis pain despite standard of care. The double-blind treatment period was 52 weeks, and the primary outcome was change from baseline in WOMAC pain at Week 12.

The posted Week 12 least-squares mean changes were -2.959 for RTX-GRT7039 and -2.847 for placebo. The unadjusted recalculated contrast was -0.112, with a 95% confidence interval from -0.528 to 0.304. This interval includes zero. Secondary pain and physical function outcomes show a broadly similar pattern of uncertain between-group contrasts. Serious adverse event counts were 17 and 14, with zero deaths reported in each group.

The registry record does not report key details including the original sample-size rationale, analysis model, missing-data methods, analysis populations, or multiplicity strategy. The posted estimates are therefore best interpreted with their uncertainty and reporting limitations in view.