Radiological Evaluation of Radiesse Implantation in the Hands: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Radiological Evaluation of Radiesse Implantation in the Hands (NCT02949921), a non-randomized na study. The primary outcome is Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 1.

2. Clinical Question

The clinical question is primarily descriptive and radiographic: whether post-treatment hand X-rays were interpreted as showing Radiesse obscuring bones. It is not framed as a randomized test of treatment against a control. The registry lists additional outcomes involving adverse events, hand-function questionnaire scores, hand-grade improvement, and aesthetic ratings after initial treatment and retreatment. Those outcome names identify what was assessed, but do not establish what the results were. Outcome values and analyses for these measures are not reported in the registry record.

3. Trial Design

The registry identifies NCT02949921 as a completed, non-randomized, parallel study with no masking. Its official title describes a post-approval safety study with radiological evaluation of implantation in the hands. The listed enrollment is 20. The condition is volume loss in the dorsum of the hand, and the intervention is Radiesse injectable implant with 2% lidocaine HCL. The recorded start date is 2015-12-01, and the primary completion date is 2018-01-02.

Participants were categorized by hand grade. One group is described as having grade 4 hands, with very severe fatty-tissue loss and marked visibility of veins and tendons. The other is described as having grade 2 or 3 hands, with moderate to severe fatty-tissue loss and mild to moderate visibility of veins and tendons. The safety record lists 10 participants at risk in each group. The full treatment descriptions are truncated in the registry record, so more detailed treatment procedures cannot be established from that record.

Because allocation was non-randomized, comparisons between the grade groups cannot be treated as randomized treatment contrasts. The categories reflect different baseline hand grades, rather than randomly assigned study treatments. The registry itself flags that the arms are not a like-for-like control comparison. No masking is recorded for the study, although the primary endpoint definition says that two radiologists interpreted the X-rays and were blinded. The scope of that blinding beyond the endpoint assessment is not reported in the registry record.

The phase is listed as not applicable. The registry lists 10 outcome measures and zero analyses. Completion status and the presence of outcome definitions do not by themselves supply results. In particular, the primary endpoint count, the secondary outcome results, and any statistical tests or estimates 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.

Before assignment: A total of 20 participants were enrolled, treated, and completed the study.

Overall Study

Analysis population for the primary outcome, as defined in the registry: All participants who were enrolled in the 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.

Population: All participants who were enrolled in the study.

6. Primary Endpoint

The registry lists the primary outcome as Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 1, measured over Month 1.

The primary endpoint counts participants with an X-ray of either hand showing bone obscuration at month 1. The registry defines obscuration as a post-treatment hand X-ray that at least one of the two blinded radiologists interpreted as Radiesse obscuring bones. The unit is participants, and the listed population is all participants enrolled in the study.

This is a binary participant-level outcome: a participant either meets the stated interpretation rule or does not. The endpoint focuses on the radiographic appearance of the implanted material in relation to hand bones. A rule based on either hand makes the endpoint participant-focused rather than a separate count for each hand. The definition also makes clear that an interpretation by at least one radiologist is sufficient; it does not require agreement by both readers.

In general, a prespecified operational definition helps make an endpoint more reproducible by clarifying what qualifies as an event, the assessment time, and the unit being counted. Radiologist blinding can help limit influence of expectations on image interpretation, although the registry does not report details about reader procedures or agreement. The actual month 1 count and any uncertainty interval or analysis are not reported in the registry record. Therefore, the endpoint definition can be described, but its observed frequency and precision cannot be assessed from the recorded results.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What kind of endpoint is the primary outcome?

The primary outcome is a participant count defined by an event rule: an X-ray of either hand at month 1 is interpreted as showing bone obscuration by Radiesse by at least one of the two blinded radiologists. In general, a binary endpoint classifies each participant according to whether the specified event occurred. A count is most informative when its denominator is also clear and when the assessment rule is applied consistently. The registry identifies the intended population as all enrolled participants, but does not report the count meeting the endpoint or the analyzed denominator.

The endpoint definition sets an inclusive reader rule: an interpretation by at least one reader qualifies. In general, this can be useful when a study wants to capture any reader-detected finding, but it does not tell the reader how often the radiologists agreed. Agreement statistics, adjudication procedures, and reader-level results are not reported in the registry record. Blinding is stated for the radiologists, but other details about image acquisition and interpretation are not reported.

What does non-randomized allocation mean for comparisons?

In general, random allocation aims to make treatment groups comparable, on average, with respect to measured and unmeasured factors before treatment. This study is recorded as non-randomized, and the groups are based on hand grade. The categories therefore represent differing levels of hand severity as described in the registry, not randomized alternatives. A contrast between those categories would be descriptive and could reflect baseline differences. The registry explicitly warns that the arms are not a like-for-like control comparison.

A parallel design means groups are followed within the same study structure rather than the record describing a crossover design. That label does not establish that the groups are comparable or that a particular statistical model was used. The registry records no masking overall, while also describing blinded radiologist interpretation for the primary endpoint. The relationship between those details and any other study procedures is not reported.

How should counts and uncertainty be understood?

In general, an event count describes how many participants met an endpoint, while an event proportion relates that count to the number assessed. Neither an event count nor a proportion alone fully conveys precision. A confidence interval is a range of values compatible with the observed data under a specified method; wider intervals generally indicate less precision. The registry record does not report a primary endpoint count, an interval, or a statistical test, so no numerical estimate of its uncertainty can be interpreted.

For safety outcomes, the record presents counts among participants at risk. Those counts are useful descriptive information, but they are not a complete account of event burden without details such as event type, timing, recurrence, and follow-up completeness. A zero count in a study group means no event was recorded in that group’s entry; it does not prove the underlying risk is zero. The record does not report additional information that would allow a more detailed safety analysis.

What do the planning assumptions describe?

The registry describes a sample-size planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. It states that the effect to detect is a stated fraction of the observed effect. These are planning assumptions, not a report of observed power. The effect estimate used and numerical planning results are not reported in the registry record. The assumptions also do not establish that they were the study’s original design rationale; the record says the illustration is not the trial’s own design.

In general, a planning calculation asks how much information a future study might need under chosen assumptions. It depends on the anticipated effect, outcome variability or event frequency, the allocation plan, and the statistical method. If the anticipated effect is uncertain, the resulting sample-size estimate is uncertain as well. A planning illustration is not evidence that a completed study had a particular probability of detecting an effect, and it should not be described as observed power.

For binary outcomes, the observed effect depends on the event information in the groups being compared. Here, the primary endpoint result is not reported, and the registry does not identify a randomized control comparison. It is therefore not possible to interpret a primary-endpoint effect from the record. The planning assumptions do not remedy that absence, and no new effect estimate can be inferred from the safety counts.

What analyses are documented?

The registry lists 10 outcome measures and zero analyses. This distinction matters: outcome definitions identify intended measurements, while analyses would describe how results were summarized or compared. The record names several secondary measures and their assessment times, but does not give their results or analysis methods. Statistical details such as model choice, covariate adjustment, handling of repeated measurements, missing-data procedures, and confidence-interval methods are not reported in the registry record.

In general, a statistical method should match the endpoint and study question. Binary outcomes can be summarized with counts and proportions; continuous questionnaire scores require summaries appropriate to their scale and distribution; repeated assessments require attention to within-participant dependence. These are general considerations, not claims about the methods used in this study. Since the registry does not report analysis specifications or results, no particular test or model should be attributed to this trial.

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("Group A: MHGS Grade 4 Hands Group", "Group B: MHGS Grade 2 or 3 Hands Group")
n      <- c(10, 10)
events <- c(0, 0)
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  Group A: MHGS Grade 4 Hands Group  10  0  0.0  0.0  30.8  0.0  27.8  0.2  28.5
ARM  Group B: MHGS Grade 2 or 3 Hands Group  10  0  0.0  0.0  30.8  0.0  27.8  0.2  28.5

11. Multiplicity, Missing Data and Analysis Populations

The registry names a primary endpoint and multiple secondary outcomes, including safety events, MHQ scores, MHGS improvement, and GAIS ratings. Several are assessed after initial treatment and following retreatment. When a study evaluates many outcomes or time points, the chance of observing at least one apparently notable result can increase if each is tested separately. In general, multiplicity procedures can address that issue, but the appropriate approach depends on the study questions and analysis plan.

The registry record lists zero analyses and does not report a multiplicity strategy, a hierarchy among secondary outcomes, or an adjustment for repeated assessment times. It is therefore not possible to determine whether multiplicity was addressed, or how any reported inferential results should be interpreted; outcome analyses are not reported in the registry record.

The record also does not report missing-data counts, reasons for missingness, or methods for handling missing observations. This is relevant because the primary endpoint is defined for all enrolled participants, while the recorded safety entries use participants at risk. The registry does not provide a participant-flow account that would clarify how many participants contributed data to each outcome or assessment time. Missingness can affect both the denominator and the interpretation of an estimate, especially when the likelihood of missing data is related to outcome status.

Analysis-population details beyond the primary endpoint’s stated population are not reported in the registry record. There is no reported intention-to-treat or per-protocol analysis designation, nor a description of exclusions from analyses. These omissions prevent assessment of whether outcome summaries include all enrolled participants or only those with available measurements.

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.

Most frequent non-serious adverse event terms

The registry’s serious adverse event summary lists zero affected participants among 10 at risk in the grade 4 group and zero among 10 at risk in the grade 2 or 3 group. Deaths are also recorded as zero in each group. These are counts from the safety record, not estimates demonstrating that the possibility of a serious event or death is absent.

The same summary lists other adverse events for 6 participants in the grade 4 group and 8 participants in the grade 2 or 3 group, with 10 at risk in each group. The record does not identify the specific events in this summary. It also does not report event timing, recurrence, or a detailed account of severity and relatedness for these entries. The listed counts should therefore be read as a limited descriptive snapshot, not as a complete characterization of safety.

The groups are non-randomized and differ by hand-grade category. Their safety counts should not be interpreted as a controlled comparison of treatment risks. The registry does not report uncertainty intervals or a statistical comparison for these safety figures.

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

The record establishes that the study was designed to examine the radiographic appearance of Radiesse implanted in the dorsum of the hands, with a primary month 1 endpoint based on X-ray interpretation. It also documents the non-randomized, parallel design, the hand-grade groups, and selected adverse-event counts. Those details help define what the study set out to observe and the limits of comparisons between its groups.

The record does not report the primary endpoint result. It therefore cannot establish how many participants met the bone-obscuration definition, how often that finding occurred among those assessed, or how precisely it was estimated. It also does not report results for the listed questionnaire, hand-grade, and aesthetic outcomes. No conclusion about the direction or magnitude of those outcomes can be drawn from their names or assessment times.

The safety summary records no serious adverse events or deaths in the listed groups, while recording other adverse events in both. These figures are descriptive and should not be interpreted as proof that serious events are impossible or as a randomized comparison between severity groups. Additional event details and uncertainty estimates are not reported.

More generally, a completed study does not automatically provide a complete statistical record. A result requires an observed estimate and enough information to understand its denominator, uncertainty, and analysis. In this case, the endpoint definitions and design are available, but the primary and secondary outcome results and statistical analyses are not reported in the registry record. The strongest interpretation is therefore about the study’s stated aims and design, not about the size, precision, or causal meaning of unreported outcomes.

14. Why This Trial Matters Statistically

This study is statistically notable because its primary endpoint has a specific image-interpretation rule: a finding qualifies if at least one of the two blinded radiologists interprets a post-treatment X-ray of either hand as showing bone obscuration. That definition makes the endpoint understandable, while also highlighting the importance of reader agreement and image-assessment procedures. Those details are not reported in the registry record.

The study’s non-randomized groups are defined by hand-grade severity. This is important for readers because a group contrast is not equivalent to a randomized comparison. The recorded design therefore places limits on causal interpretation, quite apart from the absence of outcome results. The registry explicitly cautions against treating the arms as a like-for-like control comparison.

The record also illustrates why an outcome list and a result are different kinds of information. A defined primary outcome and several named secondary outcomes show what was intended to be assessed. They do not reveal the observed values, their precision, or how analyses were conducted. With zero analyses listed and no primary result reported, readers cannot assess statistical evidence for the radiographic outcome.

Finally, safety counts are informative but bounded. The record gives serious-event, death, and other-event counts by group, yet does not provide detailed event descriptions or uncertainty measures. Reading those counts descriptively, rather than as proof of absence or a controlled group comparison, preserves what the data can support without overstating what the registry documents.

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.

A central limitation of the registry record is that it does not report the primary endpoint count or its analyzed denominator. Although the endpoint definition and population are specified, the radiographic result and any uncertainty estimate are absent. This prevents evaluation of the observed frequency and its precision.

The record lists zero analyses, and does not report results for the named secondary outcomes. Statistical methods, including any adjustment, model, or treatment of repeated measurements, are not reported in the registry record. Missing-data counts, reasons for missingness, and analysis-population details are also not reported. These gaps limit assessment of completeness and reproducibility.

The non-randomized design uses groups defined by hand grade, and the registry cautions that they are not like-for-like control arms. Any between-group difference would therefore be difficult to attribute to treatment rather than group characteristics. No control group is identified in the record.

The safety summary is limited to counts by group. Specific other adverse-event terms, event timing, recurrence, and more detailed severity or relatedness information are not reported in the registry record. The record also does not report radiologist agreement procedures beyond the endpoint’s rule and the statement that readers were blinded. The treatment descriptions are truncated, leaving complete administration details unavailable. Together, these limitations mean the record supports a description of study structure and selected safety counts, but not a full outcome or safety assessment.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Radiological Evaluation of Radiesse Implantation in the Hands — NCT02949921.
• Registry record last updated 2023-11-29; status last verified 2023-11.
• Results first posted 2019-03-14.
• 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

NCT02949921 is a completed, non-randomized, parallel study with no masking, listed as a post-approval safety study of radiological evaluation after Radiesse implantation in the hands. Enrollment is recorded as 20. The groups are categorized by hand grade, and the intervention is Radiesse injectable implant with 2% lidocaine HCL.

The primary endpoint is the number of participants with an X-ray of either hand interpreted as showing bone obscuration at month 1, using a definition requiring interpretation by at least one of two blinded radiologists. The endpoint result is not reported in the registry record. The record lists 10 outcome measures and zero analyses.

The safety entries record zero serious adverse events and zero deaths in each group, with other adverse events recorded for 6 participants in the grade 4 group and 8 participants in the grade 2 or 3 group. These are descriptive counts; the registry does not report detailed event terms or inferential analyses.