Open-Label Study for Shoulder Dislocation Using MG-1: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Open-Label Study for Shoulder Dislocation Using MG-1 (NCT01528319), a na na study. The primary outcome is Surgery Success.

2. Clinical Question

This is a descriptive question about outcomes after the procedure in the enrolled group, rather than a comparative question about treatment effects. Without a control group, any observed outcome would not by itself establish what would have happened to the same participants under a different approach. The available record gives the endpoint definition and the timeframe, but not the primary outcome count, the proportion meeting the definition, or an uncertainty estimate. The registry lists secondary outcome categories concerning procedure success, clinical function, laboratory changes, and adverse events. Those categories indicate additional areas of evaluation, but the record does not give enough detail to reconstruct their measures or results. The clinical question can therefore be stated clearly, while its primary outcome answer remains unavailable in the registry record.

3. Trial Design

The registry describes an open clinical trial of arthroscopic Bankart repair using MG-1 for shoulder dislocation. The study is marked completed. Its start is listed as 2011-12, and its primary completion is listed as 2012-08. Enrollment is listed as 24. The listed phase and allocation are NA, and masking is listed as NONE. The model is single-group, so the record describes one intervention group rather than randomized treatment groups.

The intervention is classified as a device. The arm description states that arthroscopic Bankart repair is applied for glenohumeral instability using MG-1. The registry’s brief summary says the study evaluates efficacy and safety of the procedure. These descriptions identify the broad purpose and intervention, but do not give the surgical protocol or further details about how the procedure was performed. Those details are not reported in the registry record.

The primary outcome is titled Surgery Success and is measured in participants. Its timeframe is 12 weeks after surgery. The success definition combines procedure success, MRI confirmation of anchors in the burr holes, maintenance of the glenohumeral ligament labral complex at the anterior edge of the glenoid cavity, and no need for retreatment. Secondary outcome labels include Procedure Success, Clinical Function Evaluation, Number of Participants With Abnormal Changes in One or More Laboratory Tests, and Adverse Event Evaluation. The record lists six outcome measures overall, but does not provide enough information to match each listed secondary category to a complete measurement specification.

The design limits the questions that can be answered. A single group can describe outcomes among participants who received the intervention, but it does not provide a concurrent control for separating intervention outcomes from other influences. Allocation is listed as NA, and the study is not a randomized comparison. The registry record does not report a protocol, participant flow, eligibility criteria, baseline characteristics, or details of treatment adherence. Those omissions make it difficult to judge how the enrolled group was assembled and how fully the intervention was delivered. The primary outcome result and analysis entries are also absent, so the design description cannot be paired with a reported estimate of surgery success.

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 Surgery Success, measured over 12 weeks after surgery.

The primary endpoint is Surgery Success, recorded as a number of participants, at 12 weeks after surgery. Its definition is a composite: procedure success must be confirmed; MRI must confirm anchors in the burr holes; the glenohumeral ligament labral complex must be maintained at the anterior edge of the glenoid cavity; and retreatment must not be needed. A participant must meet the stated conditions for the endpoint’s definition to be satisfied.

A composite endpoint can capture more than one aspect of a clinical outcome in a single measure. In general, this can be useful when several conditions are considered relevant to the study question. It also means that the components should be interpreted together: the overall count does not reveal how many participants met each component separately unless those component results are reported. The record does not report separate component counts.

The endpoint is used to describe success under the study’s prespecified registry definition at the stated follow-up time. The registry record does not report how the endpoint was assessed beyond the MRI confirmation requirement, who made the assessments, or how uncertain or missing assessments were handled. Most importantly, it does not report the number of participants meeting the definition. The endpoint can therefore be explained, but the posted record does not support a conclusion about the observed surgery-success result or its precision.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry gives a limited account of the statistical methods. It identifies a participant-count primary endpoint and provides its timeframe and clinical definition, but it does not report an analysis plan or primary result. The explanations below distinguish those record details from general statistical principles that help readers understand what would ordinarily matter for this kind of outcome.

What does a participant-count endpoint represent?

The endpoint is recorded as the number of participants meeting the Surgery Success definition. In general, a count is a direct summary of how many people satisfy a stated criterion. When a study aims to describe a binary outcome such as success or not meeting the success definition, analysts may also present the count relative to the number assessed. The registry record does not report a primary count or a proportion, so neither can be interpreted.

The endpoint combines several conditions, including MRI confirmation and the absence of a need for retreatment. In general, a composite endpoint’s overall result can conceal differences among its components. For example, readers may want to know whether an overall result is driven by one component or whether the components show a similar pattern. That requires component-level results, which are not reported in the registry record.

Why does the study design matter?

The record identifies the design as single-group, with no masking and no randomized comparison. In general, a single-group study can summarize outcomes among those receiving an intervention, but it cannot use a concurrent control group to estimate a between-group treatment difference. Randomization, when used, helps make comparison groups similar on average with respect to measured and unmeasured factors. That protection is not available through the design.

Open-label status means masking is listed as NONE; it does not establish how every measurement was conducted. In general, knowledge of treatment assignment can influence subjective assessments or decisions about care. The MRI confirmation element may offer an imaging-based criterion, but the registry does not report assessor procedures or whether image assessments were independent. No further claims about bias or assessment safeguards can be made from the record.

What can an uncertainty interval tell readers?

In general, a confidence interval describes the range of estimates reasonably compatible with the observed data under a specified statistical model. A narrower interval indicates greater statistical precision under that model, while a wider interval indicates less precision. An interval does not correct for missing outcomes, biased measurement, or the lack of a control group. The registry record does not provide a confidence interval for the primary endpoint or any other primary-outcome uncertainty estimate.

For a participant-level binary outcome, an analysis may report an estimated success proportion and uncertainty around it. The exact method depends on the analysis plan and data properties. The record does not identify a method, a denominator for the primary analysis, or a missing-data approach. It would therefore be inappropriate to infer an interval or choose a particular method on the study’s behalf.

What does the sample-size illustration mean?

The sample-size section is described as a planning illustration based on an observed effect, not as the trial’s own design. Its stated assumptions are 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 tables, it specifies total events; for other tables, it specifies participants per arm. These are planning conventions, not observed study outcomes.

In general, a sample-size calculation estimates how much information a planned study would need under chosen assumptions. It is sensitive to the target effect, variability or event frequency, significance level, power target, allocation, and statistical method. If the assumptions do not match the actual design or outcome, the resulting illustration may not describe the study’s planning needs. Here, the illustration assumes two arms and equal allocation, while the registry record describes a single-group study. It must not be read as the design used for this trial or as observed power. The record does not report the trial’s own sample-size justification.

What statistical analysis is documented?

The registry lists zero analysis entries. It does not report an analysis population, a statistical model, a hypothesis test, handling of missing observations, or interim analyses. These are not details that can be reconstructed from the endpoint definition or enrollment listing. General statistical concepts can explain what such methods are for, but cannot establish which choices were made in this study. Readers should therefore treat the posted statistical information as incomplete: the outcome is defined, but its analysis and primary result are not reported in the registry record.

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("MG-1")
n      <- c(24)
events <- c(23)
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  MG-1  24  23  95.8  78.9  99.9  79.8  99.3  79.6  99.0

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists six outcome measures overall and gives four secondary outcome labels: Procedure Success, Clinical Function Evaluation, Number of Participants With Abnormal Changes in One or More Laboratory Tests, and Adverse Event Evaluation. It does not report a multiplicity strategy, such as whether any secondary outcomes were designated as confirmatory or how multiple statistical tests would be handled. No analysis entries are listed. The four labels do not reveal which outcomes were formally tested or whether results were selected for reporting.

Multiplicity matters when several outcomes or comparisons are tested. In general, conducting many tests can increase the chance of a finding that appears statistically notable by chance. Methods to address this issue depend on the planned objectives and analysis plan. The registry record does not report such a plan, so no adjustment or unadjusted interpretation can be attributed to the investigators.

The record also does not report how missing outcome data were handled, whether any participants lacked an endpoint assessment, or which participants were included in the primary analysis. The enrollment listing of 24 does not by itself establish the number with an evaluable 12-week outcome. In general, missingness can affect both the denominator and the interpretation of an estimated outcome, particularly if the likelihood of missing data is related to the outcome. Without participant flow and missing-data details, the effect of missingness cannot be assessed.

Analysis populations, including whether analyses were based on everyone enrolled or a subset, are not reported in the registry record. The record also does not report interim analyses or stopping rules. Those omissions should be treated as unknown, not as evidence that a particular procedure was or was not used.

12. 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.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: pyogenic arthritis involving shoulder region (4.2%).

For the MG-1 group, the registry lists 24 participants at risk for serious adverse events and 1 affected. For other adverse events, it lists 24 at risk and 7 affected. The record identifies Pyogenic arthritis involving shoulder region as the leading serious term and displays 4.2% beside it. These figures are descriptive entries in the posted record; they are not estimates from a comparison against a control group.

Serious and other adverse events are separate categories in the registry presentation. The counts should not be combined, and the record does not explain whether participants could appear in both categories. It also does not provide event-level timing, duration, severity details beyond the serious classification, or a description of how events were judged related to the device or procedure. The listed term and percentage should therefore be read as the registry’s reported entry, not as a complete account of safety experience.

In general, safety counts are easier to interpret when the observation period, event definitions, ascertainment methods, and comparison context are clear. Some of those details are not reported in the registry record. The posted figures describe the events recorded for this group; they do not by themselves establish causation or quantify excess risk relative to another treatment.

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

This study record documents an open-label, single-group evaluation of arthroscopic Bankart repair using MG-1 for shoulder dislocation. It identifies the primary endpoint and the conditions that define Surgery Success at 12 weeks after surgery. It also reports adverse-event counts for the MG-1 group. These details help readers understand what the study set out to evaluate and what safety information is posted.

The record does not report the primary endpoint result. It therefore does not show how many participants met the surgery-success definition or how precise such an estimate might be. A missing result cannot be treated as either success or failure. The record’s stated enrollment of 24 does not substitute for a reported endpoint count, nor does it confirm how many participants had an assessment at the primary time point.

The design also sets limits on interpretation. With one group and no randomized comparator, the study cannot directly estimate a treatment difference. Outcomes observed after the procedure would be descriptions of that group, not a controlled estimate of what MG-1 changed. The available safety counts are similarly descriptive and have no comparison group in this record.

In general, statistical significance, clinical importance, and precision are different ideas. A statistical test addresses compatibility with a specified model and hypothesis; clinical importance concerns the relevance of an effect; precision concerns uncertainty around an estimate. The registry does not report a primary estimate, statistical test, or confidence interval, so these aspects cannot be assessed for surgery success. Nor does the record report an analysis plan that would clarify how outcomes were evaluated.

The appropriate reading is narrow: the registry describes the intervention, design, endpoint definition, and selected safety figures, but it does not provide the primary outcome result or enough analysis detail for a full statistical assessment. Nothing in the posted information alone supports a comparative claim about MG-1.

14. Why This Trial Matters Statistically

This trial is statistically instructive because it separates a well-defined endpoint from an interpretable result. The registry gives a detailed composite definition for Surgery Success at 12 weeks after surgery, including procedure success, MRI confirmation of anchors, maintenance of the specified ligament-labral complex position, and no need for retreatment. Yet the primary result is not reported in the registry record. A precise definition is important, but it cannot replace outcome data.

The single-group design is another central statistical feature. It can describe outcomes in participants who received the procedure, but cannot establish a comparative effect without a control group. The registry’s design labels make that limitation visible. They also explain why the planning illustration based on two equal arms should not be mistaken for the trial’s actual design or for observed power.

The safety entries illustrate why counts need context. The record gives at-risk and affected counts, along with a leading serious-event term and a percentage. Those data allow a limited description of what was recorded, but they do not provide a control comparison, detailed event histories, or causal assessments. Statistical interpretation depends not only on the numerical summary but also on definitions, follow-up, denominators, and analytic methods.

Finally, the record lists several outcome areas but no analysis entries. This makes it impossible to judge how multiplicity, missing data, or analysis populations were handled. The example highlights a practical lesson for clinical researchers: registry outcome definitions, results, and statistical methods each contribute different information. When results or methods are absent, readers should state that limitation rather than fill the gap with assumptions.

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.

Several limitations specific to this record constrain interpretation. The primary Surgery Success result is not reported, so the central endpoint cannot be summarized or assessed for precision. The record gives enrollment as 24, but does not report the number assessed at 12 weeks, the number meeting each endpoint component, or participant flow through follow-up.

The design is single-group and open-label, with allocation listed as NA and masking as NONE. There is no like-for-like control comparison. Any outcomes observed in the group would therefore lack a concurrent comparator for estimating a treatment difference. The registry does not report the surgical protocol, eligibility criteria, participant characteristics, or further details about intervention delivery, which limits assessment of the group and conduct of the study.

The registry lists six outcome measures, four secondary outcome labels, and zero analysis entries. It does not report statistical methods, analysis populations, multiplicity handling, missing-data procedures, interim analyses, or the trial’s sample-size justification. It also does not report component-level primary endpoint results or details on who assessed the outcome.

Safety reporting is limited to group-level counts and a leading serious-event term with its displayed percentage. Event-level descriptions, timing, duration, causal assessment, and a comparator are not reported in the registry record. These gaps prevent a fuller account of the safety findings. The planning illustration uses assumptions for a two-arm comparison, while the trial is described as single-group; it should not be treated as a description of the actual trial design.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Open-Label Study for Shoulder Dislocation Using MG-1 — NCT01528319.
• Registry record last updated 2014-08-04; status last verified 2014-07.
• Results first posted 2014-08-04.
• 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

The registry record describes a completed, open-label, single-group study of arthroscopic Bankart repair using MG-1 for shoulder dislocation. Enrollment is listed as 24; the start is 2011-12 and primary completion is 2012-08. The primary endpoint is Surgery Success at 12 weeks after surgery, defined using procedure success, MRI confirmation of anchors, maintenance of the specified ligament-labral complex position, and no need for retreatment.

The primary endpoint result is not reported in the registry record, and zero analysis entries are listed. The record identifies six outcome measures and names four secondary outcome categories. For MG-1, it lists 1 of 24 at risk as affected by a serious adverse event and 7 of 24 at risk as affected by other adverse events; the leading serious term is listed with 4.2%. The single-group design does not provide a direct comparison with another treatment.