This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Arthrex Eclipse™ Shoulder Prosthesis (NCT01790113), a non-randomized na study. The primary outcome is Composite Clinical Success.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01790113 |
| Phase | NA |
| Condition | Osteoarthritis |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 303 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Arthrex, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
People with degenerative joint disease; the listed condition is osteoarthritis. The primary endpoint description refers to Eclipse subjects, but it does not specify a separate eligibility population.
Intervention
Eclipse™ Total Shoulder Replacement, listed as a device intervention.
Comparator
Univers™ II Total Shoulder Replacement, listed as an active comparator and device intervention.
Primary question
At the 2 year timeframe, does the Eclipse group meet the registry-defined composite clinical-success criteria? The record does not report the success rate or a statistical comparison between the groups.
The study title and brief summary describe a prospective, randomized comparison of safety and effectiveness. However, allocation is recorded as NON RANDOMIZED. That distinction matters: the registry entry does not support treating the groups as randomized, like-for-like comparison groups. Differences in their observed outcomes, if reported, would not by themselves establish that the device caused those differences.
The primary endpoint is described specifically for Eclipse subjects. It combines improvement and final-score requirements for the Adjusted Constant Score, radiographic criteria, and the absence of specified events through study completion. The registry record does not clarify whether the same composite definition was applied to the Univers™ II group, or how success rates were to be compared. Those details are not reported in the registry record.
The record lists 303 for enrollment and has a TERMINATED status. It gives no primary endpoint result, estimate of the difference between groups, confidence interval, or p-value. Consequently, the clinical question can be described from the endpoint definition, but the posted results do not answer it with an efficacy comparison.
3. Trial Design
The study is described as prospective and multicenter, with a parallel-group model. It compares Eclipse™ Total Shoulder Replacement with Univers™ II Total Shoulder Replacement in patients with degenerative joint disease. Osteoarthritis is the listed condition. The sponsor is Arthrex, Inc. The record lists enrollment as 303, a start date of 2013-02-04, primary completion on 2019-06-07, and status as TERMINATED.
There is an important inconsistency in how the design is described. The official title and brief summary use “randomized” wording, while the allocation field records NON RANDOMIZED. The registry record therefore does not establish that assignment was random. The record also lists no masking. The arms are labeled Active Comparator: Univer II and Experimental: Eclipse; the arm descriptions identify the respective prostheses. Those labels do not resolve the allocation inconsistency or establish that the groups were comparable at baseline.
The registry gives adverse-event group counts, with 79 at risk in the Univers II group and 224 at risk in the Eclipse group. These are the figures recorded for those group entries; the record does not explain the relationship between these figures, the enrollment entry, and each analysis population. The primary endpoint description refers to a 24 month assessment and also uses events through each subject’s completion of the study. The stated endpoint timeframe is 2 year.
Although the record contains a primary endpoint definition and adverse-event entries, it reports 0 analyses. No primary success rates, treatment-effect estimates, confidence intervals, or inferential tests are posted. The reason the study was terminated, the detailed recruitment history, the allocation process, and any changes to the planned design are not reported in the registry record. The title’s randomized wording should therefore not be substituted for the recorded non-randomized allocation.
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: The treated population was 303 subject, with 224 Eclipse subjects and 79 Univers II subjects.
Overall Study
| Stage | Univers™ II | Eclipse™ |
|---|---|---|
| STARTED | 79 | 224 |
| COMPLETED | 76 | 149 |
| NOT COMPLETED | 3 | 75 |
Reasons for not completing this period:
| Reason | Univers™ II | Eclipse™ |
|---|---|---|
| Adverse Event | 2 | 7 |
| Study ended due to FDA clearance | 1 | 68 |
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: 303 were treated (224 Eclipse and 79 Univers II).
| Characteristic | Unit | Active Comparator: Univer II | Experimental: Eclipse | Total |
|---|---|---|---|---|
| Participants analysed | 79 | 224 | 303 | |
| Age, Continuous | years | 66 (23 to 85) | 66 (37 to 86) | 66 (23 to 86) |
| Sex: Female, Male: Female | Participants | 22 | 66 | 88 |
| Sex: Female, Male: Male | Participants | 57 | 158 | 215 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 0 | 4 | 4 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 79 | 220 | 299 |
| Region of Enrollment: United States | Participants | 79 | 224 | 303 |
6. Primary Endpoint
The registry lists the primary outcome as Composite Clinical Success, measured over 2 year.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | percentage of success rate |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is Composite Clinical Success, expressed as a percentage of success rate at the 2 year timeframe. It is a composite because success requires meeting criteria in several domains rather than satisfying a single measurement. The registry describes four requirements for an Eclipse subject: an improvement in Adjusted Constant Score of at least 10 from baseline to the 24 month time-point, a final score threshold written in the record as “> or + to 54,” radiographic success at Month 24, and no reoperation, removal, or modification of a study component and no serious device-related complications through study completion.
Radiographic success is defined as the absence of clinically significant humeral radiolucency, humeral migration or subsidence relative to the 3 month time-point, glenoid migration or subsidence relative to the 3 month time-point, device disassembly or fracture, and periprosthetic fracture, as described in the radiographic protocol. The protocol itself is not reported in the registry record.
As a general statistical concept, a composite endpoint can capture several clinically relevant ways an outcome may be considered unsuccessful. It can also make interpretation less straightforward: a combined success rate does not show which component most often determined the result. The registry record does not report component-specific results, the primary success rate, or how the final score threshold’s wording should be interpreted. Therefore, the endpoint definition can be described, but its observed performance cannot be assessed from the posted results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record defines a primary composite endpoint but does not post its result. It lists 1 outcome measure and 0 analyses. There is no reported composite success percentage, group contrast, confidence interval, or p-value. Without those results, the record cannot establish how often the endpoint was met or how the groups compared on it. The absence of a posted result is not evidence that either group did or did not meet the criteria.
Interpretation is further limited by the design information. The official title and brief summary describe a randomized study, but the allocation field says NON RANDOMIZED. This record should therefore not be read as documenting a randomized comparison. In a non-randomized study, group differences may reflect factors other than the prosthesis, including differences in the people receiving each device or in their care. The registry record does not report baseline group characteristics or adjusted comparative analyses that could help assess those possibilities.
The adverse-event entries report serious-event counts of 12 among 79 at risk for the Univers II group and 26 among 224 at risk for the Eclipse group. The entries also report other adverse-event counts of 42 among 79 and 54 among 224, respectively. Deaths are recorded as 0 and 1, respectively. These are descriptive entries; the record does not provide a statistical comparison, clarify the event-counting method, or explain whether the counts represent people, events, or another unit. No causal interpretation should be drawn from the raw counts alone.
The list of serious-event terms includes “Non device /procedure related SAE” at 12.7%, “Cancer” at 3.8%, “Arthritis” at 3.8%, “Urinary retention” at 3.8%, “Procedure Related” at 2.7%, and “Atrial fibrillation” at 1.3%. The registry does not state the denominator or detailed grouping method for these percentages in the entry summarized by the record, so they should not be treated as directly comparable group-specific risks.
The status is TERMINATED, but the reason for termination is not reported in the registry record. No conclusion about comparative effectiveness or safety can be supported by a primary endpoint estimate because none is posted. The available entries support a description of the study design, endpoint definition, and recorded adverse-event figures, not a judgment that either device is superior or safer.
9. Statistical Methods Explained
What does a composite endpoint represent?
As a general statistical concept, a composite endpoint combines several criteria into a single outcome classification. Under this record’s definition, a subject must satisfy the stated score, imaging, reoperation, component-modification, and serious device-related complication requirements to count as a success. This approach can represent more than a single dimension of outcome. However, the overall percentage alone would not reveal which criterion most often prevented success. Component-level counts would be needed to understand the composition of the result. Such component results are not reported in the registry record.
The endpoint is expressed as a percentage of success rate, but the record does not post the numerator, denominator, or resulting percentage. It also does not report a comparative estimate for Eclipse versus Univers™ II. A percentage without a clearly stated analysis population and denominator can be difficult to interpret, and those details are not reported for the primary endpoint.
What can a group comparison establish?
As a general concept, a comparison estimates how outcomes differ between groups under the analysis being used. A randomized allocation, when properly conducted, can help balance measured and unmeasured prognostic factors on average. Here, however, the allocation field is NON RANDOMIZED despite randomized wording in the title and brief summary. The registry record does not describe the allocation procedure. A crude group difference, were one available, could not automatically be interpreted as an effect caused by the device. Adjustment methods may address measured differences, but they cannot guarantee removal of unmeasured confounding.
No primary outcome comparison is posted, and the record lists 0 analyses. It is therefore not possible to assess whether the sponsor used an unadjusted or adjusted model, how missing observations were handled, or which covariates were included. The statistical analysis plan is not reported in the registry record.
How should uncertainty be read?
In general, a confidence interval describes the range of effect estimates reasonably compatible with the observed data and the statistical method, under its assumptions. A narrow interval indicates greater precision than a wide interval, but neither establishes that an estimate is free from bias. No confidence interval for the primary endpoint or group contrast is reported in the registry record. A p-value, which in general evaluates how incompatible data are with a specified null model, is also not reported. Without estimates and uncertainty measures, the precision of any primary comparison cannot be evaluated.
What do planning illustrations mean?
The registry’s stated assumptions for planning illustrations describe a calculation based on the observed effect, using a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The stated effect to detect is a fraction of the observed effect. These are planning assumptions, not evidence about the trial’s original design. The record does not report the trial’s own sample-size justification, whether these calculations informed recruitment, or the effect estimate used in the illustrations. Any resulting sample-size figures are planning illustrations and not observed power.
As a general principle, power is a design property associated with assumptions about an effect, variability, sample size, and analysis. It is not a retrospective measure that proves whether a result is reliable. No observed power calculation or original statistical plan is reported in the registry record. The record also does not state whether any interim analyses were planned or conducted.
Why does event counting matter?
For adverse events, a count of affected participants differs from a count of all events if a participant can experience repeated events. The registry entries do not clarify which counting convention applies to the serious and other event figures. General statistical comparisons of event rates also depend on a defined observation period and consistent ascertainment. The record gives no detailed exposure-time analysis or comparative statistical model, so the adverse-event counts should be read descriptively.
General methods for analyzing count outcomes may account for over-dispersion, which occurs when observations vary more than a simple count model expects. Whether over-dispersion was assessed or handled in this study is not reported in the registry record. No particular model should be attributed to the investigators from the posted information.
10. Multiplicity, Missing Data and Analysis Populations
The primary endpoint is composite, and its definition contains several requirements. Separately, the adverse-event information includes serious events, other events, deaths, and named serious-event terms. When many outcomes or comparisons are examined, the chance of obtaining an apparently notable result by chance can increase. As a general statistical principle, a prespecified testing hierarchy or multiplicity adjustment may help control that issue. The registry record does not report a multiplicity strategy, a testing hierarchy, or which outcomes were formally tested. It also reports 0 analyses, so there are no posted inferential results to evaluate for multiplicity.
Missing data can affect both the composite endpoint and group comparisons. For example, a subject without a Month 24 assessment may not have all information needed to classify the score and radiographic criteria. This is a general issue, not a claim that missing observations occurred in this study. The registry record does not report missing endpoint counts, reasons for missingness, imputation methods, or sensitivity analyses. It does not explain how incomplete follow-up was handled when evaluating reoperation, removal, modification, or serious device-related complications through study completion.
The analysis population is also not described for the primary endpoint. The record does not state whether the intended analysis included all enrolled subjects, only those treated, only those with evaluable follow-up, or another population. The adverse-event entries list group-specific numbers at risk, but these do not define the primary endpoint analysis population. No per-protocol or intention-to-treat analysis is reported in the registry record.
The study’s allocation is recorded as NON RANDOMIZED, so the familiar intention-to-treat interpretation associated with random assignment cannot be assumed from the title wording. The detailed allocation method and any prespecified handling of departures from assigned treatment are not reported in the registry record. These gaps limit assessment of selection, missingness, and analysis choices.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Active Comparator: Univer II | 12 | 79 | 15.2% |
| Experimental: Eclipse | 26 | 224 | 11.6% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Active Comparator: Univer II | 0 of 79 |
| Experimental: Eclipse | 1 of 224 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Active Comparator: Univer II | 42 of 79 |
| Experimental: Eclipse | 54 of 224 |
Most frequent serious adverse event terms
| Event term | Organ system | Active Comparator: Univer II | Experimental: Eclipse |
|---|---|---|---|
| Non device /procedure related SAE | General disorders | 10 of 79 | 18 of 224 |
| Arthritis | Musculoskeletal and connective tissue disorders | 3 of 79 | 8 of 224 |
| Procedure Related | Musculoskeletal and connective tissue disorders | 2 of 79 | 6 of 224 |
| Cancer | General disorders | 3 of 79 | 1 of 224 |
| UTI | Infections and infestations | 1 of 79 | 2 of 224 |
| Urinary retention | Renal and urinary disorders | 3 of 79 | 0 of 224 |
| Device -Related SAE | Musculoskeletal and connective tissue disorders | 0 of 79 | 2 of 224 |
| Atrial fibrillation | Cardiac disorders | 1 of 79 | 1 of 224 |
| Blood Cancer | Blood and lymphatic system disorders | 0 of 79 | 2 of 224 |
| Chest Pain | Cardiac disorders | 0 of 79 | 2 of 224 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Active Comparator: Univer II | Experimental: Eclipse |
|---|---|---|---|
| Arthritis | Musculoskeletal and connective tissue disorders | 14 of 79 | 27 of 224 |
| Cardiac disorders | Cardiac disorders | 14 of 79 | 11 of 224 |
| Anemia | Blood and lymphatic system disorders | 9 of 79 | 13 of 224 |
| Joint swelling | Musculoskeletal and connective tissue disorders | 5 of 79 | 3 of 224 |
Serious events with the highest arm-level rate: non device /procedure related sae (12.7%), cancer (3.8%), arthritis (3.8%), urinary retention (3.8%), procedure related (2.7%).
The serious adverse-event entries list 12 affected or recorded events among 79 at risk in the Univers II group and 26 among 224 at risk in the Eclipse group. The registry labels the groups Active Comparator: Univer II and Experimental: Eclipse. The entries for other adverse events are 42 among 79 and 54 among 224, respectively. Deaths are recorded as 0 for Univers II and 1 for Eclipse. These figures should be read as registry entries, not as a demonstrated difference in risk.
The record does not explain whether the figures count participants with at least one event, all events, or another unit. It also does not report a formal comparison, confidence intervals, exposure time, severity breakdown, or detailed rules for deciding whether events were device-related. The listed serious-event terms and percentages do not include a clearly stated denominator in the record. Their percentages therefore should not be interpreted as group-specific risks without further information.
As a general statistical concept, raw event counts are sensitive to the number of people observed and the duration of observation. The recorded groups have different at-risk counts, and the registry does not provide an adjusted safety analysis. The serious-event entries are descriptive and do not establish that either prosthesis caused or prevented an event.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a prospective, multicenter comparison of Eclipse™ and Univers™ II shoulder prostheses was registered for patients with degenerative joint disease, with osteoarthritis listed as the condition. It defines Composite Clinical Success as the primary endpoint and describes the criteria intended to classify success. It also posts adverse-event entries for the two groups and identifies the study status as TERMINATED.
It does not establish the observed primary success rate. No result for the composite endpoint, group comparison, confidence interval, or p-value is reported. The record therefore cannot show how precisely success was estimated or whether any observed difference would be compatible with chance. It also cannot identify which composite component most affected the outcome because component-level results are not posted.
The record does not establish that allocation was randomized: allocation is recorded as NON RANDOMIZED, even though the title and brief summary use randomized wording. This means the study should not be interpreted as a documented randomized trial on the basis of its title alone. Without a reported analysis and information about baseline characteristics, differences between groups cannot be attributed to the devices.
The adverse-event figures are counts in registry group entries, not a complete comparative safety analysis. The record does not report the counting convention, adjusted estimates, or uncertainty around the counts. They do not prove that one device is safer or less safe than the other. The reason for termination, statistical analysis plan, missing-data procedures, and analysis populations are also not reported in the registry record.
In short, the record is informative about the intended endpoint and selected descriptive safety entries, but it is insufficient for a quantitative conclusion about comparative effectiveness or safety. This distinction is important: a defined outcome and recorded event counts are not substitutes for posted outcome estimates and a transparent account of how they were analyzed.
13. Why This Trial Matters Statistically
This trial record illustrates why design fields and narrative descriptions need to be read together. The title and brief summary describe a randomized comparison, whereas the allocation field records NON RANDOMIZED. That discrepancy changes how a reader should interpret any between-group contrast. Randomization can support a causal comparison when properly conducted; a non-randomized allocation leaves greater concern that group differences may reflect factors beyond treatment. The registry does not describe the allocation process further.
The primary outcome also highlights the trade-off involved in composite endpoints. Combining score improvement, radiographic criteria, and event-free requirements can provide a broad definition of success. But without component results, a success percentage would not show which element drove the classification. In this record, even the overall primary success result is not posted, so neither the overall outcome nor its components can be evaluated.
The safety entries show why counts need context. Group entries have different numbers at risk, and the registry does not describe the event-counting rules, follow-up exposure, or comparative analysis. Reading raw counts as though they were adjusted risks would overstate what the record establishes. General statistical interpretation requires attention to denominators, observation time, uncertainty, and study design.
Finally, the record lists 0 analyses. This makes the distinction between a registered question and a reported answer especially clear. A detailed endpoint definition does not provide an estimate, and a planning illustration does not show observed precision or observed power. The record is therefore useful for understanding what the study set out to assess and what descriptive entries were posted, while leaving the primary comparative question unanswered in the registry results.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The principal limitation is the absence of posted primary endpoint results. The registry defines Composite Clinical Success at the 2 year timeframe but gives no success percentage, numerator, denominator, group contrast, confidence interval, or p-value. It lists 1 outcome measure and 0 analyses. The primary clinical comparison therefore cannot be quantified from the registry record.
Design information is internally inconsistent: the title and brief summary describe randomization, while the allocation field says NON RANDOMIZED. The allocation procedure is not reported. The record also lists no masking, but does not explain implementation details. Because the analysis populations and baseline group characteristics are not reported, the comparability of the groups cannot be assessed.
The endpoint definition refers to radiographic assessment and a radiographic protocol, but the protocol is not included in the registry record. The final score threshold is written as “> or + to 54,” which leaves its intended comparison unclear. The record does not report component-level outcome results or clarify whether the composite definition was applied to both groups.
Safety entries lack a stated counting convention and do not include comparative estimates or uncertainty measures. The detailed follow-up exposure, event adjudication procedures, and denominator for the listed serious-event percentages are not reported in the registry record. Missing outcome data, their reasons, and the methods used to address them are also not described.
The status is TERMINATED, but the reason for termination is not reported. The original sample-size justification, statistical analysis plan, multiplicity approach, interim analyses, and analysis populations are not reported in the registry record. These omissions constrain interpretation beyond the limitations imposed by the non-randomized allocation.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Arthrex Eclipse™ Shoulder Prosthesis — NCT01790113.
- Registry record last updated 2021-02-03; status last verified 2019-10.
- Results first posted 2021-01-29.
- 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.
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18. Record Summary
NCT01790113 is a prospective, multicenter, parallel-group study of Eclipse™ and Univers™ II shoulder prostheses in patients with degenerative joint disease; osteoarthritis is the listed condition. The official title and brief summary describe a randomized study, but allocation is recorded as NON RANDOMIZED. The record lists enrollment as 303, status as TERMINATED, and no masking.
The primary endpoint is Composite Clinical Success at the 2 year timeframe. Its definition includes Adjusted Constant Score improvement and final-score criteria, radiographic success, and the absence of specified reoperations, component changes, and serious device-related complications. The record lists 1 outcome measure and 0 analyses, and does not report primary endpoint results or a comparative estimate.
Adverse-event entries include serious and other event counts and deaths for both groups. The counting methods and statistical comparison are not reported. The reason for termination, allocation procedure, analysis populations, missing-data methods, and statistical plan are not reported in the registry record.