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 A Prospective Randomized Postmarket Clinical Study of the TRANSITION Stabilization System (NCT02184520), a randomized na study. The primary outcome is Fusion Rates.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02184520 |
| Phase | NA |
| Condition | Acute Instabilities Thoracic, Lumbar and Sacral Spine, Chronic Instabilities Thoracic, Lumbar and Sacral Spine, Deformities of the Thoracic, Lumbar and Sacral Spine |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 1 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Globus Medical Inc |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned people with acute or chronic instabilities, or deformities, of the thoracic, lumbar and sacral spine. The registry record describes the device as an adjunct to fusion. It does not report characteristics of an enrolled or analyzed patient population, and the listed enrollment is 1; the record also says endpoint data were not collected.
Intervention
The intervention was the TRANSITION Stabilization System. The registry identifies it as a device used as an adjunct to fusion. Details of how the device was used, the fusion procedures, or other care are not reported in the registry record.
Comparator
The other randomized arm was REVERE Stabilization System. The registry does not describe additional comparator care, or report participant-level outcomes for either arm. It therefore does not establish whether the two groups differed in fusion rates or safety outcomes.
Primary question
The primary outcome was fusion rates at 24 months. In principle, this asks whether fusion was achieved in the study population and how the outcome compares between the randomized device arms. The registry states that the study was terminated before primary and secondary endpoint data collection, so the posted results do not answer that comparison.
In general, a randomized comparison aims to estimate differences between assigned groups while limiting the influence of factors that could otherwise shape treatment selection. That design intention does not replace outcome data: without reported endpoint observations and an analysis, the clinical question remains unanswered by this registry record. The record does not report why the study ended, how many sites began recruitment, or whether any participants received either device.
3. Trial Design
The study was a randomized, parallel-group postmarket clinical study of two devices: TRANSITION Stabilization System and REVERE Stabilization System. The stated purpose was to evaluate TRANSITION as an adjunct to fusion for acute or chronic spinal instability or spinal deformity in the thoracic, lumbar and sacral spine. The registry describes the study as intended to provide postmarket surveillance data to the FDA in accordance with a 522 order.
The planned enrollment was described as up to 360 subjects at no more than 20 sites. The registry enrollment field lists 1. This is a registry entry, not a report of a completed analysis population; the record explicitly states that the study ended before primary and secondary endpoint data collection. It does not report how enrollment was defined or provide a participant flow account.
Allocation is recorded as randomized, masking as none, and the model as parallel. The registry does not report the randomization sequence method, allocation concealment, assignment ratio, or whether the two groups received otherwise similar care. No masking means the registry does not describe masking of participants, clinicians, or outcome assessors; more detailed role-specific masking information is not reported in the registry record.
The study start date is 2016-04-19, and the listed primary completion date is 2016-10-20. Its status is terminated. The record does not state the date or reason for termination, whether recruitment began at any site, or whether the planned follow-up was carried out. The primary endpoint timeframe is 24 months, but the record says data collection did not reach the primary or secondary endpoints. The study phase is listed as NA. No inference about the conduct or results of the trial can fill the gap left by the absent outcome data.
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 study was terminated prior to primary and secondary endpoint data collection, therefore no study data is reported.
Overall Study
| Stage | TRANSITION | REVERE |
|---|---|---|
| STARTED | 0 | 0 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: The study was terminated prior to primary and secondary endpoint data collection, therefore no study data is reported.
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: The study was terminated prior to primary and secondary endpoint data collection, therefore no study data is reported.
| Characteristic | Unit | TRANSITION | REVERE | Total |
|---|---|---|---|---|
| Participants analysed | 0 | 0 | 0 | |
| Age, Categorical: <=18 years | — | — | — | |
| Age, Categorical: Between 18 and 65 years | — | — | — | |
| Age, Categorical: >=65 years | — | — | — | |
| Sex: Female, Male: Female | — | — | — | |
| Sex: Female, Male: Male | — | — | — | |
| Race (NIH/OMB): American Indian or Alaska Native | — | — | — | |
| Race (NIH/OMB): Asian | — | — | — | |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | — | — | — | |
| Race (NIH/OMB): Black or African American | — | — | — | |
| Race (NIH/OMB): White | — | — | — | |
| Race (NIH/OMB): More than one race | — | — | — | |
| Race (NIH/OMB): Unknown or Not Reported | — | — | — |
6. Primary Endpoint
The registry lists the primary outcome as Fusion Rates, measured over 24 months.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was titled Fusion Rates, with a timeframe of 24 months. Fusion is the outcome named by the registry for assessing the study’s central clinical question: whether fusion occurred after use of a stabilization device as an adjunct to fusion. The registry does not provide an operational definition of fusion, such as the criteria, assessment method, assessor, or rules for classifying an outcome. Those details are not reported in the registry record.
In general, a fusion-rate endpoint expresses how often a prespecified definition of fusion is met in the population being assessed. It is used because the occurrence of fusion is directly relevant to the stated treatment purpose. For a randomized comparison, the endpoint would ordinarily be assessed in each assigned group and analyzed according to a prespecified method. The registry does not report such group-level results or an analysis method for this endpoint.
The stated timeframe matters because an endpoint measured at a particular follow-up point describes outcome status at that time, not necessarily earlier or later status. Here, however, the record says the study was terminated before primary and secondary endpoint data collection. It reports no fusion observations, denominators, effect estimate, uncertainty interval, or statistical test. Consequently, the endpoint’s intended meaning can be described, but its observed value and any comparison between TRANSITION and REVERE cannot be evaluated from the posted results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a randomized study comparing TRANSITION Stabilization System with REVERE Stabilization System, with fusion rates at 24 months as the primary endpoint. The decisive limitation for interpretation is that the record says the study was terminated before primary and secondary endpoint data collection. It reports no study data for the primary outcome and no analyses. Thus, the posted results do not estimate a fusion rate for either arm and do not estimate a difference between the arms.
The registry enrollment field lists 1, while the brief description had planned for up to 360 subjects at no more than 20 sites. Neither entry supplies endpoint observations. The enrollment field should not be mistaken for an analyzed sample size or evidence that an endpoint was measured. The record does not give a flow of participants through screening, assignment, treatment, follow-up, and analysis, so the extent of participation and follow-up cannot be reconstructed.
Safety results require the same caution. The adverse-event fields list zero participants at risk and zero affected for serious and other events in both arms, and zero deaths. These entries do not establish that no adverse events occurred. In the context of a record explicitly stating that endpoint data were not collected, the zeros cannot be interpreted as a complete, observed safety comparison. The record supplies no safety analysis, event narratives, or explanation of how those fields were populated.
No effect estimate or confidence interval is reported. In general, a confidence interval communicates the precision of an estimated effect; it cannot be interpreted when the underlying estimate and outcome data are absent. There is also no reported statistical test or p-value. The lack of a reported test is not evidence that the arms were equivalent, nor that one was superior. It means the posted record provides no inferential result for the treatment comparison.
The registry lists the study as terminated, but does not report the reason for termination. It would therefore be unwarranted to attribute termination to efficacy, safety, recruitment, funding, or any other cause. The most defensible conclusion is limited: the record documents a planned randomized postmarket comparison and its intended endpoint, but supplies no endpoint findings with which to judge the comparative outcomes.
9. Statistical Methods Explained
What does randomization contribute?
In general, randomization assigns participants to study groups by chance. Its purpose is to reduce systematic differences in prognostic factors between groups at assignment, supporting a fair comparison of outcomes. It does not guarantee that groups will be identical, and it cannot produce an effect estimate without outcome observations. The registry identifies this study as randomized, but does not report the sequence-generation method, allocation concealment, assignment ratio, or a detailed analysis plan. Those features cannot be inferred from the word randomized alone.
What does the parallel design mean?
In general, a parallel-group design assigns each participant to one study arm and compares outcomes across arms. This differs from a design in which the same participant receives multiple interventions in sequence. The registry lists a parallel model and names TRANSITION and REVERE as the two arms. It does not provide participant-level assignment or outcome data, so no between-arm comparison can be reconstructed.
How should the primary endpoint be analyzed?
The endpoint is Fusion Rates at 24 months. In general, an analysis of a binary fusion outcome might report the number meeting the endpoint and the number assessed in each group, then estimate a between-group contrast with an uncertainty interval. Other endpoint definitions or analysis approaches could require different methods. The registry record does not define the fusion assessment, report group denominators or outcome counts, or specify the statistical model or contrast. No analysis can be reproduced from the posted information.
Because the record states that data collection did not reach the primary or secondary endpoints, there is no observed outcome effect to interpret. A p-value would address compatibility between data and a specified null hypothesis under a statistical model; without reported endpoint data and a test, no such result is available. Likewise, a confidence interval would describe uncertainty around an estimated contrast, but neither a contrast nor its interval is reported. The absence of these quantities is not evidence of no difference.
What does the lack of masking imply?
The registry records masking as none. In general, masking can limit the influence of knowledge about assigned treatment on care, reporting, or outcome assessment. Its importance depends on the outcome and the roles involved. The record does not describe role-specific masking or the method used to assess fusion, so the potential influence of unmasked assessment cannot be characterized. No claim about resulting bias is justified from the registry entry alone.
Can the safety entries be analyzed?
The record lists zero at-risk and affected counts for serious and other adverse events in each group, as well as zero deaths. In general, event counts need a defined observation period, a population at risk, and consistent event ascertainment to support a safety comparison. Here, the registry gives no event descriptions or analysis, and explicitly says endpoint data were not collected. The entries therefore do not support a conclusion about the presence, absence, or relative frequency of adverse outcomes.
What do planning calculations mean?
In general, sample-size planning translates assumptions about a target effect, variability, significance level, and desired power into a planning requirement. It is distinct from observed evidence and cannot show that a completed study had a particular probability of finding an effect. The planning assumptions associated with this record describe a two-sided significance level of 0.05, equal allocation, and a normal approximation, with illustrations based on a fraction of an observed effect. However, the registry does not report an observed effect or endpoint data from which such an effect can be obtained. No planning illustration can therefore be read as an empirical result or as the study’s original justification. The protocol’s sample-size justification and statistical plan are not reported in the registry record.
More generally, sample-size calculations depend on the assumptions used and are not a substitute for estimates and uncertainty intervals from observed data. The registry’s planned enrollment of up to 360 subjects describes the intended scope, not the number analyzed or the amount of information available for an endpoint comparison. The listed enrollment of 1 likewise does not provide the missing endpoint counts, follow-up information, or effect estimate.
What can be concluded from the record?
Methodologically, the available information supports describing the intended randomized, parallel comparison and its 24-month fusion-rate endpoint. It does not support recalculation of an effect, assessment of precision, evaluation of model assumptions, or a test of the treatment contrast. The record reports no analyses and no primary outcome observations. Any statistical statement about comparative efficacy or safety would go beyond the posted information.
10. Multiplicity, Missing Data and Analysis Populations
The registry identifies Fusion Rates at 24 months as the primary outcome and indicates one outcome measure. It also states that primary and secondary endpoint data were not collected. The record does not report an analysis plan, a hierarchy of hypotheses, or a procedure for controlling multiplicity across endpoints, time points, or comparisons. The information available is therefore insufficient to assess how multiple statistical tests would have been handled had endpoint data been collected.
In general, multiplicity arises when several hypotheses or outcome comparisons are tested; without an appropriate plan, the chance of a false-positive finding across those tests can increase. That general concern does not imply that multiple tests were performed in this study. No analyses are reported, so there are no reported p-values or findings to adjust.
The registry does not describe missing-data methods, participant withdrawals, loss to follow-up, or the number of participants with endpoint assessments. Since the record says endpoint data collection did not occur, the absence of results should not be recast as ordinary missing values among a known set of completed assessments. It is not possible to assess whether data were missing for particular participants, what mechanism might explain missingness, or whether imputation or sensitivity analyses were used.
The analysis populations are also not reported. The registry does not say whether analyses were planned for all randomized participants, those treated, or those with available endpoint assessments. In general, these choices affect the population to which an estimate applies. With no reported analysis or endpoint data, no analysis population or missing-data strategy can be evaluated.
11. What the Result Does, and Does Not, Mean
The record establishes that a randomized, parallel-group postmarket study was intended to compare TRANSITION Stabilization System with REVERE Stabilization System for use as an adjunct to fusion. It identifies fusion rates at 24 months as the primary endpoint and describes a target population with acute or chronic spinal instability or spinal deformity in the thoracic, lumbar and sacral spine. These details define the study question, not its answer.
The record does not report fusion results, a treatment-effect estimate, a confidence interval, or a statistical test. It therefore cannot show whether fusion rates differed, how large any difference might have been, or how precisely a difference was estimated. No conclusion that the devices had similar outcomes, different outcomes, or no effect is supported by the posted results.
The adverse-event entries show zeros in the registry’s event fields for both arms, but the record also states that endpoint data were not collected. Those entries do not establish that participants experienced no adverse events, and they do not establish comparative safety. Safety interpretation would require documented ascertainment and a defined population and follow-up, none of which are reported as results.
The registry lists enrollment as 1 and describes an intended enrollment of up to 360 subjects at no more than 20 sites. These entries do not establish the number of participants with outcome assessments or the number included in an analysis. The record does not report participant flow, follow-up completion, or reasons for termination. It also does not explain whether the listed enrollment reflects actual participation in a way that would permit outcome interpretation.
In general, a completed randomized trial can provide an estimate of a treatment contrast if outcomes are measured and analyzed appropriately. Randomized design alone is not evidence of benefit or harm, and a planned endpoint is not an observed result. The scientifically appropriate interpretation is that this registry record documents an intended comparison but provides no endpoint findings from which comparative clinical conclusions can be drawn.
12. Why This Trial Matters Statistically
This trial is statistically important as an example of the distinction between a registered study design and an informative outcome analysis. The registry records randomization, two device arms, a parallel model, and a named primary endpoint. Those design features describe what the study was intended to investigate. They do not establish what happened to participants or whether the devices differed on the endpoint.
The record also illustrates why enrollment targets and outcome data answer different questions. The brief summary describes a plan for up to 360 subjects at no more than 20 sites, while the enrollment field lists 1. Neither figure supplies the missing fusion observations, group denominators, follow-up, or statistical estimates. Statistical interpretation depends on measured data and a clearly described analysis, not on the intended scale of a study alone.
Another important distinction is between zero values in registry event fields and a demonstrated absence of events. Because the record states that endpoint collection did not occur and provides no safety analysis, the zeros should not be read as a reassuring safety finding. Clear separation of data-entry fields from analyzed evidence helps prevent an unsupported conclusion.
Finally, the record’s terminated status is relevant context but does not explain why the study ended. The reason is not reported in the registry record, so no causal account of termination is warranted. For clinicians, researchers, and readers assessing evidence, the key statistical lesson is that a planned randomized comparison cannot answer its clinical question when outcome data and analyses are unavailable. Transparent reporting of the endpoint, participant flow, analysis population, missing data, and uncertainty would be needed for a comparative estimate; those results are absent from this record.
13. 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 central trial-specific limitation is that the registry states the study was terminated before primary and secondary endpoint data collection. Although the primary endpoint and its timeframe are named, no endpoint observations or analyses are reported. This prevents estimation of fusion rates in either arm and prevents any comparison between TRANSITION and REVERE.
The registry lists enrollment as 1, whereas the brief description specifies an intended enrollment of up to 360 subjects at no more than 20 sites. The record does not provide participant flow or explain the relationship between the enrollment entry and any actual treatment or follow-up. The listed enrollment cannot be treated as an analysis population or as evidence that outcomes were assessed.
The reason for termination is not reported in the registry record. Nor does the record describe site activation, recruitment progress, treatment exposure, follow-up, withdrawals, or endpoint assessment procedures. The fusion endpoint is not operationally defined, and no statistical analysis plan, analysis population, missing-data method, or multiplicity strategy is reported. These omissions leave the study’s conduct and intended inferential procedures incompletely characterized.
Safety fields list zero counts for events and deaths in both arms, but no corresponding safety analysis or explanation of ascertainment is reported. Given the statement that endpoint data were not collected, these entries cannot establish that events were absent. The record also does not report the underlying participant-time or population at risk needed to interpret event counts.
Finally, the study’s postmarket surveillance purpose and planned design do not remedy the lack of observed results. The record supplies no effect estimate, confidence interval, or test. These limitations are specific to this registry record and prevent statistical conclusions about comparative efficacy or safety.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: A Prospective Randomized Postmarket Clinical Study of the TRANSITION Stabilization System — NCT02184520.
- Registry record last updated 2021-03-15; status last verified 2021-02.
- Results first posted 2021-03-15.
- 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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17. Record Summary
NCT02184520 is a randomized, parallel-group postmarket clinical study of TRANSITION Stabilization System and REVERE Stabilization System. It was intended to evaluate TRANSITION as an adjunct to fusion for acute or chronic instability or deformity of the thoracic, lumbar and sacral spine. The primary endpoint was Fusion Rates at 24 months.
The study is listed as terminated. The record states that termination occurred before primary and secondary endpoint data collection and that no study data are reported. It lists enrollment as 1; the planned enrollment was up to 360 subjects at no more than 20 sites. No endpoint analysis, effect estimate, uncertainty interval, or statistical test is reported. The listed adverse-event fields contain zero counts, but they do not establish an absence of events in the context of the stated lack of endpoint data. The reason for termination and the details of the statistical plan are not reported in the registry record.