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 Motorized Continuous Cold Therapy Versus Standard Post-op Icing Protocol for Two Foot and Ankle Procedures (NCT00950183), a randomized phase 4 study. The primary outcome is Visual Analog Scale (VAS) Pain Scores.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00950183 |
| Phase | Phase 4 |
| Condition | Narcotic Consumption, Pain, Wound Healing |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 36 |
| Arms in the primary outcome | n/a |
| Lead sponsor | OrthoCarolina Research Institute, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Patients undergoing primary first metatarsal osteotomy (PMO) or lateral ankle ligament reconstruction (LAR). The registry lists an enrollment of 36, but also states that the study ended before randomization; it does not establish how many patients entered either treatment group.
Intervention
The planned intervention was the Iceman® motorized cold therapy unit. The study description concerns postoperative use of this device after one of the two foot and ankle procedures.
Comparator
The planned comparison was ice used under the standard postoperative icing protocol. The registry record does not describe further details of how either cooling approach was to be administered.
Primary question
The primary endpoint was Visual Analog Scale (VAS) pain scores, assessed from postoperative day 1 up to postoperative day 14. The broader study description also identifies narcotic consumption, wound healing, patient satisfaction, and complications as topics of interest. No primary endpoint data were analyzed.
3. Trial Design
The registry describes a Phase 4, randomized, parallel-group study with no masking. Its intended comparison was the Iceman® Cold Therapy unit with ice among patients having primary first metatarsal osteotomy or lateral ankle ligament reconstruction. The stated enrollment is 36. That registry figure should not be read as the number randomized or treated: the arm description says the study was terminated prior to randomization of patients.
The study status is terminated. The registry lists a start of 2007-02 and a primary completion of 2010-12. These entries describe the registered study timeline; they do not indicate that the planned treatment comparison was completed. OrthoCarolina Research Institute, Inc. is identified as the sponsor.
Random allocation, when carried out, is intended to reduce systematic differences between groups at the point of assignment. A parallel design means each participant would be assigned to one group rather than receiving both approaches in sequence. Here, those design features describe the planned study, not an achieved comparison: the record explicitly says randomization did not occur. The record does not explain the reason for termination, how many patients were screened or enrolled, or whether any received either cooling approach.
The registry lists several clinical topics and secondary outcomes, but there are no posted analyses. As a result, the design can be described, while its comparative performance cannot be estimated from this 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: The study was terminated before patients were randomized to the treatment arms. Thus, it is not possible to report the results for the individual treatment arms.
Overall Study
| Stage | Foot and Ankle Surgery |
|---|---|
| STARTED | 36 |
| COMPLETED | 0 |
| NOT COMPLETED | 36 |
Analysis population for the primary outcome, as defined in the registry: Data not analyzed due to study termination
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.
| Characteristic | Unit | Foot and Ankle Surgery |
|---|---|---|
| Participants analysed | 36 | |
| Age, Continuous | Years | 56 (25 to 75) |
| Sex: Female, Male: Female | Participants | 33 |
| Sex: Female, Male: Male | Participants | 3 |
6. Primary Endpoint
The registry lists the primary outcome as Visual Analog Scale (VAS) Pain Scores, measured over postop day 1 up to postop day 14.
| 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 Visual Analog Scale (VAS) Pain Scores, with the stated timeframe extending from postoperative day 1 up to postoperative day 14. The registry gives no score values, scale range, schedule of individual assessments, or summary measure across that timeframe. It states that the data were not analyzed due to study termination.
In general, a VAS is used to record a participant’s subjective assessment of pain along a visual scale. Repeated pain assessments can describe how reported pain changes over a postoperative period. Such measurements are useful in a comparison because pain is an experience reported by the participant, rather than a direct measurement of tissue healing or medication use. The details needed to interpret a particular VAS result—such as the scale anchors, how repeated scores would be summarized, and the analysis population—are not reported in the registry record.
Accordingly, the endpoint is identifiable, but there is no observed treatment contrast or estimate of its precision to interpret. The planned timeframe alone does not show what pain scores patients experienced.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central finding is that the planned primary endpoint was not analyzed. The registry states that the study was terminated before patients were randomized, and explicitly says the VAS data were not analyzed due to study termination. There is therefore no posted comparison of pain scores between motorized cold therapy and ice. There is no estimate of the size or direction of a treatment difference, and no confidence interval or significance test for the primary endpoint.
The registry’s enrollment entry is 36, but this does not resolve the absence of randomization. It should not be interpreted as 36 randomized participants, as a completed sample in either arm, or as evidence that outcome measurements were collected. The record gives a single arm description and notes that randomization did not occur. The number of participants who may have been screened, enrolled, or exposed to treatment is not reported in the registry record.
The planned study concerned more than pain. Its description includes narcotic consumption, wound healing, and patient satisfaction; the listed secondary outcomes also include narcotic pain medication usage, patient satisfaction, surgical complications, and postoperative complications. However, the record reports zero analyses. It does not present comparative results for these outcomes, and the presence of an outcome in a registry is not itself evidence of a measured or analyzed result.
The accompanying tables and plots should therefore be read as summaries of what the registry records, not as evidence of treatment effects. In particular, a blank or unavailable result is not a finding of no difference. It means the record does not contain an analyzed comparison from which a difference could be estimated. Nor can the termination be interpreted as a result favoring either approach: the reason for termination is not reported in the registry record.
In general, an estimate describes the observed difference, while a confidence interval describes the uncertainty around that estimate under the analysis assumptions. Neither is available for the primary endpoint. There is consequently no basis in the posted results for judging how large or precise a comparative effect might have been. The record supports a description of the intended question and the study’s termination, but not an efficacy conclusion.
9. Statistical Methods Explained
The statistical methods that can be described are limited by the lack of analyzed outcomes. The registry identifies the intended allocation and design, but a planned randomized comparison is not the same as a completed randomized analysis. The record does not report a statistical analysis plan, model, adjustment strategy, or inferential results. The explanations below distinguish general statistical ideas from methods documented for this study.
What randomization would contribute
In general, randomization assigns participants to groups using a chance process. Its purpose is to make treatment assignment independent of measured and unmeasured participant characteristics on average, thereby supporting a fair comparison. It does not guarantee that two groups will be identical, especially in a small study, and it does not correct problems caused by missing outcome data or deviations from assigned treatment.
The registry labels this study randomized, but its arm description states that patients were not randomized before termination. Thus randomization is a feature of the planned design, not a procedure that can be assumed to have generated comparable treatment groups in the posted data. No group-level baseline characteristics or participant flow are reported in the registry record.
What a parallel-group comparison would estimate
In general, a parallel-group trial compares outcomes in separate groups assigned to different approaches. For a continuous endpoint such as a pain score, an analysis might summarize scores within each group and estimate a between-group contrast. The choice of summary and model matters, particularly when the endpoint is measured repeatedly over time. The registry names the VAS endpoint and its timeframe, but does not report how multiple measurements would be combined or modeled.
No mean, median, variability measure, treatment contrast, confidence interval, or p-value is posted for VAS pain. It is therefore not possible to reproduce or assess an endpoint analysis. The same issue applies to the other planned outcomes: there are no reported outcome estimates or analyses to interpret.
Why uncertainty measures matter
In general, a confidence interval gives a range of values compatible with an estimate under the statistical model and assumptions used. It helps readers assess precision, not just whether an estimate crosses a decision threshold. A p-value addresses compatibility between data and a specified null model; it does not measure the size or importance of an effect. Neither type of inference can be discussed for this trial’s outcomes because the registry reports no analyses.
Precision depends on factors such as the number of informative observations, outcome variability, and the analysis method. The enrollment entry alone cannot establish precision. In particular, it cannot substitute for the number of randomized participants with measured outcomes, which is not reported.
What the sample-size section can and cannot say
In general, a sample-size calculation is a planning exercise based on assumptions about the effect to detect, variability, significance level, allocation, and analysis. It does not establish what happened in a trial and is not a measure of observed power. The sample-size material is intended as a planning illustration, not as a report of the trial’s design justification or its observed power. The registry record does not report the trial’s own sample-size justification.
Here, there is no analyzed observed effect from which to build a meaningful effect-based planning illustration for the primary comparison. The available record also indicates that the primary outcome has fewer than two arms for analysis. Therefore, any absent or unavailable sample-size output should not be interpreted as evidence about a clinically relevant effect or the adequacy of the original plan.
What cannot be reconstructed
The registry does not report a model for repeated VAS measurements, handling of baseline pain, covariate adjustment, assumptions about the outcome distribution, or a strategy for multiple outcomes. It also does not describe any interim analyses or stopping rules. These details are not recoverable from the stated endpoint and design alone. In general, statistical choices should be prespecified and interpreted in light of the data actually collected; here, the record does not contain the analyses needed to evaluate such choices.
In summary, the statistical interpretation is constrained not by a complicated model but by the absence of analyzed outcome data. The posted information identifies the intended comparison and endpoint, while leaving the analysis methods and results unreported.
10. Multiplicity, Missing Data and Analysis Populations
The registry identifies a primary VAS pain endpoint and several additional topics, including narcotic consumption, wound healing, patient satisfaction, and complications. It lists narcotic pain medication usage, patient satisfaction, surgical complications, and postoperative complications as secondary outcomes. Considering multiple endpoints can raise multiplicity concerns: in general, testing several hypotheses without an appropriate plan can increase the chance of at least one apparently notable result arising by chance. The registry record does not report a multiplicity adjustment or a hierarchy for interpreting these outcomes.
This concern is prospective rather than a reason to reinterpret posted findings, because the record reports zero analyses and no endpoint results. It is not possible to determine which outcomes were collected, whether all planned outcomes were assessed, or what testing strategy would have been used.
Missing-data methods and analysis populations are also not reported in the registry record. The record does not describe how incomplete VAS assessments, withdrawals, or other unavailable outcomes would have been handled. It does not identify an intention-to-treat, per-protocol, or other analysis population. Since randomization did not occur, the record also does not establish a randomized population for an intention-to-treat comparison.
In general, missingness can affect both the number of observations contributing to an estimate and the validity of the comparison, depending on why outcomes are unavailable. No missing-data assumptions or sensitivity analyses can be assessed. The termination and absence of analyses leave these questions unresolved rather than answered by the results.
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 |
|---|---|---|---|
| Foot and Ankle Surgery | 0 | 36 | 0.0% |
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 |
|---|---|
| Foot and Ankle Surgery | 0 of 36 |
The adverse-event summary lists 36 participants at risk for serious adverse events and 0 affected, and 36 at risk for other adverse events and 0 affected. These are the figures recorded under the single group description, Foot and Ankle Surgery. They are not a comparison between the Iceman® group and the ice group.
The registry also says the study was terminated before randomization. The adverse-event figures should therefore not be read as evidence that 36 patients were randomized or that treatment-related safety was established. The record does not explain how the at-risk denominators were defined, whether participants received either intervention, what period of observation was used, or how events were collected. No serious adverse event terms are listed.
In general, a zero count means that no events appear in the reported summary; it does not establish that an intervention carries no risk. Safety interpretation depends on the number actually exposed, completeness of follow-up, and consistency of event ascertainment. Those details are not reported in the registry record. The posted figures are best understood as limited registry entries, not as a complete comparative safety analysis.
12. What the Result Does, and Does Not, Mean
This record describes a planned comparison of motorized cold therapy with ice after two foot and ankle procedures. It names pain scores as the primary endpoint and identifies several additional outcomes. It also documents a crucial limitation: the study was terminated prior to randomization, and the primary pain data were not analyzed.
What the record does show is the intended design, interventions, outcome topics, registered enrollment, and termination status. It lists 36 as the enrollment and reports zero analyses. It also includes adverse-event counts, but does not provide enough detail to treat them as a comparative safety assessment. These registry entries describe the registry record; they do not constitute estimates of clinical benefit or harm.
What the record does not show is whether one cooling approach produced lower pain scores, reduced medication use, affected wound healing or satisfaction, or changed complication rates. No treatment difference, uncertainty interval, or statistical test is available. The absence of a reported effect is not evidence that the approaches are equivalent, just as the termination itself does not establish that either approach was favored.
In general, a randomized comparison can support causal interpretation when allocation is implemented, outcomes are collected, and analyses appropriately account for the design and missing data. Here, the record explicitly indicates that randomization was not reached. The planned design therefore cannot supply the protections of an implemented randomized comparison in the absence of randomized participants and analyzed outcomes.
The appropriate conclusion is narrow: the registry documents a trial intended to study postoperative pain and related outcomes, but does not provide analyzed evidence to answer its comparative question. The reason for termination and the fate of any collected information are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial matters statistically because it illustrates the difference between a registered research question and an answer supported by analyzed data. A registry can specify an intervention, comparator, endpoint, and intended design. Those entries are useful for understanding what investigators planned to study, but they cannot substitute for participant allocation, outcome observations, and analysis.
The record labels the design randomized and parallel, yet also states that termination occurred before randomization. This distinction is important when reading any associated tables or safety figures. A design label describes the intended method; it does not demonstrate that the method was implemented. The enrollment entry of 36 likewise should not be mistaken for a randomized analysis population.
It also illustrates why a missing result is not a null result. Without an estimate and its uncertainty, readers cannot assess the size, direction, or precision of a treatment contrast. No significance test can fill that gap, and a zero-event registry entry is not, by itself, a complete safety evaluation.
In general, transparent reporting of participant flow, analysis populations, endpoint methods, missing data, and uncertainty helps readers evaluate how much weight to give results. These details are not reported, and the record contains no analyses. The statistical lesson is therefore about limits of inference: planned methods and named outcomes can frame a question, while conclusions require observed and analyzed data. This boundary is especially important when a registry lists an enrollment figure or adverse-event counts that might otherwise be mistaken for evidence from a completed comparison.
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 main limitation is that the registry states the study was terminated before randomization and that the primary endpoint data were not analyzed. There is no posted comparative result for pain or for the listed secondary outcomes. Consequently, the record cannot establish the size, direction, or precision of any difference between the planned approaches.
The participant flow is unclear. Although the registry lists enrollment of 36, it does not report how many people were screened, enrolled, treated, or followed, and it explicitly says randomization did not occur. The arm description does not document actual exposure to either intervention. The reason for termination is not reported in the registry record.
Endpoint detail is limited. The record names VAS pain scores and the timeframe, but does not report the scale range, assessment schedule within that period, summary measure, or analysis method. The registry also does not report a statistical analysis plan, sample-size justification, missing-data strategy, analysis populations, multiplicity approach, or interim analyses.
The adverse-event summary gives counts but does not explain the denominators, exposure, observation period, or event-collection procedures. It should not be treated as a complete safety comparison. Finally, the planning material cannot overcome the lack of an observed primary effect or two analyzed arms. These limitations arise from what is and is not documented in the registry record; they prevent a comparative statistical conclusion.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Motorized Continuous Cold Therapy Versus Standard Post-op Icing Protocol for Two Foot and Ankle Procedures — NCT00950183.
- Registry record last updated 2016-08-22; status last verified 2014-10.
- Results first posted 2014-11-04.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry record describes a Phase 4, randomized, unmasked, parallel-group study comparing the Iceman® Cold Therapy unit with ice after primary first metatarsal osteotomy or lateral ankle ligament reconstruction. It lists an enrollment of 36, a start of 2007-02, and a primary completion of 2010-12. The study status is terminated, and the arm description states that termination occurred prior to randomization.
The primary endpoint was VAS pain scores from postoperative day 1 up to postoperative day 14. The record says these data were not analyzed due to termination and reports zero analyses. Secondary topics include medication use, satisfaction, and complications. Adverse-event counts are listed, but do not establish a randomized safety comparison. The reason for termination, actual participant flow, and the statistical analysis plan are not reported in the registry record. The posted information therefore describes the intended study but does not answer its comparative clinical question.