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 Percutaneous US Guided Elbow Tenotomy With the TenJet HydroSurgery System (NCT03487250), a registered phase not stated study. The primary outcome is Change in Elbow Pain Using Visual Analog Scale (VAS).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03487250 |
| Phase | Phase not stated |
| Condition | Elbow, Tennis |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 29 |
| Arms in the primary outcome | n/a |
| Lead sponsor | HydroCision, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned patients with elbow tendinosis, listed in the registry under “Elbow, Tennis.” Baseline data included 29 participants contributing 32 elbows. This distinction matters because some outcome information is reported by elbow, while participant counts are also given.
Intervention
The intervention was percutaneous ultrasound-guided medial and lateral tenotomy using the TenJet HydroSurgery System. The registry describes the study as evaluating acute and long-term clinical outcomes after the procedure.
Comparator
The registry describes one TenJet System arm. It does not report a comparator arm or a randomized allocation. The record therefore does not establish a like-for-like control comparison.
Primary question
The primary endpoint was change in elbow pain measured with the Visual Analog Scale (VAS), with assessment planned from 2 weeks through 12 months. The registry defines change as baseline minus follow-up, so positive values would indicate improvement. The numerical VAS results and estimates of change are not reported in the registry record.
The clinical question is whether pain scores changed after the tenotomy procedure over the stated follow-up period. A change within a treated group can describe what happened to the measured scores after treatment, but it cannot by itself distinguish the procedure’s contribution from other explanations for change. Without a reported comparator, the record does not support a comparative treatment-effect estimate. The endpoint is described, but the registry record does not report the observed changes, their variability, or inferential analyses.
3. Trial Design
The study is identified as a prospective, multicenter evaluation of percutaneous ultrasound-guided elbow tenotomy using the HydroCision TenJet HydroSurgery System. Its registry status is completed. The listed start date is 2016-08-04 and the primary completion date is 2019-04-20. The listed enrollment is 29.
The registry describes a TenJet System arm receiving ultrasound-guided medial and lateral tenotomy. It does not report a comparator arm, and allocation is not stated. The record therefore describes an evaluation of outcomes after the intervention rather than a randomized comparison between treatments. The study’s stated purpose was to evaluate acute and long-term clinical outcomes in patients with elbow tendinosis.
The primary outcome was change in elbow pain using the VAS, with measurements at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months. The registry also lists change in elbow function using the Patient-Rated Elbow Evaluation Questionnaire (PREE) as a secondary outcome. The record lists 2 outcome measures and no analyses.
Baseline information for the primary outcome included 29 participants contributing 32 elbows, while follow-up was analyzed per elbow. At 12 months, the Participant Flow information reports 27 elbows from 25 participants completing follow-up. VAS outcome data were available for 26 elbows at that timepoint. The reason for the difference between follow-up completion and outcome availability is not reported in the registry record.
The registry does not report the study’s sample-size justification, an inferential statistical plan, or the details of any interim analyses. Although the study is marked completed, numerical primary or secondary outcome results are not reported in the registry record. Completion status alone does not provide evidence about the size, precision, or direction of an outcome change.
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
| Stage | TenJet System |
|---|---|
| STARTED | 29 |
| COMPLETED | 25 |
| NOT COMPLETED | 4 |
Reasons for not completing this period:
| Reason | TenJet System |
|---|---|
| Lost to follow-up, withdrawn, or pursuing surgical intervention | 4 |
Analysis population for the primary outcome, as defined in the registry: Baseline includes 29 participants contributing 32 elbows; follow-up is analyzed per elbow. At the 12-month timepoint, 27 elbows (25 participants) completed follow-up, as reported in the Participant Flow. However, VAS outcome data were available for 26 elbows. One elbow did not have a recorded VAS score at 12 months due to a missing patient-reported outcome. Therefore, analyses of VAS at 12 months are based on the 26 elbows with available data.
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: Baseline includes 29 participants contributing 32 elbows. Baseline measures are reported at the elbow level where indicated.
| Characteristic | Unit | TenJet System |
|---|---|---|
| Participants analysed | 29 | |
| Age, Continuous | years | 48.0 (33 to 65) |
| Sex: Female, Male: Female | Participants | 19 |
| Sex: Female, Male: Male | Participants | 10 |
| Region of Enrollment: United States | participants | 29 |
| Height (cm) | centimeters | 158.75 (157.48 to 190.5) |
| Weight (kg) | kilograms | 83.73 (54.43 to 147.87) |
| Mean Duration of Symptoms | months | 27.0 (4 to 96) |
| Elbow Tendinosis Diagnosis (medial / lateral / both): Medial location | elbows | 4 |
| Elbow Tendinosis Diagnosis (medial / lateral / both): Lateral location | elbows | 26 |
| Elbow Tendinosis Diagnosis (medial / lateral / both): Both | elbows | 2 |
| Mean BMI | kg/m^2 | 29.8 (29.8 to 29.8) |
6. Primary Endpoint
The registry lists the primary outcome as Change in Elbow Pain Using Visual Analog Scale (VAS), measured over Up to 12 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | VAS Score |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in elbow pain measured with the Visual Analog Scale. The registry defines the VAS range as 0 (no pain) to 10 (intolerable pain), with higher scores indicating worse pain. Change is defined as baseline score minus follow-up score. Under that convention, a positive change represents a lower pain score at follow-up than at baseline; a negative change would represent a higher score.
Pain is a patient-reported outcome, so the measure captures the participant’s own assessment rather than an examiner’s rating of a physical sign. Repeating the measure at the listed timepoints can describe how reported pain changes over follow-up. The 12-month timeframe is the longest specified assessment in this record.
Interpreting a mean change requires attention to its variability and to how many observations contribute at each timepoint. A group mean can describe the average change while concealing variation among participants or elbows. The registry record does not report the mean changes, standard deviations, confidence intervals, or individual-level data needed to assess the magnitude and precision of the observed outcome.
Because baseline data include more elbows than participants, and follow-up is described per elbow, the unit of analysis is important. The record does not explain how dependence between two elbows from the same participant was handled. The PREE is listed as a secondary measure of elbow function, but numerical results for it are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a clinically relevant outcome and a sequence of follow-up assessments, but it does not report numerical VAS results. No mean changes, standard deviations, confidence intervals, or analysis estimates are listed. As a result, the direction and magnitude of change in the posted results cannot be assessed from this record. The stated scoring convention clarifies how a reported value would be interpreted, but it does not establish what values were observed.
The study is a prospective, multicenter evaluation of the TenJet System, not a reported randomized comparison. With no comparator arm described, a change from baseline would be a within-group finding. Even if numerical changes were available, they would describe the observed course in the evaluated group; they would not isolate the effect of the procedure from changes over time, concurrent care, expectations, or other influences. The registry record does not report analyses addressing such alternative explanations.
The counts also need to be read at the correct level. Baseline data are described as 29 participants contributing 32 elbows. Follow-up is analyzed per elbow. At 12 months, the Participant Flow information reports 27 elbows from 25 participants completing follow-up, while VAS data were available for 26 elbows. These figures indicate that the completion and outcome-data counts are not identical. The reason the VAS value was unavailable for one of the elbows completing follow-up is not reported in the registry record.
Repeated measurements at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months can show whether recorded scores vary over time. They also raise questions about how the repeated observations were analyzed and how conclusions across timepoints were handled. The registry lists no analyses, and its statistical analysis plan is not reported in the registry record. It is therefore not possible to determine which method, if any, was used to account for repeated measurements or the relationship between elbows from one participant.
The study is marked completed, but completion is not the same as a complete results report. The registry record names the PREE as a secondary outcome and lists 2 outcome measures, but gives no numerical outcome findings or analysis estimates. The available record supports describing the study question, intervention, endpoint definition, and follow-up counts. It does not support a conclusion about the size or precision of pain change, or about a comparative effect.
9. Statistical Methods Explained
Statistical methods determine how raw outcome observations are combined and how uncertainty is represented. The registry record describes a continuous primary measure, but lists no analyses. The explanations below are general; they do not identify methods used in this study.
What does a mean change represent?
For a continuous outcome, a mean summarizes the average value across the observations included in an analysis. Here, the endpoint is defined as baseline VAS minus follow-up VAS. Under this direction convention, positive values correspond to lower follow-up pain scores. A mean change would describe the average difference under that definition, not the change experienced by every participant or elbow.
A mean can be affected by values that are unusually high or low, and it may conceal substantial variation. It also depends on the observations included. When follow-up data are missing, the mean among observed cases may not represent the full group if missingness is related to pain or other factors. The registry record does not report the numerical means or the approach used for missing outcomes.
Why report a standard deviation?
A standard deviation describes how spread out observations are around their mean. A small standard deviation indicates that observations lie relatively close to the mean; a larger one indicates more dispersion. It is not itself a measure of uncertainty in the mean. The uncertainty in a mean estimate also depends on the amount of information contributing to that estimate and on the analysis structure.
The primary outcome is described as a mean with standard deviation, but the registry record does not report numerical values for either. Without them, readers cannot assess the observed spread of change or judge whether the average represents a fairly consistent pattern or a wide range of outcomes.
What would a confidence interval add?
In general, a confidence interval gives a range of values compatible with the data under a specified statistical procedure. It communicates precision as well as the point estimate: a narrower interval indicates greater precision, while a wider interval indicates less precision. An interval should be interpreted alongside the endpoint definition, analysis population, and assumptions behind the method. No confidence intervals for the primary outcome are reported in the registry record.
Why does the unit of analysis matter?
The registry reports baseline information for 29 participants contributing 32 elbows and says follow-up was analyzed per elbow. Two elbows from one participant may have more similar outcomes to each other than outcomes from different participants. In general, treating correlated observations as independent can understate uncertainty. Appropriate approaches can account for clustering or repeated observations, but the registry record does not report whether such an approach was used.
The outcome is also measured repeatedly over time. In general, repeated observations from the same elbow are related, so methods for longitudinal data may model that dependence. An analysis at each timepoint, a model of the trajectory, and a comparison of change over time answer different statistical questions. The record specifies assessment times but does not report which, if any, of these approaches was used.
What does the record say about testing?
The record lists no analyses. It does not report a hypothesis test, p-value, confidence interval, covariate adjustment, or model for the primary outcome. These details are not reported in the registry record. A reader should not infer that a particular method was used from the outcome definition or from the prospective, multicenter description.
In general, a p-value addresses how compatible data are with a specified null model under the assumptions of a test. It is not a measure of effect size, clinical importance, or the probability that a hypothesis is true. An estimate and its uncertainty are needed to understand both the direction and precision of an outcome. No such numerical estimate is available in this registry record.
How should planning calculations be understood?
In general, a sample-size calculation is a planning exercise based on assumptions about the effect to detect, variability, allocation, significance level, and desired power. It is not a result observed in a completed study, and it does not establish the power actually achieved. The study’s sample-size justification is not reported in the registry record. No numerical planning estimates are reported in the registry record, so no such values can be interpreted.
10. Multiplicity, Missing Data and Analysis Populations
The primary VAS endpoint is scheduled at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months. The registry also lists PREE change as a secondary outcome, and identifies 2 outcome measures. Examining multiple outcomes or timepoints can increase the chance of obtaining at least one apparently notable result by chance when many statistical tests are conducted. In general, a statistical plan may address this through a prespecified primary timepoint, an adjustment procedure, or a clear distinction between confirmatory and exploratory analyses.
The registry record lists no analyses and does not report a multiplicity strategy, a designated primary timepoint among the VAS assessments, or how the secondary outcome was incorporated into inference. Those details are not reported in the registry record. Since no numerical outcome analyses are listed, there is no reported set of p-values or intervals to evaluate for multiplicity.
Missingness is also relevant. At 12 months, the Participant Flow information reports 27 elbows from 25 participants completing follow-up, while VAS outcome data were available for 26 elbows. One elbow therefore lacked a recorded VAS value despite being included among those completing follow-up. The reason and the method used to address missing outcome data are not reported in the registry record. No missing-data assumptions, imputation method, or sensitivity analysis is described.
The baseline participant and elbow counts differ, and follow-up is analyzed per elbow. The analysis population and handling of within-participant clustering are not reported in the registry record. These omissions limit assessment of how representative the analyzed observations are and how uncertainty was calculated.
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 |
|---|---|---|---|
| TenJet System | 0 | 29 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| TenJet System | 0 of 29 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| TenJet System | 2 of 29 |
Most frequent non-serious adverse event terms
| Event term | Organ system | TenJet System |
|---|---|---|
| Worsening Pain | Musculoskeletal and connective tissue disorders | 2 of 29 |
The registry lists 29 at risk for the TenJet System arm. It reports 0 affected for serious adverse events and 0 deaths. For other adverse events, the record reports 2 affected among 29 at risk. No serious adverse event terms are listed, and the record does not provide event descriptions for the other adverse events.
These are descriptive registry figures. A zero count for reported serious events means that none are recorded in that category in this entry; it does not establish that a risk is absent. The record does not describe how adverse events were collected, how long participants were monitored for safety, or whether all events were judged related to the intervention. The figures also do not provide a comparison with another treatment or with an untreated group.
For those reasons, the safety information is limited to the counts recorded in this arm. The registry record does not report details that would clarify the nature, timing, severity, or attribution of the 2 other adverse events.
12. What the Result Does, and Does Not, Mean
The record establishes that a completed prospective, multicenter evaluation assessed ultrasound-guided medial and lateral elbow tenotomy using the TenJet System. It defines pain change on the VAS, specifies the direction in which improvement would be represented, and lists assessments through 12 months. It also identifies PREE change as a secondary outcome.
The registry record does not report numerical outcome results. It therefore does not show the observed average VAS change, its variability, or its precision. It also does not report numerical PREE findings. No conclusion about the magnitude or consistency of outcome change can be drawn from the endpoint definitions and follow-up counts alone.
The study record describes a single intervention arm and does not report randomized allocation or a comparator. Consequently, the design information does not support a direct treatment comparison. In general, a before-and-after change can reflect multiple influences over time, and without a comparator it is difficult to separate those influences from the intervention itself. The registry record does not report analyses that would resolve this limitation.
The reported follow-up information identifies a difference between the count completing 12-month follow-up and the count with recorded VAS outcome data. It does not give the reason for the missing score or explain how missing outcomes were handled. That uncertainty, together with the absence of a reported analysis plan, limits assessment of the primary endpoint.
The safety entry records no serious adverse events and no deaths, and reports 2 affected for other adverse events. These are registry counts, not comparative estimates of safety. Overall, the record is useful for understanding the study question, intervention, outcome definitions, and some follow-up and safety counts. It does not provide the numerical findings needed to judge outcome size, precision, or comparative effects.
13. Why This Trial Matters Statistically
This study illustrates why an endpoint description and a results report answer different questions. The registry explains how pain was measured, the direction used to define change, and when follow-up was planned. Those details make the intended outcome interpretable, but without numerical estimates they do not tell readers what change was observed or how uncertain it was.
It also highlights the importance of stating the unit of analysis. Baseline information is described as 29 participants contributing 32 elbows, while follow-up is analyzed per elbow. When observations can come from more than one elbow per participant, the statistical treatment of their dependence can affect uncertainty. The registry record does not report how this issue was handled.
The 12-month information further shows why outcome availability and follow-up completion should not be treated as interchangeable. The record reports 27 elbows from 25 participants completing follow-up, while VAS data were available for 26 elbows. Without an explanation of missingness or an analysis method, readers cannot assess the potential impact on the endpoint estimate.
Finally, the single-arm description sets a boundary on interpretation. A prospective multicenter design can describe outcomes over time across the study sites, but a within-group change is not a randomized comparison. Statistical reporting should make clear which question an estimate addresses and which uncertainties remain. In this case, the registry record provides the clinical framework and some descriptive counts, but no numerical outcome analyses.
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.
Several trial-specific limitations follow from the information recorded. The registry describes one TenJet System arm and does not report a comparator or randomized allocation. The record therefore cannot support a direct comparison with another intervention or control condition.
The primary endpoint is specified at repeated timepoints, but no numerical VAS results or analyses are listed. The registry record does not report a designated primary timepoint for inference, the statistical model, any adjustment for repeated observations, or a method for accounting for two elbows from one participant. These omissions prevent assessment of the precision and validity of any estimated change.
At 12 months, the record reports 27 elbows from 25 participants completing follow-up and VAS data for 26 elbows. It does not explain why one elbow lacked a recorded VAS value, describe other missing data, or state how missing observations were handled. The potential effect of missingness on the reported outcomes is therefore not assessable.
The record names PREE change as a secondary outcome but reports no numerical secondary results. It also lists no analyses, and does not report a multiplicity plan or sample-size justification. Finally, the safety information is limited to counts: descriptions and attribution of the other adverse events are not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Percutaneous US Guided Elbow Tenotomy With the TenJet HydroSurgery System — NCT03487250.
- Registry record last updated 2026-05-07; status last verified 2026-04.
- Results first posted 2026-05-07.
- 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
This completed, prospective, multicenter evaluation studied percutaneous ultrasound-guided medial and lateral elbow tenotomy using the TenJet HydroSurgery System. The listed enrollment is 29, and the registry describes a single intervention arm without a reported comparator.
The primary outcome was VAS pain change through 12 months, defined as baseline minus follow-up; positive values indicate improvement. PREE change was listed as a secondary outcome. The registry record lists 2 outcome measures and no analyses, and does not report numerical outcome results.
Baseline data included 29 participants contributing 32 elbows. At 12 months, 27 elbows from 25 participants completed follow-up, while VAS data were available for 26 elbows. The reason for the unavailable VAS value is not reported in the registry record. The safety entry reports 0 serious adverse events, 2 affected for other adverse events, and 0 deaths.