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 Longitudinal Outcomes Study of the Subchondroplasty® Procedure in the Foot/Ankle (NCT03087396), a registered phase not stated study. The primary outcome is Foot Function Index-Revised (FFI-R) Short Form Score at 24 Months.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03087396 |
| Phase | Phase not stated |
| Condition | Insufficiency Fractures, Stress Fracture, Stress Fracture, Ankle, Foot and Toes |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 148 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Zimmer Biomet |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned people undergoing, or who had undergone, the Subchondroplasty Procedure in the foot and/or ankle in a standard clinical setting. The registry record lists insufficiency fractures and stress fractures, including stress fractures of the ankle, foot and toes, among the conditions of interest. Enrollment was 148. The primary-outcome description says participants were analyzed together, with subgroup analyses by whether treatment was on-label or off-label; it does not state the number contributing data to the primary outcome at 24 months.
Intervention
The intervention is described as treatment of insufficiency fractures using the Subchondroplasty procedure. The registry record identifies a device intervention. The on-label group is described as using AccuFill® mixed with blood or saline according to the IFU. Off-label treatment is described as AccuFill® mixed with platelet-rich plasma or bone marrow aspirate concentrate. These are descriptions of the treatment groups, not evidence that their outcomes can be compared as if treatment had been randomly assigned.
Comparator
No randomized control group is reported. The registry record does not state how allocation to the on-label or off-label treatment groups occurred. The off-label group was included for exploratory comparison, and the record cautions that the groups are not a like-for-like control comparison. Differences between their outcomes, if reported, could reflect differences in the people treated or other aspects of care, as well as differences in treatment.
Primary question
The primary outcome was the Foot Function Index-Revised Short Form score at 24 months. It is a percentage-scale measure of foot pain, disability and activity limitation, with higher scores indicating more pain or worse function. The central question is what scores participants had at that follow-up. The registry record does not report the score, its standard deviation, or the number analyzed at that timepoint, so it does not establish the observed outcome or its precision.
3. Trial Design
NCT03087396 is a completed post-market clinical outcomes study sponsored by Zimmer Biomet. Its stated purpose was to collect short- and long-term outcomes among people undergoing, or who had undergone, the Subchondroplasty Procedure in the foot and/or ankle in a standard clinical setting. The study began on 2017-03-10, and the primary completion date was 2023-08-23. The registry lists enrollment of 148.
The intervention is described as treatment of insufficiency fractures and is classified as a device intervention. The study was not a randomized comparison: the registry record does not state allocation, and it explicitly cautions that the treatment groups are not a like-for-like control comparison. The on-label group is described as treatment with AccuFill® mixed with blood or saline per IFU. The off-label group is described as treatment with AccuFill® mixed with platelet-rich plasma or bone marrow aspirate concentrate. Off-label subjects were included for exploratory comparison.
Outcomes listed in the study description include pain medication use, pain, function, activity levels and patient satisfaction. The primary outcome is the FFI-R Short Form score at 24 months. Listed secondary outcomes include pain and functional performance assessed with the Numeric Pain Score and the FFI-R Short Form at several follow-up times, including 6-weeks, 12-weeks, 3 months, 6 months and 1 year. The registry lists 16 outcome measures, but the primary score and its participant count are not reported in the registry record. The record does not describe a separate untreated or standard-care comparator.
As a post-market study in standard clinical practice, the design is intended to describe outcomes in the treated population rather than to isolate a causal treatment effect through random assignment. The registry record does not report the allocation process, a protocol-level statistical plan, or details of the sample-size justification. These absences limit what can be inferred about design choices and planned comparisons.
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 | Subchondroplasty With AccuFill® |
|---|---|
| STARTED | 148 |
| COMPLETED | 88 |
| NOT COMPLETED | 60 |
Reasons for not completing this period:
| Reason | Subchondroplasty With AccuFill® |
|---|---|
| Surgical Revision | 12 |
| Death | 1 |
| Physician Decision | 3 |
| Withdrawal by Subject | 5 |
| Lost to Follow-up | 39 |
Analysis population for the primary outcome, as defined in the registry: All participants were analyzed together for outcomes, with subgroup analyses for on-label (mixed with blood or saline per IFU) and off-label (mixed with platelet-rich plasma or bone marrow aspirate concentrate) treatments. Off-label subjects were included for exploratory comparison. At 24 months, N=98 reflects participants with available outcome data at that visit.
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: Participants had ≥1 bone marrow lesion (BML) in the foot/ankle and underwent the Subchondroplasty® procedure using AccuFill® bone substitute material. Per the Instructions For Use (IFU), AccuFill® was intended to be mixed with blood or saline; however, some participants received off-label treatment where other materials (e.g., platelet rich plasma or bone marrow aspirate concentrate) were used. All participants are reported together for baseline measures.
| Characteristic | Unit | Subchondroplasty With AccuFill® |
|---|---|---|
| Participants analysed | 148 | |
| Age, Continuous | years | 45.27 (SD 12.61) |
| Sex: Female, Male: Female | Participants | 85 |
| Sex: Female, Male: Male | Participants | 63 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 20 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 120 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 8 |
| Race/Ethnicity, Customized: Black or African American | Participants | 4 |
| Race/Ethnicity, Customized: Native Hawaiian or other Pacific Islander | Participants | 1 |
| Race/Ethnicity, Customized: White | Participants | 125 |
| Race/Ethnicity, Customized: Other | Participants | 5 |
| Race/Ethnicity, Customized: Decline to Respond | Participants | 5 |
| Race/Ethnicity, Customized: Asian | Participants | 5 |
| Race/Ethnicity, Customized: Unknown or Not Reported | Participants | 3 |
| Region of Enrollment: Canada | participants | 7 |
| Region of Enrollment: United States | participants | 141 |
| Pain and functional performance at baseline by the Foot Function Index: Pain | Percentage scale | 65.7 (SD 18.2) |
| Pain and functional performance at baseline by the Foot Function Index: Stiffness | Percentage scale | 61.0 (SD 21.4) |
| Pain and functional performance at baseline by the Foot Function Index: Difficulty | Percentage scale | 69.9 (SD 17.9) |
| Pain and functional performance at baseline by the Foot Function Index: Activity Limitation | Percentage scale | 65.4 (SD 20.2) |
| Pain and functional performance at baseline by the Foot Function Index: Social Issues | Percentage scale | 50.9 (SD 20.6) |
| Pain and functional performance at baseline by the Numeric Pain Scale (NPS) | Points on a scale (0-10) | 5.2 (SD 2.3) |
| Foot Function Index at Baseline | Percentage scale | 62.5 (SD 16.6) |
| Subject quality-of-life at baseline by the EQ-5D-5L | Index score (0-1) | 0.5 (SD .3) |
6. Primary Endpoint
The registry lists the primary outcome as Foot Function Index-Revised (FFI-R) Short Form Score at 24 Months, measured over 24 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Percentage scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the Foot Function Index-Revised Short Form score at 24 months. The measure addresses foot pain, disability and activity limitation. Items are scored from 1 to 4, where 1 is best and 4 is worst; a response of 5 means not applicable and does not indicate worse function. Subscale scores are calculated from applicable items and converted to a 0-100% scale. Higher scores indicate more pain or worse function.
A foot-specific patient-reported measure can capture symptoms and functional limits that may not be represented by a clinical assessment alone. A follow-up measure also describes participants’ status at a particular time after treatment. It does not, by itself, show how much participants changed from baseline or what would have happened without the procedure. Interpreting change requires the relevant baseline and follow-up results, along with information about who contributed data at each timepoint.
The registry record identifies the endpoint as a mean with standard deviation, but does not report the mean, standard deviation, or number analyzed at 24 months. The value of the primary endpoint and its precision therefore cannot be assessed from the registry record. No claim about the magnitude or direction of the observed score is supported by the posted record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The study’s primary outcome is a continuous measure of foot pain, disability and activity limitation at 24 months. Its direction is clinically important for reading a score: higher values on the 0-100% scale represent more pain or worse function. However, the registry record does not report the primary mean, standard deviation or number of participants analyzed. Consequently, it is not possible to describe the observed 24-month score, assess its precision, or determine how it relates to baseline from the record.
The study description says that outcomes were analyzed together for all participants, with subgroup analyses for on-label and off-label treatment. It also states that off-label subjects were included for exploratory comparison. The registry record cautions that the groups are not a like-for-like control comparison and does not state how treatment allocation occurred. Therefore, even if subgroup results were available, a difference between these groups would not by itself identify an effect caused by the treatment mixture. Differences in participant characteristics, clinical decisions or other factors could also contribute.
The named secondary outcomes cover pain and functional performance, including Numeric Pain Score and FFI-R Short Form measures at follow-up times from 6-weeks through 1 year. The record lists 16 outcome measures, but does not provide the results needed to describe their values or patterns. It also does not report estimates, confidence intervals or p-values for the primary outcome. The count of analyses listed in the record is zero. This means the registry entry does not provide a statistical analysis result that can be interpreted for the primary endpoint.
A confidence interval, in general, expresses uncertainty around an estimate: narrower intervals indicate greater precision under the assumptions used to calculate them. No confidence interval for the primary outcome is reported in the registry record, so the uncertainty around the mean cannot be assessed. A standard deviation would describe variation among observed scores, whereas a confidence interval would address precision of an estimated mean; neither should be treated as a substitute for the other.
The record also lists serious adverse events and other adverse events by treatment group. Those figures describe reported events in the recorded groups; they do not establish that the procedure caused an event. The small off-label group and the absence of a randomized control group are important context for interpreting any apparent differences. Overall, the registry record documents the study’s objectives and some safety counts, but does not report the primary outcome result needed to evaluate the 24-month functional status.
9. Statistical Methods Explained
The primary measure is continuous: it can take values along a numeric scale rather than being limited to categories such as event or no event. The registry specifies that the primary outcome is summarized as a mean and standard deviation. In general, the mean describes the central level of observed scores, while the standard deviation describes how spread out individual scores are around that mean. These answer different questions. A mean alone does not show whether participants’ scores were tightly clustered or highly variable.
What does the scale measure?
The FFI-R Short Form measures foot pain, disability and activity limitation. Its items use scores from 1 to 4, with 1 representing the best response and 4 the worst; 5 means not applicable and is not a worse score. Subscales are calculated from applicable items and converted to a 0-100% scale. Higher values represent more pain or worse function. This direction matters: a larger score should not be described as better function. The scale’s interpretation also depends on the applicable items used for each participant and on the scoring approach. The registry description explains the basic scoring but does not report further scoring or missing-item rules.
What can a follow-up mean establish?
A mean score at 24 months would describe the observed group at that follow-up, provided the number analyzed and the distribution of available data were also understood. It would not automatically quantify change from baseline. To describe change, baseline and follow-up scores must be compared using an appropriate analysis, and the record must clarify how participants with incomplete follow-up were handled. The registry record does not report the primary score or the number analyzed at 24 months, nor does it describe the missing-data method. Thus, neither the level of the observed score nor a change from baseline can be reconstructed from the record.
How should uncertainty be read?
In general, a confidence interval gives a range of values compatible with the data and the statistical assumptions used for the estimate. It conveys the precision of an estimate, not the spread of individual participant scores. The standard deviation conveys that spread. A p-value, when reported, addresses compatibility with a specified null hypothesis under an analysis model; it does not measure the size or clinical importance of an outcome. The registry record does not report a confidence interval or p-value for the primary endpoint, so these aspects of the result cannot be assessed.
Why does over-dispersion matter?
In general, over-dispersion occurs when observed variability is greater than a statistical model expects. If a model assumes less variability than the data contain, its standard errors may be too small and its confidence intervals too narrow. This concern is especially relevant to outcomes modeled as counts or rates, where a simple model may not capture differences between participants. The primary endpoint in this study is a continuous score summarized with a mean and standard deviation; the registry does not report an over-dispersion assessment or a model-based analysis. No conclusion about such an assessment can be drawn from the record.
What do the planning calculations represent?
The planning illustrations use the observed effect as a reference and assume a two-sided significance level of 0.05, equal allocation between two arms and a normal approximation. The effect to detect is defined as a stated fraction of the observed effect. In general, these assumptions describe hypothetical planning scenarios. They are not evidence that the trial was designed with those assumptions, and they are not observed power. The registry record does not report its own sample-size justification. Because the primary outcome result is not reported, readers should not treat a planning illustration as a substitute for the missing outcome estimate or as evidence about the actual design rationale.
What do the treatment groups allow?
The on-label and off-label groups are not described as randomized arms. The registry does not state how allocation occurred and explicitly cautions that the groups are not a like-for-like control comparison. A comparison between groups in a nonrandomized setting can reflect differences in who received each treatment, in clinical decisions, or in other factors, as well as any treatment-related difference. The record characterizes the off-label comparison as exploratory. It does not report an adjustment strategy for potential confounding.
These principles explain how the stated measures and assumptions should be read; they do not establish which statistical procedures were actually used beyond what the registry reports. The record does not provide the primary estimate, its variability, an uncertainty interval, or a detailed analysis plan. Statistical interpretation must therefore remain limited to the design description and reported event counts.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 16 outcome measures, including multiple pain and functional assessments at different follow-up times. When many outcomes or timepoints are examined, the chance of at least one apparently notable result can increase. In general, a prespecified hierarchy or multiplicity adjustment can help control that concern, but the registry record does not report whether either was planned or used. It also does not report a complete statistical analysis plan or a set of primary and secondary comparisons with associated inference procedures.
The primary endpoint is identified as the FFI-R Short Form score at 24 months. The record describes the population as analyzed together, with subgroup analyses by on-label and off-label treatment, and calls the off-label comparison exploratory. It does not describe whether subgroup analyses were prespecified, how any comparisons were adjusted, or whether other analysis populations were defined. The number of analyses listed in the record is zero, and no primary-outcome analysis result is reported.
Missing-data handling is also not reported in the registry record. The record does not give the number with an observed primary score at 24 months, reasons for missing follow-up, or an approach for incomplete questionnaires or follow-up visits. This matters because an observed mean among participants with available data may differ from the mean that would have been observed if all enrolled participants had complete follow-up, particularly if availability is related to health or outcome. Without participant counts and a stated method, the extent and possible impact of missing data cannot be assessed.
These gaps do not prove that no multiplicity or missing-data procedures were used; they mean the procedures are not reported in the registry record. Interpretation should not assume a particular analysis population, adjustment, imputation method or follow-up completeness.
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 |
|---|---|---|---|
| Subchondroplasty With AccuFill® (On-Label) | 24 | 142 | 16.9% |
| Subchondroplasty With AccuFill® (Off-Label) | 1 | 6 | 16.7% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Subchondroplasty With AccuFill® (On-Label) | 1 of 142 |
| Subchondroplasty With AccuFill® (Off-Label) | 0 of 6 |
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 |
|---|---|
| Subchondroplasty With AccuFill® (On-Label) | 44 of 142 |
| Subchondroplasty With AccuFill® (Off-Label) | 3 of 6 |
Most frequent serious adverse event terms
| Event term | Organ system | Subchondroplasty With AccuFill® (On-Label) | Subchondroplasty With AccuFill® (Off-Label) |
|---|---|---|---|
| Right ankle pain | Musculoskeletal and connective tissue disorders | 2 of 142 | 0 of 6 |
| Pain similar to pre-existing level with ambulation | Musculoskeletal and connective tissue disorders | 1 of 142 | 0 of 6 |
| Contracture of fifth toe, TTP and spasming of the extensor tendon | Musculoskeletal and connective tissue disorders | 1 of 142 | 0 of 6 |
| Degenerative disc | Musculoskeletal and connective tissue disorders | 1 of 142 | 0 of 6 |
| Exacerbation of lymphedema of right leg | Skin and subcutaneous tissue disorders | 1 of 142 | 0 of 6 |
| Fibroid Uterus causing abnormal uterine bleeding | Reproductive system and breast disorders | 1 of 142 | 0 of 6 |
| Fibrous coalition | Musculoskeletal and connective tissue disorders | 1 of 142 | 0 of 6 |
| Glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 142 | 0 of 6 |
| Intractable subacute left foot postoperative pain | Musculoskeletal and connective tissue disorders | 1 of 142 | 0 of 6 |
| Iron deficiency, anemia | Blood and lymphatic system disorders | 1 of 142 | 0 of 6 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Subchondroplasty With AccuFill® (On-Label) | Subchondroplasty With AccuFill® (Off-Label) |
|---|---|---|---|
| Increase in VAS pain score | Musculoskeletal and connective tissue disorders | 4 of 142 | 0 of 6 |
| Right ankle pain | Musculoskeletal and connective tissue disorders | 3 of 142 | 0 of 6 |
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | 2 of 142 | 0 of 6 |
| Sinus tarsi syndrome | Musculoskeletal and connective tissue disorders | 2 of 142 | 0 of 6 |
| Post traumatic arthritis | Musculoskeletal and connective tissue disorders | 2 of 142 | 0 of 6 |
| 1 inch superficial non healing wound | Injury, poisoning and procedural complications | 1 of 142 | 1 of 6 |
| Ankle instability | Musculoskeletal and connective tissue disorders | 1 of 142 | 0 of 6 |
| Increased numeric pain score postop | Musculoskeletal and connective tissue disorders | 1 of 142 | 0 of 6 |
| Increased numeric pain score postop | Musculoskeletal and connective tissue disorders | 1 of 142 | 0 of 6 |
| Increased VAS pain score due to increased activity | Musculoskeletal and connective tissue disorders | 1 of 142 | 0 of 6 |
Serious events with the highest arm-level rate: stress fracture (or stress response of metatarsal) (16.7%), right ankle pain (1.4%), pain similar to pre-existing level with ambulation (0.7%), contracture of fifth toe, ttp and spasming of the extensor tendon (0.7%), degenerative disc (0.7%).
The registry reports serious adverse events by treatment group. In the on-label group, 142 participants were listed as at risk and 24 as affected; in the off-label group, 6 were listed as at risk and 1 as affected. The corresponding other-adverse-event counts were 44 of 142 and 3 of 6. Deaths are listed as 1 in the on-label group and 0 in the off-label group. These are descriptive counts as recorded, not estimates of comparative treatment effects.
The serious-event terms listed include Stress Fracture (or Stress Response of Metatarsal) at 16.7%, Right ankle pain at 1.4%, and several other terms at 0.7% each. The registry record does not provide enough detail in this entry to establish the basis for attributing an event to treatment or to interpret these figures as causal risks. The term list should be read as reported safety information, not as proof that treatment caused the events.
The off-label group is much smaller in the recorded safety counts, and the groups were not randomized control arms. Counts and percentages across such groups should not be treated as a fair head-to-head comparison. The record does not state allocation, and it cautions that the groups are not like-for-like controls. Serious-event counts also do not summarize event severity, timing, recurrence or the full clinical context. The registry record does not report those details in the listed safety information.
12. What the Result Does, and Does Not, Mean
This registry record describes a completed post-market study intended to collect short- and long-term outcomes after the Subchondroplasty Procedure in the foot and/or ankle. It identifies pain and function as important outcomes and names the FFI-R Short Form score at 24 months as the primary endpoint. It also describes treatment groups and reports some adverse-event counts. These details help characterize the study’s question and the information recorded about safety.
The record does not report the primary 24-month score, its standard deviation, or the number of participants analyzed. It therefore cannot establish the observed level of foot pain, disability or activity limitation at that timepoint, nor the precision of an estimated mean. The outcome description alone is not a result. Similarly, the list of secondary measures does not show whether scores changed or what the pattern of outcomes was.
The study is not described as randomized, allocation is not stated, and the registry cautions that on-label and off-label groups are not like-for-like controls. A difference between those groups, if one were reported, could not automatically be attributed to the treatment mixture. The off-label comparison is explicitly exploratory.
The serious and other adverse-event counts are descriptive. They should not be used alone to infer that the procedure caused an event or to compare safety between the groups. The registry record does not supply enough information about event timing, attribution or participant-level context to support those conclusions.
In general, a completed study can contribute useful evidence even when a registry entry does not include results. For this record, however, the missing primary outcome and analysis details prevent a statistical assessment of the central functional endpoint. The study description supports conclusions about what was intended to be measured and how groups were characterized, not a conclusion about the procedure’s effectiveness.
13. Why This Trial Matters Statistically
This study is statistically notable as a post-market evaluation in a standard clinical setting, where outcomes can reflect routine care and the characteristics of people who receive treatment. Such settings can provide descriptive information about a treated population. They do not, without an appropriate comparison strategy, isolate what outcomes would have been under an alternative treatment or no treatment.
The registry distinguishes on-label use from off-label treatment mixtures and describes the latter comparison as exploratory. It also warns that the groups are not like-for-like controls. That caution is central to sound interpretation: a group contrast is not automatically a causal effect, particularly when allocation is not stated and randomization is not reported.
The chosen primary endpoint focuses on patient-reported pain, disability and activity limitation. The FFI-R Short Form’s direction is clearly specified: higher values indicate more pain or worse function. This helps prevent a common interpretive error in which a higher score might otherwise be assumed to represent improvement. Reporting a mean with standard deviation would also allow readers to distinguish the group’s average score from variation among participants, but those results are not reported in the registry record.
The entry lists multiple outcomes and follow-up times, raising general questions about multiplicity, missing data and analysis populations. The record does not provide enough information to resolve those questions. Recognizing these reporting gaps is important: a stated endpoint and a completed status do not substitute for outcome estimates and uncertainty measures. In this case, statistical caution is not a judgment about the treatment; it reflects the limits of the information recorded.
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 for interpreting this study from the registry record is that the primary outcome result is not reported. The FFI-R Short Form mean and standard deviation at 24 months, and the number analyzed at that timepoint, are absent. Without those details, readers cannot assess the observed functional score, its variability or its precision.
The record does not report a comparison with a randomized control group. Allocation is not stated, and the registry cautions that the on-label and off-label groups are not like-for-like controls. The off-label subgroup is described as exploratory. Consequently, subgroup differences could not be treated as an unconfounded estimate of a treatment effect.
The registry entry does not describe the sample-size justification, a detailed statistical plan, multiplicity procedures, missing-data methods or the analysis population in sufficient detail to evaluate them. It also does not state how many participants completed the primary assessment or explain the reasons for any unavailable data. These omissions limit assessment of selection and follow-up effects.
The study description includes several outcomes and timepoints, but their results are not reported in the registry record. The serious adverse-event listing gives group counts and selected terms, but does not provide the timing and context needed to evaluate attribution or comparative risk. Enrollment of 148 describes the study size, but does not establish how many participants contributed to each outcome. These are limitations of the information available in the registry entry, not proof that the underlying study lacked analyses or further documentation.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Longitudinal Outcomes Study of the Subchondroplasty® Procedure in the Foot/Ankle — NCT03087396.
- Registry record last updated 2026-04-09; status last verified 2024-01.
- Results first posted 2026-04-09.
- 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
NCT03087396 is a completed post-market outcomes study of the Subchondroplasty® Procedure in the foot and/or ankle, sponsored by Zimmer Biomet. The registry lists enrollment of 148, a start date of 2017-03-10 and a primary completion date of 2023-08-23.
The primary endpoint is the FFI-R Short Form score at 24 months, a 0-100% measure of foot pain, disability and activity limitation in which higher scores indicate more pain or worse function. The registry describes on-label and off-label treatment groups and identifies the latter comparison as exploratory. It cautions that the groups are not like-for-like controls and does not state allocation.
The record lists serious and other adverse-event counts, but does not report the primary score, its standard deviation, the number analyzed at 24 months, or a statistical analysis result. Missing-data procedures, multiplicity handling and the study’s sample-size justification are not reported in the registry record. The entry therefore describes the study’s aims and design context but does not provide the primary outcome result needed to assess the central functional question.