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 Subchondroplasty® Knee RCT (NCT03112200), a randomized na study. The primary outcome is Composite Clinical Success.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03112200 |
| Phase | NA |
| Condition | Bone Marrow Edema, Knee Pain Chronic, Knee Osteoarthritis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 131 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Zimmer Biomet |
| Results posted | Yes |
2. Clinical Question
Population
Participants with bone marrow lesions in the knee were the intended study population. The registry lists chronic knee pain and knee osteoarthritis among the conditions associated with the trial. Eligibility criteria and further details about the enrolled population are not reported in the registry record.
Intervention
The intervention was Subchondroplasty with arthroscopy. The registry describes the Subchondroplasty portion as occurring before or after arthroscopy at the surgeon’s discretion. The operative procedures were to be performed under aseptic conditions.
Comparator
The comparison group received arthroscopy alone. The registry description lists possible procedures including partial meniscectomy, lavage, debridement, loose body removal, synovectomy, and removal of osteophytes. The full list of procedures is not reported in the registry record.
Primary question
The trial asked whether Subchondroplasty with arthroscopy was superior to arthroscopy alone for treatment of knee bone marrow lesions. Superiority was to be assessed using Composite Clinical Success at month 12. Success required freedom from subsequent secondary surgical intervention and, among participants free from such intervention, improvement in KOOS pain of at least 10 points at 12 months. The registry record does not report the observed primary-outcome result, so the treatment comparison cannot be judged from the posted results.
3. Trial Design
The registry describes a multicenter, prospective, randomized, single-blinded, two-arm, parallel-group trial. Participants were assigned to Subchondroplasty with arthroscopy or arthroscopy alone. The record identifies the study as completed and lists enrollment as 131. Its brief summary describes an approximate planned enrollment of 134 participants in the Subchondroplasty group and 67 in the arthroscopy-alone group. The reason for the difference between those planned figures and the recorded enrollment is not reported in the registry record.
The intervention combined Subchondroplasty and arthroscopy, with the order of those procedure components left to the surgeon’s discretion. The comparator involved arthroscopy of the study knee and could include one or more procedures listed in the record, such as partial meniscectomy, lavage, or debridement. These descriptions indicate that the comparison was between treatment strategies rather than between two identical arthroscopic procedures with only a single standardized component differing.
Single-blinded is the masking designation, but which participants or study personnel were blinded is not reported in the registry record. The method used to generate the random allocation sequence, allocation concealment, and any stratification factors are also not reported. The study phase is listed as not applicable.
The registry lists secondary outcomes covering KOOS subscale scores, numeric pain scores, EQ-5D scores, and global satisfaction, assessed at different follow-up times. It reports 13 outcome measures and one analysis, but does not provide enough information to reconstruct a complete analysis plan from those counts alone. The primary outcome description specifies testing superiority at month 12 using p < 0.01. The rationale for that threshold and the trial’s sample-size justification are not reported in the registry 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.
Overall Study
| Stage | Subchondroplasty With Arthroscopy | Arthroscopy Alone |
|---|---|---|
| STARTED | 88 | 43 |
| COMPLETED | 77 | 40 |
| NOT COMPLETED | 11 | 3 |
Reasons for not completing this period:
| Reason | Subchondroplasty With Arthroscopy | Arthroscopy Alone |
|---|---|---|
| Failure | 3 | 3 |
| Withdrawal by Subject | 3 | 0 |
| Lost to Follow-up | 1 | 0 |
| Other | 4 | 0 |
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 | Subchondroplasty With Arthroscopy | Arthroscopy Alone | Total |
|---|---|---|---|---|
| Participants analysed | 88 | 43 | 131 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 71 | 33 | 104 |
| Age, Categorical: >=65 years | Participants | 17 | 10 | 27 |
| Age, Continuous | years | 57.3 (SD 9.0) | 58 (SD 9.3) | 57.5 (SD 9.0) |
| Sex: Female, Male: Female | Participants | 47 | 19 | 66 |
| Sex: Female, Male: Male | Participants | 41 | 24 | 65 |
| Race/Ethnicity, Customized: American Indian or Alaska Native | Participants | 0 | 1 | 1 |
| Race/Ethnicity, Customized: Asian | Participants | 3 | 1 | 4 |
| Race/Ethnicity, Customized: Black or African American | Participants | 4 | 2 | 6 |
| Race/Ethnicity, Customized: Decline to Respond | Participants | 2 | 1 | 3 |
| Race/Ethnicity, Customized: Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race/Ethnicity, Customized: White | Participants | 75 | 37 | 112 |
| Race/Ethnicity, Customized: Hispanic or Latino | Participants | 4 | 1 | 5 |
| Region of Enrollment: Canada | participants | 6 | 3 | 9 |
| Region of Enrollment: United States | participants | 82 | 40 | 122 |
| KOOS Subscale Scores: Pain | units on a scale | 42.5 (SD 15.3) | 42.9 (SD 15.0) | 42.6 (SD 15.2) |
| KOOS Subscale Scores: Activities of Daily Living | units on a scale | 47.4 (SD 17.1) | 50.7 (SD 19.4) | 48.48 (SD 17.88) |
| KOOS Subscale Scores: Symptoms | units on a scale | 48.4 (SD 21.4) | 49.7 (SD 18.5) | 48.83 (SD 20.50) |
| KOOS Subscale Scores: Sports and Recreation | units on a scale | 17.6 (SD 20.2) | 17.6 (SD 18.4) | 17.6 (SD 19.63) |
| KOOS Subscale Scores: Quality of Life | units on a scale | 17.3 (SD 14.2) | 19.6 (SD 17.0) | 18.05 (SD 15.17) |
| Numeric Pain Score | Score (0-10) | 6.5 (SD 1.8) | 5.9 (SD 2.2) | 6.3 (SD 1.94) |
| EQ-5D Index Score | Index Score | 0.1 (SD 0.3) | 0.2 (SD 0.4) | .13 (SD .34) |
| Imaging Completed at Baseline | Participants | 68 | 33 | 101 |
| Number of Bone Lesions: 1 | Participants | 59 | 30 | 89 |
| Number of Bone Lesions: 2 | Participants | 29 | 13 | 42 |
| EQ-5D Overall Health | Points on a scale (0-100) | 75.7 (SD 16.8) | 76.0 (SD 14.1) | 75.8 (SD 16.06) |
6. Primary Endpoint
The registry lists the primary outcome as Composite Clinical Success, measured over Superiority will be statistically tested at month 12 at p<0.01.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
Composite Clinical Success combines a surgical outcome with a patient-reported pain outcome. A participant counted as a success only if there was freedom from subsequent secondary surgical intervention and, among participants free from that intervention, a clinically meaningful reduction in self-reported pain. The pain criterion was an improvement in KOOS pain of at least 10 points at 12 months.
The registry defines subsequent secondary surgical intervention to include partial or total joint arthroplasty, or a bone grafting or bone substitute procedure, in the study knee. Thus, the endpoint is not simply a change in pain score. A participant who met the pain criterion but underwent a qualifying subsequent procedure would not meet the stated success definition. The registry does not report further rules for classifying participants with missing pain assessments or incomplete follow-up.
A composite can combine outcomes that matter in different ways and produce one overall measure for a planned treatment comparison. It can also make interpretation less straightforward: the overall success result does not, by itself, show how much each component contributed. Separate component results would help distinguish the contribution of subsequent procedures from the contribution of pain improvement. Those component results are not reported in the registry record.
The primary endpoint is expressed as a count of participants with an event, and its intended assessment time is month 12. The registry record gives the endpoint definition and planned testing threshold, but does not report the observed success counts or a treatment-effect estimate. Consequently, the size and precision of the primary comparison are not available from the posted results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The available registry information establishes the question and the planned design, but does not establish the result of the primary comparison. No Composite Clinical Success counts by treatment group, treatment-effect estimate, confidence interval, or primary-outcome p-value are reported in the registry record. The stated p < 0.01 is the planned criterion for statistical testing at month 12; it is not an observed p-value and should not be read as evidence that the criterion was met.
For a binary endpoint such as success or failure, a treatment comparison would ordinarily describe the number of participants meeting the endpoint in each group and quantify the contrast between groups. A confidence interval would communicate the range of effect estimates compatible with the data under the analysis assumptions. Without those results, neither the direction nor the magnitude of the observed primary treatment contrast can be described, and its precision cannot be assessed.
The primary endpoint also has two linked requirements. A group-level success result would combine freedom from specified subsequent procedures with the KOOS pain improvement criterion among participants free from those procedures. Without component-specific results, even a reported composite contrast would not show which requirement chiefly accounted for any difference. The registry record does not report component counts or the handling of participants who lacked a month-12 assessment.
The registry lists secondary outcomes for pain, KOOS subscales, EQ-5D, and satisfaction at specified follow-up times. However, the registry information available for this analysis does not report treatment-comparison estimates for those outcomes. Their presence in the outcome list is not a substitute for results, and it does not establish whether any secondary comparison favored either group.
Adverse-event counts are reported separately from the primary endpoint. Those counts describe recorded events and participants at risk, but are not a replacement for an efficacy analysis. The event figures should be interpreted descriptively: the registry record does not report a statistical comparison of safety outcomes, an adjustment strategy, or enough detail to determine how exposure time or differing follow-up was handled.
In statistical terms, absence of a posted primary estimate is not evidence of no difference, nor is it evidence of a difference. The appropriate conclusion is narrower: the registry describes a randomized superiority trial and its intended endpoint, while the posted results do not allow the primary treatment effect or its uncertainty to be evaluated.
9. Statistical Methods Explained
Randomization is intended to create treatment groups that are comparable, on average, with respect to both measured and unmeasured baseline characteristics. This supports a fair comparison when the assigned groups are analyzed appropriately. Randomization does not guarantee identical groups in a particular trial, and it does not by itself resolve problems caused by missing outcomes, departures from assigned treatment, or incomplete reporting. The record identifies the allocation as randomized but does not report the sequence-generation or concealment methods.
What does the planned superiority test mean?
Superiority testing asks whether the data support a difference in favor of one treatment strategy under a prespecified statistical framework. The registry states that superiority was to be statistically tested at month 12 at p < 0.01. This is a decision threshold, not a result. An observed p-value would need to be reported alongside the endpoint counts and effect estimate to show how the data compare with the null hypothesis under the chosen model. No such primary-outcome result is reported in the registry record.
General explanation: a p-value describes how unusual data at least as incompatible with a specified null hypothesis would be if that hypothesis and the analysis assumptions were correct. It does not measure the probability that either treatment is effective, and it does not measure the size or clinical importance of an effect. A confidence interval serves a different purpose: it displays the uncertainty around an estimated effect on a chosen scale. The registry record does not report a primary confidence interval.
How should a binary composite be understood?
The endpoint classifies participants according to whether they satisfy the stated success definition. It combines freedom from qualifying subsequent intervention with a specified KOOS pain improvement among those free from intervention. General explanation: binary outcomes are often summarized using participant counts and a treatment contrast such as a difference in success probabilities, a ratio, or an odds-based measure. The choice of effect scale affects interpretation. The registry record does not report a primary effect estimate or identify an effect scale in the information available for this analysis.
Composite endpoints can increase the scope of an outcome by combining more than one clinically relevant event or measure. They can also obscure differences between components if only the overall classification is reported. In this trial, a composite result would not alone show whether the group comparison was driven by subsequent surgery, pain improvement, or both. Component-level results are not reported in the registry record.
What do the sample-size illustrations represent?
The sample-size illustrations use the observed effect as a planning reference and consider an effect that is a stated fraction of that observed effect. The stated assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. Such figures are planning illustrations, not observed trial outcomes and not observed power. They do not show that the trial had a particular probability of detecting an effect, and they are not the trial’s original sample-size justification. The registry record does not report that justification.
General explanation: sample-size planning depends on assumptions about the effect worth detecting, variability or event frequency, the significance threshold, and the allocation between groups. If the actual effect differs from the planning assumption, the operating characteristics differ as well. An illustration based on an observed effect is especially dependent on that observed estimate and should not be treated as a prospective design rationale. The registry record does not provide enough information to verify the assumptions or reconstruct the original design calculation.
What information is needed to assess the analysis?
A complete interpretation would ordinarily identify the analysis population, the model or test used, the treatment-effect scale, handling of missing observations, and rules for intercurrent events such as subsequent procedures. The registry defines qualifying subsequent intervention as part of the endpoint, but other analysis details are not reported in the registry record. The record also does not specify whether participants were analyzed according to randomized assignment or another population definition.
General explanation: missing outcome data can affect a comparison when the probability of missingness is related to outcome or treatment. Statistical methods may make assumptions about the unobserved values, and sensitivity analyses can examine how conclusions change under alternative assumptions. Without the missing-data rules and the number of participants assessed at each time point, readers cannot judge the potential impact of incomplete follow-up.
Over-dispersion is relevant when count data vary more than the assumed statistical model allows, which can make standard errors too small if ignored. The primary endpoint is described as a participant count for a binary composite, not as a repeated event-rate outcome. No over-dispersion model is reported, and there is no basis in the registry record for attributing one to the primary analysis. This is a general distinction between count-based outcomes and event-rate analyses, not a claim about the model used in this trial.
10. Multiplicity, Missing Data and Analysis Populations
The primary endpoint description specifies a superiority test at month 12 with p < 0.01. The registry record does not report why this threshold was chosen, whether it reflects a multiplicity adjustment, or how the threshold relates to other planned analyses. A stated testing threshold should not be confused with evidence that the primary comparison achieved statistical significance.
The registry lists secondary outcomes spanning KOOS subscales, numeric pain, EQ-5D measures, and satisfaction at several follow-up times. When multiple outcomes or time points are tested, the chance of at least one apparently unusual result can increase if each test is considered separately. General methods for addressing multiplicity include prespecifying a hierarchy of tests or adjusting the testing procedure, but the registry record does not report a strategy for the secondary outcomes. It also does not provide results with which to assess any such strategy.
The record lists 13 outcome measures and one analysis. Those counts do not specify which outcomes were included in that analysis, how repeated time points were handled, or whether the analysis count covers all planned comparisons. The primary outcome is described through a composite definition and month-12 testing, but the posted information does not provide a single primary treatment estimate for review.
Missing-data methods and analysis populations are not reported in the registry record. In particular, the record does not specify how participants without a month-12 KOOS pain score were classified, whether imputation was used, or which population was used for the primary analysis. It also does not state whether the analysis followed randomized assignment. These omissions limit assessment of the assumptions behind any treatment comparison.
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 Arthroscopy | 13 | 88 | 14.8% |
| Arthroscopy Alone | 5 | 43 | 11.6% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Subchondroplasty With Arthroscopy | 0 of 88 |
| Arthroscopy Alone | 0 of 43 |
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 Arthroscopy | 30 of 88 |
| Arthroscopy Alone | 14 of 43 |
Most frequent serious adverse event terms
| Event term | Organ system | Subchondroplasty With Arthroscopy | Arthroscopy Alone |
|---|---|---|---|
| Total knee replacement (study knee) | Surgical and medical procedures | 5 of 88 | 1 of 43 |
| Total knee arthroplasty (contralateral, non-study knee) | Musculoskeletal and connective tissue disorders | 1 of 88 | 1 of 43 |
| Unicompartmental knee arthroplasty (study knee) | Musculoskeletal and connective tissue disorders | 1 of 88 | 1 of 43 |
| Displaced MFC fracture | Musculoskeletal and connective tissue disorders | 1 of 88 | 0 of 43 |
| Revision amputation, left small finger at middle phalanx | Injury, poisoning and procedural complications | 0 of 88 | 1 of 43 |
| Right arm fracture requiring ORIF | Injury, poisoning and procedural complications | 0 of 88 | 1 of 43 |
| Right breast cancer with surgical intervention and radiation therapy | Reproductive system and breast disorders | 0 of 88 | 1 of 43 |
| Right rotator cuff repair, biceps tenodesis | Surgical and medical procedures | 1 of 88 | 0 of 43 |
| Knee debridement, medial and lateral meniscectomy (contralateral, non-study knee) | Surgical and medical procedures | 1 of 88 | 0 of 43 |
| L1 vertebral fracture due to osteoarthritis | Musculoskeletal and connective tissue disorders | 1 of 88 | 0 of 43 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Subchondroplasty With Arthroscopy | Arthroscopy Alone |
|---|---|---|---|
| Increased knee pain (possibly, probably, or definitely related) | Musculoskeletal and connective tissue disorders | 6 of 88 | 0 of 43 |
| Increased Pain (non-knee, not related) | General disorders | 2 of 88 | 3 of 43 |
| Fall, accident, or collision | Injury, poisoning and procedural complications | 3 of 88 | 2 of 43 |
| Osteoarthritis (not related) | Musculoskeletal and connective tissue disorders | 3 of 88 | 1 of 43 |
| Knee effusion (not related) | Musculoskeletal and connective tissue disorders | 0 of 88 | 3 of 43 |
| Knee Effusion (possibly, probably, or definitely related) | Musculoskeletal and connective tissue disorders | 1 of 88 | 1 of 43 |
| AccuFill Leakage (possibly, probably, or definitely related) | Injury, poisoning and procedural complications | 2 of 88 | 0 of 43 |
| Knee Osteoarthritis (possibly, probably, or definitely related) | Musculoskeletal and connective tissue disorders | 2 of 88 | 0 of 43 |
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 88 | 1 of 43 |
| Knee Bursitis (not related) | Musculoskeletal and connective tissue disorders | 1 of 88 | 1 of 43 |
Serious events with the highest arm-level rate: total knee replacement (study knee) (5.7%), revision amputation, left small finger at middle phalanx (2.3%), total knee arthroplasty (contralateral, non-study knee) (2.3%), right arm fracture requiring orif (2.3%), right breast cancer with surgical intervention and radiation therapy (2.3%).
For Subchondroplasty with arthroscopy, the registry reports 13 participants with serious adverse events among 88 at risk, and 30 with other adverse events among 88 at risk. For arthroscopy alone, it reports 5 participants with serious adverse events among 43 at risk, and 14 with other adverse events among 43 at risk. The recorded number of deaths is 0 in each group.
The registry lists serious adverse-event terms including total knee replacement (study knee), reported as 5.7%; revision amputation, left small finger at middle phalanx, reported as 2.3%; total knee arthroplasty (contralateral, non-study knee), reported as 2.3%; right arm fracture requiring ORIF, reported as 2.3%; right breast cancer with surgical intervention and radiation therapy, reported as 2.3%; and unicompartmental knee arthroplasty (study knee), reported as 2.3%.
These figures are descriptive counts and listed terms. They do not, on their own, establish a causal relationship to a procedure or indicate whether the groups differ statistically. The registry record does not report a comparative safety analysis, definitions beyond the recorded event categories, or information about event timing and exposure duration. Serious-event counts should therefore be read separately from the primary Composite Clinical Success outcome.
12. What the Result Does, and Does Not, Mean
The registry record describes a randomized comparison of Subchondroplasty with arthroscopy against arthroscopy alone for knee bone marrow lesions. It identifies a planned month-12 superiority assessment based on Composite Clinical Success, with a stated threshold of p < 0.01. It also records adverse-event counts and lists secondary outcomes. These details describe the study question and some reported safety information.
The posted results do not include the primary success counts or a treatment-effect estimate. They also do not include a confidence interval or observed primary p-value. As a result, the primary comparison cannot be characterized as favoring either treatment strategy, and its statistical precision cannot be assessed. The planned significance threshold is not itself a result.
Even if the composite outcome result were available, interpreting it would require attention to its two parts: freedom from specified subsequent surgery and the KOOS pain improvement criterion among participants free from that surgery. A composite alone would not establish which component contributed to the overall finding. Separate component results and details on missing assessments would help clarify that interpretation; they are not reported in the registry record.
The registry’s adverse-event counts provide descriptive information, but they are not a formal comparative safety analysis and do not identify whether an event was caused by the assigned procedure. The secondary outcome list similarly indicates planned or registered measures, not the direction or size of results.
Accordingly, the available record supports a description of the design, endpoint, and recorded adverse events, but not a conclusion about efficacy or comparative benefit. Lack of a posted treatment-effect result should not be interpreted as evidence that the treatments are equivalent, nor as proof of a difference. The statistical conclusion remains undetermined from the results reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of a randomized comparison built around a composite endpoint rather than a single symptom score. Composite Clinical Success combines avoidance of specified subsequent procedures with a patient-reported pain improvement criterion. That structure illustrates why endpoint definitions matter: the meaning of a success count depends on the criteria applied to each participant and on how each component is reported.
The trial also highlights the distinction between a prespecified testing rule and an observed result. The registry states a month-12 superiority test at p < 0.01, but the threshold does not tell readers whether the data met it, how large any contrast was, or how precise an estimate might be. A treatment estimate and its uncertainty are central to statistical interpretation, not merely a significance decision.
The difference between the registry’s approximate planned group enrollment and its recorded total enrollment also underscores the importance of distinguishing a design description from final participant accounting. The record does not explain that difference. It likewise does not report the original sample-size justification, analysis population, or missing-data methods. Those omissions show why enrollment and randomization labels alone are not enough to reconstruct an analysis.
Finally, the listed secondary outcomes and adverse-event counts represent different kinds of evidence. Outcome lists do not substitute for outcome estimates, while safety counts do not answer the primary efficacy question. A complete statistical account would connect endpoint definitions, analysis methods, participant flow, estimates, and uncertainty. The registry information permits the design and intended question to be described, but leaves the central treatment comparison unresolved.
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 most important limitation for interpreting the trial statistically is that the registry record does not report the primary Composite Clinical Success result. No group-specific success counts, treatment-effect estimate, confidence interval, or observed p-value are available. Consequently, the intended superiority comparison cannot be evaluated from the posted results.
The endpoint combines a procedural criterion with a patient-reported pain criterion. Although the registry defines both, it does not report separate component results or further details on how participants with missing pain assessments were classified. Without component-level information, any composite result would be difficult to attribute to one part of the definition.
The record identifies the study as single-blinded but does not say who was blinded or how blinding was maintained. It does not report allocation concealment, the randomization procedure, or details of the analysis population. Methods for missing data and departures from assigned treatment are also not reported.
The registry lists secondary outcomes at multiple follow-up times but does not report a multiplicity strategy for those outcomes. The stated primary testing threshold is available, but its rationale is not. The registry also does not report the original sample-size justification. The sample-size illustrations are described as planning exercises based on the observed effect and should not be taken as the trial’s design calculation or as observed power.
Enrollment is recorded as 131, while the brief summary describes approximate planned group sizes of 134 and 67. The registry record does not explain the difference. Finally, adverse-event counts are descriptive and do not include a reported comparative analysis or details sufficient to assess event timing and exposure. These reporting gaps constrain interpretation even though the trial’s broad design and primary endpoint are specified.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Subchondroplasty® Knee RCT — NCT03112200.
- Registry record last updated 2026-05-14; status last verified 2023-09.
- Results first posted 2026-05-14.
- 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
The registry record describes NCT03112200, a completed, multicenter, prospective, randomized, single-blinded, parallel-group trial comparing Subchondroplasty with arthroscopy against arthroscopy alone for knee bone marrow lesions. Recorded enrollment is 131. The primary endpoint is Composite Clinical Success at month 12, defined by freedom from specified subsequent secondary surgical intervention and a KOOS pain improvement of at least 10 points among participants free from such intervention. The planned superiority test is stated at p < 0.01.
The registry lists secondary outcomes covering KOOS, numeric pain, EQ-5D, and satisfaction, and reports adverse-event counts for both groups. However, the primary-outcome comparison, its uncertainty, analysis-population definition, missing-data methods, and multiplicity strategy are not reported in the registry record. The available information therefore supports a description of the trial’s design and endpoint, but not a statistical conclusion about the primary treatment effect.