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 Pinnacle RSA Study (NCT04070989), a non-randomized na study. The primary outcome is Mean Superior Cup Migration (Subsidence) at 6 Week and 2 Years.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04070989 |
| Phase | NA |
| Condition | Osteoarthritis, Degenerative Arthritis |
| Allocation | Non-Randomized |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 100 |
| Arms in the primary outcome | n/a |
| Lead sponsor | DePuy Orthopaedics |
| Results posted | Yes |
2. Clinical Question
Population
People undergoing total hip arthroplasty for osteoarthritis or degenerative arthritis. The registry lists a planned enrollment of 100 and defines the primary analysis population as the Per Protocol Analysis Set.
Intervention
A Pinnacle Acetabular Shell implanted as part of total hip arthroplasty, with an AltrX Polyethylene Liner and Corail Femoral Stem. The registry describes posterior, lateral, and anterior surgical approaches.
Comparator
There is no separate control group. The study is non-randomized and single-group; the three surgical approaches are described as separate groups, not as randomized treatment arms or like-for-like controls.
Primary question
What is the mean superior cup migration, measured as vertical Y translation in millimeters by radiostereometric analysis, at 6 week and 2 years? The registry says results were intended to be summarized for each surgical approach separately and combined.
This is a measurement-focused question about the position of the acetabular shell after implantation. Radiostereometric analysis (RSA) is the named measurement method. The registry identifies superior cup migration, also called subsidence or Y translation, as the primary endpoint. The brief objective emphasizes mean migration over the first two years after implantation, while the registered primary outcome title specifies measurements at 6 week and 2 years. The record does not resolve whether additional timing details were used in the analysis.
The study also lists other RSA measurements, linear head penetration, and the Harris Hip Score among its secondary outcomes. Those outcomes broaden the planned assessment beyond vertical migration, but their results are not reported in the registry record. Because there is no randomized control group, the primary question is descriptive: it concerns the observed migration in the studied cohort, rather than a causal comparison between implant strategies.
3. Trial Design
The Pinnacle RSA Study is described as a multicenter, non-controlled, prospective radiostereometric analysis study of the Pinnacle Acetabular Shell. Its allocation is non-randomized, its model is single-group, and masking is listed as none. The registry lists an enrollment of 100. The study status is terminated; the recorded start date is 2019-12-03 and the primary completion date is 2023-06-12.
The study intervention is total hip arthroplasty using the Pinnacle Acetabular Shell, with an AltrX Polyethylene Liner and Corail Femoral Stem. The registry describes three surgical approaches: posterior, lateral, and anterior. For each, it specifies a Sector, Gription shell without screws. The approaches are not randomized groups and should not be treated as a controlled comparison. Differences between them could reflect factors other than the approach, and the registry does not report an adjustment strategy for such differences.
The primary outcome is a continuous measurement: mean superior cup migration, expressed in millimeters and described as vertical Y translation measured with RSA. The primary outcome record names 6 week and 2 years as the time points. The brief study objective focuses on migration over the first two years after implantation. The analysis population is named as the Per Protocol Analysis Set. The registry record does not report the criteria defining that set or the number of participants included in it.
Secondary outcomes include RSA-measured subsidence at 3 Months, 6 Months and 1 Year; other RSA translations and rotations; linear head penetration; and patient-reported outcomes measured with the Harris Hip Score. The registry lists 9 outcome measures but contains no analysis entries. It does not report a statistical analysis plan, a sample-size justification, or how the three approaches were intended to be combined or contrasted beyond saying that the primary outcome would be summarized separately and combined.
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: Out of total 100 participants enrolled, 84 participants underwent surgery via either posterior, lateral, or anterior approach. The remaining 16 participants were either withdrawn prior to surgery or the study was terminated prior to surgery and thus they were not included in a surgical approach group.
Overall Study
| Stage | Posterior Approach | Lateral Approach | Anterior Approach |
|---|---|---|---|
| STARTED | 40 | 20 | 24 |
| COMPLETED | 29 | 10 | 0 |
| NOT COMPLETED | 11 | 10 | 24 |
Reasons for not completing this period:
| Reason | Posterior Approach | Lateral Approach | Anterior Approach |
|---|---|---|---|
| Death | 1 | 0 | 0 |
| Study Terminated by Sponsor | 7 | 8 | 23 |
| Withdrawal by Subject | 0 | 1 | 0 |
| Inclusion/Exclusion Criteria not met | 2 | 0 | 1 |
| Other | 1 | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: Per Protocol Analysis Set
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: Safety analysis set included all enrolled participants who received total hip arthroplasty (THA) surgery. Participants were analyzed according to the surgical approach applied during the study.
| Characteristic | Unit | Posterior Approach | Lateral Approach | Anterior Approach | Total |
|---|---|---|---|---|---|
| Participants analysed | 40 | 20 | 24 | 84 | |
| Age, Continuous | years | 69.53 (SD 8.85) | 65.0 (SD 9.39) | 60.5 (SD 12.72) | 65.87 (SD 10.81) |
| Sex: Female, Male: Female | Participants | 20 | 11 | 9 | 40 |
| Sex: Female, Male: Male | Participants | 20 | 9 | 15 | 44 |
| Race and Ethnicity Not Collected | Participants | — | — | — | 0 |
| Primary Diagnosis: Osteoarthritis | Participants | 5 | 6 | 23 | 34 |
| Primary Diagnosis: Avascular necrosis | Participants | 1 | 0 | 1 | 2 |
| Primary Diagnosis: Degenerative Joint Disease | Participants | 34 | 14 | 0 | 48 |
| BMI | kg/m2 | 31.19 (SD 6.73) | 30.36 (SD 6.75) | 30.32 (SD 5.43) | 30.74 (SD 6.33) |
6. Primary Endpoint
The registry lists the primary outcome as Mean Superior Cup Migration (Subsidence) at 6 Week and 2 Years, measured over At 6 week and 2 years.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | mm |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is mean superior cup migration, described as subsidence or vertical Y translation, measured by radiostereometric analysis in millimeters. The outcome record specifies measurement at 6 week and 2 years, and states that results were intended to be summarized for each surgical approach separately and combined. The primary analysis population is the Per Protocol Analysis Set.
Migration is a measure of change in the shell’s position relative to the reference used for RSA. In this study, the chosen direction is superior movement, represented by Y translation. The mean describes the average measurement in the analyzed participants; it does not describe how much participants vary around that average. The registry lists standard deviation as the dispersion measure, which is intended to describe that variability.
As a general statistical point, a continuous measurement can retain information about the size and direction of observed changes, rather than reducing the outcome to a yes-or-no event. The unit, time point, measurement method, and analysis population are all needed to interpret such a mean. The registry record describes these elements, but it does not report the mean, standard deviation, confidence interval, participant count analyzed, or actual endpoint results. Therefore, the endpoint can be explained from the record, but the observed magnitude and precision of migration cannot be assessed from its posted results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the intended primary outcome but does not provide numerical results for it. No mean migration estimate, standard deviation, confidence interval, or analysis result is reported. The record also lists 0 analysis entries. As a result, the posted record does not establish what migration was observed at 6 week or 2 years, how variable measurements were, or how precise an estimate might be.
The outcome is defined as mean superior cup migration in millimeters, measured by RSA and analyzed in the Per Protocol Analysis Set. Those details describe the planned endpoint, not a finding. Although the brief objective refers to the first two years after implantation and the primary outcome title names 6 week and 2 years, neither description substitutes for endpoint data. The registry record does not report whether all intended measurements were collected or the number contributing to each time point.
The study is non-randomized, non-controlled, and single-group. It lists posterior, lateral, and anterior approaches, with plans to summarize the primary endpoint for each approach and combined. These groups do not form a randomized comparison. Any observed differences across approaches, if reported elsewhere, would not by themselves demonstrate that the approach caused those differences. The registry record does not report adjusted comparisons or other methods intended to account for differences among participants or clinical settings.
The record does contain safety figures. Serious adverse event affected counts are listed for the posterior, lateral, and anterior groups, alongside the numbers at risk; other adverse event affected counts and deaths are also listed. These figures describe what the record posts, but they do not establish whether an event was caused by the implant, procedure, or another factor. The record does not report event definitions, follow-up completeness, attribution, or a comparative safety analysis.
General statistical interpretation depends on estimates and their uncertainty, not only on an endpoint definition or a planned enrollment. Without posted primary outcome estimates and uncertainty measures, neither the size of migration nor the precision of its estimated mean can be evaluated. The registry’s status of terminated does not itself explain why the study ended or what results were obtained. Those details are not reported in the registry record.
9. Statistical Methods Explained
The registry describes a continuous primary outcome, a mean, with standard deviation as its dispersion measure. It names RSA as the method for measuring superior cup migration in millimeters. The primary time points are listed as 6 week and 2 years, and the stated analysis population is the Per Protocol Analysis Set. However, the registry record does not report endpoint estimates or an analysis plan. The following explains the statistical concepts relevant to those descriptions in general; it does not imply that a particular method was used in this study.
What does a mean describe?
In general, a mean is an average of measurements within an analysis group. For a continuous outcome such as migration, it gives a summary of the group’s central level of measurement. It can be useful for describing the overall direction and magnitude of a measured quantity, but it does not show the distribution of individual measurements. A mean alone cannot indicate whether most observations are close to it or whether observations are widely dispersed.
The registry lists standard deviation as the dispersion measure. In general, standard deviation describes how spread out individual measurements are around their mean. It is not the same as the uncertainty of the mean. The standard error and a confidence interval concern uncertainty in estimating the mean, whereas standard deviation concerns variation among measurements. No standard deviation or confidence interval for the primary endpoint is reported in the registry record.
What does a confidence interval add?
In general, a confidence interval gives a range of values compatible with the data and a specified statistical procedure. Its width reflects the precision of an estimate under that procedure and depends on matters such as variability and the amount of usable data. A narrow interval generally indicates greater precision than a wide one, but neither interval width nor inclusion of a particular value alone establishes clinical importance. The registry record does not report a confidence interval for mean migration.
A confidence interval would need to be interpreted together with the measurement definition, time point, population, and analysis approach. If measurements from the same participant are taken at multiple times, those measurements may be related. In general, an analysis that treats related observations as independent can misrepresent uncertainty. The registry lists several measurement times across its primary and secondary outcome descriptions, but the statistical handling of repeated measurements is not reported.
What does the study design allow?
In general, a non-controlled study can describe outcomes in the participants observed, but it cannot provide the same basis for causal attribution as a well-designed randomized comparison. The record describes three surgical approaches, yet allocation is non-randomized and the study model is single-group. The approaches therefore should not be read as randomized treatment arms. Any difference among their observed summaries could reflect participant characteristics, clinical context, or other factors, as well as the approach itself. The registry does not report an adjustment strategy or a formal comparison among approaches.
The registry says primary results were intended to be summarized by approach and combined. A combined mean would be a cohort-level description, while separate means would describe the groups separately. In general, a combined summary can conceal variation between groups, and separate summaries can be imprecise when group sizes are limited. The record does not provide primary outcome results or the analysis counts needed to assess those issues.
What can be said about planning and power?
The registry lists enrollment of 100, but does not report the sample-size justification or its assumptions. The planning illustrations associated with this trial are based on an observed effect, use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; their target effect is expressed as a fraction of the observed effect. These are planning illustrations, not evidence that the study had a particular probability of detecting an effect. They are not observed power, and the registry record does not describe them as the trial’s original design justification.
In general, power is a design-stage probability calculated under specified assumptions about the effect, variability, analysis, and sample size. It does not measure whether an observed result is reliable after data collection. A post hoc calculation framed as power based on an observed effect is especially difficult to interpret as evidence about the result’s certainty. The more directly informative quantities for interpreting an estimate are the estimate itself and its uncertainty, neither of which is reported for the primary endpoint.
Why might over-dispersion matter?
General statistical methods for counts often rely on assumptions about how variable the counts are. Over-dispersion means the observed variability exceeds what a simpler model assumes; if ignored, uncertainty can be understated. This concept is not directly a description of the primary endpoint, which is a continuous mean. It could matter in other settings involving event counts, but the registry record does not report a count-model analysis or an over-dispersion assessment.
Overall, the registry supplies endpoint definitions and design descriptors but not enough analysis output to evaluate the primary estimate, its uncertainty, or the statistical comparisons. No particular test, model, covariate adjustment, or interim analysis should be inferred from the stated design alone; these are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists multiple outcomes and time points: the primary migration endpoint is specified at 6 week and 2 years, while secondary outcomes include subsidence at 3 Months, 6 Months and 1 Year, other RSA translations and rotations, linear head penetration, and Harris Hip Score. Considering multiple outcomes or time points can raise a multiplicity question. In general, the more statistical questions examined, the greater the chance that at least one result may appear notable by chance. The registry record does not report whether any multiplicity adjustment or hierarchy among outcomes was planned.
The record identifies the Per Protocol Analysis Set for the primary outcome, but it does not define the set, report its size, or describe how participants were classified. It does not report how missing measurements were handled, whether data were imputed, or how incomplete follow-up was addressed. No number of participants analyzed at each time point is given. Without this information, it is not possible to judge how missing observations may have affected the estimates or whether the analyzed participants differed from those enrolled.
The registry lists 0 analysis entries and does not report interim analyses, stopping rules, or a statistical analysis plan. The absence of these details from the registry record should not be taken as evidence that a particular procedure was or was not used outside the record. The study status is terminated, but the record does not state the reason for termination or describe its implications for data collection and analysis.
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 |
|---|---|---|---|
| Posterior Approach | 8 | 40 | 20.0% |
| Lateral Approach | 2 | 20 | 10.0% |
| Anterior Approach | 5 | 24 | 20.8% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Posterior Approach | 1 of 40 |
| Lateral Approach | 0 of 20 |
| Anterior Approach | 0 of 24 |
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 |
|---|---|
| Posterior Approach | 9 of 40 |
| Lateral Approach | 4 of 20 |
| Anterior Approach | 7 of 24 |
Most frequent serious adverse event terms
| Event term | Organ system | Posterior Approach | Lateral Approach | Anterior Approach |
|---|---|---|---|---|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | 5 of 40 | 2 of 20 | 1 of 24 |
| Tendonitis | Musculoskeletal and connective tissue disorders | 0 of 40 | 0 of 20 | 1 of 24 |
| Duodenal ulcer | Gastrointestinal disorders | 1 of 40 | 0 of 20 | 0 of 24 |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | 1 of 40 | 0 of 20 | 0 of 24 |
| Gastrointestinal ulcer | Gastrointestinal disorders | 1 of 40 | 0 of 20 | 0 of 24 |
| Corona virus infection | Infections and infestations | 1 of 40 | 0 of 20 | 0 of 24 |
| Influenza | Infections and infestations | 1 of 40 | 0 of 20 | 0 of 24 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 1 of 40 | 0 of 20 | 0 of 24 |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 1 of 40 | 0 of 20 | 0 of 24 |
| Atrioventricular block complete | Cardiac disorders | 1 of 40 | 0 of 20 | 0 of 24 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Posterior Approach | Lateral Approach | Anterior Approach |
|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | 2 of 40 | 0 of 20 | 1 of 24 |
| Iliotibial band syndrome | Injury, poisoning and procedural complications | 2 of 40 | 0 of 20 | 0 of 24 |
| Incision site discharge | Injury, poisoning and procedural complications | 2 of 40 | 0 of 20 | 0 of 24 |
| Bursitis | Musculoskeletal and connective tissue disorders | 0 of 40 | 1 of 20 | 1 of 24 |
| Stitch abscess | Infections and infestations | 0 of 40 | 2 of 20 | 0 of 24 |
| Acetabulum fracture | Injury, poisoning and procedural complications | 1 of 40 | 0 of 20 | 0 of 24 |
| Femur fracture | Injury, poisoning and procedural complications | 1 of 40 | 0 of 20 | 0 of 24 |
| Incision site erythema | Injury, poisoning and procedural complications | 0 of 40 | 1 of 20 | 0 of 24 |
| Muscle spasms | Musculoskeletal and connective tissue disorders | 1 of 40 | 0 of 20 | 0 of 24 |
| Limb asymmetry | Musculoskeletal and connective tissue disorders | 0 of 40 | 0 of 20 | 1 of 24 |
Serious events with the highest arm-level rate: osteoarthritis (12.5%), tendonitis (4.2%), cataract (4.2%), type 2 diabetes mellitus (4.2%), adrenocortical carcinoma (4.2%).
The registry reports serious adverse event affected counts and numbers at risk by surgical approach. In the posterior group, 8 affected participants are listed among 40 at risk; in the lateral group, 2 among 20 are listed; and in the anterior group, 5 among 24 are listed. For other adverse events, the corresponding figures are 9 among 40, 4 among 20, and 7 among 24. Deaths are listed as 1 in the posterior group, 0 in the lateral group, and 0 in the anterior group.
These are descriptive figures, not evidence that an event was caused by the shell or procedure. The registry record does not report attribution, event definitions, timing, severity beyond the serious/non-serious grouping, or completeness of follow-up. It also does not report a statistical comparison across approaches. Because allocation was non-randomized, group figures should not be interpreted as a controlled comparison.
The record lists serious terms and percentages including Osteoarthritis at 12.5%, Tendonitis at 4.2%, Cataract at 4.2%, Type 2 diabetes mellitus at 4.2%, Adrenocortical carcinoma at 4.2%, and Duodenal ulcer at 2.5%. These entries identify reported terms and their listed percentages; the registry record does not make clear from these entries alone how the percentages were calculated or whether the terms were considered related to treatment.
12. What the Result Does, and Does Not, Mean
The study addresses a focused measurement question: the mean superior migration of a Pinnacle Acetabular Shell after total hip arthroplasty, measured by RSA. The registry defines the measurement, unit, time points, and intended analysis population. It also describes summaries by surgical approach and combined. These features make the intended outcome clear, but they do not reveal the observed result.
The registry record does not report the mean migration, its standard deviation, a confidence interval, or the number analyzed for the primary endpoint. Therefore, it is not possible to tell from the posted results how much migration was observed, how variable it was, or how precisely the mean was estimated. No conclusion about the endpoint’s magnitude should be inferred from enrollment, study status, or the existence of planned outcome definitions.
The design also limits what comparisons could establish. This was a non-randomized, non-controlled, single-group study, with three described surgical approaches. The approaches were not allocated randomly and are not like-for-like controls. Consequently, even if separate outcome summaries were available, a difference between approaches would not by itself show that the approach caused the difference. The registry does not report an adjustment method for possible differences among groups.
The adverse event figures are descriptive and do not establish causation or comparative safety. The record does not report whether events were attributed to the device or procedure, nor does it provide the detail needed to assess the completeness of event ascertainment. The record’s terminated status likewise does not explain whether the study ended as planned, why it ended, or what conclusions the investigators reached.
In general, a clinical outcome should be interpreted using its estimate, precision, population, measurement timing, and study design. Here the endpoint definition and design can be described, but the primary results needed to assess the observed migration and its uncertainty are not reported in the registry record. Thus the record supports an account of what the study set out to measure, not a conclusion about the size or meaning of the measurement.
13. Why This Trial Matters Statistically
This study is statistically notable for centering a continuous, imaging-based measurement rather than a clinical event count. Mean superior cup migration is specified in millimeters and assessed with RSA, allowing the primary question to be framed in terms of the amount of vertical movement. The registry also identifies standard deviation as the planned way to describe variability. In principle, reporting both a mean and an appropriate measure of uncertainty can help readers distinguish the estimated group average from variation across participants.
The study also illustrates why a clear endpoint definition is not enough for statistical interpretation. The registry identifies the measurement direction, unit, time points, and analysis population, but it does not report the endpoint estimate, uncertainty, or analysis count. Without those quantities, the planned measurement cannot be evaluated as an observed result. This distinction between a registered outcome and a posted finding is important when reading clinical trial records.
Its non-randomized, non-controlled design is another important statistical feature. The posterior, lateral, and anterior approaches are presented as groups for separate summaries, but they are not randomized comparisons. This makes descriptive reporting possible while limiting causal interpretation of differences between groups. General principles of design apply: random allocation helps balance measured and unmeasured factors on average, whereas non-random allocation may leave group differences that complicate comparisons.
Finally, the record lists multiple outcomes and time points, making multiplicity and missing-data handling relevant questions. It does not report an adjustment strategy, analysis plan, or approach to missing measurements. The study therefore serves as a useful example of why interpretation depends not only on the endpoint and study design, but also on complete reporting of estimates, uncertainty, and analysis decisions.
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 central limitation for interpreting the primary outcome is that the registry record does not report its numerical results. The mean, standard deviation, confidence interval, number analyzed, and participant counts at each measurement time are absent. The record therefore does not permit assessment of the observed migration or the precision of its estimate. It lists 0 analysis entries despite defining a primary outcome.
The study is non-randomized, non-controlled, and described as single-group. Although it presents posterior, lateral, and anterior approaches, those groups are not randomized controls. Comparisons across them would be vulnerable to differences among participants or clinical settings. The registry record does not report an adjusted comparison or a method for addressing such differences.
Several reporting details are not included: the reason for termination, the criteria for the Per Protocol Analysis Set, the analyzed sample size, missing-data handling, and the statistical analysis plan. The primary outcome title specifies 6 week and 2 years, while the brief objective describes migration over the first two years; the record does not explain further timing or analysis details. The record also does not report whether multiplicity was addressed across the listed outcomes and time points.
Safety figures lack reported attribution and detailed definitions in the registry record. They cannot establish that adverse events were caused by the implant or procedure, and the non-randomized design does not support a controlled safety comparison. The registry’s enrollment of 100 is not a sample-size justification; that justification is not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Pinnacle RSA Study — NCT04070989.
- Registry record last updated 2025-12-19; status last verified 2025-12.
- Results first posted 2025-10-21.
- 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 Pinnacle RSA Study (NCT04070989) is a prospective, multicenter, non-controlled study of the Pinnacle Acetabular Shell in total hip arthroplasty. It is listed as non-randomized, single-group, and unmasked, with enrollment of 100 and status terminated. The record lists osteoarthritis and degenerative arthritis as conditions.
The primary outcome is mean superior cup migration, measured as vertical Y translation by RSA in millimeters, at 6 week and 2 years. The intended analysis population is the Per Protocol Analysis Set, with summaries planned by posterior, lateral, and anterior approach and combined. Secondary outcomes include additional RSA measures, linear head penetration, and Harris Hip Score.
The registry record does not report primary outcome results, uncertainty estimates, an analysis plan, or missing-data methods. It posts descriptive adverse event figures by approach, but does not report attribution or comparative safety analyses. The recorded study dates are 2019-12-03 and 2023-06-12, and the reason for termination is not reported in the registry record.