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 Fixation Using Alternative Implants for the Treatment of Hip Fractures (FAITH-2) (NCT01908751), a randomized phase 3 study. The primary outcome is Number of Participants With Patient Important Outcomes.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01908751 |
| Phase | Phase 3 |
| Condition | Femoral Neck Fractures |
| Allocation | Randomized |
| Design model | Factorial |
| Masking | Quadruple |
| Enrollment | 91 |
| Arms in the primary outcome | n/a |
| Lead sponsor | McMaster University |
| Results posted | Yes |
2. Clinical Question
Population
The trial concerned young adults aged 18–60 with femoral neck fractures. The record states that 91 patients were randomized in the pilot trial and that 86 were deemed eligible and included in the analyses. It does not report further eligibility details or a complete account of participant characteristics.
Intervention
The surgical intervention was a sliding hip screw, crossed in the factorial design with vitamin D supplementation. The supplement was vitamin D3 drops, described as a six-month supply. The record also identifies cancellous screws and a vitamin D placebo as the corresponding alternatives.
Comparator
The surgical comparison was sliding hip screw versus cancellous screws; the biologic comparison was vitamin D versus placebo. The factorial structure represents these as four combinations of fixation and supplementation. The record does not provide a comparative primary-outcome estimate for either factor.
Primary question
At 12 months post-surgery, how many participants experienced one or more of four patient-important outcomes: re-operation, femoral head osteonecrosis, severe femoral neck malunion, or nonunion? The registry record defines this composite endpoint but does not report the outcome counts or a statistical comparison between groups.
These questions concern two treatment dimensions, not a single head-to-head comparison between one combined regimen and another. In a factorial trial, each factor can be examined across the levels of the other factor, subject to the analysis plan and any interaction between factors. Whether the investigators planned or reported such analyses is not reported in the registry record. The posted information therefore establishes the intended comparisons and endpoint, but does not allow a conclusion about the relative outcomes for either fixation method or supplement assignment.
3. Trial Design
FAITH-2 is described as a multicentre, randomized, 2x2 factorial trial of treatment for femoral neck fractures. The record lists phase 3 and characterizes the study as a pilot trial. Its two randomized dimensions were surgical fixation—sliding hip screw or cancellous screws—and supplementation—vitamin D or placebo. Crossing these choices produces four treatment combinations. The record reports quadruple masking, but does not specify which participant, clinical, or assessment roles were masked or how masking was maintained.
The study began in 2014-09, had a primary completion date of 2019-03-18, and is listed as terminated. A reason for termination is not reported in the registry record. Enrollment is recorded as 91. The primary endpoint description says 86 participants were deemed eligible and included in the analyses; it also says 43 were allocated to each fixation method. The supplementation allocation description is incomplete in the record, although it states that 45 were allocated to vitamin D.
For the vitamin D combinations, the arm descriptions specify a six-month supply of vitamin D3 drops. For placebo combinations, participants were to receive identical placebo drops without active ingredient, also for six months. The exact dose-instructions text is incomplete for the vitamin D arms, so further details should not be inferred.
Random allocation can reduce systematic differences between groups at baseline, while masking can limit some forms of bias in care or outcome assessment. These are design features, not evidence that every source of bias was prevented. The registry record does not report the allocation procedure, concealment details, adherence, protocol deviations, or an account of how the factorial comparisons were analyzed.
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: 91 patients were enrolled into the FAITH-2 pilot trial. Five of these enrolments were subsequently determined to be ineligible (not between the ages of 18-60 years, pathological fracture, no femoral neck fracture, did not provide informed consent (2 patients)). Therefore, 86 participants were included in the analysis.
Overall Study
| Stage | Sliding Hip Screw + Vitamin D Supplementation | Cancellous Screws + Vitamin D Supplementation | Sliding Hip Screw + Vitamin D Placebo | Cancellous Screws + Vitamin D Placebo |
|---|---|---|---|---|
| STARTED | 22 | 23 | 21 | 20 |
| COMPLETED | 17 | 18 | 16 | 16 |
| NOT COMPLETED | 5 | 5 | 5 | 4 |
Analysis population for the primary outcome, as defined in the registry: 91 patients were randomized into the FAITH-2 pilot trial. 86 patients were deemed eligible and included in the analyses. Of the 86 participants, 43 were allocated to receive a sliding hip screw and 43 were allocated to receive CS. Regarding supplementation treatment, 45 were allocated to receive vitamin D, and 41 were allocated to receive placebo.
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 | Sliding Hip Screw + Vitamin D Supplementation | Cancellous Screws + Vitamin D Supplementation | Sliding Hip Screw + Vitamin D Placebo | Cancellous Screws + Vitamin D Placebo | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 22 | 23 | 21 | 20 | 86 | |
| Age, Continuous | years | 41.0 (SD 11.2) | 40.3 (SD 13.0) | 45.2 (SD 11.5) | 37.9 (SD 13.7) | 41.1 (SD 12.4) |
| Sex: Female, Male: Female | Participants | 5 | 7 | 8 | 3 | 23 |
| Sex: Female, Male: Male | Participants | 17 | 16 | 13 | 17 | 63 |
| Race/Ethnicity, Customized: Indigenous | Participants | 0 | 0 | 1 | 0 | 1 |
| Race/Ethnicity, Customized: South Asian | Participants | 1 | 0 | 0 | 1 | 2 |
| Race/Ethnicity, Customized: Southeast Asian (Filipino) | Participants | 0 | 0 | 1 | 0 | 1 |
| Race/Ethnicity, Customized: Hispanic/Latino | Participants | 1 | 0 | 0 | 1 | 2 |
| Race/Ethnicity, Customized: White | Participants | 14 | 19 | 18 | 17 | 68 |
| Race/Ethnicity, Customized: Black | Participants | 4 | 3 | 1 | 1 | 9 |
| Race/Ethnicity, Customized: Mixed (Black & White) | Participants | 1 | 0 | 0 | 0 | 1 |
| Race/Ethnicity, Customized: Middle Eastern | Participants | 1 | 1 | 0 | 0 | 2 |
| Region of Enrollment: Canada | participants | 7 | 7 | 7 | 7 | 28 |
| Region of Enrollment: United States | participants | 15 | 16 | 14 | 13 | 58 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Patient Important Outcomes, measured over 12 months post-surgery.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with one or more patient-important outcomes, assessed at 12 months post-surgery. It is a composite: a participant qualifies if any one of the listed events occurred. These are an unplanned surgery related to fracture treatment; evidence of femoral head osteonecrosis on follow-up imaging; severe femoral neck malunion, defined as shortening >10 mm in any plane on follow-up x-rays; or nonunion, defined using a Radiographic Union Score for Hip threshold at 6 months or greater post-injury.
Composite endpoints are used to capture several clinically consequential outcomes in a single endpoint. This can be useful when different events matter to patients but may occur through different pathways. The combined count answers whether a participant experienced at least one component; it does not show which component drove a group difference. Components may also differ in frequency, severity, timing, and how they are assessed. Component-specific results are therefore important for interpretation.
The endpoint’s definition is reported, but its group counts, component counts, effect estimate, and uncertainty are not reported in the registry record. The posted data do not support a comparison of the composite between randomized groups. The record also does not give the prespecified RUSH threshold used to define nonunion.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record supplies the trial’s design and endpoint definition but not comparative results for the primary endpoint. It is therefore not possible to describe the direction, size, or precision of a primary-outcome difference between sliding hip screw and cancellous screw assignment, or between vitamin D and placebo assignment. No primary-outcome event counts, confidence intervals, or inferential test results are reported in the registry record. The absence of these results is not evidence that the treatments had equal outcomes.
The primary endpoint combines four distinct events into a participant-level count. Even if a composite difference were reported, it would need to be interpreted alongside its components: a difference could be driven largely by one component, while the others showed a different pattern. The registry record gives the definitions but not the component-level results. The endpoint is assessed at 12 months post-surgery, while nonunion is defined by a radiographic threshold at 6 months or greater post-injury. These time references are part of the endpoint definition and should not be treated as interchangeable.
The factorial design addresses two treatment dimensions. A factorial analysis may estimate the effect of each assigned factor while accounting for the other, and may also examine whether the effects vary across combinations. Such interpretation depends on the analysis actually prespecified and conducted. The registry record does not report those analyses, an interaction assessment, or a statistical plan. The four combination groups listed in the adverse-event record do not provide primary-outcome comparisons.
The record identifies 91 randomized patients and 86 eligible participants included in analyses. This difference raises questions about the path from randomization to analysis, but the reasons for exclusion and the handling of missing outcome data are not reported in the registry record. Without those details, it is not possible to assess whether the analyzed population preserved the benefits of randomization or whether missingness could have affected estimates.
The safety figures describe affected participants within the four combinations, but they do not replace efficacy results. The record does not provide a complete explanation of adverse-event ascertainment or the denominators’ relationship to the primary analysis population. The trial is labeled terminated, but termination alone does not establish why the study ended or what its findings were.
Overall, the available information supports a description of the intended clinical question, trial structure, endpoint, and posted safety counts. It does not support a conclusion about comparative primary outcomes, treatment effects, statistical significance, or precision.
9. Statistical Methods Explained
Statistical concepts below are general explanations, not claims about analyses performed in FAITH-2. The registry record reports no analyses in its analysis count, and does not report a statistical analysis plan or primary-outcome estimates. The endpoint and trial structure can still be used to explain what a suitable analysis would need to address, without assuming that it was used.
What does a participant count represent?
The primary outcome is a binary participant-level measure: whether a participant experienced at least one qualifying event by the endpoint definition. A participant who experienced multiple components still meets the composite definition. An analysis of this outcome would ordinarily compare the proportion of participants with an event across randomized groups, while accounting for the intended factorial comparisons and the chosen analysis population. The registry record does not report such proportions or a comparison.
Different effect measures answer different questions. A risk difference describes an absolute contrast in event probability; a relative measure describes a proportional contrast. These are general options, not reported FAITH-2 results. Neither should be calculated without the necessary group outcome counts and a defined comparison. A confidence interval expresses the uncertainty around an estimate under the analysis assumptions. It is not a guarantee that the true effect lies inside the interval, nor does it by itself establish whether an effect is clinically important.
Why does the factorial structure matter?
A 2x2 factorial design assigns participants across combinations of two treatment factors. In general, the main effect of one factor can be estimated by comparing participants assigned to its levels across the other factor, if the planned analysis supports that pooling. An interaction asks whether the effect of one factor differs according to the level of the other. If interaction is important, an overall main-effect estimate may not adequately describe each combination. The record does not report whether the FAITH-2 analysis pooled across combinations, tested interaction, or used another strategy.
Randomization concerns assignment, whereas analysis choices concern how observed outcomes are compared. Intention-to-treat analysis generally retains participants according to randomized assignment, even when treatment was not followed exactly. Other analysis populations may use different inclusion rules. These approaches can answer different questions and may be vulnerable to different biases. The registry record reports 86 eligible participants included in analyses after 91 were randomized, but does not report the reasons for that difference or the analysis-population rules.
What do the planning assumptions mean?
The record describes a sample-size planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The target effect is described as a stated fraction of the observed effect. For time-to-event illustrations, the stated convention is a total number of events using the Schoenfeld approach; other illustrations use participants per arm. No planning values are reported in the registry record for the endpoint.
Such calculations are planning illustrations, not observed power. They show how a hypothetical future design might be sized under assumptions; they do not establish the probability that a completed trial detected an effect, and they do not substitute for a confidence interval around an observed estimate. An illustration based on an observed effect can also depend strongly on that estimate, especially when the trial is small or results are unstable. No sample-size justification or original design calculation is reported in the registry record.
How should uncertainty and multiplicity be considered?
Statistical uncertainty reflects both the observed data and the model used to analyze them. A narrow interval generally indicates more precision than a wide interval, but precision depends on event frequency, sample size, design, and analytic assumptions. Because primary-outcome counts and uncertainty estimates are absent, the precision of FAITH-2’s treatment comparisons cannot be assessed from the registry record.
Multiplicity arises when investigators assess several outcomes, comparisons, time points, or hypotheses. Multiple tests can raise the chance of at least one chance-positive finding if each is interpreted without accounting for the testing strategy. A prespecified hierarchy, adjustment, or other strategy may address this, but no such plan is reported. General principles cannot establish which strategy the investigators used.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists seven outcome measures, including the primary participant-level composite and secondary measures of fracture-healing complications, SF-12 physical and mental composite scores, Hip Outcome Score activities-of-daily-living and sports scales, and radiographic fracture healing. Multiple outcomes can create multiplicity: the more comparisons or time points examined, the more important it is to know which analyses were planned and how the interpretation accounted for them. The registry record does not report a multiplicity strategy, an outcome hierarchy, or results for the listed secondary measures.
The analysis count is recorded as zero. No inferential primary-outcome analyses are reported in the registry record. The statistical analysis plan, model specifications, covariate adjustments, handling of factorial interaction, and any interim analyses are not reported in the registry record. An interim analysis should not be assumed either to have occurred or not to have occurred.
The population description states that 91 patients were randomized and 86 were deemed eligible and included in analyses. Reasons for exclusion, group-specific analysis populations, follow-up completeness, and missing-outcome counts are not reported in the registry record. Missing data can affect estimates when the likelihood of having an observed outcome is related to treatment assignment or outcome status. The direction and size of any such effect cannot be determined without details of missingness and the analysis approach.
Randomized assignment supports a fair comparison when participants are analyzed appropriately, but exclusions after randomization can weaken that protection. The record does not establish whether the reported eligible population was the prespecified population or how protocol deviations were handled. It also does not report sensitivity analyses for missing data. These omissions limit assessment of how robust any treatment estimate would be; no estimate is posted to assess in the first place.
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 |
|---|---|---|---|
| Sliding Hip Screw + Vitamin D Supplementation | 5 | 22 | 22.7% |
| Cancellous Screws + Vitamin D Supplementation | 6 | 23 | 26.1% |
| Sliding Hip Screw + Vitamin D Placebo | 9 | 21 | 42.9% |
| Cancellous Screws + Vitamin D Placebo | 5 | 20 | 25.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Sliding Hip Screw + Vitamin D Supplementation | 0 of 22 |
| Cancellous Screws + Vitamin D Supplementation | 0 of 23 |
| Sliding Hip Screw + Vitamin D Placebo | 0 of 21 |
| Cancellous Screws + Vitamin D Placebo | 0 of 20 |
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 |
|---|---|
| Sliding Hip Screw + Vitamin D Supplementation | 2 of 22 |
| Cancellous Screws + Vitamin D Supplementation | 3 of 23 |
| Sliding Hip Screw + Vitamin D Placebo | 3 of 21 |
| Cancellous Screws + Vitamin D Placebo | 3 of 20 |
Most frequent serious adverse event terms
| Event term | Organ system | Sliding Hip Screw + Vitamin D Supplementation | Cancellous Screws + Vitamin D Supplementation | Sliding Hip Screw + Vitamin D Placebo | Cancellous Screws + Vitamin D Placebo |
|---|---|---|---|---|---|
| Nonunion | Musculoskeletal and connective tissue disorders | 2 of 22 | 3 of 23 | 2 of 21 | 2 of 20 |
| Painful Hardware or Hardware Failure/Breakage | Musculoskeletal and connective tissue disorders | 1 of 22 | 1 of 23 | 4 of 21 | 1 of 20 |
| Osteonecrosis, symptomatic | Musculoskeletal and connective tissue disorders | 1 of 22 | 2 of 23 | 1 of 21 | 1 of 20 |
| Post-traumatic femoral acetabular impingement & hip range of motion restrictions | Musculoskeletal and connective tissue disorders | 0 of 22 | 0 of 23 | 2 of 21 | 0 of 20 |
| Aortic valve replacement due to intravalvular prosthetic regurgitation | Cardiac disorders | 0 of 22 | 0 of 23 | 0 of 21 | 1 of 20 |
| Infection (deep) | Musculoskeletal and connective tissue disorders | 1 of 22 | 0 of 23 | 0 of 21 | 0 of 20 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Sliding Hip Screw + Vitamin D Supplementation | Cancellous Screws + Vitamin D Supplementation | Sliding Hip Screw + Vitamin D Placebo | Cancellous Screws + Vitamin D Placebo |
|---|---|---|---|---|---|
| Osteonecrosis, asymptomatic | Musculoskeletal and connective tissue disorders | 1 of 22 | 1 of 23 | 0 of 21 | 1 of 20 |
| Delayed Union | Musculoskeletal and connective tissue disorders | 0 of 22 | 1 of 23 | 0 of 21 | 1 of 20 |
| Accident/Fall | Musculoskeletal and connective tissue disorders | 0 of 22 | 0 of 23 | 1 of 21 | 1 of 20 |
| Rash/Skin Irritation | Skin and subcutaneous tissue disorders | 0 of 22 | 0 of 23 | 2 of 21 | 0 of 20 |
| Hypertension | Cardiac disorders | 0 of 22 | 1 of 23 | 0 of 21 | 0 of 20 |
| Meniscal tear | Musculoskeletal and connective tissue disorders | 1 of 22 | 0 of 23 | 0 of 21 | 0 of 20 |
Serious events with the highest arm-level rate: painful hardware or hardware failure/breakage (19.0%), nonunion (13.0%), post-traumatic femoral acetabular impingement & hip range of motion restrictions (9.5%), osteonecrosis, symptomatic (8.7%), aortic valve replacement due to intravalvular prosthetic regurgitation (5.0%).
The adverse-event record presents four combinations of fixation and supplementation. For each combination, it reports participants at risk and participants affected by serious adverse events and other adverse events, as well as deaths. The serious-event counts are 5 of 22 for sliding hip screw with vitamin D supplementation, 6 of 23 for cancellous screws with vitamin D supplementation, 9 of 21 for sliding hip screw with vitamin D placebo, and 5 of 20 for cancellous screws with vitamin D placebo. The recorded death count is 0 in each combination.
For other adverse events, the affected-participant counts are 2 of 22, 3 of 23, 3 of 21, and 3 of 20, respectively, in the same combination order. These are descriptive counts, not adjusted comparisons. They should not be combined across groups or treated as evidence that one treatment caused more or fewer events. The record does not report a statistical safety comparison, event timing, severity grades beyond the serious-event classification, or the relationship between safety and analysis populations.
The listed serious-event terms include painful hardware or hardware failure/breakage (19.0%), nonunion (13.0%), post-traumatic femoral acetabular impingement and hip range of motion restrictions (9.5%), symptomatic osteonecrosis (8.7%), aortic valve replacement due to intravalvular prosthetic regurgitation (5.0%), and deep infection (4.5%). The registry record does not specify the denominator or whether these categories overlap, so the percentages should be read as posted rather than interpreted as mutually exclusive shares. Event counts alone do not establish whether an event was caused by an assigned treatment.
12. What the Result Does, and Does Not, Mean
The record identifies a randomized factorial pilot trial and defines a clinically focused composite endpoint for participants with femoral neck fractures. Its primary question is whether participants experienced any one of four important outcomes by 12 months post-surgery, in relation to two assigned treatment factors: fixation method and supplementation. The record also provides descriptive adverse-event figures for the four treatment combinations.
What it does not provide is the comparative primary-outcome result. There are no reported primary event counts by group, effect estimates, confidence intervals, or statistical tests. Consequently, the posted information does not establish whether outcomes differed between fixation assignments or supplementation assignments, how large any difference was, or how precisely a difference was estimated. This lack of a reported comparison is not evidence of no effect or of equivalence.
The endpoint is composite, so a result for the combined measure would not by itself explain which event mattered most to the comparison. Component-specific outcome data would be needed to distinguish patterns in re-operation, osteonecrosis, severe malunion, and nonunion. Those results are not reported in the registry record.
The adverse-event counts are descriptive and are not a substitute for the primary-outcome analysis. They do not establish causation, and the record does not report a formal safety comparison. Similarly, the study’s terminated status does not state why it ended, whether termination was related to recruitment, conduct, funding, or findings, or whether any particular conclusion followed. Such reasons are not reported in the registry record.
The appropriate reading is therefore limited: the record supports understanding what FAITH-2 was designed to compare, who was included in the described analysis population, how the primary endpoint was defined, and what adverse-event counts were posted. It does not support a treatment recommendation or a conclusion that either intervention is superior, equivalent, or ineffective.
13. Why This Trial Matters Statistically
FAITH-2 is statistically notable because it places two treatment questions in a factorial design: a comparison of fixation methods and a comparison of supplementation. This structure can use the same randomized trial to study more than one factor, but the interpretation depends on the planned model, the treatment of interaction, and the outcome data. Without reported analyses, the design alone does not show what either comparison found.
The endpoint also illustrates a common trade-off in clinical-trial design. Combining several patient-important events can capture a broader picture of outcome, but a single composite count can conceal differences among its components. Re-operation, imaging evidence of osteonecrosis, severe malunion, and nonunion are defined in distinct ways. A sound interpretation would consider both the composite and the components; the registry record provides the definitions but not their results.
The record’s distinction between randomized and analyzed populations is important for statistical reading. It reports 91 randomized patients and 86 deemed eligible and included in analyses, without explaining the intervening exclusions. Because randomization supports comparability through assigned groups, post-randomization exclusions merit transparent explanation. The available description does not provide enough information to evaluate that process.
Finally, the record demonstrates why design details and outcome reporting should be read separately. Randomization and masking describe methods intended to reduce bias; they do not replace outcome estimates, uncertainty intervals, or a transparent account of analysis. The posted adverse-event counts add descriptive safety information, but cannot answer the primary efficacy question. The trial’s design is clear enough to frame its intended questions, while the absent comparative results limit the statistical conclusions that can be drawn.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
Several trial-specific limitations of interpretation arise from the registry record. It labels the study a phase 3 trial and also calls it a pilot trial. The record does not explain the relationship between those descriptions, nor does it provide a sample-size justification. Enrollment is reported as 91, but that figure alone cannot establish whether the trial was designed to estimate effects precisely or to assess feasibility.
The primary population description reports 91 randomized patients and 86 eligible participants included in analyses. It gives 43 participants allocated to each fixation method, but does not report why participants were excluded from the analyses, whether exclusions differed across groups, or how missing outcomes were handled. Supplementation allocation information is incomplete; the record states that 45 were allocated to vitamin D but does not give a complete account of the other allocation details in the primary population description.
The registry record does not provide primary or secondary comparative outcome results, confidence intervals, analysis methods, or a prespecified statistical plan. It also does not report the threshold value for the RUSH definition of nonunion, despite describing that threshold as predetermined. The descriptions of masking do not identify which roles were masked. Adherence, treatment crossover, protocol deviations, and follow-up completeness are not reported in the registry record.
The adverse-event listing provides counts and selected event-term percentages, but does not explain the percentages’ denominators or whether categories overlap. A reason for the terminated status is also not reported. These gaps restrict interpretation of the trial’s conduct and results; they should not be filled by inference.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Fixation Using Alternative Implants for the Treatment of Hip Fractures (FAITH-2) — NCT01908751.
- Registry record last updated 2020-11-30; status last verified 2020-11.
- Results first posted 2020-11-30.
- 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
FAITH-2 is a randomized, quadruple-masked, 2x2 factorial pilot trial listed as phase 3. It studied sliding hip screw versus cancellous screws and vitamin D versus placebo for femoral neck fractures in young adults aged 18–60. The record lists enrollment of 91, a start date of 2014-09, primary completion on 2019-03-18, and status as terminated.
The primary endpoint is the number of participants with one or more of four patient-important outcomes at 12 months post-surgery. The registry record states that 86 participants were deemed eligible and included in analyses, but does not report comparative primary-outcome results, uncertainty estimates, or the analysis plan. Descriptive serious and other adverse-event counts are posted for the four treatment combinations, with 0 deaths recorded in each. The reason for termination and the reasons for exclusions from the analysis population are not reported in the registry record.