Toolkit for Optimal Recovery After Orthopedic Injury: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Toolkit for Optimal Recovery After Orthopedic Injury (NCT04973696), a randomized na study. The primary outcome is Feasibility of Recruitment Among All Patients.

2. Clinical Question

The registry describes a randomized feasibility study of TOR versus MEUC in people with acute orthopedic injury. Its stated purpose was to assess whether study procedures and program delivery met benchmarks for feasibility, acceptability, and appropriateness in preparation for a subsequent efficacy trial. This makes the central question one about whether the research approach and intervention delivery can be carried out, rather than whether TOR changes a clinical outcome.

The primary recruitment measure is defined as the number of participants who consented out of those who were eligible. The record explicitly distinguishes this measure from the 195 participants enrolled and randomized. It does not report the eligible count, the number who consented, or the resulting recruitment measure. Therefore, recruitment performance cannot be quantified from the posted primary outcome information.

The study also lists secondary feasibility outcomes concerning randomization, adherence, referrals, protocol fidelity, homework, therapist ratings, and staff perceptions. These indicate a broader interest in the practicality and acceptability of the study, but their results are not reported in the registry record. No clinical benefit or lack of benefit can be inferred from the recruitment endpoint or from the stated feasibility aims.

3. Trial Design

This was a multisite, randomized, double-masked, parallel-design feasibility study. The registry lists an enrollment of 195 and names Massachusetts General Hospital as the sponsor. The study status is completed. Its recorded start date is 2021-09-21, and its primary completion date is 2023-08-15.

Participants were assigned to TOR or MEUC. TOR was a behavioral intervention described as an individual, four-session program delivered synchronously by live video. Its stated purpose was to teach mind-body skills to patients at risk for persistent pain and disability after acute orthopedic injury. The MEUC condition included educational material in a physical pamphlet and a website downloaded as an app, along with usual care as determined by the medical team. Further detail about how the usual-care component varied across participants is not reported in the registry record.

The study’s stated primary aim was to determine whether study methodology and intervention delivery met a priori benchmarks for feasibility, acceptability, and appropriateness. The listed procedures include implementation, randomization, and outcome assessment. The registry also lists secondary measures addressing staff referral, adherence, fidelity, satisfaction, and acceptability. Those measures fit the feasibility purpose: they concern whether study activities could be implemented and experienced as intended, not a definitive test of clinical efficacy.

The registry identifies the study as phase NA. It does not report the randomization sequence method, allocation concealment, the roles of the masked parties, or procedures for maintaining masking. The precise site-level recruitment and assignment procedures are also not reported in the registry record. Although the title describes a multisite study, these details should not be inferred from the design labels alone.

The primary outcome is recruitment among eligible patients, while the stated enrollment figure describes participants enrolled and randomized. Since the eligible denominator and consenting numerator are not reported, the recruitment endpoint cannot be reconstructed. Nor does the registry record provide an arm-by-arm primary outcome comparison or a statistical analysis 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

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

Population: Participants were individuals with recent orthopaedic injuries (1-2 months prior) with elevator pain anxiety and/or pain catastrophizing.

6. Primary Endpoint

The registry lists the primary outcome as Feasibility of Recruitment Among All Patients, measured over At the end of the entire enrollment period of the study, which was about 1 year and 10 months..

The primary endpoint is titled “Feasibility of Recruitment Among All Patients.” It is defined as the number of participants who consented to participate out of those eligible, assessed at the end of the enrollment period. The endpoint is therefore intended to describe whether the study could recruit eligible patients, an operational question relevant to planning a later trial.

Recruitment feasibility is useful because the ability to identify eligible people and obtain consent affects whether a future study can be conducted as intended. It is distinct from the number enrolled and randomized: the registry explicitly notes that the recruitment count is not the same as the 195 participants enrolled and randomized. The eligible denominator and consenting numerator are not reported in the registry record, so the recruitment measure itself cannot be calculated from the posted information.

This endpoint does not measure persistent pain, disability, treatment response, or the comparative effect of TOR and MEUC. The registry’s description of the study mentions prevention of persistent pain and disability as the broader motivation, but the primary endpoint recorded concerns recruitment feasibility. The outcome’s timeframe is the end of the entire enrollment period, described as about 1 year and 10 months. Results for this endpoint are not reported in the registry record.

For a recruitment count to be interpreted as a recruitment proportion or rate, its underlying numerator and denominator and any chosen time basis would need to be available. The registry does not report a recruitment proportion, rate, or related uncertainty interval. Consequently, the primary endpoint supports no quantitative conclusion about how easily eligible patients were recruited.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies a randomized, double-masked, parallel feasibility study. These design terms describe how the study was organized, but do not by themselves specify the statistical methods used to evaluate its outcomes. The statistical analysis plan is not reported in the registry record, and the record lists 0 analysis records. The explanation below distinguishes general statistical principles from methods documented for this study.

What does the primary endpoint count?

The primary endpoint concerns the number of eligible patients who consented to participate by the end of the enrollment period. It is a recruitment measure. The description distinguishes this count from the 195 participants who were enrolled and randomized. To interpret recruitment, the numerator and denominator need to be clear: the count of consented eligible patients and the total number eligible. Neither count is reported in the registry record. Without them, the endpoint cannot be reconstructed, and a recruitment proportion cannot be determined from the enrollment figure alone.

As a general statistical point, counts and proportions answer related but different questions. A count reports how many events or people met a definition. A proportion relates that count to a defined population at risk or eligible for the outcome. A rate additionally requires a time basis. The registry’s primary endpoint description identifies a count among eligible patients, but does not post the underlying count or denominator, nor a rate or uncertainty interval.

What does randomization contribute?

In general, random assignment is intended to make comparison groups more comparable with respect to factors that could affect outcomes. It does not guarantee identical groups, and it does not resolve missing or unreported results. To interpret a randomized comparison, readers need outcome data by arm, a clear analysis population, and an analysis method suited to the outcome. Arm-specific primary endpoint results are not reported in the registry record. The record also does not describe the randomization sequence generation or allocation concealment.

The parallel design indicates that the two assigned groups were studied as separate arms rather than as a crossover sequence. The double-masked designation is a registry design label. The identities of masked parties and the procedures used to maintain masking are not reported in the registry record. These details matter when assessing potential bias, but should not be inferred from the label.

What can be said about statistical testing?

No primary outcome analysis is posted. The registry record does not report a test statistic, p-value, effect estimate, or confidence interval for recruitment or for an arm comparison. A confidence interval is a general statistical tool that expresses the precision of an estimate under a specified method; it does not establish that an effect is important or causal by itself. Without a posted estimate and interval, precision cannot be assessed for the primary endpoint.

The registry notes planning illustrations based on an observed effect and identifies a two-sided significance level of 0.05, equal allocation, and a normal approximation as assumptions for those illustrations. These are planning assumptions, not observed study outcomes or proof of power. Sample-size illustrations are not observed power. The registry does not report the study’s own sample-size justification or an analysis plan, so the planning assumptions should not be treated as evidence that the completed trial was designed or analyzed according to a particular inferential procedure.

How should multiple outcomes be understood?

The record lists 41 outcome measures and a set of secondary feasibility outcomes. In general, when many outcomes are examined, the chance of at least one apparently unusual finding can increase if many statistical tests are conducted without accounting for multiplicity. Different approaches can address this, but the choice depends on the study aims and analysis plan. A multiplicity strategy is not reported in the registry record. Since no analysis records are posted, it is not possible to determine which outcomes were tested, whether any adjustment was used, or how outcome findings were prioritized.

What is unknown about the data?

Statistical interpretation also depends on how missing observations, withdrawals, and deviations from assigned treatment are handled. Those procedures are not reported in the registry record. The record lists measures of fidelity and adherence, but does not provide their results or say how they would enter an analysis. The analysis population is not reported: the registry does not say whether the intended analyses would include all randomized participants, only participants with observed outcomes, or another defined group.

These omissions limit interpretation rather than demonstrate a flaw in the study. The registry record supports a description of the planned feasibility focus and design, but not a reconstruction of the statistical analysis. Any numerical estimates or conclusions beyond the posted counts would require information not reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 41 outcome measures, including secondary measures of randomization and adherence, staff referral, fidelity to procedures, homework adherence, therapist ratings, and staff satisfaction and acceptability. The record does not report a statistical plan describing how these outcomes were prioritized or whether any formal multiplicity strategy was used. It also lists 0 analysis records, so there are no posted tests or estimates from which to assess how the outcomes were handled.

As a general principle, examining many outcomes can increase the chance of finding an apparently notable result by chance when each is tested separately. Methods for managing that issue depend on whether outcomes are exploratory or confirmatory and on the study’s aims. The registry does not report that distinction or an adjustment strategy. The number of listed outcomes alone does not show that a multiplicity problem occurred; it shows why interpretation would benefit from a stated analysis plan and results.

Missing-data methods, withdrawals, and completeness of outcome collection are not reported in the registry record. The record does not state how missing observations would be handled or whether any sensitivity analyses were planned. The analysis population is also not reported, so it is unclear which participants would have been included in outcome analyses.

The study lists feasibility outcomes about adherence and procedural fidelity, but their results and their role in any analysis are not reported. The primary recruitment outcome’s numerator and eligible denominator are also absent. As a result, neither missing-data handling nor analysis-population choices can be evaluated, and the primary recruitment measure cannot be independently derived from the enrollment count.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: pneumonia and hospitalization (3.3%), diagnosis of ankle septic arthritis and hospitalization (2.0%), suicide attempt and subsequent hospitalization (1.5%).

The registry reports serious and other adverse events by study site, rather than presenting a comparison by randomized arm. Massachusetts General Hospital lists 1 serious adverse event among 66 at risk and 0 other adverse events among 66 at risk. Dell Medical School lists 0 serious adverse events among 48 at risk and 2 other adverse events among 48 at risk. Vanderbilt University Medical Center lists 1 serious adverse event among 30 at risk and 0 other adverse events among 30 at risk. The University of Kentucky College of Medicine lists 1 serious adverse event among 51 at risk and 1 other adverse event among 51 at risk. Deaths are listed as 0 at each site.

The registry also names “Pneumonia and hospitalization” at 3.3%, “Diagnosis of ankle septic arthritis and hospitalization” at 2.0%, and “Suicide attempt and subsequent hospitalization” at 1.5% among its top serious event terms. The denominator and relationship between these term percentages and the site-level counts are not reported in the registry record, so those percentages should not be combined or reinterpreted as arm-specific risks.

These are descriptive registry figures. The record does not provide a randomized-arm safety comparison, a method for attributing events to an intervention, or context for assessing differences across sites. Site-level counts alone do not establish whether an event was caused by either study condition.

12. What the Result Does, and Does Not, Mean

This trial addresses a practical and important stage in clinical research: whether a mind-body program and the procedures needed to study it can be delivered to patients with acute orthopedic injury who are considered at risk for chronic pain and disability. The stated aim was to assess feasibility, acceptability, and appropriateness, with a view toward a subsequent efficacy trial. That aim is different from demonstrating whether the program changes pain or disability.

The registry record identifies a randomized comparison of TOR with MEUC and describes the two conditions. It also lists feasibility outcomes spanning recruitment, randomization, adherence, referrals, fidelity, and staff or therapist perceptions. However, the results for these measures are not reported in the registry record. The primary endpoint’s eligible denominator and consent count are missing, so the central recruitment measure cannot be assessed.

The 195 participants enrolled and randomized describe enrollment, not the primary recruitment outcome. The record explicitly distinguishes these quantities. Without the number of eligible patients and the count who consented, the enrollment figure cannot show what fraction of eligible patients joined or whether recruitment met a benchmark.

The posted information also does not provide comparative clinical outcome estimates, confidence intervals, or analysis results. Thus, it does not establish that TOR improves outcomes, and it does not establish that TOR has no effect. Those conclusions would require relevant outcome data and an appropriate analysis. The randomized design label alone cannot substitute for those results.

The site-level adverse-event figures provide descriptive safety information, but not a comparison between TOR and MEUC. They should not be interpreted as proof that either condition caused or prevented an event. Overall, the registry record describes the study’s structure and aims, while leaving its central feasibility findings and any comparative clinical conclusions unreported.

13. Why This Trial Matters Statistically

Feasibility studies help determine whether the processes needed for a later clinical trial can be carried out. In this study, the stated concerns included recruitment, randomization, study procedures, outcome assessment, and delivery of a four-session live-video program. The listed secondary outcomes extend that focus to referral pathways, adherence, fidelity, homework, and perceptions of staff and therapists. Such measures can identify operational questions that a later efficacy study would need to address.

The primary recruitment endpoint is especially relevant because it is defined in relation to eligible patients, rather than merely the number enrolled. That distinction matters statistically: enrollment alone does not provide the denominator needed to understand recruitment among eligible people. Since the registry does not report the eligible count or the consent count, the posted record cannot show how recruitment performed against the study’s feasibility aim.

The study’s randomized structure is also pertinent to future trial planning, but feasibility and efficacy are separate questions. Assessing whether assignment and intervention delivery are workable is not the same as estimating comparative clinical effects. The record gives no outcome analyses with which to judge efficacy, and the statistical plan is not reported.

For statisticians and clinical researchers, this record illustrates why outcome definitions, denominators, analysis populations, missing-data plans, and outcome-prioritization procedures matter. Without those details and results, readers can identify the intended questions but cannot evaluate the estimates or their precision. The study’s stated purpose makes these operational measures important, yet the registry’s lack of posted results prevents assessment of whether the intended benchmarks were attained.

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 primary limitation for interpreting this trial record is that the primary recruitment outcome is defined but its result is not reported. The endpoint requires the number who consented and the number eligible; neither is posted. The enrollment figure of 195 is explicitly distinguished from the recruitment measure and cannot replace those missing values.

The registry lists 41 outcome measures but 0 analysis records. It does not report results for the primary or secondary feasibility outcomes, estimates of uncertainty, or arm-specific outcome comparisons. Consequently, it is not possible to assess whether recruitment, adherence, referrals, fidelity, or acceptability met the intended benchmarks.

Important analytic details are also not reported in the registry record. These include the statistical analysis plan, the analysis population, missing-data handling, multiplicity procedures, and the methods used to generate and conceal randomization assignments. The double-masked designation is recorded, but the masked parties and maintenance procedures are not described. These are reporting gaps; the record does not establish whether such procedures were absent from the study itself.

The eligible population is described generally as patients with acute orthopedic injury at risk for chronic pain and disability. Detailed eligibility criteria and the method for determining risk are not reported. The brief description identifies the intervention’s format and broad mind-body content, but further curriculum detail is not available in the registry record. The description of usual care likewise does not specify how care varied across participants.

Finally, safety information is presented by site rather than by randomized arm, and the relationship between the listed serious-event terms and site counts is not explained. These data therefore cannot support a comparative safety assessment. Collectively, these limitations mean that the record is useful for identifying the study’s design and stated purpose, but not for judging its feasibility results or clinical effects.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Toolkit for Optimal Recovery After Orthopedic Injury — NCT04973696.
• Registry record last updated 2025-06-27; status last verified 2025-06.
• Results first posted 2025-06-27.
• 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.

18. Record Summary

NCT04973696 is a completed multisite randomized, double-masked, parallel feasibility study sponsored by Massachusetts General Hospital. It compared the Toolkit for Optimal Recovery after Orthopedic Injury, a four-session individual live-video program, with minimally enhanced usual care consisting of educational materials and usual care determined by the medical team. The registry lists 195 participants enrolled and randomized.

The stated primary endpoint is recruitment feasibility, defined by the number who consented among eligible patients at the end of the enrollment period. The record notes that this is not the same as the enrollment count, but does not report the eligible count, consent count, or endpoint result. It lists 41 outcome measures and 0 analysis records.

Serious and other adverse events are reported by site, with 0 deaths listed at each site. The record does not report the study’s statistical analysis plan, primary or secondary outcome results, missing-data approach, analysis population, or comparative clinical estimates. Its stated focus is feasibility, acceptability, and appropriateness rather than a definitive efficacy assessment.