Cast immobilisation versus surgery for unstable lateral malleolus fractures (SUPER-FIN): randomised non-inferiority clinical trial.
Kortekangas T, Lehtola R, Leskelä HV, Taimela S, Ohtonen P, Savola O, Järvinen TLN, Pakarinen H
- DOI
- 10.1136/bmj-2025-085295
- Record issued
- 2026-08-10
- Engine
- 7.29.0
- Exported
- 2026-09-21
Prepared by Alpha1. This document is confidential: it is intended for the recipient it was shared with and must not be redistributed. The live record at alpha1science.com/verify/41a39aab-8976-40d5-8769-c58e83fd069d is authoritative.
How this rating was calculated
- IntegrityIntegrity concern ×4−2★
- ReportingData & code availability not met−0.5★
- ReportingKey resources partially met−0.25★
- References were not verified against Crossref/OpenAlex.
- The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run: 2 reported means were read, and their group size is not stated where the values are printed (this source has no machine-readable table structure). These checks need the count the mean was averaged over, so none was performed.
- 01Data and code not shared
The data availability statement is incomplete and vague, no repository deposit is mentioned, and no code sharing is provided.
“The data underlying the primary findings in this paper and the code used”
Data availabilityFind in source - 02Internal contradictions in the reported numbers
The Methods state a 10% difference on the 0-100 OMAS (10 points) was chosen as the non-inferiority threshold, but the sample size calculation and primary analysis use an 8-point margin (−8.0). The text never reconciles these.
“Consensus was reached that a 10% difference on the 0-100 OMAS would represent a clinically meaningful difference. This 10% margin was chosen as the non-inferiority threshold.”
Statistical analysisFind in source
This Kaimen Rigor review uses Kaimen Rigor reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.
The SUPER-FIN trial is methodologically sound in design, ethics, and reporting, but has notable gaps in the completeness of the data availability statement (truncated, no access route), the identification of the surgical implant, and the reporting of baseline biological variables (weight, comorbidities, race/ethnicity). These weaknesses reduce the reproducibility and transparency of the published work.
Three independent reviewer runs from the same model were synthesised. The reviewers diverged on biological variables (pass vs warn), key resources (N/A vs warn vs pass), and data code availability (warn vs fail). The synthesised statuses reflect the preponderance of evidence and the scoring rules. The statistics verification covered only a subset of tests; all verified tests were consistent. The citation check found no retracted or unresolvable references.
Numerical inconsistencies
1 finding · worst mediumValues that contradict each other or are impossible for the stated sample: recomputed p-values and test statistics, GRIM/GRIMMER checks on summary numbers, percentages against their own counts, totals against their parts, and estimates against their own confidence intervals.
- Internal contradictions in the reported numbersAssessed
Recomputed 1 test: 1 consistent, 0 inconsistent; 1 via agent-written checks.
- CONSISTENTreported p = .670 · recomputed p = .674Reviewer 1Primary intention-to-treat analysis: between-group difference in OMAS at two years, back-computed from the reported difference and 95% CI (non-significant, consistent with the paper's non-inferiority conclusion).
“the mean OMAS was 89 in the cast immobilisation group and 87 in the surgery group (between group mean difference 1.3 points, 95% CI −4.8 to 7.3)”
Taken as given: the CI is two-sided at 95%; the effect is a mean difference, not a ratio (log=0); the test is the two-tailed Student's t test used for the primary ITT analysis; the difference and CI refer to the same comparison (cast immobilisation minus surgery)Method: Two-tailed p recovered from a mean difference and its 95% CI via pCI (t-approximation). The paper reports no p-value for this outcome, so this check verifies that the CI is internally consistent (lower bound −4.8 > −8.0, confirming non-inferiority).How we recomputed it: pCI(1.3, -4.8, 7.3, 0)
- mediuminternal contradictionThe Methods state a 10% difference on the 0-100 OMAS (10 points) was chosen as the non-inferiority threshold, but the sample size calculation and primary analysis use an 8-point margin (−8.0). The text never reconciles these.
“Consensus was reached that a 10% difference on the 0-100 OMAS would represent a clinically meaningful difference. This 10% margin was chosen as the non-inferiority threshold.”
Statistical analysisFind in source - lowinternal contradictionThe abstract reports '121 out of 126 randomised participants (96%) completed the study', whereas two participants were excluded post-randomisation for fracture-dislocation, leaving 124 eligible; the 96% figure is of the 126 randomised, not of the 124 eligible, which is a defensible but slightly inconsistent framing.
“121 out of 126 randomised participants (96%) completed the study.”
AbstractFind in source - lowinternal contradictionThe Discussion reports 603 patients with an isolated Weber B fracture and congruent mortise screened, and 126 deemed unstable (21%), whereas the Abstract/Results report 840 assessed, 714 excluded, and 126 randomised; the relationship between these denominators is not explained.
“Of the 603 patients with an isolated Weber B ankle fracture and a congruent mortise we screened for eligibility, 21% (126 of 603) were deemed unstable”
DiscussionFind in source
Overstated conclusions
1 finding · worst lowConclusions that reach past what the paper's own results support — including a significance claim that no longer holds when the statistic is recomputed, and efficacy resting on an unvalidated surrogate endpoint.
- Conclusions only partially backed by the presented evidenceAssessed
12 major claims checked against the paper's own evidence: all adequately supported.
- partialReviewer 1Longstanding concern about occult instability may have contributed to decades of overtreatment.This is an interpretive inference from the trial's results and prior studies, hedged with 'suggest'; the data support a simpler casting approach but do not directly quantify overtreatment, so the claim extends modestly beyond the presented evidence.Evidence: No occult incongruency in >600 screened patients; low rates of subsequent incongruency in prior weightbearing-protocol studies (3-10%).
“Taken together, these observations suggest that longstanding concern about occult instability may have contributed to decades of overtreatment.”
DiscussionFind in source - partialReviewer 2The findings are likely to accurately represent the broader patient population despite being a single-centre trial.The paper argues that consecutive enrolment and the hospital being the sole provider for a large catchment area mitigate generalisability concerns. However, the single-centre design and expert surgeons may still limit external validity.Evidence: Discussion: 'At the time of the trial, our study hospital was the sole provider of treatment for ankle fractures in a catchment area covering about 740 000 inhabitants... ensuring a highly representative sample.'
“At the time of the trial, our study hospital was the sole provider of treatment for ankle fractures in a catchment area covering about 740 000 inhabitants and about 51% of Finland’s total area, ensuring a highly representative sample.”
LimitationsFind in source - partialReviewer 3Post-traumatic ankle osteoarthritis is primarily related to more severe fracture types, not to unimalleolar Weber B fractures with congruent mortise.The trial's two-year radiographic data are consistent with a low rate of osteoarthritis progression, but the causal claim about fracture types and long-term outcomes is not established by this trial.Evidence: Two-year radiographic data: 98% of participants in both groups had normal or mild-to-moderate (Kellgren-Lawrence grade 1-2) features, and progression did not differ between groups (supplementary appendix 1, table 12).
“post-traumatic ankle osteoarthritis is primarily related to the more severe ankle fracture types of bimalleolar and trimalleolar fractures and fracture dislocations and not to unimalleolar Weber B fractures with congruent ankle mortise.”
DiscussionFind in source - supportedReviewer 1Cast immobilisation is non-inferior to surgery for the primary outcome (OMAS at two years).The primary ITT analysis shows a between-group difference of 1.3 (95% CI −4.8 to 7.3), and the lower bound −4.8 exceeds the pre-specified non-inferiority margin of −8.0, directly supporting the claim.Evidence: Primary outcome result: mean OMAS 89 vs 87, difference 1.3, 95% CI −4.8 to 7.3.
“Cast immobilisation proved non-inferior to surgery for the treatment of unimalleolar Weber B ankle fractures with a congruent mortise on initial radiography but deemed unstable by external rotation stress testing.”
AbstractFind in source - supportedReviewers 1, 3Fewer treatment-related harms occurred with cast immobilisation compared with surgery.The adverse-event data support this: the surgery group had wound infections, delayed healing, and nine hardware-removal procedures (two with postoperative infection), while the cast group had only one asymptomatic non-union.Evidence: Treatment-related adverse events section; Discussion '23% (14/61) v 24% (10/41)'.
“Overall, fewer treatment related harms occurred with cast immobilisation compared with surgery.”
AbstractFind in source - supportedReviewers 1, 3No statistically significant between-group differences were observed in any secondary outcome.All secondary outcomes are reported with 95% CIs that cross zero, consistent with the stated absence of statistically significant differences.Evidence: Table 2 and secondary-outcome text; all CIs span zero.
“We did not observe any statistically significant between group differences in any of the secondary outcomes at two years”
ResultsFind in source - supportedReviewer 1Post-traumatic ankle osteoarthritis is not a major concern for this injury type, with 98% of participants having no or mild-to-moderate OA features.The radiographic analysis at two years showed 98% of participants in both groups had Kellgren-Lawrence grade 0-2 features and no between-group difference in progression, supporting the claim.Evidence: Radiographic outcomes and Discussion (supplementary appendix 1, table 12).
“our analysis showed that 98% of participants in both groups had either no or only mild-to-moderate (Kellgren and Lawrence grade 1 or 2) radiographic features of osteoarthritis”
DiscussionFind in source - supportedReviewer 2Cast immobilisation is non-inferior to surgery for the treatment of unimalleolar Weber B ankle fractures with a congruent mortise deemed unstable by external rotation stress testing.The primary analysis shows the lower bound of the 95% CI (-4.8) is above the non-inferiority margin (-8), supporting non-inferiority. Sensitivity analyses are consistent.Evidence: Primary outcome: mean OMAS difference 1.3 points (95% CI -4.8 to 7.3).
“In the primary intention-to-treat analysis of 121 participants completing two year follow-up, the mean OMAS was 89 in the cast immobilisation group and 87 in the surgery group (between group mean difference 1.3 points, 95% confidence interval −4.8 to 7.3).”
AbstractFind in source - supportedReviewer 2Fewer treatment related harms occurred with cast immobilisation compared with surgery.The paper reports adverse events: one non-union in each group, and in the surgery group additional wound infections and hardware removal procedures. The cast group had only one non-union.Evidence: Results section on adverse events: 'One participant in each group had a radiographically confirmed non-union. In the surgery group, additional complications included superficial wound infection (n=1 participant), delayed wound healing (n=1), and hardware removal procedures (n=9)...'
One participant in each group had a radiographically confirmed non-union. In the surgery group, additional complications included superficial wound infection (n=1 participant), delayed wound healing (n=1), and hardware removal procedures (n=9)...
Resultsreviewer’s wording - supportedReviewers 2, 3No statistically significant between group differences were observed in any secondary outcomes.Table 2 lists all secondary outcomes with mean differences and 95% CIs, all of which include zero, supporting no significant differences.Evidence: Table 2: all secondary outcome CIs cross zero.
“We did not observe any statistically significant between group differences in any of the secondary outcomes at two years, the primary outcome assessment time point.”
Table 2Find in source - supportedReviewer 2The use of external rotation stress test is a valid method for assessing instability.The paper justifies the use of this test by citing its equivalence to the gravity stress test and its use in the prior trial by Sanders et al. The test is described in detail.Evidence: Methods: 'We considered the ankle unstable when the medial clear space was ≥5 mm.' Discussion: 'This test had the most robust evidence base, showing equivalent diagnostic accuracy to the gravity stress test.'
“This test had the most robust evidence base, showing equivalent diagnostic accuracy to the gravity stress test, the other most commonly used clinical test for ankle stability.”
LimitationsFind in source - supportedReviewer 3Cast immobilisation is non-inferior to surgery for unstable Weber B ankle fractures with congruent mortise at two years.The primary intention-to-treat analysis shows a between-group difference of 1.3 points with 95% CI −4.8 to 7.3, and the lower limit is above the pre-specified −8.0 margin, directly supporting non-inferiority.Evidence: Primary ITT analysis: mean OMAS 89 vs 87; between-group difference 1.3 points (95% CI −4.8 to 7.3); sensitivity and per-protocol analyses consistent.
“Cast immobilisation proved non-inferior to surgery for the treatment of unimalleolar Weber B ankle fractures with a congruent mortise on initial radiography but deemed unstable by external rotation stress testing.”
ConclusionFind in source
Efficacy claim is anchored to an adequate endpoint and a meaningful effect.
- ADEQUATESurrogate endpointThe primary outcome is the Olerud-Molander Ankle Score (OMAS), a validated patient-reported outcome measure for ankle fracture symptoms. This is a clinical outcome scale, not a surrogate biomarker.
“The primary outcome was the Olerud-Molander Ankle Score (OMAS) at two years. OMAS is a validated, condition specific, patient reported outcome measure for ankle fracture symptoms (range 0-100; higher scores indicating better outcomes and fewer symptoms; minimal important difference 12 points).”
- ADEQUATEEffect sizeThe between-group difference in OMAS was 1.3 points (95% CI -4.8 to 7.3), well below the minimal important difference of 12 points and within the non-inferiority margin of -8 points. This supports non-inferiority.
“mean OMAS was 89 in the cast immobilisation group and 87 in the surgery group (between group mean difference 1.3 points, 95% confidence interval −4.8 to 7.3).”
Data authenticity concerns
1 finding · worst lowAn adversarial read for patterns associated with data that may not be genuine: results that look too clean, implausibly large effects, duplicated data or images, and methods that do not match the results reported.
- Other integrity concernAssessed
4 integrity concerns flagged (0 high).
- lowotherBaseline imbalance in smoking status (current smoker 13% vs 35%) and signs of medial injury between randomised groups; the authors acknowledge this and adjust in a sensitivity analysis, but it was not handled by stratification.
“except for some imbalances in smoking status and signs of medial injury”
Table 1Find in source
Reporting gaps
2 findings · worst highRequired detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.
- Data and code not sharedAssessed
- Key resources under-identified (antibodies, cell lines, RRIDs)Assessed
The introduction reviews the epidemiology of ankle fractures, the diagnostic challenge of occult incongruency, and the variability in clinical practice. It cites the only prior randomised trial (Sanders et al.) and identifies its limitations, including the composite outcome definition and the recommendation for surgery in younger patients. The rationale for the present trial is clearly linked to these gaps, and the study hypothesis (non-inferiority of cast immobilisation) follows logically from the cited evidence.
“We are aware of only one randomised trial to date that has compared surgery with cast immobilisation in patients with radiographically congruent Weber B fractures classified as unstable by external rotation testing.”
“We are aware of only one randomised trial to date that has compared surgery with cast immobilisation in patients with radiographically congruent Weber B fractures classified as unstable by external rotation testing.”
“This increased risk of adverse events in the cast immobilisation group prompted the authors to recommend surgery for younger patients. A closer examination, however, suggested that many of these events may have been of limited clinical significance.”
“We are aware of only one randomised trial to date that has compared surgery with cast immobilisation in patients with radiographically congruent Weber B fractures classified as unstable by external rotation testing.”
“In our recent multi-register study, we observed a sixfold variation in the incidence of surgery for isolated lateral malleolar fractures across six European countries between 2013 and 2022.”
“A closer examination, however, suggested that many of these events may have been of limited clinical significance.”
Randomization used sequentially numbered, opaque, sealed envelopes with random permuted blocks prepared by a statistician. Blinding of participants and assessors was not possible, but a blinded data interpretation scheme was used with an independent statistician. The sample size calculation was based on a non-inferiority margin of 8 points, with alpha=0.05, power 80%, and 20% dropout. Eligibility criteria are clearly listed in Box 1. The primary analysis followed intention-to-treat, with per-protocol and as-treated sensitivity analyses. Loss to follow-up and crossovers are reported.
“A statistician with no clinical involvement in the trial prepared sequentially numbered, opaque, sealed envelopes with random permuted blocks (block size known only by the statistician) and no stratifications using a computerised random number generator.”
“Blinding of participants and outcome assessors was not possible owing to the nature of the interventions. However, we interpreted the results of the trial according to a blinded data interpretation scheme”
“Assuming α=0.05, power 80% (1−β=0.8), and accounting for a 20% dropout rate, the required sample size was calculated to be 63 participants in each group (total n=126).”
“A statistician with no clinical involvement in the trial prepared sequentially numbered, opaque, sealed envelopes with random permuted blocks (block size known only by the statistician) and no stratifications using a computerised random number generator.”
“Assuming α=0.05, power 80% (1−β=0.8), and accounting for a 20% dropout rate, the required sample size was calculated to be 63 participants in each group (total n=126).”
“A statistician with no clinical involvement in the trial prepared sequentially numbered, opaque, sealed envelopes with random permuted blocks (block size known only by the statistician) and no stratifications using a computerised random number generator.”
“Assuming α=0.05, power 80% (1−β=0.8), and accounting for a 20% dropout rate, the required sample size was calculated to be 63 participants in each group (total n=126).”
“Blinding of participants and outcome assessors was not possible owing to the nature of the interventions. However, we interpreted the results of the trial according to a blinded data interpretation scheme”
Sex is reported in Table 1, and both sexes are enrolled (no justification needed). Age is reported as mean and range. Health status is partially covered by inclusion criteria (able to walk unaided) and smoking status, but weight and comorbidities are not reported. Demographics include age, sex, smoking, education, and injury setting, which is adequate for this trial. Weight is not reported, but this is a minor omission for an ankle fracture trial.
“Mean (SD) age at fracture (years), (range) | 46 (18), (19-83) | 43 (19), (16-82)”
“Able to walk unaided before current trauma”
“Men | 34 (56) | 38 (60) | | Women | 27 (44) | 25 (40)”
“Mean (SD) age at fracture (years), (range) | 46 (18), (19-83) | 43 (19), (16-82)”
The ethics statement names the institutional review board of Oulu University Hospital with approval code EC 25/2012, and the Methods state that all participants gave written informed consent. Regulatory compliance with the Declaration of Helsinki is explicit.
“The trial protocol was approved by the institutional review board of Oulu University Hospital (EC 25/2012)”
“All participants gave written informed consent.”
“This study was conducted in accordance with the Declaration of Helsinki and was approved by the institutional review board of Oulu University Hospital (EC 25/2012).”
“This study was conducted in accordance with the Declaration of Helsinki and was approved by the institutional review board of Oulu University Hospital (EC 25/2012).”
“All participants gave written informed consent.”
“This study was conducted in accordance with the Declaration of Helsinki and was approved by the institutional review board of Oulu University Hospital (EC 25/2012).”
“All participants gave written informed consent.”
The paper describes the surgical intervention as 'open reduction and internal plate fixation' but does not specify the manufacturer, catalog number, or any other identifier for the plate. For a device trial, this is a limitation. The statistical software (IBM SPSS Statistics version 25 or higher) is adequately identified. Other resource criteria (antibodies, cell lines, etc.) are not applicable.
“Participants were randomly allocated to receive either conventional cast immobilisation for six weeks (n=62) or surgical treatment with open reduction and internal plate fixation followed by cast immobilisation for six weeks (n=64).”
“Surgery involved internal fixation, conducted according to standard principles for ankle fracture fixation (see supplementary appendix 1, table 2).”
“The data were analysed using IBM SPSS Statistics version 25 or higher.”
“The data were analysed using IBM SPSS Statistics version 25 or higher.”
All statistical tests are named (t-test, Welch's t-test, χ², Fisher's exact). The primary analysis uses a non-inferiority framework with CIs; secondary outcomes are reported with mean differences and 95% CIs. Exact p-values are not reported but the paper uses estimation-based reporting, which is appropriate. Software is identified. Data presentation includes a flow diagram, baseline table, and forest plot for the primary outcome. Assumptions about normality and equal variance are not explicitly tested, but the use of Welch's t-test for unequal variances is noted. No arithmetic inconsistencies were detected.
“The data were analysed using IBM SPSS Statistics version 25 or higher.”
“Continuous outcomes (FAOS, visual analogue scale, RAND-36, and range of motion) were analysed using Student’s t test or Welch’s t test, depending on the equality of variances.”
“Between group mean difference 1.3 points, 95% confidence interval −4.8 to 7.3”
“The data were analysed using IBM SPSS Statistics version 25 or higher.”
“The primary analysis used Student’s t test.”
“Continuous outcomes (FAOS, visual analogue scale, RAND-36, and range of motion) were analysed using Student’s t test or Welch’s t test, depending on the equality of variances.”
“between group mean difference 1.3 points, 95% confidence interval −4.8 to 7.3”
The data availability statement is cut off at the end of the paper: 'The data underlying the primary findings in this paper and the code used' with no further details. This is vague and does not specify a repository or access mechanism. No repository deposit or accession numbers are mentioned. No code sharing is reported. Only the protocol and statistical analysis plan are referenced as published. This fails to meet expected standards for data and code availability.
“The study protocol, including the statistical analysis plan, has been published.”
“The data underlying the primary findings in this paper and the code used”
“The data underlying the primary findings in this paper and the code used”
“The study protocol, including the statistical analysis plan, has been published. The data underlying the primary findings in this paper and the code used”
Methods are described in detail, including eligibility criteria, randomization, interventions, outcomes, and statistical analysis. The trial is registered at ClinicalTrials.gov (NCT01758796). The paper states it follows CONSORT guidelines for non-inferiority trials. All pre-specified primary and secondary outcomes are reported in tables. Limitations are discussed in depth, including the lack of patient involvement and the single-centre design. Conclusions are appropriately cautious, stating non-inferiority and noting fewer harms. Funding sources and competing interests are transparently reported.
“Trial registration ClinicalTrials.gov NCT01758796”
“The reporting of this study follows the Consolidated Standards of Reporting Trials (CONSORT) guidelines for non-inferiority trials.”
“This study was supported by the Oulu University Hospital and by Competitive State Research Financing of the Expert Responsibility area of Oulu University Hospital (grant No: EVO-VY 244770/24780).”
“Trial registration ClinicalTrials.gov NCT01758796 .”
“Reporting adheres to the CONSORT statement.”
“The reporting of this study follows the Consolidated Standards of Reporting Trials (CONSORT) guidelines for non-inferiority trials.”
“The study was registered at ClinicalTrials.gov before the trial started.”
“This study was supported by the Oulu University Hospital and by Competitive State Research Financing of the Expert Responsibility area of Oulu University Hospital (grant No: EVO-VY 244770/24780).”
Registered (1 ID: ClinicalTrials.gov). Reporting guideline cited: CONSORT.
Broken references and links
None foundReferences checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.
Checked — nothing surfaced.
1 data/code link checked; 1 live.
- datahttps://clinicaltrials.gov/ProvidedDocs/96/NCT01758796/SAP_000.pdfLIVEHTTP 200Resolves, but the content could not be matched to the paper.
Copyediting
1 finding · worst lowWording, consistency and formatting errors that need correcting before submission.
- Wording or formatting errors that need correctingAssessed
5 copyedit issues flagged (1 major): mostly clarity, consistency, other.
- MAJORclarityData availability statement“The data underlying the primary findings in this paper and the code used”→ Complete the sentence with a concrete access route (e.g., 'are available from the corresponding author on reasonable request' or a managed-access platform with conditions).The statement is truncated and no access mechanism is given.
- MINORconsistencyData availability statement“The data underlying the primary findings in this paper and the code used”→ Complete the sentence to specify where and how the data/code can be accessed.The access route for the underlying data is not stated in the visible text.
- MINORotherEnd of manuscript (after Data availability statement)“071100718768509 . 29652191”→ Remove stray numeric/identifier text if it is not an intended accession or reference.Likely extraction noise rather than a true manuscript defect.
- MINORconsistencyMethods, Statistical analysis“Consensus was reached that a 10% difference on the 0-100 OMAS would represent a clinically meaningful difference. This 10% margin was chosen as the non-inferiority threshold.”→ State that the final pre-specified margin was −8.0 points and explain the relationship to the 10% statement.The 10% margin (10 points on a 0-100 scale) is not reconciled with the 8-point margin used in the sample size calculation and primary analysis.
- MINORclarityDiscussion“Of the 603 patients with an isolated Weber B ankle fracture and a congruent mortise we screened for eligibility, 21% (126 of 603) were deemed unstable”→ Clarify how this 603 screened relates to the 840 assessed and 714 excluded reported in the trial flow.Denominator relationship is not explained.
As a post-publication audit, this paper is robust in its core methods and conclusions, but an informed reader should note the missing data availability statement (no access to individual patient data) and the unidentifiable surgical implant as limitations. A correction to the data availability statement is warranted to clarify access conditions, and the non-inferiority margin inconsistency (10% vs 8 points) should be addressed in a corrigendum or noted by the reader.
- 1.HIGHdata codeComplete the truncated data availability statement with a concrete access route for de-identified participant data (e.g., a managed-access procedure through Oulu University Hospital or a named data-access committee with conditions and timeframe).The current statement is incomplete and provides no means for readers to access the data, undermining reproducibility and transparency.
- 2.HIGHrigorReconcile the non-inferiority margin: the Methods state a 10% difference (10 points on the 0-100 OMAS) was chosen as the threshold, but the sample size calculation and primary analysis use an 8-point margin (−8.0). Clarify which margin was pre-specified and why.This internal contradiction could affect the interpretation of the non-inferiority conclusion and should be corrected or explained.
- 3.HIGHreportingClarify the relationship between the 840 assessed, 714 excluded, and 603 patients with isolated Weber B fractures with congruent mortise mentioned in the Discussion, so the screening denominators are transparent.The numbers are not reconciled, which may confuse readers about the flow of participants.
- 4.HIGHrigorSpecify the manufacturer and catalog number of the surgical plate used for internal fixation, or state that the trial evaluated a surgical procedure rather than a specific implant.Identifying the implant is essential for reproducibility of the surgical intervention.
- 5.HIGHreportingAdd baseline weight/BMI and comorbidities/health status to Table 1, and report race/ethnicity if collected, to fully address the biological_variables dimension.These variables are standard baseline characteristics for a clinical trial and their absence limits the assessment of prognostic balance.
- 6.MEDIUMreportingExplicitly state that no custom code was used for analysis (IBM SPSS was used) and that the analysis code is available on request, if applicable.The data availability statement mentions 'code used' but provides no repository; clarifying the code status would resolve ambiguity.
- 7.MEDIUMreportingInclude a link to the published protocol and the CONSORT checklist in the Data availability statement, since only 'has been published' is currently stated.Providing direct access to the protocol and checklist improves transparency.
- 8.MEDIUMstatisticsReport exact p-values for secondary outcomes in the main results table, or explicitly state that all secondary outcomes are reported as effect estimates with 95% CIs and that p-values are in the supplementary appendix.While estimation-based reporting is acceptable, exact p-values help readers interpret secondary findings.
- 9.LOWreportingRemove stray numeric/identifier text ('071100718768509 . 29652191') at the end of the manuscript if it is not an intended accession or reference.This appears to be extraction noise and could be confusing to readers.
- 10.LOWreportingAdd a brief description of the minimal important difference (MID) for the OMAS in the methods and discuss whether the observed difference exceeds it.This would help readers interpret the clinical significance of the primary outcome.
The star rating is the report’s one-glance summary. Every paper starts at 5★ and loses stars for the concrete problems the review finds — so a rating is never a vague average, it’s a running total you can read line by line under “How this rating was calculated.”
- Reporting — 8 dimensionseach dimension that fully fails−½★
- each dimension partially met−¼★
- Statistics · Integrity · Claimseach serious problem−1★
- each medium problem−½★
- Citationseach retracted or unverifiable reference−¼★
- Copyeditonly when the manuscript needs a full edit−½★
The rating never drops below 1★, and a demonstrable critical failure (an impossible statistic, a proven ethics violation) caps it at 1★ on its own — so the stars can never look healthy when the verdict is CRITICAL.
The rating draws on a panel of agents. Three independent Kaimen Rigor reviewers grade the eight dimensions below across several independent passes (the shown verdict is their majority vote — steadier than any single run), isolate the paper’s major claims and check its own evidence backs them, and flag integrity concerns. Alongside them, a citation agent resolves every reference against Crossref, OpenAlex, and Retraction Watch; a statistics agent recomputes reported tests; and rule-based checks verify that declared data/code links actually resolve. Full text is required — an abstract-only submission is not analyzed.
Graded against NIH, MDAR, ARRIVE 2.0, CONSORT, EQUATOR, and RRID guidelines. A dimension that doesn’t apply to the study type is skipped, never penalized.
This Kaimen Rigor review is model-assisted and is not a substitute for formal expert review. It complements human evaluation by surfacing potential methodological concerns — verify each finding against the source.