Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Cast immobilisation versus surgery for unstable lateral malleolus fractures (SUPER-FIN): randomised non-inferiority clinical trial.

Name: Kaimen Rigor review — Cast immobilisation versus surgery for unstable lateral malleolus fractures (SUPER-FIN): randomised non-inferiority clinical trial.
Item: Cast immobilisation versus surgery for unstable lateral malleolus fractures (SUPER-FIN): randomised non-inferiority clinical trial.
Rating: 82
Author: Alpha1

Kortekangas T, Lehtola R, Leskelä HV, Taimela S, Ohtonen P, Savola O, Järvinen TLN, Pakarinen H

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$Kaimen Rigor review — 2.25★ (Weak), 0 critical, 5 high issues for “Cast immobilisation versus surgery for unstable lateral malleolus fractures (SUPER-FIN): randomised non-inferiority clinical trial.”$

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This rigor review was examined and confirmed by Alpha1 Editorial · August 10, 2026

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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

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DOI

10.1136/bmj-2025-085295

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Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

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

Paper source

Cast immobilisation versus surgery for unstable lateral malleolus fractures (SUPER-FIN): randomised non-inferiority clinical trial.

Read full text (PMC)

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Links back to this Kaimen Rigor review.

Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 10, 2026

Kaimen Rigor review

Kaimen Rigor reviewed

2.25 / 5

Weak — serious problems found

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×4−2★
ReportingData & code availability not met−0.5★
ReportingKey resources partially met−0.25★

Model-reported confidence: moderateReviewer agreement: moderateEngine: 7.29.0Source: full text

Not verified in this report

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.

Biggest issues

01Data and code not shared
highDisclosurereviewer-assessedFull detail
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
mediumArithmeticreviewer-assessedFull detail
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

Findings by category

101ArithmeticNumerical inconsistencies 102OverreachOverstated conclusions 103AuthenticityData authenticity concerns 204DisclosureReporting gaps 05AvailabilityNone found 106CopyeditCopyediting

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 medium

Values 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.

Overstated conclusions

1 finding · worst low

Conclusions 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.

Efficacy claim is anchored to an adequate endpoint and a meaningful effect.

Data authenticity concerns

1 finding · worst low

An 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).

Reporting gaps

2 findings · worst high

Required 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

Eight Dimensions6 pass · 1 warn · 1 fail

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.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The study clearly establishes its scientific foundation, citing the relevant prior literature (including the only previous RCT by Sanders et al.), a multi-register study showing wide practice variation, and articulating a logical rationale for the non-inferiority hypothesis.

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.”

Introduction ¶5Find in source

paraphrase[Introduction, final paragraph]

“We conducted a prospective randomised parallel group non-inferiority trial to compare the outcomes of cast immobilisation with surgery in patients with a unimalleolar Weber B fracture with a congruent mortise deemed unstable after external rotation stress testing.”

PASSReviewer 2· 95% conf

The paper clearly establishes the scientific foundation by citing prior research, providing a logical rationale, and addressing limitations of previous work.

Evidence

Introduction ¶1Find in source

paraphrase[Introduction, final paragraph]

“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.”

DiscussionFind in source

PASSReviewer 3· 90% conf

The scientific premise is well grounded in prior research, with a clear rationale for the non-inferiority question and explicit discussion of limitations of previous work.

Evidence

Introduction ¶4Find in source

“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.”

Introduction ¶3Find in source

“A closer examination, however, suggested that many of these events may have been of limited clinical significance.”

DiscussionFind in source

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.

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The trial design is rigorous: adequate randomisation method and unit, explicit open-label rationale with a blinded data-interpretation scheme, a detailed a priori power calculation, clearly pre-specified inclusion/exclusion criteria, and defined analysis populations (ITT, per-protocol, as-treated).

Evidence

“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.”

MethodsFind in source

“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”

MethodsFind in source

“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).”

Statistical analysisFind in source

PASSReviewer 2· 95% conf

The study design is rigorous, with adequate randomization, blinding of data interpretation, a priori power analysis, clear eligibility criteria, and handling of missing data and outliers.

Evidence

MethodsFind in source

paraphrase[Methods, Blinding]

“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).”

Statistical analysisFind in source

PASSReviewer 3· 95% conf

Randomisation, allocation concealment, power calculation, eligibility criteria, and analysis populations are clearly described; blinding is unfeasible but handled via a blinded data-interpretation scheme.

Evidence

MethodsFind in source

“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).”

Statistical analysisFind in source

MethodsFind in source

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.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthINADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 80% conf

Sex, age, and a range of demographic/baseline characteristics (smoking, education, injury setting, pain, medial-clear-space width, signs of medial injury) are reported in the baseline table for this human trial.

Evidence

paraphrase[Table 1]

“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)”

Table 1Find in source

“Able to walk unaided before current trauma”

Box 1, Eligibility criteriaFind in source

PASSReviewer 2· 85% conf

Sex and age are reported, and demographics are adequate for the study type, though weight and detailed health status are not reported.

Evidence

paraphrase[Table 1]

“Sex: Men 34 (56), Women 27 (44) [cast immobilisation group]”

paraphrase[Table 1, Results]

“Mean (SD) age at fracture (years), (range) 46 (18), (19-83) [cast immobilisation group]”

absence[Table 1, Methods]

Weight is not reported.

WARNReviewer 3· 75% conf

Sex and age are reported, but weight/health status are not fully reported and demographic reporting lacks race/ethnicity and detailed comorbidities.

Evidence

“Men | 34 (56) | 38 (60) | | Women | 27 (44) | 25 (40)”

Table 1Find in source

“Mean (SD) age at fracture (years), (range) | 46 (18), (19-83) | 43 (19), (16-82)”

Table 1Find in source

absence[Table 1 and Methods]

Weight, comorbidities, and race/ethnicity are not reported.

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.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical compliance is fully documented: a named institutional review board approved the protocol with a reference number, written informed consent was obtained from all participants, and adherence to the Declaration of Helsinki is stated.

Evidence

“The trial protocol was approved by the institutional review board of Oulu University Hospital (EC 25/2012)”

MethodsFind in source

“All participants gave written informed consent.”

MethodsFind in source

“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).”

EthicsFind in source

PASSReviewer 2· 95% conf

Ethical approval by a named IRB, informed consent, and regulatory compliance are all reported and adequate.

Evidence

“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).”

MethodsFind in source

“All participants gave written informed consent.”

MethodsFind in source

paraphrase[Methods, Ethics statements]

“This study was conducted in accordance with the Declaration of Helsinki...”

PASSReviewer 3· 98% conf

Named IRB approval with protocol number, written informed consent, and Declaration of Helsinki compliance are all reported.

Evidence

“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).”

EthicsFind in source

“All participants gave written informed consent.”

MethodsFind in source

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.

Sub-criteria

mycoplasma testingN/A

reagents identifiedINADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (3) — the votes behind the verdict

N/AReviewer 1· 85% conf

This is a surgical/procedural comparison (cast immobilisation vs open reduction and internal plate fixation) that evaluates no investigational drug, biologic, device, or bench reagent; the standard plate and cast are standard-of-care materials, not the intervention under test.

Evidence

“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).”

AbstractFind in source

WARNReviewer 2· 90% conf

The surgical implant (plate) is not identified by vendor or catalog number, representing a key resource reporting gap; software is adequately identified.

Evidence

“Surgery involved internal fixation, conducted according to standard principles for ankle fracture fixation (see supplementary appendix 1, table 2).”

MethodsFind in source

“The data were analysed using IBM SPSS Statistics version 25 or higher.”

Statistical analysisFind in source

PASSReviewer 3· 80% conf

The trial compares two procedures and uses no investigational drug, biologic, or wet-lab reagents; the statistical software is identified with name and version.

Evidence

“The data were analysed using IBM SPSS Statistics version 25 or higher.”

Statistical analysisFind in source

paraphrase[Methods, Interventions]

“The interventions are cast immobilisation and standard open reduction with internal plate fixation; no drug, biologic, or bench reagent is specified.”

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.

Sub-criteria

tests namedADEQUATE

exact p valuesN/A

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedINADEQUATE

mathematical plausibilityPASS

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 85% conf

Statistical reporting is complete for the clinical-trial idiom: tests are named, the primary analysis uses effect estimates with 95% CIs, the software and version are identified, per-group n and dispersion are given, and the statistics I could recompute are internally plausible.

Evidence

paraphrase[Results, Primary outcome]

“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)”

“The data were analysed using IBM SPSS Statistics version 25 or higher.”

Statistical analysisFind in source

“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.”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

Statistical tests are named, effect sizes are reported with CIs, software is identified, and data presentation is adequate. Assumptions are not formally verified but the approach is acceptable for a large trial.

Evidence

paraphrase[Methods, Statistical analysis]

“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. Categorical variables (eg, treatment related adverse events) were analysed with χ 2 test or Fisher’s exact test...”

“Between group mean difference 1.3 points, 95% confidence interval −4.8 to 7.3”

Table 2Find in source

“The data were analysed using IBM SPSS Statistics version 25 or higher.”

Statistical analysisFind in source

PASSReviewer 3· 85% conf

Tests are named, effect estimates with 95% CIs are reported, software is identified, and data presentation follows the clinical-trial idiom; p-values are not printed in the main text, consistent with estimation-based reporting.

Evidence

“The primary analysis used Student’s t test.”

Statistical analysisFind in source

“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.”

Statistical analysisFind in source

“between group mean difference 1.3 points, 95% confidence interval −4.8 to 7.3”

ResultsFind in source

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.

Sub-criteria

code sharingNOT REPORTED

accession numbersN/A

repository depositNOT REPORTED

data availability statementINADEQUATE

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 70% conf

A data availability statement is present and the protocol/SAP is published, but the visible portion of the statement does not name a concrete access route (repository, accession, or managed-access committee) for the underlying individual patient data.

Evidence

“The study protocol, including the statistical analysis plan, has been published.”

Data availabilityFind in source

“The data underlying the primary findings in this paper and the code used”

Data availabilityFind in source

FAILReviewer 2· 95% conf

The data availability statement is incomplete and vague, no repository deposit is mentioned, and no code sharing is provided.

Evidence

“The data underlying the primary findings in this paper and the code used”

Data availabilityFind in source

absence[Data availability statement]

No repository deposit is mentioned.

absence[Data availability statement]

No code sharing is reported.

FAILReviewer 3· 70% conf

The data availability statement is truncated and does not specify a concrete access route, repository, or code-sharing mechanism.

Evidence

“The study protocol, including the statistical analysis plan, has been published. The data underlying the primary findings in this paper and the code used”

Data availabilityFind in source

absence[Data availability statement]

No repository, DOI, accession, or managed-access platform is stated.

absence[Data availability statement and Methods]

No public code repository is identified.

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.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

Reporting is transparent and complete: detailed methods, prospective trial registration with a number, explicit CONSORT adherence, all outcomes reported including negative/null results, a thorough limitations discussion, proportional conclusions, and full funding/COI disclosures.

Evidence

“Trial registration ClinicalTrials.gov NCT01758796”

AbstractFind in source

“The reporting of this study follows the Consolidated Standards of Reporting Trials (CONSORT) guidelines for non-inferiority trials.”

MethodsFind in source

“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).”

FundingFind in source

PASSReviewer 2· 95% conf

The manuscript is transparent and complete: methods are detailed, trial is registered, reporting follows CONSORT, all outcomes are reported, limitations are discussed, conclusions are proportional, and funding/COI are disclosed.

Evidence

“Trial registration ClinicalTrials.gov NCT01758796 .”

AbstractFind in source

“Reporting adheres to the CONSORT statement.”

Statistical analysisFind in source

paraphrase[Discussion, 'Strengths and limitations of this study']

“Regarding limitations, single centre trials conducted by experts... are typically believed to enhance internal validity at the expense of external validity (generalisability).”

PASSReviewer 3· 95% conf

The trial is registered, reporting follows CONSORT, methods are detailed, limitations are discussed, and funding/COI are disclosed.

Evidence

“The reporting of this study follows the Consolidated Standards of Reporting Trials (CONSORT) guidelines for non-inferiority trials.”

Methods ¶1Find in source

“The study was registered at ClinicalTrials.gov before the trial started.”

AbstractFind in source

FundingFind in source

Registered (1 ID: ClinicalTrials.gov). Reporting guideline cited: CONSORT.

Broken references and links

None found

References 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.

Copyediting

1 finding · worst low

Wording, 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.

Kaimen Rigor Action ItemsFinal pass before journal submission

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 code
Complete 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.
HIGHrigor
Reconcile 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.
HIGHreporting
Clarify 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.
HIGHrigor
Specify 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.
HIGHreporting
Add 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.
MEDIUMreporting
Explicitly 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.
MEDIUMreporting
Include 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.
MEDIUMstatistics
Report 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.
LOWreporting
Remove 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.
LOWreporting
Add 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.

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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

Read full text (PMC)

DOI

10.1136/bmj-2025-085295

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Record fingerprint

360b8dc8800aa9af1c9556a285dfdc22232d7c51518ff5778af8318ec47179a2

Verify via API

Issued Aug 10, 2026Engine 7.29.0

Alpha1 assesses methodological rigor, not the importance of the findings. See how we calibrate →

Kaimen Rigor review

Kaimen Rigor reviewed

2.25 / 5

Weak — serious problems found

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×4−2★
ReportingData & code availability not met−0.5★
ReportingKey resources partially met−0.25★

Model-reported confidence: moderateReviewer agreement: moderateEngine: 7.29.0Source: full text

Not verified in this report

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.

Biggest issues

01Data and code not shared
highDisclosurereviewer-assessedFull detail
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
mediumArithmeticreviewer-assessedFull detail
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

Findings by category

101ArithmeticNumerical inconsistencies 102OverreachOverstated conclusions 103AuthenticityData authenticity concerns 204DisclosureReporting gaps 05AvailabilityNone found 106CopyeditCopyediting

Numerical inconsistencies

1 finding · worst medium

Internal contradictions in the reported numbersAssessed

Recomputed 1 test: 1 consistent, 0 inconsistent; 1 via agent-written checks.

Overstated conclusions

1 finding · worst low

Conclusions only partially backed by the presented evidenceAssessed

12 major claims checked against the paper's own evidence: all adequately supported.

Efficacy claim is anchored to an adequate endpoint and a meaningful effect.

Data authenticity concerns

1 finding · worst low

Other integrity concernAssessed

4 integrity concerns flagged (0 high).

Reporting gaps

2 findings · worst high

Data and code not sharedAssessed
Key resources under-identified (antibodies, cell lines, RRIDs)Assessed

Eight Dimensions6 pass · 1 warn · 1 fail

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

Evidence

Introduction ¶5Find in source

paraphrase[Introduction, final paragraph]

PASSReviewer 2· 95% conf

The paper clearly establishes the scientific foundation by citing prior research, providing a logical rationale, and addressing limitations of previous work.

Evidence

Introduction ¶1Find in source

paraphrase[Introduction, final paragraph]

DiscussionFind in source

PASSReviewer 3· 90% conf

The scientific premise is well grounded in prior research, with a clear rationale for the non-inferiority question and explicit discussion of limitations of previous work.

Evidence

Introduction ¶4Find in source

“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.”

Introduction ¶3Find in source

“A closer examination, however, suggested that many of these events may have been of limited clinical significance.”

DiscussionFind in source

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

Evidence

MethodsFind in source

“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).”

Statistical analysisFind in source

PASSReviewer 2· 95% conf

The study design is rigorous, with adequate randomization, blinding of data interpretation, a priori power analysis, clear eligibility criteria, and handling of missing data and outliers.

Evidence

MethodsFind in source

paraphrase[Methods, Blinding]

“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).”

Statistical analysisFind in source

PASSReviewer 3· 95% conf

Evidence

MethodsFind in source

“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).”

Statistical analysisFind in source

MethodsFind in source

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthINADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 80% conf

Evidence

paraphrase[Table 1]

“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)”

Table 1Find in source

“Able to walk unaided before current trauma”

Box 1, Eligibility criteriaFind in source

PASSReviewer 2· 85% conf

Sex and age are reported, and demographics are adequate for the study type, though weight and detailed health status are not reported.

Evidence

paraphrase[Table 1]

“Sex: Men 34 (56), Women 27 (44) [cast immobilisation group]”

paraphrase[Table 1, Results]

“Mean (SD) age at fracture (years), (range) 46 (18), (19-83) [cast immobilisation group]”

absence[Table 1, Methods]

Weight is not reported.

WARNReviewer 3· 75% conf

Sex and age are reported, but weight/health status are not fully reported and demographic reporting lacks race/ethnicity and detailed comorbidities.

Evidence

“Men | 34 (56) | 38 (60) | | Women | 27 (44) | 25 (40)”

Table 1Find in source

“Mean (SD) age at fracture (years), (range) | 46 (18), (19-83) | 43 (19), (16-82)”

Table 1Find in source

absence[Table 1 and Methods]

Weight, comorbidities, and race/ethnicity are not reported.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

Evidence

“The trial protocol was approved by the institutional review board of Oulu University Hospital (EC 25/2012)”

MethodsFind in source

“All participants gave written informed consent.”

MethodsFind in source

“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).”

EthicsFind in source

PASSReviewer 2· 95% conf

Ethical approval by a named IRB, informed consent, and regulatory compliance are all reported and adequate.

Evidence

“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).”

MethodsFind in source

“All participants gave written informed consent.”

MethodsFind in source

paraphrase[Methods, Ethics statements]

“This study was conducted in accordance with the Declaration of Helsinki...”

PASSReviewer 3· 98% conf

Named IRB approval with protocol number, written informed consent, and Declaration of Helsinki compliance are all reported.

Evidence

“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).”

EthicsFind in source

“All participants gave written informed consent.”

MethodsFind in source

Sub-criteria

mycoplasma testingN/A

reagents identifiedINADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (3) — the votes behind the verdict

N/AReviewer 1· 85% conf

Evidence

AbstractFind in source

WARNReviewer 2· 90% conf

The surgical implant (plate) is not identified by vendor or catalog number, representing a key resource reporting gap; software is adequately identified.

Evidence

“Surgery involved internal fixation, conducted according to standard principles for ankle fracture fixation (see supplementary appendix 1, table 2).”

MethodsFind in source

“The data were analysed using IBM SPSS Statistics version 25 or higher.”

Statistical analysisFind in source

PASSReviewer 3· 80% conf

The trial compares two procedures and uses no investigational drug, biologic, or wet-lab reagents; the statistical software is identified with name and version.

Evidence

“The data were analysed using IBM SPSS Statistics version 25 or higher.”

Statistical analysisFind in source

paraphrase[Methods, Interventions]

“The interventions are cast immobilisation and standard open reduction with internal plate fixation; no drug, biologic, or bench reagent is specified.”

Sub-criteria

tests namedADEQUATE

exact p valuesN/A

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedINADEQUATE

mathematical plausibilityPASS

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 85% conf

Evidence

paraphrase[Results, Primary outcome]

“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)”

“The data were analysed using IBM SPSS Statistics version 25 or higher.”

Statistical analysisFind in source

“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.”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

Evidence

paraphrase[Methods, Statistical analysis]

“Between group mean difference 1.3 points, 95% confidence interval −4.8 to 7.3”

Table 2Find in source

“The data were analysed using IBM SPSS Statistics version 25 or higher.”

Statistical analysisFind in source

PASSReviewer 3· 85% conf

Evidence

“The primary analysis used Student’s t test.”

Statistical analysisFind in source

“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.”

Statistical analysisFind in source

“between group mean difference 1.3 points, 95% confidence interval −4.8 to 7.3”

ResultsFind in source

Sub-criteria

code sharingNOT REPORTED

accession numbersN/A

repository depositNOT REPORTED

data availability statementINADEQUATE

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 70% conf

Evidence

“The study protocol, including the statistical analysis plan, has been published.”

Data availabilityFind in source

“The data underlying the primary findings in this paper and the code used”

Data availabilityFind in source

FAILReviewer 2· 95% conf

The data availability statement is incomplete and vague, no repository deposit is mentioned, and no code sharing is provided.

Evidence

“The data underlying the primary findings in this paper and the code used”

Data availabilityFind in source

absence[Data availability statement]

No repository deposit is mentioned.

absence[Data availability statement]

No code sharing is reported.

FAILReviewer 3· 70% conf

The data availability statement is truncated and does not specify a concrete access route, repository, or code-sharing mechanism.

Evidence

“The study protocol, including the statistical analysis plan, has been published. The data underlying the primary findings in this paper and the code used”

Data availabilityFind in source

absence[Data availability statement]

No repository, DOI, accession, or managed-access platform is stated.

absence[Data availability statement and Methods]

No public code repository is identified.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

Evidence

“Trial registration ClinicalTrials.gov NCT01758796”

AbstractFind in source

“The reporting of this study follows the Consolidated Standards of Reporting Trials (CONSORT) guidelines for non-inferiority trials.”

MethodsFind in source

FundingFind in source

PASSReviewer 2· 95% conf

Evidence

“Trial registration ClinicalTrials.gov NCT01758796 .”

AbstractFind in source

“Reporting adheres to the CONSORT statement.”

Statistical analysisFind in source

paraphrase[Discussion, 'Strengths and limitations of this study']

“Regarding limitations, single centre trials conducted by experts... are typically believed to enhance internal validity at the expense of external validity (generalisability).”

PASSReviewer 3· 95% conf

The trial is registered, reporting follows CONSORT, methods are detailed, limitations are discussed, and funding/COI are disclosed.

Evidence

“The reporting of this study follows the Consolidated Standards of Reporting Trials (CONSORT) guidelines for non-inferiority trials.”

Methods ¶1Find in source

“The study was registered at ClinicalTrials.gov before the trial started.”

AbstractFind in source

FundingFind in source

Registered (1 ID: ClinicalTrials.gov). Reporting guideline cited: CONSORT.

Broken references and links

None found

References 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.

Copyediting

1 finding · worst low

Wording, 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.

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
HIGHdata code
Complete 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.
HIGHrigor
Reconcile 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.
HIGHreporting
Clarify 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.
HIGHrigor
Specify 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.
HIGHreporting
Add 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.
MEDIUMreporting
Explicitly 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.
MEDIUMreporting
Include 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.
MEDIUMstatistics
Report 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.
LOWreporting
Remove 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.
LOWreporting
Add 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.

Full text (45,344 chars)Analyzed: Aug 10, 2026