Rigor Reviewed

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

Name: Adcurare Rigor Record — 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: 96
Author: Adcurare

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

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$Adcurare Rigor Review — 4.75★ (Strong), 0 critical, 5 high issues for “Cast immobilisation versus surgery for unstable lateral malleolus fractures (SUPER-FIN): randomised non-inferiority clinical trial.”$

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Adcurare Editorial

This rigor review was examined and confirmed by Adcurare Editorial · July 7, 2026

Adcurare Rigor Review

Rigor Reviewed

4.75 / 5

Strong — minor issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

ReportingStatistical analysis partially met−0.25★

Model-reported confidence: highReviewer agreement: moderateEngine: 7.6.0Source: full text

Problems surfaced1 type

Statistical reporting gaps (tests, assumptions, effect sizes)

This Adcurare Rigor Review uses AI 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.

This is a well-conducted and reported non-inferiority clinical trial with strengths in randomization, trial registration, data/code sharing, and ethical approvals. The main weaknesses are incomplete reporting of the surgical implant (manufacturer/catalog number omitted), missing per-protocol and missing-data analyses for the non-inferiority design, lack of exact p-values for secondary outcomes, and a small discrepancy in participant numbers in the abstract versus Table 1.

All three reviewers evaluated the full manuscript text. Dimensions not applicable to this human clinical trial (e.g., housing conditions, IACUC) were excluded. The reviewers agreed on six dimensions; divergences on study design and key resources were resolved by weighing the specific evidence — the missing per-protocol/missing-data reporting and implant identification constitute meaningful gaps warranting a warn.

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

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

Reporting

Eight Dimensions7 pass · 1 warn

The Introduction cites multiple prior studies, including the only previous RCT by Sanders et al., and discusses its limitations (e.g., composite outcome and conservative definition of delayed union). The rationale for the trial—variation in practice and need for robust evidence—is clearly linked to the non-inferiority hypothesis. The paper explicitly addresses how the current trial overcomes prior limitations (e.g., stringent instability criteria, high follow-up rate).

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

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

Evidence

direct quote[Introduction, paragraph 6]

“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. … differences in the incidence of adverse events prompted the authors to recommend consideration of surgery for younger patients.”

direct quote[Introduction, paragraph 6]

“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.”

direct quote[Discussion, 'Strengths and weaknesses in relation to other studies']

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

PASSReviewer 2· 95% conf

The paper clearly establishes the scientific premise, citing prior research on the diagnostic challenge of occult incongruency and the only previous randomized trial, and provides a logical rationale for the study.

Evidence

direct quote[Introduction, paragraphs 1-4]

direct quote[Introduction, paragraph 4]

direct quote[Discussion, paragraph 2]

“The authors' decision to recommend surgery on the basis of a composite outcome (compromised fracture healing), a construct that has not subsequently gained widespread acceptance, likely reflects a cautiousness rooted in the longstanding concern within orthopaedics...”

PASSReviewer 3· 95% conf

The paper clearly establishes its scientific foundation by citing prior work, including the only previous RCT on the topic, and provides a logical rationale for the study.

Evidence

direct quote[Introduction, paragraph 5]

direct quote[Discussion, paragraph 1]

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

direct quote[Introduction, paragraph 5]

Randomization used sequentially numbered opaque sealed envelopes with random permuted blocks (computer-generated). Blinding was not possible due to the nature of interventions, but a blinded data interpretation scheme was employed. An a priori power analysis was performed (alpha=0.05, 80% power, 20% dropout). Inclusion and exclusion criteria are explicitly listed in Box 1. The primary analysis was intention-to-treat, with per protocol and as-treated sensitivity analyses.

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· 95% conf

The study design is rigorous: randomization with concealed allocation, pre-specified sample size calculation, clear inclusion/exclusion criteria, and appropriate handling of missing data and analysis populations.

Evidence

direct quote[Methods, Randomisation]

“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.”

direct quote[Methods, Statistical analysis, paragraph 1]

“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).”

direct quote[Methods, Box 1]

“Inclusion criteria: Skeletally mature (≥16 years) people; Isolated Weber B fibula fracture and no widening of the mortise on static ankle radiography; … Exclusion criteria: Ankle fracture-dislocation; …”

PASSReviewer 2· 95% conf

The study design is rigorous for a clinical trial, with adequate randomization, a pre-specified non-inferiority margin, a power analysis, and clear inclusion/exclusion criteria. Blinding was not possible but was addressed with a blinded data interpretation scheme.

Evidence

direct quote[Methods, Randomisation]

direct quote[Methods, Statistical analysis]

“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).”

direct quote[Methods, Blinding]

“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...”

FAILReviewer 3· 95% conf

The trial uses adequate randomization and has a published protocol, but critical design elements for a trial of this type are missing or inadequate: no blinding of participants or assessors (stated as not possible), no a priori power analysis reported (only mentioned in the protocol), and no pre-specified handling of missing data or analysis population beyond ITT (ITT only, no per-protocol for non-inferiority).

Evidence

direct quote[Methods, Blinding]

“Blinding of participants and outcome assessors was not possible owing to the nature of the interventions.”

direct quote[Methods, Statistical analysis]

“The sample size calculation, detailed in the published protocol, was based on a two arm design comparing surgery with non-operative treatment.”

direct quote[Methods, Statistical analysis]

“The primary analysis followed the intention-to-treat principle, with participants analysed in their randomised groups.”

Sex is reported in Table 1, with 56% men and 44% women in the cast group, and 60% men and 40% women in the surgery group. Since both sexes are included, a scientific justification for a single-sex study is not applicable. Age is reported as mean (SD) and range, and health status is implicitly addressed through the inclusion/exclusion criteria (e.g., able to walk unaided, no diabetic neuropathy). Species/strain/source and housing conditions are not applicable for a human trial. Demographics are reported in Table 1, including age, sex, smoking status, education level, and injury setting.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

Biological variables (sex, age, and health status) are well reported for the human participants, and demographics are detailed.

Evidence

direct quote[Table 1]

“Mean (SD) age at fracture (years), (range): 46 (18), (19-83) [cast immobilisation]; 43 (19), (16-82) [surgery]. Sex: Men 34 (56%), Women 27 (44%) [cast]; Men 38 (60%), Women 25 (40%) [surgery].”

direct quote[Table 1]

“Level of education (ISCED categories), Injury setting, Smoking status, and signs of medial injury are tabulated.”

PASSReviewer 2· 95% conf

Key biological variables for a human clinical trial are adequately reported, including age, sex, and other demographics. Sex is reported for both groups, and since both sexes are enrolled, a justification for single-sex is not applicable.

Evidence

direct quote[Table 1]

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

direct quote[Table 1]

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

direct quote[Table 1]

“Smoking status: Non-smoker 34 (56), Former smoker 9 (15), Current smoker 8 (13), Missing 10 (16) [Cast immobilisation group]”

PASSReviewer 3· 95% conf

Sex, age, health status and comorbidity-related variables (smoking, etc.) are reported, and demographics are well described.

Evidence

direct quote[Results, Table 1]

“Sex: Men 34 (56), Women 27 (44) ... Men 38 (60), Women 25 (40)”

direct quote[Results, Table 1]

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

direct quote[Results, Table 1]

“Smoking status: Non-smoker 34 (56) ... Current smoker 8 (13) ... Injury setting ... Leisure activity 44 (72)”

The trial protocol was approved by the institutional review board of Oulu University Hospital (EC 25/2012). Written informed consent was obtained from all participants. The study was conducted in accordance with the Declaration of Helsinki.

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 approval is documented with a named IRB and protocol number, informed consent was obtained, and regulatory compliance (Declaration of Helsinki) is stated.

Evidence

direct quote[Methods, paragraph 1 and Ethics statements]

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

direct quote[Methods, paragraph 1]

“All participants gave written informed consent.”

direct quote[Ethics statements]

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

PASSReviewer 2· 95% conf

Ethical approvals are adequately reported. The study was approved by a named institutional review board with a protocol number, written informed consent was obtained, and compliance with the Declaration of Helsinki is stated.

Evidence

direct quote[Methods, paragraph 1]

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

direct quote[Methods, paragraph 1]

“All participants gave written informed consent.”

direct quote[Ethics statements]

“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).”

PASSReviewer 3· 95% conf

Ethics approval by a named IRB with protocol number, informed consent, and regulatory compliance are all reported.

Evidence

direct quote[Methods, first paragraph under 'Methods']

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

direct quote[Methods, first paragraph under 'Methods']

“All participants gave written informed consent.”

direct quote[Ethics statements]

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

The surgical intervention is described in detail, including the use of standard principles for ankle fracture fixation and preoperative antibiotics. The cast immobilisation intervention is also described. The statistical software is identified as IBM SPSS Statistics version 25 or higher. Antibodies, cell lines, mycoplasma testing, and organisms are not applicable as this is a human clinical trial without a wet-lab component. Reagents are not applicable beyond the surgical materials, which are described in general terms.

Sub-criteria

mycoplasma testingN/A

reagents identifiedN/A

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 85% conf

The surgical implant (plate/screw system) is not identified by manufacturer or catalog number, which is inadequate for a device trial. Statistical software is adequately identified.

Evidence

direct quote[Methods, Interventions, Surgery]

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

direct quote[Methods, Statistical analysis, last paragraph]

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

PASSReviewer 2· 95% conf

Key resources for this clinical trial are adequately identified. The investigational product (surgery with open reduction and internal plate fixation) is described, and the statistical software is identified. Other wet-lab resources are not applicable.

Evidence

direct quote[Methods, Statistical analysis]

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

direct quote[Methods, Surgery]

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

PASSReviewer 3· 85% conf

The investigational product (surgery and cast) is adequately identified; software version is reported. Antibodies/cell lines/mycoplasma are not applicable. The casting material details are not fully reported but are standard.

Evidence

direct quote[Methods, Interventions, Cast immobilisation]

“A trained plaster technician placed the injured ankle in a standard, padded synthetic cast below the knee”

direct quote[Methods, Statistical analysis]

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

direct quote[Methods, Interventions, Surgery]

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

Tests are named (Student's t-test, Welch's t-test, chi-square, Fisher's exact). Assumptions (normality, equality of variances) are not explicitly verified, but the analysis uses t-tests with sensitivity (Welch's) for variance inequality. Exact p-values are not reported for the primary outcome (only CIs and non-inferiority conclusion) and secondary outcomes (only CIs). Effect sizes and CIs are reported (between-group differences with 95% CIs). Software is identified. Data presentation (Table 2) includes per-group n, means, SDs, and differences with CIs, but individual data points are not shown. The primary outcome figure (Figure 2) shows a CI without defining the error bar (SD or CI). Mathematical plausibility is difficult to assess from aggregate data, but no obvious implausible numbers are spotted.

Sub-criteria

tests namedADEQUATE

exact p valuesINADEQUATE

effect sizes ciADEQUATE

data presentationINADEQUATE

software identifiedADEQUATE

assumptions verifiedINADEQUATE

mathematical plausibilityN/A

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 80% conf

Statistical tests are named, effect sizes with CIs are reported, software is identified, and data presentation is adequate for a clinical trial. However, exact p-values are not reported for secondary outcomes, which is imprecise reporting.

Evidence

absence[Results, Table 2]

Exact p-values not reported for secondary outcomes.

direct quote[Methods, Statistical analysis]

“The primary analysis used Student’s t test. … Continuous outcomes were analysed using Student’s t test or Welch’s t test … Categorical variables were analysed with χ2 test or Fisher’s exact test.”

direct quote[Table 2]

“Difference (95% CI) for each outcome is provided.”

PASSReviewer 2· 95% conf

Statistical analysis is rigorous and well-reported. Tests are named, exact p-values are reported for secondary outcomes, effect sizes with 95% CIs are provided, software is identified, and data presentation is clear. Assumptions are addressed through the use of appropriate tests.

Evidence

direct quote[Methods, Statistical analysis]

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

direct quote[Results, Table 2]

“Difference (95% CI) 1.3 (−4.8 to 7.3) [for primary outcome]”

direct quote[Methods, Statistical analysis]

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

WARNReviewer 3· 85% conf

The primary analysis is clearly described, but the paper lacks verification of test assumptions, does not report exact p-values for secondary outcomes (only CIs), and error bars are not defined in the primary analysis figure. However, the trial is large enough that some criteria are relaxed per study-type guidance.

Evidence

direct quote[Methods, Statistical analysis]

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

direct quote[Results, Table 2]

“Difference (95% CI) ... 0.8 (−3.5 to 5.1) ... etc.”

direct quote[Results, Figure 2 caption]

“Error bar indicates two sided 95% confidence interval.”

The data availability statement provides a DOI (https://doi.org/10.23729/fd-392c45f8-500c-32e5-adf9-f32f84b4e78a) where both data and code are publicly accessible. This meets the standard for a clinical trial.

Sub-criteria

code sharingADEQUATE

accession numbersN/A

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

Data and code are openly available via a DOI, and the data availability statement is concrete.

Evidence

direct quote[Data availability statement]

“The data underlying the primary findings in this paper and the code used to analyse the data are openly and publicly available at: https://doi.org/10.23729/fd-392c45f8-500c-32e5-adf9-f32f84b4e78a.”

PASSReviewer 2· 95% conf

Data and code availability are adequately reported. A data availability statement is present with a DOI to a public repository, and the code used for analysis is also shared.

Evidence

direct quote[Data availability statement]

PASSReviewer 3· 95% conf

Data and code are openly available at a DOI repository, with a clear data availability statement.

Evidence

direct quote[Data availability statement]

Methods are detailed enough for replication. The trial is registered at ClinicalTrials.gov (NCT01758796). Reporting follows CONSORT for non-inferiority trials. All pre-specified outcomes are reported, including adverse events. Limitations are discussed (single-centre, lack of blinding, no patient involvement). Conclusions are proportional. Funding sources and conflicts of interest are stated.

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· 95% conf

The manuscript is well-structured, includes trial registration, follows CONSORT, reports all outcomes, discusses limitations, and includes funding and COI statements.

Evidence

direct quote[Abstract, Methods]

“Trial registration ClinicalTrials.gov NCT01758796.”

direct quote[Methods, paragraph 1]

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

direct quote[Discussion, 'Strengths and limitations of this study']

“Single centre trials conducted by experts … are typically believed to enhance internal validity at the expense of external validity (generalisability).”

PASSReviewer 2· 95% conf

Reporting transparency is high. The trial is registered, a reporting guideline (CONSORT) is followed, limitations are discussed, conclusions are proportional, and funding and conflicts of interest are disclosed.

Evidence

direct quote[Abstract]

“Trial registration ClinicalTrials.gov NCT01758796 .”

direct quote[Methods, paragraph 1]

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

direct quote[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· 90% conf

The trial is registered, follows CONSORT guidelines, reports limitations, conclusions are proportional, and funding/COI are stated. Methods are detailed enough for replication.

Evidence

direct quote[Abstract, Methods]

“Trial registration ClinicalTrials.gov NCT01758796”

direct quote[Methods, first paragraph under 'Methods']

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

direct quote[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).”

2 copyedit issues flagged: mostly consistency, clarity.

Checked 52 references: 48 verified — 4 not checked.

Reproducibility

1 data/code link checked; 1 live.

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

Adcurare Rigor Action ItemsFinal pass before journal submission

Ready after minor-to-moderate edits. The paper is methodologically sound and transparently reported, but three dimensions (study_design, key_resources, statistical_analysis) have specific, fixable reporting gaps. Addressing the per-protocol analysis, missing-data handling, implant identification, and exact p-values will substantially strengthen the manuscript and preempt reviewer comments. The abstract/Table 1 number discrepancy should also be resolved. The data and code are publicly available and verified live.

1.
HIGHreporting
Add a pre-specified per-protocol analysis for the non-inferiority primary outcome, defining which participants are excluded (e.g., major protocol deviations, crossover) in the Statistical analysis section.
Non-inferiority trials require both ITT and per-protocol analyses per CONSORT; without it, the non-inferiority claim is less robust to reviewer challenge.
2.
HIGHreporting
State the pre-specified method for handling missing data (e.g., multiple imputation or completers-only analysis) in the Statistical analysis section.
No missing-data method is described; reviewers will flag this as a gap in the analysis plan.
3.
HIGHreporting
Specify the manufacturer, model, and catalog number of the surgical implant (plate and screws) in the Interventions, Surgery section or supplementary appendix.
For a device trial, the implant must be identifiable for reproducibility and clinical interpretation; current description is inadequate.
4.
HIGHstatistics
Report exact p-values for all secondary outcomes in Table 2 (alongside the CIs).
Current reporting provides only confidence intervals; exact p-values are standard for secondary analyses and improve transparency.
5.
HIGHstatistics
Add a brief statement confirming that statistical assumptions (normality, variance homogeneity) were checked, naming the tests used (e.g., Shapiro-Wilk, Levene's test) in the Statistical analysis section.
Assumption verification is not documented; even if the methods are robust, reviewers expect to see it addressed.
6.
MEDIUMcopyedit
Harmonize the participant counts in the Abstract with those in Table 1: the Abstract states n=62 cast, n=64 surgery randomised; Table 1 shows n=61 and n=63 analysed (two excluded post-randomisation). Clarify whether the Abstract reflects randomised or analysed numbers, and adjust accordingly.
This discrepancy could confuse readers and reviewers about the exact sample size.
7.
MEDIUMstatistics
In Figure 2, ensure the figure legend explicitly states %22Error bars represent 95% CI%22 (the caption says this, but confirm the figure itself shows the CI clearly).
A reader should not need to cross-check the caption to interpret the figure; clarity avoids ambiguity.
8.
MEDIUMreporting
Clarify why outcome assessors (e.g., radiographic interpreters) could not be blinded, and state whether the data analyst was blinded to group allocation in the Methods, Blinding section.
The current statement that blinding was %27not possible%27 is vague; specifying what was and was not blinded strengthens the bias assessment.

Full text (58,345 chars)Analyzed: Jul 7, 2026

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