2.1

This systematic review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines . The study protocol was registered in the International Prospective Register of Systematic Reviews (PROSPERO) under registration code CRD42025648440.

2.2

A systematic literature search was performed across PubMed, Scopus, and Web of Science from their inception until September 22, 2024. The search was restricted to studies published in English. Keywords and medical subject headings related to pilon fractures and PROMs were used, including terms such as “pilon fracture,” “plafond fracture,” “distal tibial fracture,” “patient-reported outcome measures,” and “questionnaire.” The complete search strategy is detailed in Supplementary Material , Table S1 . A librarian was consulted in designing the search, but the final search was performed by the study team.

2.3

After removing duplicates, all identified articles were imported into the Rayyan online tool for screening . Two independent reviewers (AA and YL) screened titles and abstracts to determine eligibility. Full-text articles of selected studies were then independently reviewed by the same two reviewers to confirm inclusion. Any disagreements were resolved through discussion with a third reviewer (HS).

Eligible studies included retrospective or prospective cohort studies, case-control studies, case series, and randomized clinical trials with a sample size greater than 10. Studies were required to assess AO-OTA 43 C tibial fractures in patients aged 18 years or older and include at least one PROM with a follow-up period of at least one year.

Exclusion criteria included systematic reviews, meta-analyses, narrative reviews, letters to the editor, case reports, studies on polytrauma patients, and studies without full-text availability. Studies with fewer than 10 participants, pediatric studies, and those that did not specify fracture classification were also excluded.

Finally, a total of 1803 studies were screened, and 87 papers met the inclusion criteria for this study. The PRISMA flowchart outlining the inclusion and exclusion process is presented in Fig. 1 .

PRISMA chart.

2.4

Two authors (** and **) independently extracted data from each included study following a pre-established protocol recorded in an online spreadsheet. The extracted data included general study information (first author, journal, year of publication, title, and sample size with patient characteristics and mean age), the number and type of PROMs used (including any patient-reported outcomes information system [PROMIS] questionnaires such as physical function and global physical/mental health), injury classification based on the AO-OTA system, and treatment details, specifying whether patients underwent open reduction and internal fixation (ORIF), external fixation (e.g., ring fixator), or non-surgical management. We defined Quality of Life (QoL) as a domain assessing patients’ perceived well-being in physical, emotional, and social aspects, distinct from functional measures such as activities of daily living.

2.5

A meta-analysis was not feasible due to variations in study designs, outcome measures, and patient populations. Instead, we conducted a descriptive analysis, presenting key findings through tables. Data extraction and organization were performed using Microsoft Excel to ensure accuracy and consistency.

3.1

A total of 87 studies were included in this review, comprising 3828 patients of whom 1966 (51.4 %) were men ( Supplementary Material , Table S2 ) . Eighty-three studies focused on operative management while four reported on non-operative management 91.9 % of studies were conducted at single centers (80/87). Only two (2.3 %) studies reported Level I evidence, and nine (10.3 %) were classified as Level II. All studies used PROMs postoperatively. Three studies explicitly validated or assessed the reliability of the PROMs utilized ^,, . No studies focused on developing new scoring tools tailored for pilon fractures ( Table 1 ) .

3.2

Among the 87 studies reviewed, there were 26 PROMs reported. The American Orthopaedic Foot and Ankle Society (AOFAS) Hindfoot-Ankle Score was the most frequently used PROM, appearing in 50 studies (57.5 %), followed by the Visual Analog Scale (VAS) for pain, reported in 19/87 studies (21.8 %), and the Short Form-36 (SF-36), a global PROM employed in 18/87 studies (20.7 %) ( Fig. 2 , Table 2 ). Foot and ankle-specific tools including the Olerud-Molander Ankle Score (OMAS) and the Foot and Ankle Outcome Score (FAOS) were used in 14/87 studies (16.1 %). Several other tools were used in only one or two of the included studies.

PROM measure frequency in the assessed literature.

3.3

Of the 26 included PROMs, 11 focused on foot and ankle-specific outcomes, while another 11 assessed general health and QoL. The remaining four PROMs included two that were musculoskeletal-specific—the Short Musculoskeletal Functioning Assessment (SMFA) and the Musculoskeletal Functioning Assessment (MFA)—and two specifically designed for pilon fractures: the Ovadia and Beals and the Teeny and Wiss scales ( Table 2 ). Twenty-two PROMs (84.6 %) were comprised of only patient-reported components, while four (15.4 %) utilized both clinician and patient-reported aspects in their instrument.

3.4

Pain was the most commonly assessed domain, reported in 65/87 studies (74.7 %), followed by physical function (57/87, 65.5 %), mental health (18/87, 20.7 %) and QoL (15/87, 17.2 %). Of the 19 assessed questionnaires that evaluated pain in their domains, pain made up an average of 41.6 % of the final score. Out of the 26 questionnaires, three (11.5 %) evaluated all four domains (SF-12, SF-36, and EQ5D), three (11.5 %) assessed three domains (Nottingham Health Profile, MFA, FAOS), 12 (46.2 %) evaluated two domains, and eight (30.8 %) focused on only one domain. Pain in total comprised 843 points out of a possible 2766 points (30.5 %).

3.5

Of the 26 PROMs included in this review, 24 (92.3 %) have undergone validation in at least one medical or surgical condition post-development. However, two tools, the Ovadia and Beal score and the Teeny and Wiss score, have not been validated beyond their initial development ( Table 3 ). A total of 21 PROMS (80.8 %) were validated on orthopaedic conditions, primarily concerning the foot, ankle, and lower extremities. The most commonly studied conditions that the PROMS were validated for included osteoarthritis (10/26, 30.8 %), fractures (8/26, 28.6 %), and musculoskeletal pain (6/26, 23.8 %), followed by ankle instability (4/26, 14.3 %) and foot deformities (4/26, 14.3 %). Notably, none of the measures have been validated specifically for tibial pilon fractures, and only two (7.7 %) have been utilized in languages other than English.

Table 3

Validation and reliability of PROMs.

Questionnaire	Anatomical Focus	Reliability/Validity	Condition(s) Studied	Citations
AOFAS	Hindfoot ankle	Mixed reliability; poor correlation with SF-36; not recommended as a sole PRO	Ankle arthritis, fractures	– Ibrahim T et al., 2007 [Reliability study] – SooHoo NF et al., 2003 [Comparison with other PROMs] – Pinsker E et al., 2011 [Correlation with SF-36]
Visual Analog Scale (VAS)	General	– Test-retest reliability: ICC = 0.97 (excellent reliability in osteoarthritic knee pain) – Moderate to strong correlations with SF-36 and Roland-Morris Disability Questionnaire (ρ = 0.38–0.84) in chronic musculoskeletal pain – Valid for acute abdominal pain, with ICC = 0.99 (high reliability); minimum clinically significant difference = 16 mm	– Chronic musculoskeletal pain – Osteoarthritic knee pain – Acute abdominal pain – Disease activity in systemic lupus erythematosus	– Boonstra et al., 2008 [Reliability and validity in musculoskeletal pain] – Alghadir et al., 2018 [Reliability and validity in osteoarthritic knee pain] – Gallagher et al., 2002 [Validation in acute abdominal pain] – Elera-Fitzcarrald et al., 2020 [Reliability in lupus disease activity]
SF-36	General	High internal consistency (Cronbach’s α 0.72–0.94); validated across diverse populations and clinical conditions; excellent responsiveness to change in health status	-Coronary artery disease -Musculoskeletal disorders -Ulcerative colitis COPD stroke childhood cancer survivors sick sinus syndrome general population	– Failde I et al., 2000 [Ischemic cardiopathy] – Beaton DE et al., 1997 [Musculoskeletal disorders] – Yarlas A et al., 2018 [Ulcerative colitis] – Mahler DA et al., 1995 [COPD] – Anderson C et al., 1996 [Stroke patients] – Reulen RC et al., 2006 [Childhood cancer survivors] – Wu Q et al., 2023 [Sick sinus syndrome] – Brazier JE et al., 1992 [General population validation] – Jenkinson C et al., 1994 [Community sample validation] – Sullivan M et al., 1995 [Swedish general population]
Olerud Molander	Ankle-specific	High test-retest reliability (ICC = 0.94, rho = 0.95); internal consistency Cronbach’s α = 0.76; validated against FAOS and Global Self-Rating Function (GSRF)	Ankle fractures (uni-, bi-, trimalleolar); post-surgical recovery	– Olerud C and Molander H, 1984 [Development of score for ankle fractures] -Nilsson GM et al., 2013 [Swedish validation oin ankle fractures]
Mazur	Ankle functionality	– Validity: Assessed via extensive clinical evaluation and gait analysis over an average follow-up of eight years in 12 patients.	– Post-traumatic arthritis – Long-term outcomes of ankle arthrodesis	– Mazur JM et al., 1979 [Ankle arthrodesis]
Foot and Ankle Outcome Score (FAOS)	Foot and ankle	– Reliability: Demonstrates good test-retest reliability with ICC values ≥ 0.72 across subscales. – Validity: Moderately correlates with SF-12 Physical Component Score for most subscales; construct and content validity validated for various conditions. – Responsiveness: Subscales (Pain, Symptoms, Activities of Daily Living, Sports/Recreation, Quality of Life) responsive to postoperative changes.	– Lateral ankle instability – Hallux valgus – Hallux rigidus – Adult acquired flatfoot deformity – Ankle osteoarthritis	– Roos EM et al., 2001 [Ankle ligament reconstruction] – Hogan MV et al., 2016 [Validated for hallux rigidus] – Chen L et al., 2012 [Validated for hallux valgus] – Mani SB et al., 2013 [Validated for acquired flat foot deformity] – Mani SB et al., 2015 [Evaluated for ankle osteoarthritis]
Foot Function Index	Foot and ankle	High internal consistency (Cronbach’s α 0.94–0.96); ICC 0.79–0.89; validated for rheumatoid arthritis and non-traumatic foot/ankle problems	-Rheumatoid arthritis -Foot pathology -Non-traumatic foot/ankle	– Budiman-Mak E et al., 1991 [Foot pain/disability] – Saag KG et al., 1996 [Rheumatoid arthritis] – Van Der Leeden M et al., 2008 [Systematic review validation in rheumatoid arthritis] – Agel J et al., 2005 [Reliability review] – Martin RL et al., 2007 [Foot and ankle outcome review]
Musculoskeletal Functional Assessment	Musculoskeletal	High internal consistency; validated through strong correlations with clinical measures and physician ratings (criterion and construct validity)	Fractures, soft-tissue injuries, repetitive motion disorders, osteoarthritis, rheumatoid arthritis	– Martin DP et al., 1996 [Development and validation] – Engelberg R et al., 1996 [Criterion and construct validity]
Numerical Rating Scale	General	Excellent test-retest reliability (ICC = 0.95); valid for acute and chronic pain; sensitive to change	-Osteoarthritis -Rheumatoid arthritis -Lupus -Chronic pain	– Alghadir A et al., 2018 [Knee osteoarthritis] – Ferraz MB et al., 1990 [Rheumatoid arthritis] – Elera-Fitzcarrald C et al., 2020 [Systemic lupus erythematosus]
Nottingham Health Profile	General	High reliability for group comparisons (ICC = 0.64–0.83); validated for chronic illness, amputation, and stroke	-Chronic lower limb ischemia -Osteoarthritis -Stroke -Limb amputation -General health	– Wann-Hansson C et al., 2004 [Chronic lower limb ischemia] – Hunt SM et al., 1981 [Reliability in osteoarthritis] – Ebrahim S et al., 1986 [Stroke outcomes] – Demet K et al., 2002 [Amputation reliability] – Cabral DL et al., 2012 [Brazilian validation in chronic stroke]
Ankle Osteoarthritis Scale	Ankle	High test-retest reliability (r = 0.97); validated for pain and disability subscales; effective in assessing end-stage ankle arthritis	-End-stage ankle arthritis -Preoperative ankle arthrodesis -Total ankle arthroplasty	– Domsic RT et al., 1998 [Validation] – Liu G et al., 2019 [Preoperative assessment of end stage ankle arthritis] – Coe MP et al., 2015 [End-stage ankle arthritis]
Glasgow Outcome Scale	General	High inter-rater reliability (Kappa = 0.89); robust test-retest reliability (KW = 0.92); strong correlations with measures of injury severity and health outcomes	Head injuries, traumatic brain injury (TBI), trauma recovery	– Pettigrew LE et al., 2003 [Test-retest reliability in-person vs telephone interviews] – Wilson JT et al., 1998 [Inter-rater reliability of structured interviews for the score] – Wilson JT et al., 2000 [Head injury] – Gabbe B et al., 2008 [Utility post-trauma]
Foot and Ankle Ability Measure	Foot and ankle	High internal consistency (α > 0.92); excellent test-retest reliability (ICC > 0.89); validated for sports and daily living	Chronic ankle instability, foot surgery, sports injuries	– Carcia CR et al., 2008 [Chronic ankle instability] – Martin RL et al., 2009 [Patients with diabetes] – Eechaute C et al., 2007 [Chronic ankle instability]
Manchester-Oxford Foot Questionnaire (MOXFQ)	Foot and ankle	High internal reliability (α = 0.93); Cronbach’s α > 0.7 for all scales; test-retest ICC ≥ 0.89; valid through correlations with SF-36 and AOFAS	Foot and ankle conditions, preoperative and postoperative surgical assessments	– Morley D et al., 2013 [Internal reliability in foot and ankle surgery] – Dawson J et al., 2011 [Foot and ankle surgery]
Foot and Ankle Disability Index (FADI)	Foot and ankle	– ICC (1 week): 0.89 (FADI) and 0.84 (FADI Sport) – ICC (6 weeks, no rehabilitation): 0.93 (FADI) and 0.92 (FADI Sport) – Responsive to changes post-rehabilitation (effect sizes: FADI = 0.52, FADI Sport = 0.71) – Test-retest reliability demonstrated across multiple studies	– Chronic Ankle Instability (CAI) – Rehabilitation outcomes in CAI – Functional limitations in CAI compared to healthy controls	– Hale & Hertel, 2005 [Reliability and sensitivity in chronic ankle instability] – Eechaute et al., 2007 [Chronic ankle instability]
SF-12	General	– Internal consistency: Cronbach’s alpha > 0.8 for PCS and MCS – Test-retest reliability: PCS (ICC = 0.89–0.91), MCS (ICC = 0.76–0.79) – Validity: Strong correlations with SF-36, predictive validity for physical and cognitive limitations	– Behavioral and mental health conditions – Non-cancer pain – Back pain – Congestive heart failure – Sleep apnea – Inguinal hernia – General population studies	– Ware & Kosinski, 1996 [Initial construction and validation] – Shah & Brown, 2020 [Validity in older adults] – Luo et al., 2003 [Reliability and responsiveness in back pain] – Hayes et al., 2017 [Validity for non-cancer pain] – Fan et al., 2008 [Surveillance tool for neck and upper extremity musculoskeletal disorders]
EQ-5D	General	– Reliability: Demonstrated reliability across multiple domains, including rheumatoid arthritis and musculoskeletal conditions. Test-retest reliability ranges from moderate to high. – Validity: Correlates well with disease-specific instruments like SF-36, LEFS, and Manchester-Oxford Foot Questionnaire (MOXFQ). Highly sensitive to changes in pain, disability, and quality of life. – Responsiveness: More responsive than other general measures for specific conditions, such as pain and ankle fracture surgery.	– Rheumatoid arthritis – Musculoskeletal disorders – Post-surgical recovery for foot and ankle fractures	– Hurst NP et al., 1997 [Validation in rheumatoid arthritis] – Dawson J et al., 2012 [Responsiveness compared with MOXFQ in foot/ankle surgery] – Garratt AM et al., 2018 [Validation in operative closed ankle fractures]
PROMIS-PI	General	– Reliability: High reliability with T-score reliability in the range of 0.96–0.99 for pain levels between 50 and 80. Internal consistency and test-retest reliability exceeded 0.80 across clinical conditions. – Validity: Demonstrated construct, criterion, and ecological validity in diverse populations. Strong correlations with other health domains like physical functioning, pain intensity, and mental health measures. – Responsiveness: Sensitive to changes in clinical states and treatments, particularly in chronic low back pain (cLBP), major depressive disorder (MDD), and osteoarthritis (OA). Standardized response means (SRM) support its use in assessing pain changes.	– Osteoarthritis – Chronic low back pain – Rheumatoid arthritis – Chronic obstructive pulmonary disease (COPD) – Major depressive disorder (MDD) – Cancer pain	– Amtmann D et al., 2010 [Development and psychometric evaluation of PROMIS-PI] – Broderick JE et al., 2013 [Validity in osteoarthritis] – Askew RL et al., 2016[Clinical validity across chronic conditions]
PROMIS- Depression, Anxiety	General	– Reliability: High internal consistency and test-retest reliability for depression and anxiety domains in both general and clinical populations. Median completion time was faster for patients with the lowest scores, suggesting a potential floor effect in certain populations. – Validity: Strong convergent validity with legacy tools such as the PHQ-9 and CESD, showing correlations ranging from 0.72 to 0.84 across all time points. Demonstrated clinical validity in orthopedic and other patient populations. – Responsiveness: Sensitive to changes over time in treatment settings, including orthopedic, chronic pain, and psychiatric conditions.	– Orthopedic surgery – Major depressive disorder – Anxiety disorders – Chronic pain – General population	– Pilkonis PA et al., 2014 [Validation in a clinical outpatient sample] – Bernstein DN et al., 2019 [Orthopedic patients]
Short Musculoskeletal Functioning Assessment (SMFA)	Musculoskeletal (general)	– Reliability: Demonstrated excellent internal consistency and stability, with Cronbach’s alpha values exceeding 0.90. – Validity: Strong content validity with minimal skew, negligible floor effects, and limited ceiling effects (<5 %). Convergent validity supported by correlations with SF-36, clinical measures (e.g., grip strength), and physician ratings (rho ≥ 0.40). – Responsiveness: Demonstrated responsiveness to health status changes over time with standardized response means ranging from 0.76 to −1.14.	– Musculoskeletal disease – Injury rehabilitation	Swiontkowski MF et al., 1999 [Development and validation, musculoskeletal disease]
PROMIS- Physical Function	General	– Reliability: Demonstrates excellent internal consistency with Cronbach’s alpha values exceeding 0.94. – Validity: Supported by strong correlations with other measures of physical function (r = 0.70–0.87). Proven convergent validity and sensitivity to change in physical function. – Responsiveness: Effectively detects meaningful changes in health status, particularly in conditions involving orthopedic trauma and chronic diseases.	– Rheumatoid arthritis – Chronic heart failure – Chronic obstructive pulmonary disease (COPD) – Cancer – Orthopedic trauma (lower extremity injuries) – Back pain	– Rose M, et al., 2014 [Calibration of the item bank to a standardized metric for improved measurement efficiency] – Schalet BD, et al., 2016 [Validation in diverse clinical samples – Rothrock NE, et al., 2019 [Reliability and responsiveness in lower extremity orthopedic trauma]
Ovadia and Beal	Pilon specific	Not further validated since initial study.	– Tibial plafond fractures – Ankle joint injuries	– Ovadia DN, Beals RK [Fractures of the tibial plafond]
Teeny and Wiss	Pilon specific	Not further validated since initial study.	– Tibial plafond fractures – High-energy trauma – Post-traumatic complications	– Teeny and Wiss, 1993 [Tibial plafond fractures]
Maryland Foot Score	Foot functional score	Good reliability in clinical contexts. MFS demonstrated good internal consistency, with a Cronbach’s alpha of 0.82	– Intra-articular calcaneal fractures – Post-treatment outcomes	– Sanders et al., 2000 [Operative displaced intraarticular calcaneal fractures]
Phillip’s Score	Ankle	Validity: Statistical analysis demonstrated significantly higher scores for patients treated with open reduction and rigid internal fixation compared to plaster cast treatment.	– Severe ankle fractures (Lauge-Hansen classification) – Post-treatment outcomes	– Phillips WA et al., 1985 [Management of severe ankle fractures]
Ambulation scale of the Sickness Impact Profile	General (Health Status)	– Reliability: Strong evidence of internal consistency and reliability across subsamples. – Validity: Validated in a sample of 278 subjects with diverse sickness severity, showing significant correlations with self-assessed health status and clinical assessments.	– General health conditions – Arthritis – Chronic disease evaluation	– Bergner M, 1981 [Development] – Bergner M, 1976 [Validation study]

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