**Background:** Chronic osteomyelitis (COM) of the lower limb is a long-standing bone infection (>6 weeks) with an estimated incidence of 21.8 cases per 100,000 person-years. Surgical management options include limb reconstruction or amputation. There is a noted lack of consistency in outcome reporting within the field, creating challenges for evidence synthesis and meta-analysis. This scoping review aimed to map outcomes used in studies surgically managing COM to aid future development of a core outcome set.
**Methods:** A comprehensive search strategy was applied to 11 databases including MEDLINE, PubMed, EMBASE, CINAHL, PsycINFO, Cochrane Library, Open Grey, Web of Science Conference Proceedings Index, Google Scholar, ISRCTN, and clinicaltrials.gov. Studies published between 1 January 2011 and 1 October 2020 were eligible. Inclusion criteria: adults (≥16 years) surgically managed for spontaneous or trauma-related lower limb COM. Studies on diabetic foot disease and peripheral vascular disease were excluded. Systematic reviews and meta-analyses were excluded to avoid duplication. Independent screening was undertaken by two reviewers. Outcomes were extracted verbatim and categorized according to the revised Williamson and Clarke taxonomy.
**Key Results:** Of 3,303 records screened, 99 studies were included. Most studies were case series (77/99; 78%), with 15 cohort studies, four completed RCTs, two ongoing trials, and one retrospective case-control study. Studies were predominantly from Europe and Asia (82/99; 83%). The included studies represented 5,809 participants (4,876 meeting eligibility criteria). A total of 511 outcomes were reported, grouped into 58 distinct outcomes. Only 143/511 outcomes (28%) had clear, in-text definitions, and 231 outcomes (45%) had details of how and when they were measured. The most commonly reported outcome was 'recurrence of osteomyelitis' (62/511; 12%), with definitions provided for approximately one-third of these. 'Eradication of infection' was reported in 34 studies, with 13 providing a working definition. 'Bone union' was reported 34 times and defined on 12 occasions. Pain was the single-most patient-reported outcome measure (14 studies) but was never formally defined. Patient-reported outcomes represented only 68/511 (13%) of all outcomes. Only one study reported on quality of life using the SF-36. Among the four published RCTs, only 5/17 outcomes (29%) had all aspects fully reported (definition, time of measurement, method of measurement). The mean follow-up periods varied substantially across studies, ranging from 5.5 months to 11 years for different outcomes.
**Clinical Implications:** This review highlights significant inconsistencies in the defining, reporting, and measuring of outcomes across studies investigating surgical management for COM of the lower limb. The lack of standardized definitions—for example, infection eradication defined variably as 'no relapse within one year' versus 'absence of clinical evidence of infection' versus requiring radiological evidence—makes cross-study comparisons unreliable. The limited use of patient-reported outcome measures (13%) suggests that outcomes important to patients, such as quality of life, functional status, and mental health, are underrepresented. The development of a standardized core outcome set through Delphi consensus, informed by both clinicians and patients, is urgently needed to enable meaningful evidence synthesis and comparison across future studies.