Study aim, setting, and design
We performed a retrospective monocentric study at a level 1 trauma center with the aim of evaluating postoperative outcomes in patients who required soft tissue reconstruction for lower leg fractures. Patient-reported outcomes, including quality of life (QoL) and the ability to return to work, were assessed via questionnaires. Follow-up scores were evaluated in the outpatient clinic, via telephone interview, or via declarations and forms mailed to and completed by patients. A minimum follow-up of 12 months was set as standard. This allows a more differentiated analysis of the outcome.
Participants and materials
We identified 22 patients who were treated surgically for lower leg fractures and underwent soft tissue reconstruction via plastic surgery from January 2012 through December 2017 by querying the hospital database and using the International Classification of Disease (ICD) code for both fractures and flap procedures (e.g. S82.5 + 5-905.0f). To avoid including patients with improper codes and those who did not fulfill our inclusion criteria, all patient charts were screened manually. All variables that were to be recorded were specified in advance in a pre-prepared spreadsheet. Inclusion criteria were patients older than 18 years of age who had sustained a traumatic open/closed lower leg fracture, localized as code 43 or 44 according to the AO/OTA classification (Arbeitsgemeinschaft für Osteosynthesefragen Foundation/Orthopaedic Trauma Association classification), primarily treated with bone stabilization and secondarily with one or more flaps for tissue reconstruction. Every patient has the same opportunity to receive physical therapies as recommended by the surgeon. Every patient was given the same recommendation and prescription for physical therapies of equal intensity and frequency.
Descriptive and outcome measures
Standard parameters that we collected were age, sex, and body mass index (BMI). Comorbidities were also recorded and categorized into four groups according to the number of comorbidities as follows: no comorbidity, 1-3 comorbidities, 4-5 comorbidities, and ≥ 6 comorbidities. Comorbidities were defined as diabetes mellitus, arterial hypertension, coronary heart disease, heart failure, asthma, COPD, emphysema, any type of tumor disease, a second tumor as an independent comorbidity, apoplexy with residuals in the history, neurological pre-existing conditions such as multiple sclerosis, rheumatic diseases, organ transplantation, congenital immune defects, HIV, cirrhosis of the liver, and kidney failure requiring dialysis. Diabetes mellitus, nicotine abuse, and alcohol/drug abuse were listed separately as nominal scale variables. Accompanying injuries to the affected ankle joints were classified as closed or open fractures (open fractures with soft tissue damage were assigned a score > 1, as indicated by Gustilo and Anderson) . Fracture morphology was classified according to the AO/OTA criteria . Complications of osteosynthesis and flap coverage were reported. The results of preoperative vascular diagnostic tests, consisting of Duplex ultrasound of the venous system and interventional angiography of the arteries, were categorized as binary variables.
Postoperative outcomes were measured using two different patient-reported outcome scores: The FAOS and its corresponding subscores is a 42-item questionnaire – including symptoms, pain, function in daily living / activities of daily living (ADL), function in sports and recreational activities (sport/rec), and QoL. The EQ-5D-5L score is a well-validated generic health-related QoL instrument [10-13]. The EQ-5D-5L is a Patient Reported Outcome (PRO) Score that uses 6 questions to assess the quality of life of patients in general, regardless of their disease. It also includes a visual analogue scale (VAS, 0-100 points) and a descriptive EQ-5D-5L system that considers the following dimensions (mobility, self-care, general activities, pain / physical complaints, fear / dejection).
Regarding the FAOS score (maximum, 100), a lower score represented more symptoms or pain, greater difficulty performing ADL and sport/rec, and poorer QoL. This rating is also valid for the EQ-5D VAS (maximum, 100).
Findings are reported by the mean value for continuous data (standard deviation between parentheses) and number for categorical data (percentage between parentheses). T-tests for continuous variables was performed between the subgroup flap ischemia yes vs. no.. All tests were two-sided, and statistical significance was set at p < 0.05. Analyses were performed using IBM SPSS Statistics version 24 software.