Elective removal vs. retaining of hardware after osteosynthesis in asymptomatic patients-a scoping review

Background: Osteosynthesis is the internal fixation of fractures or osteotomy by mechanical devices (also called hardware). After bone healing, there are two options: one is to remove the hardware, the other is to leave it in place. The removal of the hardware in patients without medical indication (elective) is controversially discussed. We performed a scoping review to identify evidence on the elective removal of hardware in asymptomatic patients compared to retaining of the hardware to check feasibility of performing a health technology assessment. In addition, we wanted to find out which type of evidence is available. Methods: A systematic literature search was performed in PubMed, Embase, EconLit, and CINAHL (November 2019). We included studies comparing asymptomatic patients with an internal fixation in the lower or upper extremities whose internal fixation was electively (without medical indication) removed or retained. We did not restrict inclusion to any effectiveness/safety outcome and considered any comparative study design as eligible. Study selection and data extraction was performed by two reviewers. Results: We identified 13476 titles/abstracts. Of these, we obtained 115 full-text publications which were assessed in detail against the inclusion criteria. We included 13 studies (1 RCT, 4 cohort studies, 8 before-after studies) and identified two ongoing RCTs. Nine assessed the removal of the internal fixation in the lower extremities (six of these syndesmotic screws in ankle fractures only) and two in the upper extremities. One study analysed the effectiveness of hardware removal in children in all types of extremity fractures. Outcomes reported included various scales measuring functionality, pain and clinical assessments (e.g. range of motion) and health-related quality of life. Conclusions: We identified 13 studies that evaluated the effectiveness/safety of hardware removal in the extremities. The follow up times were short, the patient groups small and the ways of measurement differed. In general, clinical heterogeneity was high. Evidence on selected topics, e.g. syndesmotic screw removal is available nevertheless not sufficient to allow a meaningful assessment of effectiveness.