Non-invasive quantitative assessment of induced component displacement can safely and accurately diagnose tibial component loosening in patients: A prospective diagnostic study

Abstract

Purpose: Aseptic loosening often requires major, expensive and invasive revision surgery. Current diagnostic modalities merely show indirect signs of loosening. A recent proof of concept study proposed a non-invasive technique for the quantitative and visual assessment of implant movement as a diagnostic aid for tibial component loosening. The primary research question addressed is whether this novel diagnostic modality can safely and effectively aid the diagnosis of aseptic loosening. Methods: This clinical study included patients suspected of aseptic total knee arthroplasty (TKA) loosening listed for revision surgery and asymptomatic patients. Safety was evaluated using a numerical rating scale (NRS) for discomfort and by registration of adverse events. Feasibility was assessed by recording the duration and ease of the procedure. Intra- and interrater reliability were evaluated. In symptomatic patients, diagnostic accuracy metrics were evaluated with intra-operative assessment as a reference test. Results: In total, 34 symptomatic and 38 asymptomatic knees with a TKA were analysed. The median NRS for discomfort during loading was 6 (interquartile range [IQR]: 3.75–7.00) in symptomatic patients and 2 (IQR: 1.00–3.00) in asymptomatic patients. No adverse events were reported. The majority of users found the use of the loading device easy. The median time spent in the computed tomography room was 9 min (IQR: 8.00–11.00). Excellent to good intra- and interrater reliabilities were achieved. Diagnostic accuracy analysis resulted in a sensitivity of 0.91 (95% confidence interval [CI]: 0.72–0.97) and a specificity of 0.72 (95% CI: 0.43–0.90). Conclusions: The proposed diagnostic method is safe, feasible, reliable and accurate in aiding the diagnosis of aseptic tibial component loosening. Level of Evidence: Level II.