%0 Journal Article
%T Non-invasive quantitative assessment of induced component displacement can safely and accurately diagnose tibial component loosening in patients: A prospective diagnostic study.
%A Buijs GS
%A Kievit AJ
%A Ter Wee MA
%A Magg C
%A Dobbe JGG
%A Streekstra GJ
%A Schafroth MU
%A Blankevoort L
%J Knee Surg Sports Traumatol Arthrosc
%V 0
%N 0
%D 2024 May 31
%M 38819937
%F 4.114
%R 10.1002/ksa.12299
%X OBJECTIVE: 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.
METHODS: Level II.