RESUMO
OBJECTIVE: The purpose of this systematic review is to assess clinical and radiographic outcomes, complications rates, rates and reasons of re-revision of isolated femoral or tibial component revisions, comparing them with total knee revisions. METHODS: A review of the published literature was performed using Medline, Embase and Cochrane libraries. The terms "isolate" and "revision" and "knee arthroplasty" or "knee replacement" were together used as MESH terms. Partial knee replacement, non-English literature, case reports and papers published before 2000 were excluded. RESULTS: Out of 911 papers, six papers met the inclusion criteria. Mean MINORS scores achieved quite low values (13.33 and 13.67). No study encompassed revisions for septic loosening or infection. Total revisions performed for instability and wear achieved better clinical outcomes: in the other cases, partial and total revisions showed no differences in clinical outcomes. Both the cohorts showed similar radiographic features. Lesser bleeding and shorter operative times were observed in partial revisions compared to total revisions. The re-revision rates were similar in most of comparative studies: only one study noticed a significant difference in the failure rate between partial (25% at 3 years) and full (7% at 3.5 years) revisions. CONCLUSIONS: The poor quality of the studies precluded sound conclusions. Isolated tibial or femoral component revision is an option when the other component is well-fixed and positioned and in absence of chronic periprosthetic infection; nevertheless, it should be carefully evaluated when the reasons for revision are wear or instability.
RESUMO
PURPOSE: Computer-assisted arthroplasty supports the surgeons in planning, simulating, and performing the replacement procedure, using robotic or navigation technologies. However, the safety of the technology has not been widely ascertained. Food and Drug Administration (FDA) database was interrogated about software-related recalls in computer-assisted arthroplasty, aiming to assess: (1) the incidence, (2) the root causes, and (3) the actions taken due to recalls. METHODS: The Medical Device Recalls database was investigated about software-related recalls in computer-assisted hip and knee arthroplasty surgery, between 2017 and 2022. The incidence of the software-related recalls, the root causes according to FDA and manufacturers, and the corrective actions taken by firms were determined. RESULTS: Eighteen recall numbers could be identified (1.6%), corresponding to 11 recall events. A total of 4634 units were involved. The FDA determined root causes were: software design (66.6%), design change (22.2%), manufacturing deployment (1, 5.6%), and design manufacturing process (5.6%). Among the manufacturers' reasons for recalls, a specific error was declared in 16 cases (88.9%). In seven cases (43.8%), a coding error about lower limb alignment assessment was identified. Seventeen software-related recalls (94.4%) were classified as class 2; only one case was class 3 (5.6%). Return of the device was the main action taken by firms (8, 44.4%), followed by software update (7, 38.9%). CONCLUSION: Software-related recalls in computer-assisted hip and knee arthroplasty were quite uncommon among all the recalls, deemed non-life threatening and usually due to software design errors. The main actions taken by manufacturers were the return of the device or the software update.
