RESUMO
Objective: The patient's knee implant performance (PKIP) is a patient-reported outcome measure, developed in the USA in English that evaluates knee functional performance before and after primary total knee arthroplasty (TKA). The PKIP assesses the level of satisfaction, confidence, and stability, while performing various activities, as well as the need for changing ways of doing activities. It comprises 24 items. The objective of this study was to present the methodology of the linguistic validation of the PKIP. Methods: The Japanese version of the PKIP was developed using a standard linguistic validation (LV) process. The LV involved the following steps: (1) conceptual analysis of the original version; (2) translation into Japanese using a dual forward/backward translation process; (3) review by an orthopaedics surgeon; (4) test on five respondents; and (5) proofreading. Results: The translation itself did not reveal major translatability issues, either cultural, semantic, or syntactic. Most of the activities listed (e.g., going up stairs, getting in/out of a car, and walking up a hill/ramp/incline) were easily translated. Only one activity was culturally sensitive and raised some discussion, i.e., "sitting down on a toilet," since the style of Japanese toilets is different from the western style. Overall, the respondents well understood the questionnaire. However, the expression "how your knee is working with your body" used in the opening sentence was an issue for both the clinician and the respondents. A compromise was found by using a Japanese equivalent of "how your knee functions with your legs." Conclusion: The rigorous translation process, which involved the collaboration of a minimum of thirteen people (sponsor, four translators, two coordinators (one in Japan and one in Europe), one clinician, and five respondents) enabled the production of a Japanese version of the PKIP conceptually equivalent to the USA English original.
RESUMO
BACKGROUND: Total hip arthroplasty (THA) requires components that meet a variety of patient factors and needs. This investigation evaluated survivorship of the PINNACLE Acetabular Cup System in primary total hip arthroplasty at 5-10 years. METHODS: In total, 1592 hips (1473 subjects) were enrolled in a multi-center, non-comparative, open-label study of the PINNACLE system: N = 896 metal-on-polyethylene (MOP), N = 667 metal-on-metal (MOM), N = 27 ceramic-on-polyethylene, and N = 2 unknown articulation. Harris Hip Score, Short Form 36, Western Ontario and McMaster Universities Osteoarthritis Index, and radiographs were collected through 10 years. Kaplan-Meier device survivorship was estimated. RESULTS: There were 41 revisions (23 MOP, 17 MOM, 1 ceramic-on-polyethylene) through 10 years: 56.5% of MOP revisions were for instability and 41.2% of MOM revisions were for adverse local tissue reaction. Kaplan-Meier device survivorship (N with further follow-up) was 97.0% (N = 720) at 5 years and 94.7% (N = 77) at 10 years. CONCLUSIONS: Medium- to long-term survivorship estimates were similar or better than other studies and registries for the PINNACLE system. LEVEL OF EVIDENCE: III.