Abstract
BackgroundMonitoring results regarding the effectiveness of knee and hip arthroplasties may be useful at the clinical, economic and patient level and help reduce the number of prosthesis revisions. In Spain, and specifically in Catalonia, there is currently no systematic monitoring of the different prosthesis models available on the market. Within this context, the aim of the project presented in this protocol is to evaluate the short- and medium-term effectiveness of knee and hip models implanted in Catalonia and to identify where the results could be better or worse than expected.MethodsA prospective observational design will be drawn up based on data from a population-based arthroplasty register for hip and knee replacements that includes data from 53 of the 61 public hospitals in Catalonia. The knee and hip prosthesis models used will be identified and classified according to the type of prosthesis, fixation and, in total hip replacements, the bearing surface. For the data analysis, two methodological approaches will be used sequentially: first, an approach based on a survival analysis, followed by an approach based on standardised revision ratios and funnel plots. Following the analyses, a panel of experts will evaluate the results to identify possible sources of bias. Lastly, those models with results better or worse than expected compared to those from the comparison group will be valued, and strengths and difficulties for routine implementation of this methodology within the Catalan Arthroplasty Register will be identified.DiscussionThe study presented in this protocol will allow us to identify the hip and knee prosthesis models whose results might be better or worse than expected. This information could have a potential impact at the patient, orthopaedic surgeon, healthcare manager, decision-making and industry levels, both in the short term and in the medium and long term.
Highlights
Monitoring results regarding the effectiveness of knee and hip arthroplasties may be useful at the clinical, economic and patient level and help reduce the number of prosthesis revisions
Design and setting of the study A prospective observational design will be drawn up based on data from the Catalan Arthroplasty Register (RACat) to describe and evaluate the functioning of the different prosthesis models used in Catalonia between 2005 and 2017
As far as we know, aside from studies that group results together by prosthesis type and clinical trials of specific prosthesis models [13,14,15, 31], this is the first study performed in Spain and one of the first worldwide, to determine the effectiveness of the set of knee and hip prosthesis models currently used
Summary
A prospective observational design will be drawn up based on data from a population-based arthroplasty register for hip and knee replacements that includes data from 53 of the 61 public hospitals in Catalonia. The knee and hip prosthesis models used will be identified and classified according to the type of prosthesis, fixation and, in total hip replacements, the bearing surface. A panel of experts will evaluate the results to identify possible sources of bias. Those models with results better or worse than expected compared to those from the comparison group will be valued, and strengths and difficulties for routine implementation of this methodology within the Catalan Arthroplasty Register will be identified
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