CHAPTER 4 Assessing Clinical Results and Outcome Measures
ARTHROPLASTY REGISTERS
Sweden began its register in 1979 with the mission of improving outcomes in hip arthroplasty.1 By a process of continual review, the Swedish registry has developed its data collection from simple demographics pertaining to primary arthroplasty (number of interventions per year or clinic and types of implant) to using three separate databases to record more comprehensive patient characteristics for primary and revision procedures and technical details of the operations. It aims to describe the epidemiology of hip replacement surgery and to identify by study of revisions risk factors for poor outcome.2 The register uses revision (exchange or extraction of one or both components) as the reliable but strict end point for failure. This end point has been shown to be valid.3 With this definition, which eliminates the problem of defining clinical failure, it has to be taken into consideration that the register underestimates the actual failure rate. For example, patients’ comorbidities may prevent further surgery, patients may be unwilling to undergo surgery, or patients may be on a lengthy waiting list at the time the assessment is made.
An important strength of the Swedish hip registry is that it collects information from all public and private clinics in Sweden, and so the data it provides reflect the results achieved by the “average” surgeon. Results are continually fed back to contributing institutions, allowing them to compare performance with the national average and consider the implants and techniques they are using. This register has been successful not only in determining failure rates and identifying risk factors, but also in improving the quality of total hip replacement in terms of implant safety and greater efficacy of surgical and cementing techniques.2
METHODS OF EARLY PREDICTION OF FAILURE
Statistical Models
Continuous monitoring methods are statistical testing procedures, which have been used in manufacturing and industry (and, less extensively, in medicine) for many years. These methods are used for the prospective monitoring of an intervention after it is in use in order to identify unacceptable or poor performance as early as possible.4 By predetermining an acceptable revision rate and setting boundaries to reduce the probability of a false alert, the use of this type of cumulative statistical model may give an advanced warning of a failing implant design or suboptimal surgical technique. National joint registries could offer a platform for this type of monitoring.4
Radiologic Models
RSA has shown that the implant either stabilizes over time or continues to migrate. The difference in these two patterns can be detected one year postoperatively. This method is extremely precise and has been shown to be accurate and reliable in predicting implant survivorship with regard to aseptic loosening.5 It essentially acts as a surrogate marker for revision status. It is particularly useful because it has sufficient accuracy and power that groups of 30 patients can be used to study new technologies, limiting the number of patients exposed to the risk of design failures, and producing an early warning of unacceptable instability long before it becomes evident clinically. RSA can also be used to compare directly the efficacy, with respect to implant stability, of different surgical techniques. For instance, reaming of the subchondral plate for cemented acetabular components6 and using different surgical approaches.7
Direct methods of measurement have been shown to be too imprecise to detect this level of early movement, even with careful standardization of patient positioning and the use of modern measurement tools.8 Adequate precision can be achieved using EBRA-Digital (Ein Bild Roentgen Analyse). This system measures two-dimensional migrations from digitized plain radiographs using software programs that include elements to measure the components, to exclude radiographs with significant positioning artifacts from the measurement series, and to interpret the measurements. Although it is precise enough to characterize two-dimensional migration patterns and identify patients at risk for later aseptic loosening within two years of surgery, it is not as precise as RSA and requires more subjects in order to have equivalent power in a prospective study.9 EBRA-Digital is suitable for use in the multicenter trial setting. Collection of data from this wider pool of subjects reduces the selection and outcome biases associated with studies from specialist centers, potentially providing surrogate outcome information that is more generalizable to the wider orthopedic community.9