Abstract
Total knee arthroplasty is a successful procedure that reduces knee pain and improves function in most patients with knee osteoarthritis. Patient dissatisfaction however remains high, and along with implant longevity, may be affected by component positioning. Surgery in obese patients is more technically challenging with difficulty identifying appropriate landmarks for alignment and more difficult exposure of the joint. Patient specific instrumentation (PSI) has been introduced with the goal to increase accuracy of component positioning by custom fitting cutting guides to the patient using advanced imaging. A strong criticism of this new technology however, is the cost associated. The purpose of this study was to determine, using a prospective, randomized-controlled trial, the cost-effectiveness of PSI compared to standard instrumentation for total knee arthroplasty in an obese patient population.
Patients with a body mass index greater than 30 with osteoarthritis and undergoing a primary total knee arthroplasty were included in this study. We randomized patients to have their procedure with either standard instrumentation (SOC) or PSI. At 12-weeks post-surgery patients completed a self-reported cost questionnaire and the Western Ontario and McMaster Osteoarthritis Index (WOMAC). We performed a cost-effectiveness analyses from a public health payer and societal perspective. As we do not know the true cost of the PSI instrumentation, we estimated a value of $100 for our base case analysis and used one-way sensitivity analyses to determine the effect of different values (ranging from $0 to $500) would have on our conclusions.
A total of 173 patients were enrolled in the study with 86 patients randomized to the PSI group and 87 to the SOC group. We found the PSI group to be both less effective and more costly than SOC when using a public payer perspective, regardless of the cost of the PSI. From a societal perspective, PSI was both less costly, but also less effective, regardless of the cost of the PSI. The mean difference in effect between the two groups was −1.61 (95% CI −3.48, 026, p=0.091). The incremental cost-effectiveness ratio was $485.71 per point increase in the WOMAC, or $7285.58 per clinically meaningful difference (15 points) in the WOMAC.
Overall, our results suggest that PSI is not cost-effective compared to standard of care from a public payer perspective. From a societal perspective, there is some question as to whether the decreased effect found with the PSI group is worth the reduced cost. The main driver of the cost difference appears to be time off of volunteer work, which will need to be investigated further. In future, we will continue to follow these patients out to one year to collect cost and effectiveness data to investigate whether these results remain past 12 weeks post-surgery.
