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Single-use versus reusable ancillaries for dual mobility cup in total hip replacement. A prospective randomized
Roger Erivan1, Nicolas Bourzat2, Aurélien Mulliez3
1Université de Clermont Auvergne, CHU de Clermont-Ferrand, CNRS, SIGMA Clermont, ICCF, 63000 Clermont-Ferrand, France.
Background:
Single-use (SU) ancillaries for cup preparation in total hip arthroplasty (THR) aim to reduce the costs of hip replacement surgery. These devices have been recently introduced, but their safety and feasibility have not been studied. Therefore, we performed a prospective randomized study aiming to assess the impact in our department of using these SU ancillaries versus standard reusable ancillaries for dual mobility THR regarding 1) the cost, 2) operative time, 3) quality of primary fixation.
Hypothesis:
We hypothesized that the use of SU ancillaries for acetabular preparation would reduce maintenance costs, and so optimise the operating procedure, reduce the overall cost of surgery, save time, while maintaining the same quality of prosthesis fitting.
Method:
We conducted a randomised, controlled, open-label, two-arm, single-centre, prospective therapeutic trial with a medico-economic objective. Inclusions were made prospectively from patients hospitalised and surgically managed in our department for arthrosis over 18 years old treated with dual mobility THR.
Results:
In the current study, 18/20 (90%) of the cases required the use of one SU reamer when using SU ancillaries. Only two cases (10%) required a second SU reamer (without SU failure regarding the acetabular implant) because there was too much subchondral bone left and not enough cancellous bone allowing correct cup fitting. We also found that the test implant supplied in the SU kit had a less secure press-fit than the reusable metal test implants. There was one of primary press-fit failure in the SU group requiring a different cup with additional screws. The estimated cost to the supplier per procedure was 20,105 euros using single-use reamers versus 26,666 euros using conventional ancillary kits, a saving of 6561 euros (p<0.001). For the healthcare institution, the median price per intervention on the differentiating points was 2648 euros versus 2580 euros, with no significant difference (p=0.297). The results show an average societal cost of 52,199 euros using single-use and 53,572 euros using reusable ancillary equipment, with a significant difference between the two groups (p<0.003). The average cost of Healthcare Risk Waste (HCRW) disposal in the SU group was 5.2 euros per intervention against 5.1 euros in the RU group, without significant difference (p=0.910). We found a similar result for the cost of disposal of non-HCRW waste per procedure: 0.37 euros in the SU group versus 0.34 in the RU group, without significant difference (p=0.345).
Conclusion:
SU ancillaries significantly reduce the table set up time and have the potential to facilitate time and cost savings but further research is needed in this direction. Our study shows that the daily workload, operating times, and the number of boxes of instruments to be sterilised are decreased. The associated environmental gain is significant. Nevertheless, the economic promise of these SU ancillaries is only partially supported in this trial owing to the small number of patients. Further work will be needed to obtain a more powerful medico-economic assessment of this promising ancillary product.
Level Of Evidence:
II; prospective randomized study.
