Practicality of Conducting a Randomized Controlled Trial to Identify Differences in Revision Risk Between Conventional and Technology-Assisted Total Knee Arthroplasty Procedures in a Patient Population at Elevated Risk of Revision – A Simulation Study

5 pages•Published: December 17, 2024

Matthew Hickey, Bassam Masri, Carolyn Anglin and Antony J. Hodgson

Abstract

Given evidence that patients with a lower age at index surgery and higher BMI have an enhanced risk of aseptic revision. In this study we used a previously developed methodology to estimate how large a comparative study would need to be to detect differences between navigated/robotic TKA and conventional TKA in both higher- and lower-risk patient populations, and how long the follow-up periods would need to be to be sufficiently powered to detect those differences.
We modeled and simulated the likely outcomes of potential RCT study designs according to our previously published method. We generated three large sets of patients with distributions of patient-specific factors characteristic of patients at a reduced or enhanced risk of aseptic revision (relative to the typical risk assumed in our previous study). We then computed the corresponding Kaplan-Meier survival curves and applied a log-rank test to each study for statistical differences in revision rates at concurrent follow-up timepoints.
The results from our simulation found survivorship differences favoring TA-TKA ranging from 2.8% to 3.9% at 15- and 20-years follow-up on the patient population at an enhanced risk of aseptic revision. Even for the patient population at the highest baseline risk of aseptic revision, comparative studies would still need to enroll at least 1750 patients in each arm of the study to have an 80% chance of showing this reduction in revision rates at 15 years of follow-up. Traditional RCT studies would require impractically large numbers of patients to be enrolled and excessively long follow-up times to demonstrate whether such a reduction actually exists.

Keyphrases: navigated tka, robotic tka, statistical simulation, total knee arthroplasty

In: Joshua W Giles and Aziliz Guezou-Philippe (editors). Proceedings of The 24th Annual Meeting of the International Society for Computer Assisted Orthopaedic Surgery, vol 7, pages 93-97.

Links:	https://easychair.org/publications/paper/4XT6
	https://doi.org/10.29007/jt8f

BibTeX entry

@inproceedings{CAOS2024:Practicality_Conducting_Randomized_Controlled,
  author    = {Matthew Hickey and Bassam Masri and Carolyn Anglin and Antony J. Hodgson},
  title     = {Practicality of Conducting a Randomized Controlled Trial to Identify Differences in Revision Risk Between Conventional and Technology-Assisted Total Knee Arthroplasty Procedures in a Patient Population at Elevated Risk of Revision – A Simulation Study},
  booktitle = {Proceedings of The 24th Annual Meeting of the International Society for Computer Assisted Orthopaedic Surgery},
  editor    = {Joshua W Giles and Aziliz Guezou-Philippe},
  series    = {EPiC Series in Health Sciences},
  volume    = {7},
  publisher = {EasyChair},
  bibsource = {EasyChair, https://easychair.org},
  issn      = {2398-5305},
  url       = {/publications/paper/4XT6},
  doi       = {10.29007/jt8f},
  pages     = {93-97},
  year      = {2024}}

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