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How Large a Study Is Needed to Detect TKA Revision Rate Reductions Attributable to Robotic or Navigated Technologies?

Matthew D Hickey1, Carolyn Anglin2, Bassam Masri3

  • 1School of Biomedical Engineering, the University of British Columbia, Vancouver, BC, Canada.

Clinical Orthopaedics and Related Research
|August 5, 2021
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Technology-assisted total knee arthroplasty (TA-TKA) may offer a small survival benefit, but detecting this requires very large randomized trials. The number needed to treat to prevent one revision is high, questioning broad adoption based on revision costs alone.

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Area of Science:

  • Orthopedic surgery
  • Biomedical engineering
  • Clinical trial design

Background:

  • Robotic and navigated total knee arthroplasty (TKA) aim to improve component placement precision and implant survivorship.
  • Despite enhanced precision, most comparative studies show no significant improvement in implant survival rates.
  • The magnitude of potential benefits necessitates evaluating the required scale of randomized trials.

Purpose of the Study:

  • To determine the necessary sample size and follow-up duration for randomized trials to detect small differences in survivorship between technology-assisted TKA (TA-TKA) and conventional TKA.
  • To assess the clinical significance of potential survivorship improvements offered by TA-TKA.

Main Methods:

  • A simulation study using estimated effect sizes from registry and clinical studies.
  • Modeled 1.5 million simulated TKA cases with patient-specific factors and assigned coronal alignment precision.
  • Conducted Monte Carlo simulations (3000 populations) to evaluate power across different cohort sizes and follow-up periods (1-25 years).

Main Results:

  • Simulations indicated survivorship differences favoring TA-TKA of 1.4%–2.0% at 15 years.
  • Detecting these differences requires 2500–4000 patients per arm in randomized trials with 80% power.
  • The number needed to treat (NNT) to prevent one revision ranged from 1000 at 2 years to 50 at 15 years for the most precise interventions.

Conclusions:

  • TA-TKA may offer a relative reduction in revision rates, but the absolute benefit is small and realized over a long follow-up period.
  • Traditional randomized controlled trials (RCTs) would need excessively large patient numbers and long follow-up to demonstrate these small benefits.
  • High NNTs suggest that broad adoption based solely on avoided revision costs may not be justified without considering system costs and patient risk factors.