Robotic Arm-assisted versus Manual (ROAM) total knee arthroplasty: a randomized controlled trial

Abstract

AimsThe primary aim was to assess whether robotic total knee arthroplasty (rTKA) had a greater early knee-specific outcome when compared to manual TKA (mTKA). Secondary aims were to assess whether rTKA was associated with improved expectation fulfilment, health-related quality of life (HRQoL), and patient satisfaction when compared to mTKA.MethodsA randomized controlled trial was undertaken, and patients were randomized to either mTKA or rTKA. The primary objective was functional improvement at six months. Overall, 100 patients were randomized, 50 to each group, of whom 46 rTKA and 41 mTKA patients were available for review at six months following surgery. There were no differences between the two groups.ResultsThere was no difference between rTKA and mTKA groups at six months according to the Western Ontario and McMaster Universities osteoarthritis index (WOMAC) functional score (mean difference (MD) 3.8 (95% confidence interval (CI) -5.6 to 13.1); p = 0.425). There was a greater improvement in the WOMAC pain score at two months (MD 9.5 (95% CI 0.6 to 18.3); p = 0.037) in the rTKA group, although by six months no significant difference was observed (MD 6.7 (95% CI -3.6 to 17.1); p = 0.198). The rTKA group were more likely to achieve a minimal important change in their WOMAC pain score when compared to the mTKA group at two months (n = 36 (78.3%) vs n = 24 (58.5%); p = 0.047) and at six months (n = 40 (87.0%) vs n = 29 (68.3%); p = 0.036). There was no difference in satisfaction between the rTKA group (97.8%; n = 45/46) and the mTKA group (87.8%; n = 36/41) at six months (p = 0.096). There were no differences in EuroQol five-dimension questionnaire (EQ-5D) utility gain (p ≥ 0.389) or fulfilment of patient expectation (p ≥ 0.054) between the groups.ConclusionThere were no statistically significant or clinically meaningful differences in the change in WOMAC function between mTKA and rTKA at six months. rTKA was associated with a higher likelihood of achieving a clinically important change in knee pain at two and six months, but no differences in knee-specific function, patient satisfaction, health-related quality of life, or expectation fulfilment were observed.Cite this article: Bone Joint J 2023;105-B(9):961–970.

Knee

“…In a robustly constructed randomized controlled trial (RCT) from Newcastle upon Tyne (UK), a cohort of 100 patients was allocated to receive either rTKA or manual TKA (mTKA) to compare early postoperative outcomes. 3 To cut to the chase, the results indicated a statistically significant improvement in pain scores within the rTKA group at the twomonth assessment point. However, this improvement was not sustained.…”

Time to challenge some entrenched practice

“…This is a weakness of our outcome measures and of using patient-reported outcome measures as the primary endpoint. 26…”

Looking ahead to autumn

“…Clement et al 15 should be congratulated on undertaking the Robotic Arm-assisted versus Manual (ROAM) study during the COVID-19 pandemic. One of the key weaknesses of these studies is that they are often done in centres where expert surgeons already do the baseline control procedure well.…”