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Does robotic surgical assistant (ROSA) functionally aligned TKA lead to higher satisfaction than conventional mechanically aligned TKA: A propensity-matched pair analysis
, Eric Xuan Liub, Jerry Yongqiang Chenb, Hee Nee Pangb, Seng Jin Yeob, Lincoln Ming Han Liowb,
⁎Corresponding author: Lincoln Ming Han Liow. lincoln.liow.m.h@singhealth.com.sg
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Received: ,
Accepted: ,
This article was originally published by Reed Elsevier India Pvt. Ltd. and was migrated to Scientific Scholar after the change of Publisher.
Abstract
Abstract
Total knee arthroplasty (TKA) is the established treatment for severe knee osteoarthritis, with robotic-assisted TKA (rTKA) proposed to enhance surgical precision and potentially improve outcomes. This study investigates whether functionally-aligned rTKA using the ROSA Knee System results in superior functional outcomes and patient satisfaction compared to conventional mechanically aligned TKA (mTKA).
We conducted a retrospective, propensity-score matched cohort study including 154 patients (46 rTKA, 108 mTKA) who underwent primary TKA by a single surgeon from October 2020 to October 2023. Functionally-aligned (FA) rTKA was performed using the ROSA Knee System. Patients were assessed using the Short-Form 36 (SF36), Knee Society Knee Score (KSKS), Knee Society Function Score (KSFS), and Oxford Knee Score (OKS) preoperatively and at 6 months postoperatively. Immediate postoperative outcomes such as pain at rest and movement, ambulation distance, and range of motion were measured. Statistical analysis evaluated results at a 95 % confidence interval, with significance at P < 0.05.
No significant differences were observed in immediate postoperative pain at rest (P = 0.988), pain during movement (P = 0.634), ambulation distance (P = 0.243), and range of motion (P = 0.752) between the groups. At 6 months, there were no significant differences between rTKA and mTKA in achieving the minimal clinically important difference for SF36 (P = 0.996), KSKS (P = 0.150), KSFS (P = 0.091), and OKS (P = 0.949). No significant differences were noted for satisfaction levels (P = 0.315) and fulfilled expectations (P = 0.557) between both groups.
At 6 months postoperatively, FA rTKA demonstrated equivalent outcomes and satisfaction levels compared to mTKA. Future research should focus on examining longer-term follow-up outcomes, quantifying gap balance in MA mTKA to allow direct comparison with rTKA and studying alternative personalised alignment rTKA strategies to enhance patient outcomes.
Keywords
Arthroplasty
Robotics
1 Introduction
Total knee arthroplasty (TKA) is established as the definitive intervention for end-stage knee osteoarthritis, and the incidence of TKA is projected to increase further.1,2 Robotic-assisted (rTKA) was introduced to potentially improve outcomes and satisfaction by increasing surgical precision and reproducibility.3 A meta-analysis by Alrejeb et al. revealed that rTKAs had superior post-operative anatomical and mechanical alignment.4 The ROSA (Robotic Surgical Assistant) knee system (Zimmer Biomet, Warsaw, Indiana) is a robotic technology that offers surgeons the option of either image-based or imageless surgical planning. This system was engineered to improve bone resection accuracy and evaluate soft tissue integrity to facilitate optimal implant placement during TKA.5–9 Additionally, it has enabled surgeons to explore alternative alignment strategies, such as personalised or functional alignment.
Functional alignment aims to restore the native plane and obliquity of the joint, as dictated by the soft-tissue envelope.10 This technique aims to execute individualized physiological limb alignment within the 0°–3° safe zone of coronal alignment and achieve patient-specific knee kinematics while limiting any soft-tissue releases.10 The surgeon, with robotic assistance, adjusts the components and bony resections based on native soft tissue tension and laxity to create postoperative balanced flexion and extension gaps. The goal is to provide a replacement that feels natural to the patient and supports long-term durability by ensuring a balanced load distribution across the joint.
Mechanically aligned TKA (mTKA) is the current gold standard technique and aims to distribute load evenly across the components in stance phase to promote symmetrical component wear and increase component durability.11 This is achieved by undertaking bone resections and placing implants perpendicular to the femoral and tibial mechanical axes, while externally rotating the femoral component, which also secondarily facilitates patella tracking.12
Recent articles have pointed out flaws of mechanical alignment (MA). High rates of patient dissatisfaction and residual pain were postulated to be possibly due to operative techniques that were not individual-specific despite great variability in patients’ anatomy.13 Choong et al. showed that rTKAs achieves greater accuracy in implant alignment and this correlated with better knee function and improved quality of life after 12 weeks.14 Existing literature specific to the ROSA knee system has highlighted its accuracy,5,6,9 however, there is currently a paucity of comparative data regarding functional outcomes and patient satisfaction between ROSA functionally-aligned (FA) rTKAs and conventional mTKA, as well as no general consensus as to whether gap-balanced, functionally-aligned rTKAs provided superior outcomes and satisfaction. Regarding the use of rTKA for different alignments, a study by Klasan et al. with a different robotic system demonstrated no benefit in modified mechanical alignment between rTKA and mTKA.15
Therefore, the aim of this retrospective matched cohort study was to assess whether ROSA FA rTKAs provided superior immediate and short-term postoperative outcomes and satisfaction as compared to mTKAs.
2 Methods
An Institutional Review Board approval (2019/2328) was granted for this retrospective study. The study included patients who underwent primary, cemented, fixed-bearing TKA by a single surgeon from October 2020 to October 2023. 46 patients who underwent robotic FA rTKA and 108 patients with mTKA who received the same implant were included in this study. Patients who had TKA performed using calipered kinematic alignment were excluded.
Of the 154 patients included in the study, 46 underwent rTKA and 108 underwent mTKA. In the mTKA group, 76 of patients were women and the mean age was 69.1 ± 7.3 years. In the rTKA group, 27 of patients were women and the mean age was 67.4 ± 7.6 years. The summarised preoperative findings are in Table 1 (Table 1).
| Before matching | After matching | ||||||||
| Mechanical (n = 97) | ROSA (n = 46) | p valuea | Standardised mean difference; Cohen's d (95 % CI) | Mechanical (n = 46) | ROSA (n = 46) | p valuea | p valueb | Standardised mean difference; Cohen's d (95 % CI) | |
| Female, n (%) | 70 (72.2) | 21 (58.3) | 0.13 | 0.14 | 25 (69.4) | 21 (58.3) | 0.33 | 0.22 | 0.11 (−0.24, 0.69) |
| Age; mean (SD) | 68.5 (7.1) | 69.6 (6.0) | 0.28 | −1.12 (−0.09, 0.68) | 68.5 (6.3) | 69.6 (6.0) | 0.33 | 0.35 | −1.06 (−0.64, 0.29) |
| Preoperative Knee Society FunctionScore | 49.6 (0, 90) | 57.4 (10, 100) | 0.03 | −8.19 (−0.79, 0.35) | 49.9 (0, 90) | 57.4 (10, 100) | 0.14 | 0.27 | −7.50 (−0.83, 0.10) |
| Preoperative Knee Society Knee Score | 38.6 (0, 90) | 45.8 (20, 94) | 0.05 | −7.14 (−0.82, −0.05) | 39.0 (11, 90) | 45.8 (20, 94) | 0.07 | 0.12 | −6.75 (−0.86, 0.07) |
| Preoperative Oxford Knee Score | 34.7 (7.2) | 31.0 (9.7) | 0.02 | 3.71 (0.08, 0.85) | 34.2 (8.3) | 31.0 (9.7) | 0.12 | 0.02 | 3.25 (−0.11, 0.83) |
| Preoperative SF36 (physical functioning) | 38.9 (0, 95) | 50.6 (0, 90) | 0.01 | −12.3 (−0.88, −0.11) | 39.4 (0, 95) | 50.6 (0, 90) | 0.06 | 0.06 | −11.1 (−0.87, 0.06) |
| Preoperative SF36 (role functioning) | 18.8 (0, 100) | 24.3 (0, 100) | 0.21 | −6.01 (−0.56, 0.21) | 20.8 (0, 100) | 24.3 (0, 100) | 0.38 | 0.80 | −3.47 (−0.56, 0.37) |
| Preoperative SF36 (bodily pain) | 33.5 (0, 100) | 41.4 (0, 100) | 0.003 | −7.80 (−0.84, −0.06) | 35.7 (0, 100) | 41.4 (0, 100) | 0.05 | 0.05 | −5.69 (−0.75, 0.18) |
| Preoperative SF36 (general health) | 68.7 (15, 100) | 74.2 (47, 100) | 0.12 | −5.60 (−0.71, 0.06) | 64.8 (27, 100) | 74.2 (47, 100) | 0.04 | 0.01 | −9.39 (−1.00, −0.06) |
| Preoperative SF36 (vitality) | 72.6 (20, 100) | 75.8 (20, 100) | 0.25 | −3.00 (−0.52, 0.24) | 71.1 (25, 100) | 75.8 (20, 100) | 0.25 | 0.18 | −4.72 (−0.67, 0.25) |
| Preoperative SF36 (social functioning) | 64.2 (0, 100) | 69.8 (0, 100) | 0.49 | −5.61 (−0.55, 0.22) | 68.1 (0, 100) | 69.8 (0, 100) | 0.96 | 0.56 | −1.74 (−0.52, 0.41) |
| Preoperative SF36 (role functioning) | 99.3 (67, 100) | 94.4 (0, 100) | 0.28 | 4.87 (−0.002, 0.77) | 100.0 (100, 100) | 94.4 (0, 100) | 0.15 | 0.16 | 5.56 (0.13, 0.80) |
| Preoperative SF36 (mental health) | 86.0 (16, 100) | 88.2 (44, 100) | 0.61 | −2.24 (−0.53, 0.24) | 83.0 (16, 100) | 88.2 (44, 100) | 0.38 | 0.30 | −5.22 (−0.78, 0.15) |
2.1 Surgical technique
All surgeries were performed by a single experienced and fellowship-trained orthopaedic surgeon. All surgeries were performed for primary osteoarthritis of the knee with intact medial and lateral collateral ligaments that have failed non-surgical treatment, and used a single implant design (Persona® Knee, Zimmer, Warsaw, Indiana).
All mTKAs were performed using standardised techniques in accordance with manufacturer's instructions to achieve balanced flexion and extension gaps. The distal femur and proximal tibia are resected and a spacer block is utilised to assess the extension gap. The surgeon would external rotate the femur component in 90° flexion to ensure a rectangular gap, referencing the anteroposterior axis (Whiteside's line), transepicondylar axis, and proximal tibia resection.
Functionally aligned rTKA was completed with the ROSA Knee System (Zimmer Biomet, Warsaw, Indiana). It allows the surgeon to proceed with a planning using a 3-dimensional virtual model based on intraoperative bony landmarks collection and ligament balancing evaluation.16 The ROSA knee platform assists the surgeon for the distal femoral cut, the femoral component sizing and positioning, the tibial cut and the ligament balance.3 After registration and landmarking with the platform, the initial knee state and native ligament tension are obtained. Distal femur and proximal tibia resections are performed and verified, resulting in a balanced extension gap. Following the resection, the FuZion® Tensor (Zimmer, Warsaw, Indiana) is used with the knee at 90° flexion to tension the flexion gap which often requires adjusting the femur component to achieve flexion gap balance. The surgeon targeted equal 19 millimiter gaps in extension/flexion, but allowed up to a 3 mm gap laterally in flexion, i.e. 19 millimiters medially and 19 to 22 millimiters laterally.
For all TKAs, the patella was not resurfaced and patelloplasty, lateral facetectomy and removal of patella osteophytes were performed. At the end of the procedure, dilute betadine irrigation was performed for 3 minutes, after which periarticular analgesia, surgeon-administered adductor canal block and topical 1500 mg tranexamic acid were administered. Closure of the incision was performed with layered barbed sutures and Dermabond® Prineo® was used as dressing for the skin.
2.2 Data collection
Patients were assessed preoperatively and demographic data such as age, gender, height, weight, and body mass index (BMI) were recorded. Functional knee parameters including range of motion (ROM) and alignment were recorded. Patient reported outcome measures (PROM) such as Short-Form 36 (SF-36), Knee Society Knee Score (KSKS), Knee Society Function Score (KSFS), Oxford Knee Score (OKS), were assessed.
After the operation, patients underwent in-hospital physiotherapy either on postoperative day 0 or day 1. All physiotherapists have a standardised protocol to assess pain in the form of the Visual Analogue Scale (VAS), maximum ambulation distance, as well as range of motion. These parameters are taken as immediate outcomes from the operation.
At 6 months follow-up, knee function, the aforementioned PROMs, as well as satisfaction levels and whether expectations were met were assessed.
2.3 Patient-reported outcome measures
SF-36 examines the physical and emotional aspect of an individual and it has been validated for individuals with knee osteoarthritis.17 It measures 8 different domains which can be categorized into physical or mental health. They are represented by physical component score (PCS) and mental component score (MCS), respectively.18,19
KSKS assesses the knee objectively for alignment, instability and ROM, whereas KSFS assesses the functional aspect of an individual's ability to perform activities such as walking, standing, advance or discretionary activities.20,21
OKS is a short 12-item PROM specifically designed to assess function and pain before and after TKA.22–24
To ascertain if measured improvements of these outcome measures related to clinical improvement, minimal clinical important difference (MCID) was used for the PROMs and the number of patients that attained MCID for these scores were recorded.
Patients were asked to rate the overall results of their treatment in terms of satisfaction and whether their expectations had been met between excellent, very good, good, fair, poor and terrible. Satisfaction is considered achieved and expectations met if the patient rated good, very good or excellent.
2.4 Statistical analysis
IBM SPSS was used to conduct the statistical analysis (IBM, version 29.0).
Propensity score matching (PSM: one case to one control) was performed to reduce selection bias and achieve optimal covariate balance. Preoperative PROMs were used as matching factors. A test of association between ROSA/mechanical and the confounders was assessed using either an independent 2-sample t-test or Wilcoxon rank-sum test depending on the distribution of the continuous variable. There were an initial 46 rTKA knees and 108 mTKA knees. After PSM, 46 pairs (rTKA vs mTKA) were identified and retained.
Wilcoxon rank-sum analysis was performed for non-parametric data and independent t-test was performed for parametric data. Results were evaluated at 95 % confidence interval with significance was evaluated at the P < 0.05 level.
3 Results
For immediate outcomes, there was no significant difference in pain at rest, pain at movement, maximum ambulation distance, and range of motion for groups (Table 2).
| Before matching | After matching | |||||
| Mechanical (n = 108) | ROSA (n = 46) | p value | Mechanical (n = 46) | ROSA (n = 46) | p value | |
| Pain at rest | 0.89 ± 1.31 | 0.93 ± 1.20 | 0.683 | 0.93 ± 1.44 | 0.93 ± 1.20 | 0.988 |
| Pain at movement | 3.14 ± 1.79 | 3.11 ± 1.78 | 0.719 | 3.28 ± 1.82 | 3.11 ± 1.78 | 0.634 |
| POD1 ambulation distance | 20.2 ± 13.1 | 24.6 ± 18.7 | 0.090 | 20.5 ± 14.7 | 24.6 ± 18.7 | 0.243 |
| ROM | 74.8 ± 18.9 | 75.8 ± 17.4 | 0.719 | 77.4 ± 17.3 | 75.8 ± 17.4 | 0.752 |
| POD1 Post-operative day 1; ROM Range of motion | ||||||
Both groups demonstrated statistically significant improvement for KSKS, KSFS, OKS and SF-36 at 6 months postoperatively. There was no statistical difference between both groups for all PROMs after matching. A high proportion of both groups met MCID threshold at 6 months for KSKS, KSFS, OKS, and SF-36 PCS, and there was no statistical difference in the proportion of patients that met MCID threshold for the PROMs (Tables 3 and 4).
| 6 month outcomes for mechanical and ROSA TKR | ||||||
| Mechanical | ROSA | p value | % that achieved MCID at 6 months | |||
| Mechanical | ROSA | p value | ||||
| KSKS | 85.1 ± 13.7 | 80.9 ± 12.3 | 0.059 | 95.7 % | 89.1 % | 0.238 |
| KSFS | 68.2 ± 22.4 | 76.3 ± 16.3 | 0.083 | 71.7 % | 82.6 % | 0.214 |
| OKS | 20.1 ± 6.73 | 19.1 ± 6.17 | 0.602 | 91.3 % | 84.8 % | 0.335 |
| SF36-PCS | 46.3 ± 10.1 | 46.6 ± 9.09 | 0.900 | 56.5 % | 56.5 % | 1.000 |
| Range of Motion | 112.9 ± 13.0 | 111.7 ± 14.1 | 0.802 | – | – | – |
| 6 month outcomes for mechanical and ROSA TKR | ||||||
| Mechanical | ROSA | p value | % that achieved MCID at 6 months | |||
| Mechanical | ROSA | p value | ||||
| KSKS | 83.3 ± 13.8 | 80.9 ± 12.3 | 0.122 | 95.4 % | 89.1 % | 0.150 |
| KSFS | 67.2 ± 22.9 | 76.3 ± 16.3 | 0.026 | 69.4 % | 82.6 % | 0.091 |
| OKS | 21.0 ± 7.0 | 19.1 ± 6.17 | 0.083 | 85.2 % | 84.8 % | 0.949 |
| SF36-PCS | 44.8 ± 10.2 | 46.6 ± 9.09 | 0.389 | 56.5 % | 56.5 % | 0.996 |
| Range of Motion | 110.4 ± 25.8 | 111.7 ± 14.1 | 0.687 | – | – | – |
| KSKS Knee Society Knee Score, KSFS Knee Society Function Score, OKS Oxford Knee Score, SF-36 PCS 36 Item Short Form Survey Physical Component Score | ||||||
A high proportion of patients also met expectations and were satisfied at 6 months postoperatively, and there was no statistical difference in the proportion of patients that had their expectations met and were satisfied between the 2 groups (Tables 5 and 6).
| Fulfilment of expectations and satisfaction at 6 months | |||
| Mechanical (n = 108) | ROSA (n = 46) | p value | |
| Expectations | 0.557 | ||
| Fulfilled | 95.7 % | 97.8 % | |
| Not fulfilled | 4.3 % | 2.2 % | |
| Satisfaction | 0.315 | ||
| Fulfilled | 97.8 % | 100 % | |
| Not fulfilled | 2.2 % | 0 % | |
| Fulfilment of expectations and satisfaction at 6 months | |||
| Mechanical (n = 108) | ROSA (n = 46) | p value | |
| Expectations | 0.624 | ||
| Fulfilled | 96.3 % | 97.8 % | |
| Not fulfilled | 3.7 % | 2.2 % | |
| Satisfaction | 0.353 | ||
| Fulfilled | 98.1 % | 100 % | |
| Not fulfilled | 1.9 % | 0 % | |
4 Discussion
This is the first study comparing the outcomes of ROSA FA rTKA and mTKA. In terms of immediate postoperative outcomes such as ambulation distance, range of motion, and pain scores, there was no significant difference between ROSA FA rTKA and mTKA groups. These findings are consistent with those of Hamilton et al., who also reported no differences in immediate postoperative pain between the two approaches.25 Conversely, there are studies demonstrating shorter length of stay for non-ROSA rTKAs. Kayani26 et al. demonstrated that rTKAs was associated with reduced postoperative pain, improved maximum knee flexion at discharge, and shorter length of stay. Intuitively, achieving better gap balance with robotic assistance should translate into noticeable immediate postoperative outcomes, however, differences in individual patient pain thresholds, patient motivation and postoperative soft tissue swelling might heavily influence these outcomes. These findings indicate that FA rTKAs are capable of delivering outcomes comparable to mTKAs from the outset.
Current studies providing comparative data on ROSA TKA have yielded mixed results regarding functional outcomes. Unlike studies that suggest superior outcomes for rTKAs, our findings revealed no significant differences between FA ROSA rTKA and MA mTKA in most PROMs at the six-month mark. In a study conducted by Mancino et al. comparing ROSA r-TKA and iASSIST navigated TKA (n-TKA, iAssist Knee, Zimmer, Warsaw, Indiana), patients who were operated with ROSA had higher KSKS and KSFS.16 In a study by Kenanidis et al., patients who had undergone ROSA rTKA had better OKS 6 months postoperatively as compared to patients who had undergone mTKA.27 However, Khan et al. reported comparable functional Delta Knee Injury and Osteoarthritis Outcome Score - Joint Replacement at the 6 month postoperative mark.28 Additionally, in the unmatched cohort, the FA ROSA rTKA group had significantly higher KSFS scores (P = 0.026) and a higher proportion attaining MCID. As FA aims to restore the knee's natural alignment and kinematics, this could have potentially resulted in a more natural-feeling knee and better functional performance in activities evaluated by the KSFS.
Analyzing results using the MCID allows for assessment of clinical relevance. In this study, the proportion of patients meeting the MCID threshold across all PROMs was similar between the two groups, which is further supported by the comparable satisfaction levels and met expectations. Overall, no significant differences were observed in short-term outcomes, MCID achievement, or satisfaction between the groups.
Despite achieving objective balanced gaps with increased accuracy and precision in FA rTKA, when compared to MA mTKA, outcomes were not clinically significant. This could be due to MA mTKA achieving similarly balanced gaps, therefore negating the consistency benefits of FA rTKA. Further studies could examine the gaps in MA mTKA to determine if gap balance affects outcomes. Our study suggests that other alignment strategies may be needed, such as kinematic alignment, where a more personalised approach to TKA could lead to better early postoperative outcomes. While accuracy may be improved and early outcomes are equivalent to MA mTKA, improved survivorship and superior outcomes have not been demonstrated as there are no long-term studies examining the ROSA knee system to date.
4.1 Limitations
This study had a number of limitations. The relatively short 6-month follow-up duration restricts our ability to evaluate long-term results and survivorship. Additionally, the limited number of patients undergoing rTKA, owing to its novelty and the single-surgeon setting, underscores the need for larger cohorts to increase generalizability of the findings. Secondly, this study was also not a randomized, blinded study. This could potentially introduce confounders that could impact the validity of our conclusions. However, in our analysis, patients underwent propensity score matching to reduce selection bias and achieve optimal covariate balance. Third, variables not collected in this study may affect PROMs such as pain management and consistent physical therapy utilization.29,30 However, as all procedures were performed by a single surgeon in the same institution, peri- and post-operative protocols were standardised.
5 Conclusions
In conclusion, FA rTKA had equivalent outcomes and proved comparable with MA mTKA in terms of patient satisfaction, PROMs and immediate postoperative outcomes. Looking ahead, future research should focus on examining longer-term follow-up outcomes and quantifying gap balances to allow for direct comparison.
CRediT authorship contribution statement
Edmund Jia Xi Zhang: Data curation, Writing – original draft preparation. William Yeo: Data Curation. Eric Xuan Liu: Supervision, Writing – review & editing. Jerry Yongqiang Chen: Supervision, Writing – review & editing. Hee Nee Pang: Supervision, Writing – review & editing. Seng Jin Yeo: Supervision, Writing – review & editing. Lincoln Ming Han Liow: Conceptualization, Writing – review & editing.
Patient consent
Consent has been obtained.
Ethical statement
An Institutional Review Board approval (2019/2328) was granted for this retrospective study.
All procedures were performed in compliance with relevant laws and institutional guidelines and have been approved by the appropriate institutional committee(s). Informed consent was obtained with the privacy rights of human subjects observed.
Funding
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
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