1. Introduction
Knee osteoarthritis (OA) is a leading cause of pain and functional disability worldwide, and the prevalence of symptomatic knee OA and the demand for total knee arthroplasty (TKA) continue to increase [
1,
2,
3,
4]. TKA relieves pain and restores function in patients with end-stage OA; however, residual gait deficits are common and may influence patient satisfaction and functional independence [
5,
6,
7,
8].
The success of TKA depends on multiple factors, including implant design. A persistent controversy is the choice between fixed-bearing (FB) and mobile-bearing (MB) tibial inserts [
9]. The FB design involves a biomechanical compromise: greater conformity may reduce contact stress but increase torque transmission and the theoretical risk of loosening, whereas lower conformity may reduce torque but increase contact stress and wear [
10].
MB designs were introduced to address this compromise by allowing the polyethylene insert to rotate or translate, thereby decoupling axial rotation from constraint. In theory, this design may promote more physiological kinematics, reduce contact stress, and improve functional outcomes [
11]. Self-alignment of the mobile platform may also increase contact area and reduce stress peaks [
12]. The clinical evidence, however, has not borne this out, and it is important to be specific about which outcomes have been examined. Meta-analyses and randomised trials comparing the two designs have reported no consistent superiority of MB over FB for patient-reported function and pain, range of motion, joint awareness, crepitus, or implant survivorship [
13,
14]. These are predominantly patient-reported and clinical endpoints; they do not directly address whether the two designs produce measurably different walking mechanics.
Instrumented gait analysis addresses that question directly. Early three-dimensional gait studies established that TKA design influences walking and stair-climbing mechanics, particularly the knee flexion–extension pattern and the quadriceps-avoidance gait that accompanies it [
15], and a systematic review of gait after knee replacement subsequently confirmed that patients retain slower walking speed, reduced stride length and diminished knee excursion relative to healthy controls even when clinical scores are satisfactory [
16]. Laboratory studies comparing bearing designs have concentrated on joint-level and transverse-plane variables, where the theoretical advantage of a rotating platform should be expressed: fluoroscopic and kinematic work has documented greater axial rotation in some MB designs, but without a corresponding change in the global walking pattern [
11,
17]. Studies that have compared spatiotemporal descriptors specifically—walking speed, cadence, stride length and interlimb symmetry—have generally found the two designs indistinguishable, although sample sizes have been modest and follow-up mostly shorter than two years [
18,
19].
Wearable inertial measurement units (IMUs) have made this kind of assessment feasible outside the gait laboratory. A single trunk-mounted sensor yields walking speed, cadence, stride length and temporal symmetry indices with documented accuracy against optoelectronic and instrumented-walkway reference systems [
20,
21,
22,
23,
24], and systematic reviews in the TKA population identify these global spatiotemporal descriptors as the parameters most consistently reported and most responsive to postoperative recovery [
25,
26,
27]. It is important to recognise what this configuration does and does not measure: it quantifies how the patient walks overall, not the conformity, contact mechanics or rotational behaviour of the implant itself. The 2-Minute Walk Test (2MWT) complements instrumented analysis by capturing sustained ambulation capacity in a single, clinically interpretable distance [
28,
29,
30,
31,
32]. Longitudinal studies applying instrumented assessment to the comparison of bearing designs nonetheless remain scarce.
Therefore, the objective of this study was to compare global spatiotemporal gait performance and ambulation capacity, measured with a wearable inertial sensor and the 2MWT, between patients who underwent TKA with FB versus MB/rotating-platform implants, across three postoperative assessments. Two research questions were addressed: whether global spatiotemporal gait performance and ambulation capacity differ between the two bearing designs across the postoperative period, and how these measures change over successive assessments within each group. Neither question was framed as a directional hypothesis, because the design permits a difference to be identified but cannot establish its absence. The study was designed to characterise global walking performance and was not intended, and is not able, to evaluate implant-level kinematics, contact mechanics or load distribution.
4. Discussion
In this cohort, no statistically significant difference in global spatiotemporal gait performance or ambulation capacity was detected between patients who received FB and those who received MB/PS-RP implants, at any of three postoperative assessments, under the two specifications of time. The correct reading of this result is narrow and worth stating precisely: under the conditions of this study, with this sample size and this measurement approach, no difference was detected. That is not the same as having shown that the two designs perform equivalently. The study prespecified no equivalence or non-inferiority margin, the sample was modest and non-randomised, a substantial proportion of observations were missing at the later assessments, and no preoperative data were available, so the absence of a detected difference is uninformative about whether a difference of clinically relevant size exists.
A second limitation of inference is more specific to this cohort and bears directly on how the result should be attributed. Because each surgeon used both a habitual bearing design and a habitual arthrotomy, surgical approach was almost perfectly collinear with bearing type: essentially all FB procedures used a transquadricipital approach and all MB/PS-RP procedures a subvastus approach. The two factors cannot be statistically separated in these data. The subvastus approach spares the extensor mechanism and has been associated with earlier recovery of quadriceps function, so it is a plausible independent influence on walking performance. Any finding in this cohort therefore concerns the combination of bearing design and approach, not bearing design alone, and the absence of a detected difference could in principle reflect two genuine effects of opposite sign that cancel. Beyond this, the source records did not document ligament balancing or the distraction force applied during balancing, limb-alignment strategy, implant manufacturer or conformity, polyethylene thickness, patellar resurfacing, soft-tissue release, preoperative deformity, Kellgren–Lawrence grade, contralateral knee status, comorbidity burden, or rehabilitation intensity. Each of these can influence postoperative stability, kinematics and gait independently of the tibial bearing. Recent evidence has quantified the distraction forces commonly applied during tension-controlled ligament-balanced TKA and has highlighted the potential relevance of individualised balancing to postoperative joint behaviour [
34]; the present dataset contains no information on this aspect of the procedure. These omissions constitute substantial confounding by indication and practice pattern, and they mean the outcomes observed here cannot be attributed specifically to FB versus MB design.
A third consideration concerns what the measurement can detect. The theoretical arguments for a rotating platform are made at the level of the joint: articular conformity, contact stress and its distribution, transverse-plane rotation and the constraint imposed on it. A single trunk-mounted IMU does not measure any of these. It measures how the whole body progresses along a corridor—speed, cadence, stride length and the temporal regularity of successive steps—and these global descriptors can remain unchanged while joint-level mechanics differ substantially. Biomechanical work has documented greater axial rotation in some MB designs [
11], and differences in loading across levels of constraint [
35], without corresponding differences in walking speed. The systematic review literature makes the same point from the clinical side: abnormal gait patterns persist after TKA even when patient-reported outcomes are satisfactory [
16], so global performance is an imperfect proxy for implant mechanics. The present finding should therefore be read as evidence about global walking performance and ambulation capacity, and not as evidence that the kinematic differences attributed to rotating-platform designs are absent or functionally irrelevant. Testing that claim requires instrumentation this study did not use.
The measurement limits are sharpest for the asymmetry-related outcome. Single trunk-mounted configurations have been validated against reference systems for walking speed, cadence and stride length, with intraclass correlation coefficients typically above 0.8 for these parameters [
20,
21,
22,
23,
24]; validation is markedly weaker for variables that require limb-specific event detection, and one recent concurrent-validity study of this sensor configuration reported good agreement for cadence, speed and stride length but poor agreement for gait-phase parameters in the same participants [
22]. Methods for deriving asymmetry from a single low-back accelerometer have been developed and validated chiefly in post-stroke cohorts [
36,
37], where interlimb differences are large; no published study has established the accuracy of this device’s symmetry index against a reference standard in a TKA or comparable arthroplasty population, where asymmetries are considerably smaller. The step-time symmetry index and the gait quality index reported here should accordingly be interpreted with more caution than the speed, cadence and stride-length results, and the absence of a detected between-group difference in symmetry is correspondingly weaker evidence. Establishing the measurement properties of trunk-derived asymmetry indices in arthroplasty populations is a prerequisite for using them to compare implant designs.
The recovery pattern was not monotonic: performance was higher at the second assessment than at the first in both groups, and lower at the third in the FB group. The linear-time models summarise the average trend and cannot represent this shape, which is why the categorical sensitivity analysis was fitted; that analysis localised the significant changes to the second-to-third interval within the FB group while showing no significant between-group difference at any visit. Interpretation of the late decline requires restraint. Six FB patients were assessed at the third visit. At that sample size, ordinary between-subject variability, or a small number of interval events not captured in the dataset, is sufficient to produce a group-level decline of the observed magnitude. Patients who underwent revision or developed infection were excluded by design, so procedure-related failure does not explain it. Contralateral knee OA is a plausible contributor, since knee OA is frequently bilateral and improved function of the operated limb may increase demand on the other side; contralateral pain exacerbation after TKA has been reported to impair functional activity [
38], and the present dataset records neither contralateral symptoms nor radiographic status. Progression of OA in other joints, an unrelated musculoskeletal injury, a fall, or intercurrent illness would have the same effect, and are equally unrecorded. The third-assessment findings are hypothesis-generating and should not be read as evidence of late divergence between designs, particularly as the between-group contrasts at that visit were not significant.
The participant flow has a further implication for the models. Eighteen patients had no second assessment and 39 no third, and part of this attrition is administrative censoring, which is unrelated to the patient’s functional status and therefore compatible with the missing-at-random assumption underlying the mixed-effects models. The remainder is non-attendance at a scheduled review, for which the records give no reason. If patients who were walking poorly were more likely to miss a review, or conversely if those who had recovered well saw less need to attend, the missingness would depend on the unobserved outcome and the assumption would be violated in a direction that cannot be determined from these data. This is a material limitation of the longitudinal estimates, particularly at the third assessment, and it cannot be resolved retrospectively.
The 2MWT distances were lower than the product of the instrumented gait speed and the test duration. This follows from the different conditions of the two measurements rather than from any inconsistency between instruments. The inertial sensor reports steady-state speed during a single straight-line pass with the acceleration and deceleration phases removed, whereas the 2MWT was performed over a 30 m course traversed repeatedly with a 180-degree turn at each end; deceleration before each turn and reacceleration afterwards reduce the average velocity sustained over the two minutes. No correction for this effect was applied to the 2MWT distance, which is reported as the raw distance walked, and no velocity was derived from it for any analysis. Interpreting the magnitude of the observed changes remains difficult because minimally clinically important differences for instrumented gait parameters have not been established in the TKA population. For the 2MWT, the within-group improvement of approximately 14 m between the first and second assessments exceeds the minimal detectable change reported for this test after knee arthroplasty, whereas the between-group differences were smaller than the reported measurement variability [
29,
31,
32], which argues against a clinically meaningful divergence between designs within the period studied.
These considerations point to a wider methodological issue. Systematic reviews of wearable gait analysis consistently report heterogeneity in sensor number and placement, sampling and filtering choices, event-detection algorithms and walking protocols, which complicates comparison across studies and constrains pooling of results [
25,
26,
27]. Single-point trunk-mounted configurations are attractive for clinical use because they are quick to apply and well tolerated, and their accuracy is greatest for the global spatiotemporal descriptors that dominate the TKA gait literature. The parameters selected here therefore correspond to those with the strongest validation support for this sensor configuration and this population, and the acquisition and processing conditions have been reported above in sufficient detail to be reproduced. Convergence on standardised acquisition and reporting protocols, and derivation of clinically important difference thresholds for instrumented parameters, would materially improve the comparability of studies of implant design.
The strengths of this study are the use of objective instrumented measurement rather than patient-reported outcomes alone, the longitudinal structure spanning three assessments, the single-centre setting with consistent assessment procedures and evaluators, and the inferential treatment of all six outcomes with a prespecified sensitivity analysis for the shape of the time trend.
4.1. Limitations
Several limitations constrain what can be concluded, in addition to the inferential, confounding and measurement limits considered above. The sample was modest and small at the third assessment, limiting power particularly for the time-by-prosthesis interaction. Allocation was non-random and followed surgeon practice, and bearing design was collinear with surgical approach. Numerous surgical, implant-related, radiographic and clinical covariates were unavailable. No preoperative assessment existed, so neither the preoperative comparability of the groups nor the absolute magnitude of postoperative recovery can be evaluated, and the first postoperative assessment cannot serve as a substitute for a preoperative baseline. The assessment interval was defined by routine review rather than by protocol, so the timing of assessments varied between patients. A single trunk-mounted sensor cannot resolve joint-level kinematics, frontal- and transverse-plane control, stance–time asymmetry, double-support time, or turning performance, and its validation for asymmetry indices in this population is absent. Finally, established minimally clinically important differences for instrumented gait parameters are lacking in TKA, so the clinical relevance of the observed changes cannot be quantified.
4.2. Implications and Future Directions
What follows for practice is therefore limited and conditional. These data provide no evidence that the choice between an FB and an MB/rotating-platform design, as used by this surgical team with their respective approaches, is associated with a different trajectory of global walking performance or ambulation capacity over the period studied. They do not establish that the designs are equivalent, and they say nothing about joint-level loading, muscle strength or neuromuscular control. The study did not compare rehabilitation strategies and therefore cannot support any recommendation about how rehabilitation should be structured; whether protocols should be differentiated by implant design is a question that requires a study in which rehabilitation is the variable under investigation.
Several directions follow for future work. The immediate methodological priorities are a prospective design with a preoperative baseline, protocol-defined assessment intervals, randomised or otherwise unconfounded allocation that separates bearing design from surgical approach, prespecified equivalence or non-inferiority margins, and structured recording of the surgical, implant and clinical covariates absent here. Adequately powered randomised and preferably multicentre trials remain necessary to determine whether the two designs are functionally comparable and, if so, within what margin. Richer instrumentation would address the measurement gap: multiple IMUs on the shank and foot, or a full optoelectronic protocol, would resolve joint angles through the gait cycle and the symmetry of their recovery, and surface electromyography of the principal muscle groups during walking would characterise muscle balance and the stability of the reconstructed joint—variables that plausibly mediate any effect of bearing design and that the present protocol could not capture. Establishing minimally clinically important differences and reference validation for trunk-derived asymmetry indices in arthroplasty populations is a prerequisite for interpreting such measurements [
30,
39]. Looking further, the framing of the question may itself need to change. Comparisons of group mean gait parameters between implant designs treat patients as interchangeable, whereas the biomechanical response to an implant depends on individual anatomy, loading, and soft-tissue behaviour. Work in adjacent areas of musculoskeletal biomechanics illustrates a different approach: subject-specific finite-element modelling combined with machine learning has been used to tune cushioning lattice structures to an individual’s plantar pressure distribution [
40] and to adapt dual-layer lattice geometry to gait-induced loading [
41]. Those studies concern footwear rather than knee implants, and the analogy should not be overstated, but the methodological framework—patient-specific loading data, computational modelling, and optimisation against an individual objective—indicates a plausible route from group-level comparison of prosthesis designs toward patient-specific selection and configuration.