Abstract：
BACKGROUND: Total Knee Arthroplasty (TKA) is frequently performed for advanced osteoarthritis, with patient-reported outcome measures (PROMs) traditionally reporting on efficacy. These subjective evaluations, although useful, may inaccurately reflect post-TKA activity levels. With technological advancements, smart implantable devices (SIDs) offer objective, real-time gait metrics, potentially providing a more accurate postoperative recovery assessment. This study compares these objective metrics with PROMs to evaluate TKA success more effectively.
METHODS: We conducted a retrospective cohort study with 88 participants undergoing TKA using a SID. Eligible patients were aged 18 years or older and had advanced osteoarthritis. We excluded those who had bilateral TKAs, joint infections, or neuromuscular disease. The SID system collected daily gait metrics, including step count, distance traveled, walking speed, stride length, cadence, and functional knee range of motion. The PROMs, including Knee Injury and Osteoarthritis Outcome Score-Joint Replacement, Veterans Rand 12 Physical Component Summary, and Veterans Rand 12 Mental Component Summary, were analyzed against SID gait metrics. Among the 88 patients, 80 provided continuous data over 12 weeks.
RESULTS: All gait metrics, except stride length, significantly increased at the 12-week point (P < .05). The PROMs also significantly improved postoperatively (P < .05). Initial low positive correlations between 12-week PROMs and SID metrics decreased after adjusting for demographic variables, leaving only weak correlations between the Veterans Rand 12 Physical Component Summary and Knee Injury and Osteoarthritis Outcome Score-Joint Replacement with functional knee range of motion (r = 0.389, P = .002; r = 0.311, P = .014, respectively), and Veterans Rand 12 Mental Component Summary with step count (r = 0.406, P = .001) and distance traveled (r = 0.376, P = .003).
CONCLUSIONS: This study indicates that both PROMs and SID gait metrics show significant improvements post-TKA, though they correlate weakly with each other, suggesting a possible discrepancy between perceived recovery and actual functional improvement. The SID gait metrics might provide a valuable addition to traditional PROMs by offering an objective representation of physical capabilities unaffected by patient compliance or subjective perceptions of recovery. Further research is needed to validate these findings in larger populations and to explore whether integrating SID metrics can enhance long-term functional outcomes.
METHODS: We conducted a retrospective cohort study with 88 participants undergoing TKA using a SID. Eligible patients were aged 18 years or older and had advanced osteoarthritis. We excluded those who had bilateral TKAs, joint infections, or neuromuscular disease. The SID system collected daily gait metrics, including step count, distance traveled, walking speed, stride length, cadence, and functional knee range of motion. The PROMs, including Knee Injury and Osteoarthritis Outcome Score-Joint Replacement, Veterans Rand 12 Physical Component Summary, and Veterans Rand 12 Mental Component Summary, were analyzed against SID gait metrics. Among the 88 patients, 80 provided continuous data over 12 weeks.
RESULTS: All gait metrics, except stride length, significantly increased at the 12-week point (P < .05). The PROMs also significantly improved postoperatively (P < .05). Initial low positive correlations between 12-week PROMs and SID metrics decreased after adjusting for demographic variables, leaving only weak correlations between the Veterans Rand 12 Physical Component Summary and Knee Injury and Osteoarthritis Outcome Score-Joint Replacement with functional knee range of motion (r = 0.389, P = .002; r = 0.311, P = .014, respectively), and Veterans Rand 12 Mental Component Summary with step count (r = 0.406, P = .001) and distance traveled (r = 0.376, P = .003).
CONCLUSIONS: This study indicates that both PROMs and SID gait metrics show significant improvements post-TKA, though they correlate weakly with each other, suggesting a possible discrepancy between perceived recovery and actual functional improvement. The SID gait metrics might provide a valuable addition to traditional PROMs by offering an objective representation of physical capabilities unaffected by patient compliance or subjective perceptions of recovery. Further research is needed to validate these findings in larger populations and to explore whether integrating SID metrics can enhance long-term functional outcomes.
摘要：
背景：全膝关节置换术（TKA）经常用于晚期骨关节炎，患者报告结果测量（PROMs）传统上报告疗效。这些主观评价，虽然有用,可能不准确地反映TKA后的活动水平。随着技术的进步，智能植入式设备(SID)提供目标，实时步态指标，可能提供更准确的术后恢复评估。本研究将这些客观指标与PROM进行了比较，以更有效地评估TKA的成功。
方法：我们进行了一项回顾性队列研究，使用SID对88名接受TKA的参与者进行了研究。符合条件的患者年龄在18岁或以上，患有晚期骨关节炎。我们排除了那些有双边TKA的人，关节感染,或者神经肌肉疾病。SID系统收集了每日步态指标，包括步数，旅行距离,步行速度,步幅长度,节奏,和功能膝盖的运动范围（ROM）。PROMs,包括膝关节损伤和骨关节炎结果评分关节置换（KOOS-JR），退伍军人-兰德-12-物理组件-摘要(VR-12-PCS)，和退伍军人-兰德-12-心理成分摘要(VR-12-MCS)，针对SID步态指标进行分析。在88名患者中，80提供了超过12周的连续数据。
结果：所有步态指标，除了步幅,在12周时显著增加(P<0.05)。术后PROM也显著改善(P<0.05)。调整人口统计学变量后，12周PROM和SID指标之间的初始低正相关降低，VR-12-PCS和KOOS-JR与功能性膝ROM之间仅存在弱相关性（分别为r=0.389，P=0.002；r=0.311，P=0.014），和VR-12-MCS，步数（r=0.406，P=0.001）和行进距离（r=0.376，P=0.003）。
结论：这项研究表明，PROM和SID步态指标均显示TKA后有显着改善，尽管它们相互关联较弱，表明感知恢复和实际功能改善之间可能存在差异。SID步态度量可以通过提供不受患者依从性或恢复的主观感知影响的物理能力的客观表示来提供对传统PROM的有价值的补充。需要进一步的研究来在更大的人群中验证这些发现，并探索整合SID指标是否可以增强长期功能结果。
方法：我们进行了一项回顾性队列研究，使用SID对88名接受TKA的参与者进行了研究。符合条件的患者年龄在18岁或以上，患有晚期骨关节炎。我们排除了那些有双边TKA的人，关节感染,或者神经肌肉疾病。SID系统收集了每日步态指标，包括步数，旅行距离,步行速度,步幅长度,节奏,和功能膝盖的运动范围（ROM）。PROMs,包括膝关节损伤和骨关节炎结果评分关节置换（KOOS-JR），退伍军人-兰德-12-物理组件-摘要(VR-12-PCS)，和退伍军人-兰德-12-心理成分摘要(VR-12-MCS)，针对SID步态指标进行分析。在88名患者中，80提供了超过12周的连续数据。
结果：所有步态指标，除了步幅,在12周时显著增加(P<0.05)。术后PROM也显著改善(P<0.05)。调整人口统计学变量后，12周PROM和SID指标之间的初始低正相关降低，VR-12-PCS和KOOS-JR与功能性膝ROM之间仅存在弱相关性（分别为r=0.389，P=0.002；r=0.311，P=0.014），和VR-12-MCS，步数（r=0.406，P=0.001）和行进距离（r=0.376，P=0.003）。
结论：这项研究表明，PROM和SID步态指标均显示TKA后有显着改善，尽管它们相互关联较弱，表明感知恢复和实际功能改善之间可能存在差异。SID步态度量可以通过提供不受患者依从性或恢复的主观感知影响的物理能力的客观表示来提供对传统PROM的有价值的补充。需要进一步的研究来在更大的人群中验证这些发现，并探索整合SID指标是否可以增强长期功能结果。
