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在机器人辅助和手动全膝关节置换术后,使用ActivPAL加速度计客观测量活动行为:一项随机对照试验(ROAM研究)的可行性研究

Objectively measured activity behaviours using the ActivPAL accelerometer following robotic and manually performed total knee arthroplasty : a feasibility study from a randomized controlled trial (ROAM study).

作者信息

Clement Nick D, Ajekigbe Bola, Ramaskandhan Jayasree, Galloway Steven, Smith Karen, Weir David J, Deehan David J

机构信息

Department of Orthopaedics, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.

Royal Infirmary of Edinburgh, Edinburgh, UK.

出版信息

Bone Joint Res. 2025 Jun 1;14(6):495-505. doi: 10.1302/2046-3758.146.BJR-2024-0239.R1.

Abstract

AIMS

To assess whether it was feasible to objectively measure activity behaviour between robotic arm-assisted (raTKA) and manually performed (mTKA) total knee arthroplasty using the ActivPAL accelerometer.

METHODS

A randomized controlled trial was undertaken and a subgroup of 40 patients underwent physical activity assessment. Patients were randomized to either mTKA (n = 18) or raTKA (n = 22). Preoperative (baseline) and 12-month postoperative physical activity assessment were undertaken using the ActivPAL accelerometer in addition to patient-reported outcome measures (PROMs): Oxford Knee Score (OKS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Forgotten Joint Score (FJS), EuroQol five-dimension questionnaire (EQ-5D), and EuroQol visual analogue scale (EQ-VAS). At 12 months, 15 patients in the raTKA group and nine in the mTKA group had paired ActivPAL data for analysis. Of the 16 patients without data, four withdrew, four were not provided with the ActivPAL due to logistical reasons, one failed to return the ActivPAL, one was allergic to the ActivPAL patch, and six failed to record or the data were corrupt.

RESULTS

There were no significant differences in the improvement in standing time (mean difference (MD) 1.6, p = 0.924), step number (MD 62.0, p = 0.970), sitting time (16.3, p = 0.777), number of sit-to-stand transitions (MD 16.3, p = 0.579), or activity scores (MD 0.0, p = 0.977) between the groups. However, the raTKA had a clinically meaningful and significantly (MD 19.8, 95% CI 0.8 to 38.8; p = 0.041) greater improvement in knee-specific pain according to the WOMAC pain score. There were no other statistically significant (p ≥ 0.113) differences between the other PROMs. There were no significant (p ≥ 0.144) correlations between changes in measures of physical activity functional assessments.

CONCLUSION

Objectively assessed physical activity was logistically difficult due to patient and data loss. There were no differences in activity with small effect sizes (≤ 0.2) between the raTKA and mTKA groups, despite differences in subjective knee pain. Improvement in subjective PROMs did not correlate with objectively measured physical activity, and the two seemed to be independent of one another.

摘要

目的

评估使用ActivPAL加速度计客观测量机器人手臂辅助全膝关节置换术(raTKA)和手动全膝关节置换术(mTKA)之间的活动行为是否可行。

方法

进行了一项随机对照试验,40例患者的亚组接受了身体活动评估。患者被随机分为mTKA组(n = 18)或raTKA组(n = 22)。除患者报告的结局指标(PROMs)外,还使用ActivPAL加速度计进行术前(基线)和术后12个月的身体活动评估:牛津膝关节评分(OKS)、西安大略和麦克马斯特大学骨关节炎指数(WOMAC)、遗忘关节评分(FJS)、欧洲五维健康量表(EQ-5D)和欧洲视觉模拟量表(EQ-VAS)。在12个月时,raTKA组有15例患者和mTKA组有9例患者有配对的ActivPAL数据用于分析。在16例没有数据的患者中,4例退出,4例由于后勤原因未提供ActivPAL,1例未归还ActivPAL,1例对ActivPAL贴片过敏,6例未记录或数据损坏。

结果

两组之间在站立时间改善(平均差(MD)1.6,p = 0.924)、步数(MD 62.0,p = 0.970)、坐姿时间(16.3,p = 0.777)、坐立转换次数(MD 16.3,p = 0.579)或活动评分(MD 0.0,p = 0.977)方面无显著差异。然而,根据WOMAC疼痛评分,raTKA在膝关节特异性疼痛方面有临床意义且显著更大的改善(MD 19.8,95%可信区间0.8至38.8;p = 0.041)。其他PROMs之间没有其他统计学显著差异(p≥0.113)。身体活动功能评估指标的变化之间没有显著相关性(p≥0.144)。

结论

由于患者和数据丢失,客观评估身体活动在后勤方面存在困难。尽管主观膝关节疼痛存在差异,但raTKA组和mTKA组之间活动量的差异较小(效应量≤0.2)。主观PROMs的改善与客观测量的身体活动不相关,两者似乎相互独立。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7229/12126250/9aff012110ae/BJR-2024-0239.R1-galleyfig1.jpg

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