创新装置在术后康复中并未提供更优的全膝关节置换术结果：来自四项随机临床试验的结果。

Innovative Devices Did Not Provide Superior Total Knee Arthroplasty Outcomes in Post-Operative Rehabilitation: Results From a Four-Arm Randomized Clinical Trial.

机构信息

Research Division, MedStar National Rehabilitation Hospital, Washington, DC; Department of Rehabilitation Medicine, Georgetown University School of Medicine, Washington, DC.

Research Division, MedStar National Rehabilitation Hospital, Washington, DC; MedStar Health Research Institute, Hyattsville, MD.

出版信息

J Arthroplasty. 2020 Aug;35(8):2054-2065. doi: 10.1016/j.arth.2020.03.048. Epub 2020 Apr 2.

DOI:10.1016/j.arth.2020.03.048

PMID:32360105

Abstract

BACKGROUND

Orthopedic surgeons face an increasing array of post-TKA (total knee arthroplasty) rehabilitation interventions that entail innovative equipment and devices, but their relative effectiveness remains unknown. The study compared patient outcomes among primary unilateral TKA patients participating in one of 4 post-TKA rehabilitation interventions-a standard-of-care intervention and 3 more recently developed physical therapy interventions.

METHODS

The Knee Arthroplasty Rehabilitation Outcomes Study is a 4-arm randomized clinical trial conducted across 15 outpatient rehabilitation clinics. The trial evaluated 4 alternative interventions: (1) a stationary recumbent bike (control intervention); (2) a body weight-adjustable treadmill; (3) a recumbent bike and use of a patterned electrical neuromuscular stimulation device; and (4) a body weight-adjustable treadmill and a patterned electrical neuromuscular stimulation device. The study's outcome measures were patient walking speed and the Knee injury and Osteoarthritis Outcome Score (KOOS) measured at therapy discharge and at follow-up.

RESULTS

The study enrolled 363 TKA patients with 90-92 patients in each of the 4 study arms. Participants were similar across the 4 groups: They were about 63 years old, 61% female, 67% white, living at home, overweight (mean body mass index = 31.6), with mostly private insurance (61%) or Medicare (32%). Walking speed was similar at admission and discharge; KOOS scores were similar at admission, discharge, and follow-up across the 4 intervention groups.

CONCLUSION

The study found no statistical or clinically meaningful differences across the 4 study arms in walking speed or KOOS outcomes. Clinicians, payers, and policy makers will want to encourage providers and patients to use the least expensive intervention since each provide similar outcomes.

TRIAL REGISTRATION

NCT02426190; https://clinicaltrials.gov/ct2/show/NCT02426190?term=NCT02426190&cntry=US&rank=1.

摘要

背景

骨科医生面临着越来越多的 TKA（全膝关节置换术）康复干预措施，这些措施需要创新的设备和装置，但它们的相对效果仍不清楚。本研究比较了参加 4 种 TKA 康复干预措施之一的单侧 TKA 患者的患者结局-标准护理干预和 3 种最近开发的物理治疗干预措施。

方法

膝关节置换康复结局研究是一项在 15 个门诊康复诊所进行的 4 臂随机临床试验。该试验评估了 4 种替代干预措施：（1）固定躺式自行车（对照干预）；（2）可调节体重的跑步机；（3）躺式自行车和使用模式化电肌肉刺激设备；（4）可调节体重的跑步机和模式化电肌肉刺激设备。该研究的结果测量指标是患者的步行速度和 Knee injury and Osteoarthritis Outcome Score（KOOS），分别在治疗出院时和随访时进行测量。

结果

该研究共纳入了 363 例 TKA 患者，每组 90-92 例。4 组患者在各方面都相似：年龄约为 63 岁，61%为女性，67%为白人，居住在家庭中，超重（平均体重指数为 31.6），大部分拥有私人保险（61%）或医疗保险（32%）。入院和出院时的步行速度相似；4 组干预组的 KOOS 评分在入院、出院和随访时相似。