全膝关节置换术后使用冷冻压缩装置辅助康复的作用：一项随机对照试验。
The role of a cryocompression device following total knee arthroplasty to assist in recovery: a randomised controlled trial.
机构信息
Perth Orthopaedic and Sports Medicine Research Institute, 31 Outram St, West Perth, WA, 6005, Australia.
Department of Orthopaedics, Royal Perth Hospital, Perth, WA, Australia.
出版信息
Knee Surg Sports Traumatol Arthrosc. 2023 Oct;31(10):4422-4429. doi: 10.1007/s00167-023-07455-3. Epub 2023 Jul 18.
PURPOSE
The study sought to investigate the effectiveness of a cryocompression Game Ready™ (GR) versus usual care protocol (UC) on early post-operative recovery following total knee arthroplasty.
METHODS
This study prospectively randomised 72 total knee arthroplasties to a 2-week (from day 0) intervention of GR treatment (n = 36, 63.9% females) or UC of ice with static compression (n = 36, 45.7% females). Knee flexion and extension range of motion (ROM), a visual analogue pain scale and limb circumference were documented at day 1, 2 and 14, as well as 6 weeks post-surgery. Medication usage and length of hospital stay were documented. Patient-reported outcome measures (PROMs) included the Knee Injury and Osteoarthritis Outcome Score and a Patient Satisfaction Questionnaire. Statistical analysis using linear mixed modelling and analysis of variance table with Satterthwaite's method were used along with two-tailed t-tests.
RESULTS
There were no significant group-by-time interactions regarding any of the outcomes. The GR group had 19% lost to follow-up at 2 weeks, while the UC group had 8%. The GR group demonstrated significantly better knee extension ROM at day 1 (p = 0.048) and day 14 (p = 0.007) compared with the UC group. There were no group differences (n.s.) observed in pain, flexion ROM, limb circumference, opioid use or PROMs. Overall, higher pain levels resulted in increased opioid intake (p = 0.002), older patients used significantly less opioids (p < 0.001) and males reported significantly less pain than females (p = 0.048). No adverse effects were observed due to either protocol.
CONCLUSION
Despite patients gaining significantly more knee extension during the initial two-week intervention period when using GR compared to UC, this effect was likely due to chance. No further significant differences were observed between the groups during or after cession of the intervention.
LEVEL OF EVIDENCE
Level 2.
目的
本研究旨在探究冷冻压缩治疗（Cryocompression）与常规护理方案（Usual care protocol）对全膝关节置换术后早期康复的影响。
方法
本研究前瞻性地将 72 例全膝关节置换术患者随机分为为期两周（从第 0 天开始）的干预组，接受冷冻压缩治疗（n=36，63.9%为女性）或常规护理方案（n=36，45.7%为女性）。分别在术后第 1、2 和 14 天以及术后 6 周记录膝关节屈伸活动范围（Range of motion，ROM）、视觉模拟疼痛评分（Visual analogue pain scale）和肢体周长。记录用药情况和住院时间。患者报告的结局测量（Patient-reported outcome measures，PROMs）包括膝关节损伤和骨关节炎结果评分（Knee Injury and Osteoarthritis Outcome Score）和患者满意度问卷。使用线性混合模型和方差分析表进行统计分析，并结合双尾 t 检验。
结果
在任何结果方面，组间均无显著的时间交互作用。冷冻压缩治疗组在第 2 周有 19%的患者失访，而常规护理组有 8%。与常规护理组相比，冷冻压缩治疗组在术后第 1 天（p=0.048）和第 14 天（p=0.007）的膝关节伸展 ROM 显著更好。两组在疼痛、屈曲 ROM、肢体周长、阿片类药物使用或 PROMs 方面均无差异（无统计学意义）。总体而言，疼痛程度越高，阿片类药物的摄入量就越大（p=0.002），年龄较大的患者使用的阿片类药物明显较少（p<0.001），男性的疼痛程度明显低于女性（p=0.048）。两种方案均未观察到不良反应。
结论
尽管与常规护理相比，冷冻压缩治疗在最初的两周干预期间使患者的膝关节伸展明显增加，但这种效果可能是偶然的。在干预结束后，两组之间没有观察到进一步的显著差异。
证据等级
2 级。
Zotero 插件