基于血流限制技术的多功能膝关节护具研制及应用研究

作者	单位	邮编
曲良^*	中国人民解放军海军第九七一医院骨科（军队临床培育专科）,山东青岛,266071	266071
牛大伟	中国人民解放军海军第九七一医院骨科（军队临床培育专科）,山东青岛,266071	266071
赵金柱	中国人民解放军海军第九七一医院骨科（军队临床培育专科）,山东青岛,266071	266071
孙培锋	中国人民解放军海军第九七一医院骨科（军队临床培育专科）,山东青岛,266071	266071
陶春生^*	中国人民解放军海军第九七一医院骨科（军队临床培育专科）,山东青岛,266071	266071

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中文摘要:

目的介绍一种基于血流限制技术原理设计的多功能膝关节护具，评价该护具在膝关节前交叉韧带重建术后患者功能康复中的应用效果。方法自主研制一种具有个体化血流限制功能的膝关节护具，主要由可调节屈伸角度主体结构及近端可调节肢体加压袖带组成。为验证其应用效果，对2022年12月至2024年8月在中国人民解放军海军第九七一医院骨科接受膝关节前交叉韧带重建手术患者61例进行回顾性分析，按术后康复过程使用护具类型设多功能护具组（n=32）与传统护具组（n=29）。多功能护具组使用膝关节多功能护具，传统护具组使用常规铰链式膝关节护具。比较两组患者在术前，术后4周、12周时主动屈膝最大活动度、健-患侧股四头肌肌肉围度差、训练后即刻疼痛VAS评分和膝关节Lysholm评分，并记录两组术后并发症等指标。结果所有患者随访3～9个月，平均（4.77±1.32）个月。两组在术后4周时主动屈膝最大活动度比较，差异无统计学意义（P＞0.05），术后12周时多功能护具组主动屈膝最大活动度优于传统护具组（P＜0.05）；两组术前均存在患侧大腿肌肉萎缩，术后12周时多功能护具组对延缓大腿肌肉萎缩的效果优于传统护具组（P＜0.05）；比较两组训练后即刻疼痛水平，术后4周、12周训练后即刻VAS评分比较无统计学意义（均P＞0.05）；术前两组患者Lysholm评分比较，差异无统计学意义（P＞0.05）；术后4周、12周时多功能护具组的Lysholm评分均高于传统护具组（均为P＜0.05）。所有受试者护具使用过程均无肢体感觉麻痹、晕厥、下肢静脉血栓形成、横纹肌溶解等并发症发生，在多功能护具组中出现2例肢体加压处皮肤瘀斑，次日自行消退缓解。结论基于血流限制技术原理设计的多功能膝关节护具具备良好便携性和可操作性，能够改善前交叉韧带重建术后患者关节活动度，延缓和改善大腿肌肉萎缩，不增加患者疼痛感，有利于加速膝关节术后患者早期功能康复。

英文摘要:

Objective To introduce a multifunctional knee brace designed based on the principle of blood flow limitation technology, and to evaluate the application effect of this brace in the functional rehabilitation of patients after anterior cruciate ligament reconstruction of the knee.Methods An independently developed knee joint brace with an individualised blood flow restriction function was created, consisting mainly of an adjustable main structure with flexion and extension angles, and a proximal adjustable limb compression cuff. To verify its effectiveness, we retrospectively analysed 61 patients who underwent knee ACL reconstruction surgery in the department of orthopaedics at No. 971 Hospital of the People's Liberation Army Navy (Military Clinical Training and Incubation Specialty) between December 2022 and August 2024. The patients were divided into two groups according to the type of brace used in the postoperative rehabilitation process: The multifunctional brace group (n=32) and the traditional brace group (n=29). The multifunctional brace group used the knee multifunctional brace reported in this article, and the traditional brace group used a commercially available conventional hinged knee brace. The two groups were compared in terms of maximum active knee flexion mobility, healthy-affected thigh circumference difference, immediate post-training pain VAS scores and knee Lysholm scores at preoperative, 4 and 12 weeks postoperatively, and postoperative complications were recorded in both groups.Results All patients were followed up for 3 to 9 months, with a mean of (4.77±1.32) months. The maximum active knee flexion mobility of the two groups at 4 weeks postoperatively was not statistically significant (P>0.05), and the maximum active knee flexion mobility of the multifunctional brace group was better than that of the traditional brace group at 12 weeks postoperatively (P<0.05); the affected thigh muscle atrophy existed in the preoperative period of the two groups, and the multifunctional brace group had a better effect than the traditional brace group on delaying the thigh muscle atrophy at 12 weeks postoperatively (P<0.05). Comparing the immediate post-training pain levels of the two groups, there was no statistically significant difference in the comparison of the VAS scores at 4 and 12 weeks postoperatively immediately after training (both P>0.05); there was no statistically significant difference in the comparison of Lysholm scores of the patients in the two groups preoperatively (P>0.05); and Lysholm scores of the multifunctional brace group were higher than those of the traditional brace group at 4 and 12 weeks postoperatively (both P<0.05). There were no complications such as limb sensory paralysis, fainting, lower extremity venous thrombosis, rhabdomyolysis, etc. in all subjects during the use of the protective gear, and there were two cases of skin ecchymosis at the pressurized place of the limb in the multifunctional protective gear group, which subsided and relieved by themselves on the next day.Conclusion The multifunctional knee brace, which is based on blood flow restriction technology, is portable and easy to maneuver. It improves joint mobility after ACL reconstruction and delays and improves thigh muscle atrophy without increasing patient pain. This accelerates early functional rehabilitation after knee surgery.

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