Petersen Wolf, Ellermann Andree, Henning Jörg, Nehrer Stefan, Rembitzki Ingo Volker, Fritz Jürgen, Becher Christoph, Albasini Alfio, Zinser Wolfgang, Laute Volker, Ruhnau Klaus, Stinus Hartmut, Liebau Christian
Klinik für Orthopädie und Unfallchirurgie, Martin Luther Krankenhaus, Grunewald, Caspar Theyß Strasse 27-31, 14193, Berlin, Germany.
Arcus Sportklinik, Rastatter Straße 17, 75179, Pforzheim, Germany.
Arch Orthop Trauma Surg. 2019 Feb;139(2):155-166. doi: 10.1007/s00402-018-3040-8. Epub 2018 Sep 25.
The use of an unloader brace is a non-surgical treatment option for patients with medial osteoarthritis (OA). However, many patients do not adhere to brace treatment, because of skin irritation due to the pads at the level of the joint space and bad fit. A new concept to unload the medial compartment of the knee is a foot ankle brace with a lever arm pressing the thigh in valgus. The aim of this prospective randomized trial was to examine the outcomes of patients with medial OA after treatment with a conventional knee unloader brace (Unloader One) and the new foot ankle orthosis (Agilium FreeStep).
For this multicenter trial, 160 patients (> 35 years) with medial OA were randomly allocated to treatment with a conventional knee unloader brace (Unloader One) or treatment with the new knee OA ankle brace (Agilium FreeStep). The primary outcome measure was pain (numerical analog scale) at baseline (T0), 8 weeks (T1), and 6 months (T2). Secondary outcome measures were knee function (Knee Injury and Osteoarthritis Outcome Score, KOOS), side effects, additional interventions, and compliance.
In both groups, walking pain improved between T0 and T1 and also between T0 and T2 without a significant group difference. For pain at sports, both groups showed a significant improvement between T0 and T2 without a significant group difference. The KOOS subscales symptoms, pain, activity, sport, and quality of life increased significantly in both treatment groups without any significant group differences at T 0, T1, and T2. There was also no significant group difference in additional interventions and weekly or daily brace use. In the Agilium FreeStep group (23.5%), significantly less patients reported bruises in contrast to the Unloader One group (66.7%).
The results of this clinical trial show that the foot ankle brace is as effective as a conventional knee unloader brace for the treatment of medial knee OA with regard to clinical outcome. The rate of side effects such as bruises was significantly lower in the Agilium FreeStep group.
DRKS00009215, 13.8.2015.
对于内侧骨关节炎（OA）患者，使用卸载支具是一种非手术治疗选择。然而，许多患者不坚持支具治疗，因为关节间隙处的垫子会引起皮肤刺激且佩戴不合适。一种用于减轻膝关节内侧间室负荷的新概念是带有杠杆臂的足踝支具，该杠杆臂可将大腿向外推。这项前瞻性随机试验的目的是研究内侧OA患者在使用传统膝关节卸载支具（Unloader One）和新型足踝矫形器（Agilium FreeStep）治疗后的疗效。
在这项多中心试验中，160例年龄大于35岁的内侧OA患者被随机分配接受传统膝关节卸载支具（Unloader One）治疗或新型膝关节OA足踝支具（Agilium FreeStep）治疗。主要结局指标是基线（T0）、8周（T1）和6个月（T2）时的疼痛（数字模拟量表）。次要结局指标包括膝关节功能（膝关节损伤和骨关节炎结局评分，KOOS）、副作用、额外干预措施和依从性。
在两组中，步行疼痛在T0至T1之间以及T0至T2之间均有所改善，且两组间无显著差异。对于运动时的疼痛，两组在T0至T2之间均有显著改善，且两组间无显著差异。在T0、T1和T2时，两个治疗组的KOOS子量表症状、疼痛、活动、运动和生活质量均显著增加，且两组间无任何显著差异。在额外干预措施以及每周或每日支具使用方面，两组间也无显著差异。与Unloader One组（66.7%）相比，Agilium FreeStep组报告有瘀伤的患者明显更少（23.5%）。
这项临床试验的结果表明，就临床结局而言，足踝支具在治疗膝关节内侧OA方面与传统膝关节卸载支具一样有效。Agilium FreeStep组的瘀伤等副作用发生率显著更低。
DRKS00009215，2015年8月13日。
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