Schmidt Sebastian, Krahl Daniel, Podszun Judith, Knecht Sophie, Zimmerer Alexander, Sobau Christian, Ellermann Andree, Ruhl Alexander
Department of Sports Medicine, ARCUS Kliniken, Pforzheim, Germany.
Department of Orthopaedic and Trauma Surgery, University Medical Centre Mannheim, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.
Knee Surg Sports Traumatol Arthrosc. 2025 Apr;33(4):1241-1251. doi: 10.1002/ksa.12430. Epub 2024 Aug 27.
Anterior cruciate ligament (ACL) rupture is one of the most common sports injuries. Regardless of the surgical treatment, patients require intensive education about the pathology, therapeutic options and physical therapy. However, it is often not possible for the patient to start physical therapy directly and schedule adequate consultations. Digital health applications are medical devices that can help bridge the gap between physiotherapy sessions and provide qualified, convenient and effective education and treatment. This study is needed to explore alternative methods to ensure continuous and effective rehabilitation for ACL patients who face delays in accessing traditional physiotherapy. The study aimed to compare app-assisted therapy plus standard of care (conventional orthopaedic and physiotherapeutic measures) versus isolated standard of care for patients with planned ACL surgery.
A monocentric, two-arm, 1:1 randomized controlled study examined 80 patients after a cruciate ligament rupture with or without meniscal injury. Patients over 18 years with a confirmed diagnosis of ACL rupture and planned surgical reconstruction using autologous grafts were included. The study criteria additionally included willingness to use the Orthopy app and sufficient German language proficiency. The study excluded patients with severe concomitant injuries, prior knee surgeries, chronic pain conditions and those not compatible with app usage. Patients were randomized and their baseline data (t0) was collected. Subsequently, they received their treatment according to their treatment group. The study included a presurgery period (2-6 weeks) and a postsurgery period (14 weeks). Interim assessments were done via online questionnaires at t1 (if more than 3 weeks before surgery) and t3, t4 and t5 (postsurgery). Additional clinical assessments were conducted at t2 (presurgery) and t6 (14 weeks postsurgery). Primary outcome measures included the knee injury and osteoarthritis outcome score (KOOS), with subjective pain and function levels (numeric rating scale [NRS]) as secondary endpoints.
The clinical trial was able to show positive outcomes on the KOOS Pain and Symptoms subscale of the primary endpoint KOOS in the interventional group compared to the standard of care group. A statistically significant pain reduction could be seen at t1 (p = 0.0005), t2 (p = 0.0068) and t4 (approximately 6 weeks after surgery; p = 0.01). A significant reduction of symptoms at t1 (p = 0.0001), t2 (p = 0.0036) and t6 (p = 0.0377) were recognized. These findings are further supported by the significant benefit of the pain NRS at t4 and positive tendencies at t3, t5 and t6. The KOOS subscales quality of life (p = 0.0066), activities of daily living (p = 0.0009) and Sport (p = 0.0484) showed significant effects before surgery.
The Orthopy app is a medical device that is both safe and effective for use. Combining the Orthopy app and standard of care can significantly improve prehabilitation and rehabilitation in surgical treatment with ACL reconstruction compared with the isolated standard of care.
Level I.
前交叉韧带（ACL）断裂是最常见的运动损伤之一。无论采用何种手术治疗，患者都需要接受关于病理、治疗选择和物理治疗的强化教育。然而，患者往往无法直接开始物理治疗并安排足够的咨询。数字健康应用程序是一种医疗设备，可以帮助弥合物理治疗疗程之间的差距，并提供合格、便捷和有效的教育与治疗。本研究旨在探索替代方法，以确保面临传统物理治疗延迟的ACL患者能够持续有效地康复。该研究旨在比较应用程序辅助治疗加标准护理（传统骨科和物理治疗措施）与计划进行ACL手术的患者单纯接受标准护理的效果。
一项单中心、双臂、1:1随机对照研究对80例有或无半月板损伤的十字韧带断裂患者进行了检查。纳入年龄超过18岁、确诊为ACL断裂且计划使用自体移植物进行手术重建的患者。研究标准还包括愿意使用Orthopy应用程序以及足够的德语能力。该研究排除了伴有严重合并伤、既往膝关节手术史、慢性疼痛疾病以及不适合使用应用程序的患者。患者被随机分组，并收集其基线数据（t0）。随后，他们根据治疗组接受治疗。该研究包括术前阶段（2 - 6周）和术后阶段（14周）。在t1（如果距离手术超过3周）、t3、t4和t5（术后）通过在线问卷进行中期评估。在t2（术前）和t6（术后14周）进行额外的临床评估。主要结局指标包括膝关节损伤和骨关节炎结局评分（KOOS），主观疼痛和功能水平（数字评分量表[NRS]）作为次要终点。
与标准护理组相比，临床试验能够显示干预组在主要终点KOOS的KOOS疼痛和症状子量表上有积极结果。在t1（p = 0.0005）、t2（p = 0.0068）和t4（术后约6周；p = 0.01）可观察到疼痛有统计学意义的减轻。在t1（p = 0.0001）、t2（p = 0.0036）和t6（p = 0.0377）可观察到症状有显著减轻。t4时疼痛NRS的显著益处以及t3、t5和t6时的积极趋势进一步支持了这些发现。KOOS子量表生活质量（p = 0.0066）、日常生活活动（p = 0.0009）和运动（p = 0.0484）在手术前显示出显著效果。
Orthopy应用程序是一种使用安全有效的医疗设备。与单纯的标准护理相比，将Orthopy应用程序与标准护理相结合可以显著改善ACL重建手术治疗中的术前康复和康复效果。
I级。
