RESUMO
INTRODUCTION: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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 OF EVIDENCE: Level I.