Abstract
Objectives:
Meniscus injuries are a common cause of knee dysfunction, often requiring surgical intervention such as meniscus repair or meniscectomy. They also frequently occur as concomitant injury in anterior cruciate ligament (ACL) ruptures. Effective pre- and postoperative rehabilitation is critical for optimizing outcomes, yet access to timely physiotherapy can be limited. Digital health applications offer a promising solution to enhance patient education and rehabilitation continuity. This prospective multicenter randomized controlled trial (RCT) evaluates the efficacy of a digital health application (Orthopy) combined with standard care compared to standard care alone in patients with meniscus and ACL injuries.
Methods:
Patients aged 18 years or older with a confirmed diagnosis of isolated or concomitant meniscus injury and planned surgical intervention were enrolled between 10/2023 and 02/2025 at 4 different study sides (n=304). Patients with a Knee Injury and Osteoarthritis Outcome Scores (KOOS) of ≤ 85 across all subscales indicating significant knee dysfunction (n=227) before surgery were included in this analysis. Patients were randomized to either the intervention group (Orthopy app plus standard of care, including conventional orthopedic and physiotherapeutic measures) or the control group (standard of care alone). Baseline data (t0) were collected, followed by a pre-surgery period (2–6 weeks) and a post-surgery period (14 weeks). Interim assessments occurred via online questionnaires at t1 (if >2 weeks pre-surgery), t3, t4, and t5 (post-surgery), with clinical evaluations at t1 (pre-surgery) and t5 (14 weeks post-surgery). The primary outcome was the KOOS Symptoms and Function, with secondary outcomes including other KOOS subscales (pain/ ADL/ QoL) as well as subjective pain and function assessed via the Visual Analogue Scale (VAS). The analysis was conducted using mixed model repeated measures (MMRM), and the results are presented as estimated marginal means (EMM).
Results:
The intervention group (gender: 40 f, 64 m; age: 47 ± 16 years), using the Orthopy app alongside standard of care, demonstrated an EMM improvement of 23.8 points in the KOOS Symptoms subscale at t5 and thus a significantly greater improvement compared to the control group (gender: 51 f, 72 m; age: 45 ± 15 years) with a EMM between-group difference of 5.5 points (p = 0.016). Secondary outcomes at final follow-up, namely KOOS pain and VAS pain, further supported the superiority of the digital intervention, with an EMM difference of 4.65 (p = 0.047) for KOOS pain and -0.74 (p = 0.003) for VAS pain. Significant reductions in pain and symptoms were also observed at multiple time points.
Conclusion:
Integrating the Orthopy app with standard care enhances post-operative outcomes in patients with isolated and concomitant meniscus injuries, offering a safe and effective tool to support rehabilitation compared to standard of care alone.