Anterior cruciate ligament rupture (S83.53, M23.61) or Anterior cruciate ligament rupture (S83.53, M23.61) with injury of the meniscus (M23.3, S83.2) S83.53 M23.61 M23.3 S83.2
Conditions
Interventions
Group 1: Surgical cohort - intervention group:
Patients who are medically determined to require surgical treatment and randomized to the intervention group will receive access to the Novio Knee app fo
Sponsors
LIME medical GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Possession of an app-enabled smartphone with Internet access that meets the app's compatibility requirements - Own e-mail address for registration - Willingness to use the app regularly and to participate in other study-related measures (visits, surveys, etc.) - For the OV cohort: = 2 weeks and = 6 weeks between study inclusion and surgery
Exclusion criteria
Exclusion criteria: - Insufficient knowledge of German - Expected insufficient compliance (e.g. due to severe mental illness) - Pregnancy - Previous or ongoing treatment with Novio Knee or a comparable digital application in the investigated indication area - Dizziness or impaired perception, e.g. due to taking specific (long-term) medication - Lack of clearance to exercise the knee - Fever, flu-like infection - Uncontrolled or uncontrolled acute and chronic inflammatory diseases - Infections or signs of infection in the knee joint after an operation - Cardiac, pulmonary, neurological and vascular risk factors that speak against the use of the intervention or participation in the study - Serious mental illness that does not allow participation in the study (e.g. severe depression, borderline) - Injury occurred more than 8 weeks ago at the time of study inclusion - Other injuries or diseases of the musculoskeletal system for which training with Novio Knee is not possible from the doctor's point of view - Re-rupture of the cruciate ligament - Osteoarthritis in the affected knee joint (Kellgren > II) - Multiligament injuries with more than 3 ligament lesions - Bony tears of the anterior cruciate ligament - Accompanying cartilage damage as soon as this is treated surgically - Dislocation of the knee - Intra-articular or periarticular fractures - Oncological diseases such as malignant tumors or metastases - Bone metabolism disorders such as known osteoporosis - Coagulation disorders, e.g. increased tendency to bleed - Severe or acute cardiovascular diseases Severe or acute metabolic diseases, e.g. uncontrolled diabetes mellitus - Autoimmune diseases that speak against participation in the study, e.g. rheumatoid polyarthritis - Other (acute) injuries or illnesses which, in the opinion of the study physician, would influence the treatment regimen planned for the study (e.g. pre- and post-operative phases in surgical cases) or could distort the study results and/or for which training with Novio Knee is not possible Contraindications of the medical device: - H54.0 Blindness and severe visual impairment, binocular - I26 Pulmonary embolism - I50 Heart failure - J18 Pneumonia - I80.2 Thrombosis, phlebitis and thrombophlebitis, other deep vessels of the lower extremities - M22.0 Habitual dislocation of the patella - M23.4 Free joint body in knee joint - M24.07 Free joint body: ankle and foot (tarsus, metatarsus, toes, ankle, other joints of foot) - M00 Purulent arthritis - M01 Direct joint infections in infectious and parasitic diseases classified elsewhere
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| KOOS = Knee Injury and Osteoarthritis Outcome Score - KOOS-Pain - KOOS-Activity of daily living - KOOS-Symptoms - Numeric Pain Rating Scale - NPRS Measurement time points of operational cohort: - T0 (baseline survey) - T1 (3-5 days pre-op) - T2 (3-5 days post-operative) - T3 (interim survey 2 weeks post-op) - T4 (interim survey 6 weeks post-op) - T5 (final survey after 12 weeks post-op) Measurement time points conservative cohort: - T0 (baseline survey) - T1 (interim survey 2 weeks after baseline) - T2 (interim survey 6 weeks after baseline) - T3 (interim survey 12 weeks after baseline) | — |
Secondary
| Measure | Time frame |
|---|---|
| - KOOS-Quality of Life - KOOS Sports - Safety (AE, SAE, etc.) Measurement time points: see above | — |
Countries
Germany
Contacts
Public ContactPhilip Rößler
Gelenkzentrum Mittelrhein
Outcome results
None listed