M23.61 S83.53 M23.2 M23.3 S83.2
Conditions
Interventions
Group 1: Intervention group:
Pre- and postoperative use of a smartphone app in addition to the orthopedic therapy standard for anterior cruciate ligament tears (with or without meniscal damage) or me
Sponsors
Orthopy Health GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients are eligible for study inclusion if the following criteria are met: - Any of the following confirmed diagnoses: o S83.53 Tear of the anterior cruciate ligament o M23.61 Internal injury of knee joint anterior cruciate ligament o S83.2 Meniscus tear, acute o M23.2- Meniscus damage due to old tear or old injury o M23.3- Other meniscal damage - From 18 years of age - More than 2 weeks between inclusion and surgery - Planned surgical treatment with autologous tendoplasty for cruciate ligament ruptures or planned surgical treatment after meniscus damage - In case of rupture of the anterior cruciate ligament - injury and surgery are less than 6 months apart - Possession and sufficient skills in the use of a smartphone (iOS or Android operating system). - Willingness as well as existing technical requirements (email and internet access) to use the Orthopy App - Willingness to train with the app on a regular basis and participate in the study surveys - Sufficient knowledge of German - Participants are capable of giving consent, have full legal capacity, and understand the nature, scope, significance, and consequences of the examination and treatment - Informed consent to participate
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study if they meet any of the following criteria: - Basket joint lesion, radial tear, root avulsion of a meniscus - Cartilage damage with need for regenerative therapy - Second ligament injury treated surgically - Multi-ligament injuries - Knee joint dislocation - Re-rupture of the anterior cruciate ligament - Pregnancy - Expected non-compliance with regard to therapy - Chronic pain patients - Use of the Orthopy app or similar health apps at study enrollment or in the past. - Participation in another study - CE determined exclusions: o I26 Pulmonary embolism o I50 Heart failure o J18 Pneumonia o I80.2 Thrombosis, phlebitis and thrombophlebitis of other deep vessels of the lower extremities o M22.0 Habitual dislocation of the patella o M23.4 Free joint body in knee joint o M24.07 Free joint body: ankle and foot (tarsus, metatarsus, toes, ankle, other joints of the foot) o M00 Purulent arthritis o M01 Direct joint infections in infectious and parasitic diseases classified elsewhere. - Other diseases and conditions that, based on the investigator's assessment, militate against study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| KOOS (knee injury and osteoarthritis outcome score) Subscale Symptoms | — |
Secondary
| Measure | Time frame |
|---|---|
| a. KOOS Pain subscale b. Subjective pain level (numerical VAS) c. Subjective function (numerical VAS) d. KOOS Activities of Daily Living subscale e. KOOS Quality of Life subscale f. KOOS Sport subscale | — |
Countries
Germany
Contacts
Public ContactGerrit Bode
Praxisklinik 2000
Outcome results
None listed