S83 M23
Conditions
Interventions
Group 1: Standard of care + Use of the app
Group 2: Standard of care
Sponsors
Orthopy Health GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Confirmed diagnosis - M23.61 (Internal injury of knee joint anterior cruciate ligament) orS83.53 (Rupture of the anterior cruciate ligament) - From the age of 18 - Planned surgical reconstruction (Arthroscopic,autologous tendoplasty) - Participants are capable of giving consent, have full legal capacity and understand the nature, extent, significance and consequences of examination and treatment - Informed consent to participate - Rupture of the anterior cruciate ligament and planned surgery less than than 6 months apart - Possession of and sufficient skills in the use of a Smartphone (iOS or Android operating system) - Willingness and existing technical to use the Orthopy app - Sufficient knowledge of German language
Exclusion criteria
Exclusion criteria: - Bucket handle lesion of a meniscus - Cartilage damage > ICRS II° - Complete second ligament injury with indication for intervention - Multi-ligament injuries - Knee joint dislocation - Neurological damage/basic diseases - Pre-surgery of the lower extremities - Pregnancy - Underlying rheumatic disease - Non-compliance - Chronic pain patients - CE-determined app use exclusions: Rheumatic, neuromuscular, or general systemic disease; obesity (BMI = 30); neoplastic disease; metabolic disease; inflammatory and systemic disease; autoimmune disease; immunocompromised patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in health status based on the KOOS (knee injury and osteoarthritis outcome score). The primary outcome will be collected: at enrollment, after 3 Weeks, 1 day pre surgery, 2 weeks post surgery, 6 weeks post surgery, 10 weeks post surgery, 14 weeks post surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Kinesiophobia (TAMPA scale) subjective pain level (numeric VAS), subjective function (numeric VAS), subjective patient satisfaction (numeric VAS) Physical therapy/ lymphatic drainage needed (yes/no), ability to work (yes/no) patient-relevant structural and procedural improvements (pSVV) Exploratory medical endpoints: Thigh circumference, and lower leg circumference and patellar center. Angular measurements (range of motion) Stability test (anteroposterior stability of the knee joint). End of study only: Coordination, quick strength, and agility Exploratory endpoints on app use (intervention group only) via custom-developed questions. | — |
Countries
Germany
Outcome results
None listed