S83.53
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - acute unilateral rupture of the anterior cruciate ligament - Indication for surgical reconstruction (arthroscopic, semitendinosus-gracilis tendoplasty) - Participants are capable of giving consent, have full legal capacity and understand the nature, extent, significance and consequences of the examination - Rupture and surgery less than 6 months
Exclusion criteria
Exclusion criteria: - bucket handle lesion of a meniscus - cartilage damage >ICRS II - complete second ligament injury with indication for intervention - multi-ligament injury - Rupture and surgery more than 6 months apart - Neurological damage and underlying disease - Pre-operations on the lower extremities - Pregnancy - Underlying rheumatic disease - Non-compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Validation of the Orthelligent system related to the subjective IKDC (International Knee Documentation Committee) after 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Validation of the Orthelligent system related to subjective IKDC after 6 months. Equivalence or superiority of sensor-assisted post-treatment compared to standard therapy, related to subjective IKDC and sensor-assisted function test after 3,6 and 12 months. Function, pain level, quality of life, return to work, return to sport. | — |
Countries
Germany
Contacts
ARCUS Kliniken