M23.61 S83.53
Conditions
Interventions
Group 1: Intervention group: Use of a smartphone app in addition to standard care for patients with an anterior cruciate ligament tear.
Study subjects are to use the app three times a week.
Group 2: C
Sponsors
Orthopy Health GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. One of the following confirmed diagnoses: o M23.61 Internal injury of the knee joint—anterior cruciate ligament o S83.53 Tear of the anterior cruciate ligament 2. Aged 18 or older 3. Planned surgical treatment with autologous tendoplasty for cruciate ligament rupture 4. Less than 3 months between injury and study enrollment 5. At least moderate knee pain with a score of = 3 on a verbal numerical rating scale (VNRS) at the enrollment visit (Baseline t0) 6. Maximum moderate knee function with a score of = 7 on a verbal numerical rating scale (VNRS) at the enrollment visit (Baseline t0) 7. Ownership of and sufficient knowledge and skills in using a smartphone (iOS or Android operating system) 8. Willingness and existing technical requirements (email and internet access) to use the Orthopy app 9. Willingness to train regularly with the app and participate in study surveys 10. Sufficient knowledge of German 11. Participants are capable of giving their consent, have full legal capacity, and understand the nature, scope, significance, and consequences of the examination and treatment 12. Consent to participate after receiving informed consent
Exclusion criteria
Exclusion criteria: 1. No planned surgical treatment of the anterior cruciate ligament 2. Planned hospital stays or surgical procedures during the study period that are not related to the intervention in this study 3. Regular use of WHO-grade = 2 analgesics prior to the enrollment date (baseline t0) 4. Meniscal root tear (meniscal lesions) 5. Surgical treatment of a second ligament injury 6. Cartilage damage requiring regenerative therapy 7. Knee joint dislocation 8. Re-rupture of the anterior cruciate ligament 9. Pregnancy 10. Patients with chronic pain (Pain persistence > 3 months or regular use of pain medication regardless of the current injury) 11. Use of the Orthopy app or similar health apps at study enrollment, in the past, or planned during the study period 12. The participant is currently enrolled in another clinical trial 13. Other diseases and conditions that, in the investigator’s judgment, preclude participation in the study 14. Manufacturer-specific exclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| KOOS subscale – Symptoms and Function The assessment time points are: t0: at least 28 days before surgery t1: 1 day before surgery t2: 3 days after surgery t3: 2 weeks after surgery t4: 6 weeks after surgery t5: 10 weeks after surgery t6: 14 weeks after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| b) KOOS-ACL subscale – Function c) VAS Pain d) LERAS-13 e) KOOS subscale – QoL f) Angle Reproduction test The assessment time points are: t0: at least 28 days before surgery t1: 1 day before surgery t2: 3 days after surgery t3: 2 weeks after surgery t4: 6 weeks after surgery t5: 10 weeks after surgery t6: 14 weeks after surgery | — |
Countries
Germany
Contacts
Public ContactGerrit Bode
Praxisklinik 2000
Outcome results
None listed