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Investigation of the effectiveness of integrated care using the Orthopy app in addition to usual care compared to usual care alone in patients with meniscal lesions – a randomized, controlled, multicenter trial

Investigation of the effectiveness of integrated care using the Orthopy app in addition to usual care compared to usual care alone in patients with meniscal lesions – a randomized, controlled, multicenter trial - Orthopy for Knee Injuries - Meniscus

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00039072
Enrollment
328
Registered
2026-04-08
Start date
2026-05-22
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M23.2 M23.3 S83.2

Interventions

Group 1: Intervention group: Postoperative use of a smartphone app in addition to standard orthopedic therapy (usual care) in patients with meniscus injuries. Study subjects are to use the app three t

Sponsors

Orthopy Health GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. One of the following confirmed diagnoses: a. M23.2 Meniscus damage due to old tear or old injury b. M23.3 Other meniscus damage c. S83.2 Meniscus tear, acute 2. Age 18 or older 3. Planned surgical treatment for meniscus lesion 4. Less than 12 months between injury and study inclusion 5. At least moderate knee pain with a score of = 3 on the verbal numerical rating scale (VNRS) at the inclusion visit (baseline t0) 6. Ownership of and sufficient knowledge and skills in using a smartphone (iOS or Android operating system) 7. Willingness and existing technical requirements (email and internet access) to use the Orthopy app 8. Willingness to train regularly with the app and participate in the study surveys/questionnaires 9. Sufficient knowledge of German 10. Participants are able to give their consent, are fully legally competent, and understand the nature, scope, significance, and consequences of the examination and treatment 11. Consent to participate in the study after receiving information

Exclusion criteria

Exclusion criteria: 1. No planned surgical treatment of the meniscus 2. Planned inpatient stays or surgical procedures during the study period that are not related to the intervention in question 3. Regular use of WHO level = 2 analgesics prior to the inclusion date (baseline t0) 4. Root tear (root lesions) on the meniscus 5. In addition to the meniscus lesion, a ligament injury that requires surgical treatment 6. Cartilage damage requiring regenerative therapy 7. Knee joint dislocation 8. Rupture of the anterior cruciate ligament 9. Pregnancy 10. Chronic pain patients (persistent pain > 3 months or regular use of pain medication regardless of the current injury) 11. Use of the Orthopy app or similar health apps at the time of study inclusion, in the past, or planned during the study period 12. The person is participating in another clinical study at the same time 13. Other diseases and conditions that, in the opinion of the investigator, preclude participation in the study 14. Manufacturer-specific exclusion criteria (see section 6.2.3)

Design outcomes

Primary

MeasureTime frame
VAS Pain (t0, t1, t2, t3, t4, t5, t6) Survey using patient questionnaire The time points are: t0: at least 7 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

MeasureTime frame
Health-related quality of life and functional limitations (WOMET) Subjective perception of pain intensity (KOOS subscale pain) Subjective perception of symptoms and functional deficits (KOOS subscale symptoms and function) Objective assessment of proprioceptive abilities (angle position sense test) The time points are: t0: at least 7 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

g.bode@praxisklinik2000.com+49 761 767 6600

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 29, 2026