se of a smartphone application (Orthopy App) to improve pre- andpostoperative therapy in patients after anterior cruciate ligament rupture(with or without meniscal damage) or meniscal damage alone comparedto conventional standard of care treatment - a randomized, controlled,multicenter study

Not Applicable

Recruiting

Conditions: M23.61
S83.53
M23.2
M23.3
S83.2
Derangement of meniscus due to old tear or injury
Other meniscus derangements
Tear of meniscus, current

Registration Number: DRKS00032793

Lead Sponsor: Orthopy Health GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 400

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
KOOS (knee injury and osteoarthritis outcome score) Subscale Symptoms

Secondary Outcome Measures

Name	Time	Method
a. KOOS Pain subscale<br>b. Subjective pain level (numerical VAS)<br>c. Subjective function (numerical VAS)<br>d. KOOS Activities of Daily Living subscale<br>e. KOOS Quality of Life subscale<br>f. KOOS Sport subscale