se of a smartphone application (Orthopy App) to improve preoperative and postoperative therapy in patients with ACL rupture compared to conventional standard of care treatment - a randomized, monocentric study.
- Conditions
- S83M23Dislocation, sprain and strain of joints and ligaments of kneeInternal derangement of knee
- Registration Number
- DRKS00028028
- Lead Sponsor
- Orthopy Health GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 80
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
- 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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in health status based on the KOOS (knee injury and osteoarthritis outcome score).<br><br>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<br>
- Secondary Outcome Measures
Name Time Method Kinesiophobia (TAMPA scale)<br><br><br>subjective pain level (numeric VAS),<br>subjective function (numeric VAS), <br>subjective patient satisfaction (numeric<br>VAS)<br><br>Physical therapy/ lymphatic drainage needed (yes/no), ability to work (yes/no) <br><br>patient-relevant structural and procedural<br>improvements (pSVV)<br><br>Exploratory medical endpoints:<br>Thigh circumference, and lower leg circumference and patellar center.<br>Angular measurements (range of motion)<br>Stability test (anteroposterior stability of the knee joint).<br><br>End of study only: Coordination, quick strength, and agility<br><br>Exploratory endpoints on app use (intervention group only) via custom-developed questions.<br>