Multi-centre, randomised, controlled, single-blinded clinical trial to prove the effectiveness of an active motion device (CAMOped) for home-use in the treatment of ruptures of the anterior cruciate ligament in addition to standardised physiotherapy rehabilitation.
- Conditions
- S83.53
- Registration Number
- DRKS00021739
- Lead Sponsor
- OPED GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 105
planned surgical treatment of a rupture of the anterior cruciate ligament
- Poor compliance or mental disorders
- Non-consentability
- Participation in another clinical study -Acute or chronic injury / restriction of the contralateral side
- Luxation of the knee joint
- Injury to the posterior cruciate ligament (from Schenck II)
- Sideband injury (MSB and LSB) > Grade I
- Cartilage damage in need of intervention that leads to a modification of the post-treatment scheme
- Operation of the lower extremity in the last 6 months
- Recurrent knee surgery, ACL revision surgery
- Neurological diseases
- Basic muscular diseases
- Injuries to the ankle or hip joint
- Clinical Gonarthrosis
- Chronic anteroposterior instability, chronic meniscopathy, cartilage defects or other diseases of the knee joint
- Limitation of movement through surgical procedures
- Postoperative infection (exclusion in ongoing study)
- Condition after deep vein thrombosis of the legs
- Clinically relevant pAVK
- Passive ROM < 70°
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Superiority of the improvement of joint function (range of motion, pain, swelling) in surgical treatment of a rupture of the anterior cruciate ligament through the additional use of an active motion device compared to the sole standardised physiotherapeutic rehabilitation after 6 weeks
- Secondary Outcome Measures
Name Time Method