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.

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. - CAn MObility Postoperatively Enhance Direct rehabilitation (CAMOPED)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00021739

Enrollment

120

Registered

2020-05-27

Start date

2020-06-08

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

S83.53

Interventions

Group 1: Treatment group receives a standardized physiotherapeutic rehabilitation and additionally a continuous active motion device, for use in a home environment daily for 4x 15-30 minutes. The use

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: planned surgical treatment of a rupture of the anterior cruciate ligament

Exclusion criteria

Exclusion criteria: - 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°

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Safety, benefit assessment, medical necessity - Joint function after 3 and 6 weeks and in the long-term after 1 and 2 years (mechanical and functional stability, coordination and proprioception) - pain reduction after 3 and 6 weeks, change in the intake of pain medication - effusion regression, wound closure after 3 and 6 weeks - Achievement of individual targets (Goal attainment scale; GAS) - Time to return to the ability to work under pressure (sports / ability to work again) - Reduction of muscle atrophy of the affected quadriceps muscle - Differences in rehabilitation depending on the chosen surgical procedure (short-term and long-term) - Frequency, length and step count of use - Frequency of re-ruptures and surgical interventions or revision interventions - health-related quality of life, self-confidence - Time to start physiotherapy, time to reach the predefined 12 physiotherapy meetings - Economy in domestic use (economic analysis) - Reduction of disturbed rehabilitation and late complications - Usability - Benefit/risk assessment - Validation of sonography as an additional measuring instrument for therapy decisions and return to sports / competition - Validation of the modified IKDC 2000 (IKDC-OPED) as a quantifiable measure for an objective decision to return to (competitive) sport - Non-inferiority of the continuous active motion device compared to the continuous passive motion device in the rehabilitation of patients with intraoperative treatment of a concomitant injury requiring intervention, leading to a change in the post-treatment regimen	—

Measure

Time frame

Safety, benefit assessment, medical necessity - Joint function after 3 and 6 weeks and in the long-term after 1 and 2 years (mechanical and functional stability, coordination and proprioception) - pain reduction after 3 and 6 weeks, change in the intake of pain medication - effusion regression, wound closure after 3 and 6 weeks - Achievement of individual targets (Goal attainment scale; GAS) - Time to return to the ability to work under pressure (sports / ability to work again) - Reduction of muscle atrophy of the affected quadriceps muscle - Differences in rehabilitation depending on the chosen surgical procedure (short-term and long-term) - Frequency, length and step count of use - Frequency of re-ruptures and surgical interventions or revision interventions - health-related quality of life, self-confidence - Time to start physiotherapy, time to reach the predefined 12 physiotherapy meetings - Economy in domestic use (economic analysis) - Reduction of disturbed rehabilitation and late complications - Usability - Benefit/risk assessment - Validation of sonography as an additional measuring instrument for therapy decisions and return to sports / competition - Validation of the modified IKDC 2000 (IKDC-OPED) as a quantifiable measure for an objective decision to return to (competitive) sport - Non-inferiority of the continuous active motion device compared to the continuous passive motion device in the rehabilitation of patients with intraoperative treatment of a concomitant injury requiring intervention, leading to a change in the post-treatment regimen

—

Countries

Germany

Contacts

Public ContactCaroline Schmidt - Lucke

Mediacc GmbH

Caroline.Schmidt-Lucke@mediacc.de+49-30-52104480

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026