ACL rupture Rupture Cruciate Ligament
Conditions
Interventions
None listed
Sponsors
Xpert Orthopedie
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Acute primary rupture of the anterior cruciate ligament * Signed patient informed consent * Willingness to present for follow-up * Age between 18 and 50 years at the time of inclusion in the study * Injury - surgery time interval of 21 days or less * BMI
Exclusion criteria
Exclusion criteria: * Co-morbidity influencing the outcome of the implant. * Hypersensetivity to metals. * Not being able to fill in the Dutch Questionnaires. * Osteo arthritis Kelgren grade 2 or more on conventional x-ray * Medical non-compliance * Unwillingness to follow the rehabilitation programme * Traumatic cartilage lesion requiring cartilage repair procedure (Microfracturing, MACI, ACT) or degenerative cartilage lesions (Outerbridge >ll and defect >1cm2) * Non-repairable meniscus lesions requiring a resection of >20% * Previous tendon removal on injured leg * Relevant permanent medication (Steroids, cytostatic drugs, ...) * Pregnancy * Reumatoid arthritis * Instability of the contralateral leg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Our primaire endpoint is the stability compared to the contralateral leg measured by a KT1000 test will be performed. This non invasive test provides an objective assessment of the amount of increased anterior knee translation between 20 and 30 degrees of knee flexion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Our secondary endpoints are the Tegner, IKDC, NRS pain and NRS instability scores. These are knee specific questionnaires specifically designed to measure outcome after knee surgery. | — |
Countries
Netherlands
Outcome results
None listed