Dynamic Intraligamentairy Stabilisation of the acute torn anterior cruciate ligament, a multicenter prospective cohort study.

Completed

Conditions: ACL rupture
Rupture Cruciate Ligament
10043237

Registration Number: NL-OMON47627

Lead Sponsor: Xpert Orthopedie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 150

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 <35
* Tegner score 6 or more

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

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Our primaire endpoint is the stability compared to the contralateral leg<br /><br>measured by a KT1000 test will be performed. This non invasive test provides an<br /><br>objective assessment of the amount of increased anterior knee translation<br /><br>between 20 and 30 degrees of knee flexion.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Our secondary endpoints are the Tegner, IKDC, NRS pain and NRS instability<br /><br>scores. These are knee specific questionnaires specifically designed to measure<br /><br>outcome after knee surgery. </p><br>