S83.53
Conditions
Interventions
Group 1: Augmentation of the anterior cruciate ligament, dynamic intraligamentary stabilization.
Clinical follow-up will be performed after 6 weeks, 3 (optional), 6, 12, 24 months.
Sponsors
Mathys Orthopädie GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Primary tear of the anterior cruciate ligament • Signed by the patient Consent form. • readiness of the patient's follow-up appointments Observed. • Age between 18 and 65 years at the time of Study inclusion. • Time interval between trauma and surgery 21 days • Meniscal suture
Exclusion criteria
Exclusion criteria: 1.Medical non-compliance 2.Unwillingness to follow the rehabilitation programme 3.Traumatic cartilage lesion requiring cartilage repair procedures (Microfracturing, MACI, ACT) or degenerative cartilage lesions (Outerbridge >II and defect >1cm2) 4.Non-repairable meniscus lesions requiring a resection of >20% 5.Previous tendon removal on injured leg 6.Relevant permanent medication (steroids, cytostatic drugs, …) 7.Pregnancy (Before the beginning of the trial, women capable of childbearing will be tested for pregnancy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary patient outcomes will include improvement in knee joint stability (Lachman test), knee joint function (Lysholm Score, IKDC Score); safety. Follow-up •6 weeks •3 months (optional) •6 months •12 months •24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| •Patient satisfaction •Work Absence After 3 months | — |
Countries
Germany
Contacts
Public ContactNatividad Zeleny
Mathys Orthopädie GmbH
Outcome results
None listed