Anterior Cruciate Ligament Rupture M23.51 S83.51
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Primary rupture of anterior cruciate ligament (for randomization) - for the accessory controll group (study arm No 3, ACL Revision with Quadriceps tendon graft) a rerupture after primary ACL reconstruction/suture is inclusion criterion - Age 16-60 years - Signed informed consent, study and privacy agreements - Succesfully completed all standard preoperative procedures especially from anaesthesological und surgical point of view - Willing to participate on follow-up examinations. - Minor concomitant injuries such as small meniscus lesions (<1/3 partial meniscectomy or minor sutures), I-II° MCL instability, bone bruise without relevant chondral lesions or hemarthros are acceptable for inclusion.
Exclusion criteria
Exclusion criteria: - No compliance - Denial of participating in rehabilitation program - Severe traumatic or degenerative chondral or meniscal injuries - Multiligamental injuries/instability of higher grades (LCL, PCL or III° MCL) - Prior donation/extraction of tendon grafts at the same leg (except for the study arm No 3 / ACL Revision group if quadriceps tendon is still available) - Relevant co-medication or co-morbidities - Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Instrumented Lachman Test side-by-side (delta in mm), measured by Rolimeter(R) determined after 12 months (3. FU). Further examination intervals: pre-/intraoperative, 1st FU 6 weeks (clin. scores and range of motion only), 2nd FU 3-6 months, 24 months, optional 5 and 10 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| functional Scores (Lysholm, IKDC, Tegner, pain scale) evaluated with an iPad based "Heartbeat ONE" Device, "Back-in-Action" Analyses, Isokinetic msucle strength measurments, walking analyses, rang of motion, Pivot Shift Test; determined after 12 months. Further examination intervals: pre-/intraoperative, 1st FU 6 weeks (clin. scores and range of motion only), 2nd FU 3-6 months, 24 months, optional 5 and 10 years. | — |
Countries
Germany
Contacts
Klinik für Unfall-, Hand- und Wiederherstellungschirurgie,Universitätsklinikum Münster