Anterior cruciate ligament rupture
Conditions
Interventions
Patients who are included in this study will be randomly assigned for ACL
reconstruction with one of the three grafts: hamstring autograft, patella
autograft or quadriceps autograft. Stratification
Sponsors
Ziekenhuisgroep Twente
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Patients active in sports, Tegner =/>5 • Primary ACL rupture, evident from anamnesis (acute trauma, snapping sensation, swelling within several hours, feeling of instability), physical examination (positive Lachman test, anterior drawertest and/or pivot shift test), radiograph and MRI • Willing to comply to the suggested (nationwide standard) rehabilitation protocol, supervised by a NFVS registerd sport-physical therapist •
Exclusion criteria
Exclusion criteria: • History of knee surgery on the same side • History of tendon removal on the same side • Accompanying ligament injury of the knee, evident from anamnesis, physical examination, radiograph and MRI, defined as an ACL rupture in combination with a posterior cruciate ligament or collateral ligament injury, • Peroperative discovery of cartilage damage; larger than 2cm2 and more than 50% depth • Peroperative discovery of meniscus injury which requires a meniscectomy of more than 20% or meniscus sutures • Osteoarthritis of Kellgren and Lawrence grade 2 or more, as evident from the radiograph • Severe malalignment of the leg • Tendency to form excessive scar tissue, such as arthrofibrosis • Muscular, neurological or vascular anomalies that influence healingtime or rehabilitation • Infection • Known hypersensitivity to any of the used materials • Long term relevant medication use such as prednisolone or cytostatics • Pregnancy at the time of inclusion or surgery • Known osteoporosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Failure= presence of pathological laxity, complaints of knee instability in the absence of any pathological laxity and/or discontinuïty of the graft on MRI or arthroscopy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures and study parameters are displayed below. Follow-up measurements are perfomed at 6 weeks, 6 months, 1, 2, 5 and 10 years postoperatively. Secondary outcomes • ACL-QOL • Failure • IKDC 2000 subjective knee evaluation score PROM's • KOOS (Knee injury and Osteoarthritis Outcome Score), demographic form, current health assessment form, knee history form • Tegner Score • Lysholm Score • VAS Anterior Knee Pain score during rest • VAS Anterior Knee Pain score during activity • VAS Kneeling Pain score • VAS Contentment score Clinimetrics • IKDC 2000 physical examination score • Instrumented anteroposterior laxity (Rolimeter) • Leg Symmetry Index (LSI) jump tests Radiology • Kellgren-Lawrence (KL) score Other • Monitoring and registration of standard side effects, complications and/or new knee injuries (contact or non-contact) that occur during the whole study, when relevant in relation to specific details from the surgery reports. optionally: Patiënts from OCON will be asked to wear movement sensors during the execution of the regular hop tests (6 months, 1 jaar en 2 jaar) in order to be able to more objectively examine knee (flexion/extension, valgus/varus), ankle en hip angles. | — |
Countries
Netherlands
Outcome results
None listed