The study is designed to evaluate the safety and efficacy of implanting the Tavor ACL prosthesis in patients with a ruptured ACL by improvement of healing kinetics as well as major adverse treatment events (AEs). it is designed to test the hypothesis that there is a difference in healing kinetics of ACL deficient knees treated by ACL reconstruction using autografts and those in which such procedure was performed with the Tavor prosthesis.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
The ACL prosthesis is intended for the treatment of ruptured ACL. It will be used as an implant to replace the native, torn ACL. Implantation will be done using arthroscopy
Shhare Zedek Medical Center
Jerusalem, Israel, Israel
RECRUITINGKnee stability, as measured by a KT-1000 Arthrometer or Lachman test post procedure
Time frame: post procedure
No treatment emergent SAEs, including Adverse Events of Interest (AEOI), 3 months post procedure.
Time frame: 3 months post procedure
Rehabilitation period, defined by Post procedure period [weeks] to successful rehabilitation phase
Rehabilitation period, defined by Post procedure period \[weeks\] to successful rehabilitation phase, as demonstrated by the ability of the patient to perform the following functional tests: * 70% of single leg 1 Rep Max on leg press vs. uninvolved * 10 single leg squats from 0-45° of flexion without loss of balance, muscle quivering, or varus/valgus moments (patella moving out of the sagittal plane) * 30 consecutive forward step-and-holds from the uninvolved to involved leg without loss of balance, muscle quivering, or varus/valgus moments (patella moving out of the sagittal plane)
Time frame: 3-6 months
Tegner Lysholm scores during the followup period
Short term Tegner Lysholm knee score \>= 65, 3 months post procedure. Long term Knee stability, as measured by a KT-1000 Arthrometer or Lachman test at 12 months post procedure. Long term Tegner Lysholm knee score \>= 84, 12 months post procedure. Procedure time, as compared to standard autograft procedure
Time frame: 12 months post op
Long term safety: no device related SAEs 12 months post procedure.
Time frame: 12 months post op
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.