Safety and Efficacy of the Knee-T-nol Anterior Cruciate Ligament (ACL) Prosthesis

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
A Single Arm, Prospective, Single Center, Study To Evaluate The Safety And Efficacy Of Tavor ACL Prosthesis In Patient With ACL Rupture

Conditions
-----------------
Anterior Cruciate Ligament Rupture

Intervention / Treatment
-----------------
* Device: Knee-T-Nol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is >= 18 years old Patient has a ruptured ACL Operated knee has full range of motion and no swelling Patient understands the study requirements and the treatment procedures and rehabilitation and provides written Informed Consent before any study-specific tests or procedures are performed. The patient commits to fully undergo the rehabilitation program and return for the scheduled post-operative follow-up visits at the clinic. Exclusion Criteria: Skeletal immaturity Pregnancy Patient with: Uncontrolled systemic hypertension Severe uncontrolled Diabetes Mellitus Epiphyses That Have Not Yet Closed Periarticular or Patella Fracture History of Metabolic Bone Disease (e.g.., Osteoporosis, Rickets) Crystal deposition disease, e.g., gout Inflammatory joint disease, e.g., rheumatoid arthritis Severe degenerative joint disease Known neoplastic disease HIV positive Current steroid therapy in excess of prednisone 5 mg/day Other severe, life-threatening systemic disease or any medical condition that interferes with their ability to participate in a rehabilitation program The subject has participated in, or is planned to participate in, any investigational drug or device study within the past 30 days and for the duration of this study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study<br> | Device: Knee-T-Nol<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee stability, as measured by a KT-1000 Arthrometer or Lachman test post procedure |  | post procedure | 
| No treatment emergent SAEs, including Adverse Events of Interest (AEOI), 3 months post procedure. |  | 3 months post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 | 12 months post op | 
| Long term safety: no device related SAEs 12 months post procedure. |  | 12 months post op | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rupture, ACL, arthroscopy, ligament, reconstruction, ACLR, accelerated rehabilitation program