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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Knee-T-Nol | Device | 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 |
| 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 |
| 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:
|
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Inclusion Criteria:
Exclusion Criteria:
Skeletal immaturity
Pregnancy
Patient with:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonathan S Yalom, B.Sc. | Contact | +972-9-7733910 | jonathan@tavormed.com | |
| Idan M Tobis, B.Sc. | Contact | +972-52-6337098 | idan@tavormed.com |
| Name | Affiliation | Role |
|---|---|---|
| Idan M Tobis, B.Sc. | Tavor Ltd. | Study Director |
| Yoram Litwin, MD | Shaare Zedek Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shhare Zedek Medical Center | Recruiting | Jerusalem | Israel | 91031 | Israel |
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| D012421 | Rupture |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| 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 |