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

Information source: Tavor Ltd.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anterior Cruciate Ligament Rupture

Intervention: Knee-T-Nol (Device)

Phase: N/A

Status: Recruiting

Sponsored by: Tavor Ltd.

Official(s) and/or principal investigator(s):
Idan M Tobis, B.Sc., Study Director, Affiliation: Tavor Ltd.
Yoram Litwin, MD, Principal Investigator, Affiliation: Shaare Zedek Medical Center

Overall contact:
Jonathan S Yalom, B.Sc., Phone: +972-9-7733910, Email: jonathan@tavormed.com


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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Knee stability, as measured by a KT-1000 Arthrometer or Lachman test post procedure

No treatment emergent SAEs, including Adverse Events of Interest (AEOI), 3 months post procedure.

Secondary outcome:

Rehabilitation period, defined by Post procedure period [weeks] to successful rehabilitation phase

Tegner Lysholm scores during the followup period

Long term safety: no device related SAEs 12 months post procedure.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


Inclusion Criteria: 1. Patient is >= 18 years old 2. Patient has a ruptured ACL 3. Operated knee has full range of motion and no swelling 4. 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. 5. The patient commits to fully undergo the rehabilitation program and return for the scheduled post-operative follow-up visits at the clinic. Exclusion Criteria: 1. Skeletal immaturity 2. Pregnancy 3. 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 4. 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.

Locations and Contacts

Jonathan S Yalom, B.Sc., Phone: +972-9-7733910, Email: jonathan@tavormed.com

Shhare Zedek Medical Center, Jerusalem 91031, Israel; Recruiting
Yoram Litwin, MD, Principal Investigator
Additional Information

Starting date: March 2011
Last updated: October 11, 2011

Page last updated: August 23, 2015

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