Status:
UNKNOWN
Safety and Efficacy of the Knee-T-nol Anterior Cruciate Ligament (ACL) Prosthesis
Lead Sponsor:
Tavor Ltd.
Conditions:
Anterior Cruciate Ligament Rupture
Eligibility:
All Genders
18-65 years
Phase:
NA
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 e...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01450332
Start Date
March 1 2011
End Date
January 1 2013
Last Update
October 12 2011
Active Locations (1)
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1
Shhare Zedek Medical Center
Jerusalem, Israel, Israel, 91031