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
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.
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 procedureNo 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 phaseTegner Lysholm scores during the followup period Long term safety: no device related SAEs 12 months post procedure.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
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