Safety and Efficacy of the Knee-T-nol Anterior Cruciate Ligament (ACL) Prosthesis
NCT ID: NCT01450332
Last Updated: 2011-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2011-03-31
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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study
Knee-T-Nol
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
Interventions
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Knee-T-Nol
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
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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Tavor Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Idan M Tobis, B.Sc.
Role: STUDY_DIRECTOR
Tavor Ltd.
Yoram Litwin, MD
Role: PRINCIPAL_INVESTIGATOR
Shaare Zedek Medical Center
Locations
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Shhare Zedek Medical Center
Jerusalem, Israel, Israel
Countries
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Central Contacts
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Other Identifiers
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TACLPPS01 Rev 4
Identifier Type: -
Identifier Source: org_study_id