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

Tavor Ltd.

Status: Unknown

Conditions: Anterior Cruciate Ligament Rupture

Treatments: Device: Knee-T-Nol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01450332

TACLPPS01 Rev 4

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

study

Experimental group

Treatment:

Device: Knee-T-Nol