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

Not Applicable

• Conditions: Anterior Cruciate Ligament Rupture
• Interventions: Device: Knee-T-Nol

• Registration Number: NCT01450332
• Lead Sponsor: Tavor Ltd.

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Status Verified: 2011-10
• Study First Submitted: 2011-10-09
• Study First Submitted QC: 2011-10-11
• Last Update Submitted: 2011-10-11
• Study First Posted: 2011-10-12
• Last Update Posted: 2011-10-12
• Primary Completion: 2012-01
• Study Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
study	Knee-T-Nol	-

Primary Outcome Measures

Name	Time	Method
Knee stability, as measured by a KT-1000 Arthrometer or Lachman test post procedure	post procedure
No treatment emergent SAEs, including Adverse Events of Interest (AEOI), 3 months post procedure.	3 months post procedure

Secondary Outcome Measures

Name	Time	Method
Rehabilitation period, defined by Post procedure period [weeks] to successful rehabilitation phase	3-6 months	Rehabilitation period, defined by Post procedure period \[weeks\] to successful rehabilitation phase, as demonstrated by the ability of the patient to perform the following functional tests: * 70% of single leg 1 Rep Max on leg press vs. uninvolved; * 10 single leg squats from 0-45° of flexion without loss of balance, muscle quivering, or varus/valgus moments (patella moving out of the sagittal plane); * 30 consecutive forward step-and-holds from the uninvolved to involved leg without loss of balance, muscle quivering, or varus/valgus moments (patella moving out of the sagittal plane)
Tegner Lysholm scores during the followup period	12 months post op	Short term Tegner Lysholm knee score \>= 65, 3 months post procedure. Long term Knee stability, as measured by a KT-1000 Arthrometer or Lachman test at 12 months post procedure.; Long term Tegner Lysholm knee score \>= 84, 12 months post procedure. Procedure time, as compared to standard autograft procedure
Long term safety: no device related SAEs 12 months post procedure.	12 months post op

Trial Locations

Locations (1)

Shhare Zedek Medical Center; 🇮🇱 Jerusalem, Israel