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

A Single Arm, Prospective, Single Center, Study To Evaluate The Safety And Efficacy Of Tavor ACL Prosthesis In Patient With ACL Rupture

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.

Study Overview

• Status: Unknown
• Conditions: Anterior Cruciate Ligament Rupture
• Intervention / Treatment: Device: Knee-T-Nol

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 91031
    • Recruiting
    • Shhare Zedek Medical Center
    • Principal Investigator: Yoram Litwin, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Rehabilitation period, defined by Post procedure period [weeks] to successful rehabilitation phase	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)	3-6 months
Tegner Lysholm scores during the followup period	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	12 months post op
Long term safety: no device related SAEs 12 months post procedure.		12 months post op

Collaborators and Investigators

• Sponsor: Tavor Ltd.
• Investigators: Study Director: Idan M Tobis, B.Sc., Tavor Ltd.; Principal Investigator: Yoram Litwin, MD, Shaare Zedek Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Anticipated): January 1, 2012
• Study Completion (Anticipated): January 1, 2013

Study Registration Dates

• First Submitted: October 9, 2011
• First Submitted That Met QC Criteria: October 11, 2011
• First Posted (Estimate): October 12, 2011

Study Record Updates

• Last Update Posted (Estimate): October 12, 2011
• Last Update Submitted That Met QC Criteria: October 11, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: ACL; arthroscopy; reconstruction; ACLR; ligament; rupture; accelerated rehabilitation program
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: TACLPPS01 Rev 4