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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Tavor Ltd..
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Tavor Ltd.
ClinicalTrials.gov Identifier:
NCT01450332
First received: October 9, 2011
Last updated: October 11, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
Anterior Cruciate Ligament Rupture
Device: Knee-T-Nol

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Arm, Prospective, Single Center, Study To Evaluate The Safety And Efficacy Of Tavor ACL Prosthesis In Patient With ACL Rupture

Resource links provided by NLM:


Further study details as provided by Tavor Ltd.:

Primary Outcome Measures:
  • Knee stability, as measured by a KT-1000 Arthrometer or Lachman test post procedure [ Time Frame: post procedure ] [ Designated as safety issue: No ]
  • No treatment emergent SAEs, including Adverse Events of Interest (AEOI), 3 months post procedure. [ Time Frame: 3 months post procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rehabilitation period, defined by Post procedure period [weeks] to successful rehabilitation phase [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]

    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 [ Time Frame: 12 months post op ] [ Designated as safety issue: No ]

    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. [ Time Frame: 12 months post op ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: March 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01450332

Contacts
Contact: Jonathan S Yalom, B.Sc. +972-9-7733910 jonathan@tavormed.com
Contact: Idan M Tobis, B.Sc. +972-52-6337098 idan@tavormed.com

Locations
Israel
Shhare Zedek Medical Center Recruiting
Jerusalem, Israel, 91031
Principal Investigator: Yoram Litwin, MD         
Sponsors and Collaborators
Tavor Ltd.
Investigators
Study Director: Idan M Tobis, B.Sc. Tavor Ltd.
Principal Investigator: Yoram Litwin, MD Shaare Zedek Medical Center
  More Information

No publications provided

Responsible Party: Tavor Ltd.
ClinicalTrials.gov Identifier: NCT01450332     History of Changes
Other Study ID Numbers: TACLPPS01 Rev 4
Study First Received: October 9, 2011
Last Updated: October 11, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Tavor Ltd.:
ACL
arthroscopy
ligament
rupture
reconstruction
ACLR
accelerated rehabilitation program

Additional relevant MeSH terms:
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on July 23, 2014