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

October 9, 2011
October 11, 2011
March 2011
January 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01450332 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Anterior Cruciate Ligament Rupture
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
Experimental: study
Intervention: Device: Knee-T-Nol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
January 2013
January 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact: Jonathan S Yalom, B.Sc. +972-9-7733910 jonathan@tavormed.com
Contact: Idan M Tobis, B.Sc. +972-52-6337098 idan@tavormed.com
Israel
 
NCT01450332
TACLPPS01 Rev 4
Yes
Tavor Ltd.
Tavor Ltd.
Not Provided
Study Director: Idan M Tobis, B.Sc. Tavor Ltd.
Principal Investigator: Yoram Litwin, MD Shaare Zedek Medical Center
Tavor Ltd.
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP