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

Primary Purpose

Anterior Cruciate Ligament Rupture

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Knee-T-Nol
Sponsored by
Tavor Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Rupture focused on measuring ACL, arthroscopy, ligament, rupture, reconstruction, ACLR, accelerated rehabilitation program

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Shhare Zedek Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

study

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
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
Long term safety: no device related SAEs 12 months post procedure.

Full Information

First Posted
October 9, 2011
Last Updated
October 11, 2011
Sponsor
Tavor Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01450332
Brief Title
Safety and Efficacy of the Knee-T-nol Anterior Cruciate Ligament (ACL) Prosthesis
Official Title
A Single Arm, Prospective, Single Center, Study To Evaluate The Safety And Efficacy Of Tavor ACL Prosthesis In Patient With ACL Rupture
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
January 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tavor Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Rupture
Keywords
ACL, arthroscopy, ligament, rupture, reconstruction, ACLR, accelerated rehabilitation program

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Knee-T-Nol
Intervention Description
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
Primary Outcome Measure Information:
Title
Knee stability, as measured by a KT-1000 Arthrometer or Lachman test post procedure
Time Frame
post procedure
Title
No treatment emergent SAEs, including Adverse Events of Interest (AEOI), 3 months post procedure.
Time Frame
3 months post procedure
Secondary Outcome Measure Information:
Title
Rehabilitation period, defined by Post procedure period [weeks] to successful rehabilitation phase
Description
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)
Time Frame
3-6 months
Title
Tegner Lysholm scores during the followup period
Description
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
Time Frame
12 months post op
Title
Long term safety: no device related SAEs 12 months post procedure.
Time Frame
12 months post op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient is >= 18 years old Patient has a ruptured ACL Operated knee has full range of motion and no swelling 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. The patient commits to fully undergo the rehabilitation program and return for the scheduled post-operative follow-up visits at the clinic. Exclusion Criteria: Skeletal immaturity Pregnancy 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan S Yalom, B.Sc.
Phone
+972-9-7733910
Email
jonathan@tavormed.com
First Name & Middle Initial & Last Name or Official Title & Degree
Idan M Tobis, B.Sc.
Phone
+972-52-6337098
Email
idan@tavormed.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Idan M Tobis, B.Sc.
Organizational Affiliation
Tavor Ltd.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yoram Litwin, MD
Organizational Affiliation
Shaare Zedek Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shhare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoram Litwin, MD

12. IPD Sharing Statement

Learn more about this trial

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

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