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

Anterior Cruciate Ligament Rupture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01450332
• Other study ID #: TACLPPS01 Rev 4
• Status: Recruiting
• Phase: N/A
• First received: October 9, 2011
• Last updated: October 11, 2011
• Start date: March 2011
• Est. completion date: January 2013

Study information

• Verified date: October 2011
• Source: Tavor Ltd.
• Contact: Jonathan S Yalom, B.Sc.
• Phone: +972-9-7733910
• Email: jonathan[@]tavormed.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2013
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Rupture
• Rupture

Intervention

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

Locations

Country	Name	City	State
Israel	Shhare Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Tavor Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee stability, as measured by a KT-1000 Arthrometer or Lachman test post procedure		post procedure	No
Primary	No treatment emergent SAEs, including Adverse Events of Interest (AEOI), 3 months post procedure.		3 months post procedure	Yes
Secondary	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	No
Secondary	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	No
Secondary	Long term safety: no device related SAEs 12 months post procedure.		12 months post op	Yes