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

NCT01450332 | Unknown DMC

• 1 other identifier: TACLPPS01 Rev 4
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament Rupture

Keywords

ACL; arthroscopy; ligament; rupture; reconstruction; ACLR; accelerated rehabilitation program

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Rehabilitation period, defined by Post procedure period [weeks] to successful rehabilitation phase

  3-6 months

• Tegner Lysholm scores during the followup period

  12 months post op

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

  12 months post op

Study Arms (1)

study

EXPERIMENTAL

Device: Knee-T-Nol

Interventions

Knee-T-Nol DEVICE

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

study

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tavor Ltd.: lead

Study Sites (1)

Shhare Zedek Medical Center

Jerusalem, Israel, 91031, Israel

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Rupture

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Idan M Tobis, B.Sc.

  Tavor Ltd.

  STUDY DIRECTOR

• Yoram Litwin, MD

  Shaare Zedek Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan S Yalom, B.Sc.

CONTACT

+972-9-7733910; jonathan@tavormed.com

Idan M Tobis, B.Sc.

CONTACT

+972-52-6337098; idan@tavormed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2011
• First Posted: October 12, 2011
• Study Start: March 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2013
• Last Updated: October 12, 2011

Record last verified: 2011-10

Locations

IL (1)