Clinical trial NCT01450332: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Anterior Cruciate Ligament Rupture
Keywords: ACL
arthroscopy
ligament
rupture
reconstruction
ACLR
accelerated rehabilitation program
Lead sponsor: Tavor Ltd.
Sponsor class: INDUSTRY
First posted: 2011-10-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Knee stability, as measured by a KT-1000 Arthrometer or Lachman test post procedure
timeFrame: post procedure
measure: No treatment emergent SAEs, including Adverse Events of Interest (AEOI), 3 months post procedure.
timeFrame: 3 months post procedure
Secondary outcomes:
measure: Rehabilitation period, defined by Post procedure period [weeks] to successful rehabilitation phase
timeFrame: 3-6 months
measure: Tegner Lysholm scores during the followup period
timeFrame: 12 months post op
measure: Long term safety: no device related SAEs 12 months post procedure.
timeFrame: 12 months post op
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shhare Zedek Medical Center
Study officials:
affiliation: Tavor Ltd.
name: Idan M Tobis, B.Sc.
role: STUDY_DIRECTOR
affiliation: Shaare Zedek Medical Center
name: Yoram Litwin, MD
role: PRINCIPAL_INVESTIGATOR
References: