This study is a post-market clinical follow-up study to fulfill the post-market surveillance obligations according to Medical Device Directive and MEDDEV 2.12-2\_Rev2\_January 2012. The data collected from this study will serve the purpose of confirming safety and performance of the TM Ardis implant. The goal of this study is to demonstrate that implant is effective in reducing patient disability.
This study is a post-market clinical follow-up (PMCF) study to fulfill the post-market surveillance obligations according to Medical Device Directive and MEDDEV 2.12-2\_Rev2\_January 2012. The data collected from this study will serve the purpose of confirming safety and performance of the TM Ardis implant. The goal of this study is to demonstrate that implant is effective in reducing patient disability, which will be assessed with the ODI questionnaire.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
The TM Ardis implant is a single device manufactured wholly from Trabecular Metal™ (porous tantalum) material, a highly porous, three-dimensional biomaterial designed for biologic fixation. is indicated for use with autogenous bone graft as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (L2- S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
OLV Ziekenhuis Department Neurosurgery
Aalst, Belgium
Vernon Jubile Hospital
Vernon, British Columbia, Canada
McGill University
Montreal, Canada
Sunnybrook Regional Hospital
Improvement in ODI score
mean change in score of the ODI from baseline to 24 months post surgery. A 15 point improvement in ODI score will be considered as a success.
Time frame: 24 months
Safety - Adverse Events
All adverse events will be assessed by incidence and time to resolution of postoperative device-related complications and serious adverse events/ incidence and time to re-operation/ incidence and time to re-vision
Time frame: 24 months
Fusion rate - X-ray
will be assessed at 3, 6, 12 and 24 months with the following fusion criteria: No evidence of radiolucency surrounding more than 50% of device, translational motion \<3 mm and angular motion \<5°.
Time frame: 3, 6, 12 and 24 month
Patient Outcomes - Mean EQ-5D
Time frame: 24 months
Modic changes - MRI
Modic changes will be assessed by MRI
Time frame: 12 and 24 months
Numerical Rating Scale (NRS) for back and leg
Patients will grade back and leg pain with a numeric scale 0 - 10
Time frame: 3 , 6, 12, and 24 months
Zung self-rating depression scale score
Patients will complete a questionaire to assess depression.
Time frame: 3, 6, 12, & 24 months
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Toronto, Canada
C.H.U. RENNES - Pontchaillou
Rennes, France
Klinikum Dortmund gGmbH
Dortmund, Germany
Asklepios Kliniken GmbH - Auguststrasse
Schwedt, Germany
St. Josef Hospital Troisdorf
Troisdorf, Germany
Fundación Jiménez Díaz - Servicio de Cirugía Ortopédica y Traumatología -Avda. Reyes Católicos,
Madrid, Spain
Sahlgrenska University Hospital Department of Orthopedics, Spine Divison
Gothenburg, Sweden