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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post market study of TM-Ardis Interbody | Other | TM-Ardis TLIF MIS or Open single or multi level implant for lumbar fusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TM-Ardis Interbody | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 months |
| Fusion rate - X-ray |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joel Batts | Zimmer Biomet Spine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OLV Ziekenhuis Department Neurosurgery | Aalst | Belgium | ||||
| Vernon Jubile Hospital |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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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°. |
| 3, 6, 12 and 24 month |
| Patient Outcomes - Mean EQ-5D | 24 months |
| Modic changes - MRI | Modic changes will be assessed by MRI | 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 | 3 , 6, 12, and 24 months |
| Zung self-rating depression scale score | Patients will complete a questionaire to assess depression. | 3, 6, 12, & 24 months |
| Vernon |
| British Columbia |
| Canada |
| McGill University | Montreal | Canada |
| Sunnybrook Regional Hospital | 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 |