Post-Market Surveillance Study of the TM Ardis Interbody Fusion System

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective, Multi-Center, Post-Market Surveillance Study to Assess the Clinical Efficacy and Fusion Rates of the Zimmer TM Ardis Interbody Fusion System

Conditions
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Degenerative Disc Disease

Intervention / Treatment
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* Device: TM-Ardis Interbody


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > or = 18 years Degenerative disc disease DDD with up to Grade 1 spondylolisthesis or retrolis-thesis at the involved level. DDD is defined as discogenic back pain with degener-ation of the disc confirmed by history and radiographic studies. ODI 40 out of 100 Back pain 4 out of 10 Mono segmental or two level lumbosacral disease Skeletally mature patients Six months failed conservative treatment. Gave written consent to take part in the study by signing the Ethics Committee's approved Patient Informed Consent Form. Physically and mentally able to comply with the protocol, including ability to read and complete required forms and adhere to the follow-up requirements of the pro-tocol. Exclusion Criteria: Prior surgical procedure at the index level(s) using the desired operative approach. Severe degenerative lesions at more than two level of the lumbosacral spine. Morbid obesity (BMI greater than or equal to 40). Active local infection in or near the operative region. Active systemic infection and/or disease. Severe osteoporosis or insufficient bone density, which in the medical opinion of the physician precludes surgery or contraindicates instrumentation. Known or suspected sensitivity to the implant materials. Endocrine or metabolic disorders known to affect osteogenesis (e.g.Paget's disease, renal osteodystrophy, hypothyroidism) Systemic disease that requires the chronic administration of nonsteroidal anti-inflammatory or steroidal drugs. Significant mental disorder or condition that could compromise the patient's ability to remember and comply with preoperative and postoperative instructions (e.g. current treatment for a psychiatric/psychosocial disorder, senile dementia, Alzheimer's disease, traumatic head injury) Neuromuscular disorder that would engender unacceptable risk of instability, implant fixation failure, or complications in postoperative care. Pregnant. Unwilling to follow postoperative instructions, in particular with respect to athletic or occupational activities. Current vertebral metastatic tumors. Symptomatic cardiac disease. Severe congenital or acquired vertebral deformities.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Post market study of TM-Ardis Interbody<br>TM-Ardis TLIF MIS or Open single or multi level implant for lumbar fusion | Device: TM-Ardis Interbody<br>* 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).<br>* Other names: Interbody Cage;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |