Overview

This trial is active, not recruiting.

Condition degenerative disc disease
Treatment tm-ardis interbody
Phase phase 4
Sponsor Zimmer, Inc.
Start date March 2014
End date December 2017
Trial size 80 participants
Trial identifier NCT02429908, CME2013-01S

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
TM-Ardis TLIF MIS or Open single or multi level implant for lumbar fusion
tm-ardis interbody Interbody Cage
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).

Primary Outcomes

Measure
Improvement in ODI score
time frame: 24 months

Secondary Outcomes

Measure
Safety - Adverse Events
time frame: 24 months
Fusion rate - X-ray
time frame: 3, 6, 12 and 24 month
Patient Outcomes - Mean EQ-5D
time frame: 24 months
Modic changes - MRI
time frame: 12 and 24 months
Numerical Rating Scale (NRS) for back and leg
time frame: 3 , 6, 12, and 24 months
Zung self-rating depression scale score
time frame: 3, 6, 12, & 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Prospective, Multi-Center, Post-Market Surveillance Study to Assess the Clinical Efficacy and Fusion Rates of the Zimmer TM Ardis Interbody Fusion System
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Zimmer, Inc..