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

Zimmer Biomet

Status and phase

Completed

Phase 4

Conditions

Degenerative Disc Disease

Treatments

Device: TM-Ardis Interbody

Study type

Interventional

Funder types

Industry

Identifiers

NCT02429908

CME2013-01S

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.