A prospective, multi-center, post-market surveillance study to assess the clinical efficacy and fusion rates of the Zimmer®TM Ardis Interbody Fusion System

Zimmer Spine (France)0 sites80 target enrollmentJanuary 27, 2014

Overview

No summary available.

Registry

who.int

Start Date

January 27, 2014

End Date

May 31, 2018

Last Updated

5 years ago

Study Type

Observational

Sex

All

Sponsor

Zimmer Spine (France)

•1\. Age 18 years or over
•2\. Degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.
•3\. ODI over or equal to 40/100
•4\. Back pain over or equal to 4/10
•5\. Mono segmental lumbosacral disease fulfilling the prior conditions: only one level between L2 and S1
•6\. Skeletally mature patients
•7\. Six months failed conservative treatment
•8\. Gave written consent to take part in the study by signing patient informed consent form
•9\. 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 protocol

•1\. Prior surgical procedure at the index level using the desired operative approach
•2\. Severe degenerative lesions at more than one level of the lumbosacral spine
•3\. Morbid obesity (BMI \= 40\)
•4\. Active local infection in or near the operative region
•5\. Active systemic infection and/or disease
•6\. Severe osteoporosis or insufficient bone density, which in the medical opinion of the physician precludes surgery or contraindicates instrumentation
•7\. Known or suspected sensitivity to the implant materials
•8\. Endocrine or metabolic disorders known to affect osteogenesis (e.g. Paget's disease, renal osteodystrophy, hypothyroidism)
•9\. Systemic disease that requires the chronic administration of nonsteroidal anti\-inflammatory or steroidal drugs
•10\. 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)