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 个研究点目标入组 80 人开始时间: 2014年1月27日最近更新: 2021年4月26日

适应症

试验速览

暂无简介。

•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)
•11. Neuromuscular disorder that would engender unacceptable risk of instability, implant fixation failure, or complications in postoperative care
•12. Pregnant
•13. Unwilling to follow postoperative instructions, in particular with respect to athletic or occupational activities
•14. Current vertebral metastatic tumors
•15. Symptomatic cardiac disease
•16. Severe congenital or acquired vertebral deformities

发起方

Zimmer Spine (France)