prospective multicenter Zimmer TM Ardis post market surveillance study
Research type
Research Study
Full 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.
IRAS ID
146191
Contact name
MARK THOMAS
Contact email
Sponsor organisation
Zimmer Spine
ISRCTN Number
ISRCTN89404187
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Interbody fusion cages were developed to stabilize the cervical or lumbar spine and facilitate fusion while maintaining load bearing capacity and disc height for patients suffering from degenerative disc disease and or spinal instability.
Manufactured entirely from Trabecular Metal™ material, the TM Ardis interbody device is intended for fusion at one or two contiguous levels in the lumbosacral spine (L2-S1). It was CE marked and marketed in 2012.
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.
There will be a total of 80 patients suffering from degenerative disc disease enrolled in a maximum of eight centers. A 18-months recruitment period is anticipated and patients will be followed for two years after the surgery. Follow-up evaluations are required at 3-months (± 2 weeks), 6-months (± 1 month), 12-months (± 1 month) and 24-months (± 2 months) post-operative. Patients will have radiological and clinical assessments and will be asked to fill il standard questionnaires.REC name
London - City & East Research Ethics Committee
REC reference
14/LO/1742
Date of REC Opinion
24 Nov 2014
REC opinion
Further Information Favourable Opinion