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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02429908
Study type	Interventional
Source	Zimmer Biomet
Contact
Status	Completed
Phase	Phase 4
Start date	March 2014
Completion date	September 14, 2018

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04848376` - Post-Market Clinical Follow-up Study of A-SPINE's Products
Active, not recruiting	`NCT05114135` - TLIF Osteo3 ZP Putty Study (Also Known as the TOP Fusion Study)	N/A
Suspended	`NCT04735185` - Stem Cells vs. Steroids for Discogenic Back Pain	N/A
Withdrawn	`NCT03223701` - Efficacy of Using Solum IV and BMC With GFC in TLIF	Phase 4
Completed	`NCT04057235` - Retrospective Review of Integrity Implants FlareHawk® for Lumbar Fusion
Not yet recruiting	`NCT06000319` - Natural Matrix Protein™ (NMP™) Fibers in Cervical and Lumbar Interbody Fusion
Active, not recruiting	`NCT02969616` - Trinity Elite in Lumbar Fusion
Completed	`NCT02558621` - New Robotic Assistance System for Spinal Fusion Surgery	N/A
Completed	`NCT02104167` - Retrospective/Prospective Data Collection on the LDR ROIC Interbody Fusion Device With VerteBRIDGE Plating
Completed	`NCT00965380` - Trinity Evolution in Posterior or Transforaminal Lumbar Interbody Fusion (PLIF/TLIF)
Terminated	`NCT00974623` - Bone Graft Materials Observational Registry	N/A
Completed	`NCT00996073` - Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion	Phase 2
Completed	`NCT00758719` - Evaluate Effectiveness of the Biomet Lumbar Spinal Fusion System
Completed	`NCT00165893` - Comparison of IDD Therapy and Non-surgical Treatment for Low Back Pain Caused by Degenerative Disc Disease	Phase 4
Terminated	`NCT01494493` - Pivotal Study of rhBMP-2/ACS/Allograft Bone Dowel for Anterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease	N/A
Recruiting	`NCT04727385` - Intervertebral DXM Gel Injection in Adults With Painful Lumbar Degenerative Disc Disease	N/A
Completed	`NCT04849429` - Intra-discal Injection of Platelet-rich Plasma (PRP) Enriched With Exosomes in Chronic Low Back Pain	Phase 1
Recruiting	`NCT04469387` - Preventive Effect of Limited Decompression on Adjacent Segment Following Posterior Lumbar Interbody Fusion	N/A
Recruiting	`NCT04056520` - Clinical and Radiological Outcomes of Posterior Cervical Fusion With Medtronic Infinity Occipitocervical-Upper Thoracic (OCT) System
Completed	`NCT04119466` - Stabilizing Training in Degenerative Disc Disease	N/A