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

PHASE4CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

March 31, 2014

Primary Completion Date

September 14, 2018

Study Completion Date

September 14, 2018

Conditions
Degenerative Disc Disease
Interventions
DEVICE

TM-Ardis Interbody

The TM Ardis implant is a single device manufactured wholly from Trabecular Metal™ (porous tantalum) material, a highly porous, three-dimensional biomaterial designed for biologic fixation. is indicated for use with autogenous bone graft as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (L2- S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

Trial Locations (10)

Unknown

OLV Ziekenhuis Department Neurosurgery, Aalst

Vernon Jubile Hospital, Vernon

McGill University, Montreal

Sunnybrook Regional Hospital, Toronto

C.H.U. RENNES - Pontchaillou, Rennes

Klinikum Dortmund gGmbH, Dortmund

Asklepios Kliniken GmbH - Auguststrasse, Schwedt

St. Josef Hospital Troisdorf, Troisdorf

Fundación Jiménez Díaz - Servicio de Cirugía Ortopédica y Traumatología -Avda. Reyes Católicos,, Madrid

Sahlgrenska University Hospital Department of Orthopedics, Spine Divison, Gothenburg

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Zimmer Biomet

INDUSTRY