Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02429908
Recruitment Status : Completed
First Posted : April 29, 2015
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Brief 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.

Condition or disease Intervention/treatment Phase
Degenerative Disc Disease Device: TM-Ardis Interbody Phase 4

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : March 2014
Actual Primary Completion Date : September 14, 2018
Actual Study Completion Date : September 14, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Post market study of TM-Ardis Interbody
TM-Ardis TLIF MIS or Open single or multi level implant for lumbar fusion
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).
Other Name: Interbody Cage




Primary Outcome Measures :
  1. Improvement in ODI score [ Time Frame: 24 months ]
    mean change in score of the ODI from baseline to 24 months post surgery. A 15 point improvement in ODI score will be considered as a success.


Secondary Outcome Measures :
  1. Safety - Adverse Events [ Time Frame: 24 months ]
    All adverse events will be assessed by incidence and time to resolution of postoperative device-related complications and serious adverse events/ incidence and time to re-operation/ incidence and time to re-vision

  2. Fusion rate - X-ray [ Time Frame: 3, 6, 12 and 24 month ]
    will be assessed at 3, 6, 12 and 24 months with the following fusion criteria: No evidence of radiolucency surrounding more than 50% of device, translational motion <3 mm and angular motion <5°.

  3. Patient Outcomes - Mean EQ-5D [ Time Frame: 24 months ]
  4. Modic changes - MRI [ Time Frame: 12 and 24 months ]
    Modic changes will be assessed by MRI

  5. Numerical Rating Scale (NRS) for back and leg [ Time Frame: 3 , 6, 12, and 24 months ]
    Patients will grade back and leg pain with a numeric scale 0 - 10

  6. Zung self-rating depression scale score [ Time Frame: 3, 6, 12, & 24 months ]
    Patients will complete a questionaire to assess depression.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > or = 18 years
  • Degenerative disc disease DDD with up to Grade 1 spondylolisthesis or retrolis-thesis at the involved level. DDD is defined as discogenic back pain with degener-ation of the disc confirmed by history and radiographic studies.
  • ODI 40 out of 100
  • Back pain 4 out of 10
  • Mono segmental or two level lumbosacral disease
  • Skeletally mature patients
  • Six months failed conservative treatment.
  • Gave written consent to take part in the study by signing the Ethics Committee's approved Patient Informed Consent Form.
  • 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 pro-tocol.

Exclusion Criteria:

  • Prior surgical procedure at the index level(s) using the desired operative approach.
  • Severe degenerative lesions at more than two level of the lumbosacral spine.
  • Morbid obesity (BMI greater than or equal to 40).
  • Active local infection in or near the operative region.
  • Active systemic infection and/or disease.
  • Severe osteoporosis or insufficient bone density, which in the medical opinion of the physician precludes surgery or contraindicates instrumentation.
  • Known or suspected sensitivity to the implant materials.
  • Endocrine or metabolic disorders known to affect osteogenesis (e.g.Paget's disease, renal osteodystrophy, hypothyroidism)
  • Systemic disease that requires the chronic administration of nonsteroidal anti-inflammatory or steroidal drugs.
  • 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)
  • Neuromuscular disorder that would engender unacceptable risk of instability, implant fixation failure, or complications in postoperative care.
  • Pregnant.
  • Unwilling to follow postoperative instructions, in particular with respect to athletic or occupational activities.
  • Current vertebral metastatic tumors.
  • Symptomatic cardiac disease.
  • Severe congenital or acquired vertebral deformities.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02429908


Locations
Layout table for location information
Belgium
OLV Ziekenhuis Department Neurosurgery
Aalst, Belgium
Canada, British Columbia
Vernon Jubile Hospital
Vernon, British Columbia, Canada
Canada
McGill University
Montreal, Canada
Sunnybrook Regional Hospital
Toronto, Canada
France
C.H.U. RENNES - Pontchaillou
Rennes, France
Germany
Klinikum Dortmund gGmbH
Dortmund, Germany
Asklepios Kliniken GmbH - Auguststrasse
Schwedt/Oder, Germany
St. Josef Hospital Troisdorf
Troisdorf, Germany
Spain
Fundación Jiménez Díaz - Servicio de Cirugía Ortopédica y Traumatología -Avda. Reyes Católicos,
Madrid, Spain
Sweden
Sahlgrenska University Hospital Department of Orthopedics, Spine Divison
Gothenburg, Sweden
Sponsors and Collaborators
Zimmer Biomet
Investigators
Layout table for investigator information
Study Director: Joel Batts Zimmer Biomet Spine

Layout table for additonal information
Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT02429908     History of Changes
Other Study ID Numbers: CME2013-01S
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
Layout table for MeSH terms
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases