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

March 14, 2019 updated by: Zimmer Biomet

A Prospective, Multi-Center, Post-Market Surveillance Study to Assess the Clinical Efficacy and Fusion Rates of the Zimmer TM Ardis Interbody Fusion System

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium
        • OLV Ziekenhuis Department Neurosurgery
  • Canada
      • Montreal, Canada
        • McGill University
      • Toronto, Canada
        • Sunnybrook Regional Hospital
    • British Columbia
      • Vernon, British Columbia, Canada
        • Vernon Jubile Hospital
  • France
      • Rennes, France
        • C.H.U. RENNES - Pontchaillou
  • Germany
      • Dortmund, Germany
        • Klinikum Dortmund gGmbH
      • Schwedt/Oder, Germany
        • Asklepios Kliniken GmbH - Auguststrasse
      • Troisdorf, Germany
        • St. Josef Hospital Troisdorf
  • Spain
      • Madrid, Spain
        • Fundación Jiménez Díaz - Servicio de Cirugía Ortopédica y Traumatología -Avda. Reyes Católicos,
  • Sweden
      • Gothenburg, Sweden
        • Sahlgrenska University Hospital Department of Orthopedics, Spine Divison

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 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 Names:
  • Interbody Cage

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
24 months
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, 6, 12 and 24 month
Patient Outcomes - Mean EQ-5D
Time Frame: 24 months
24 months
Modic changes - MRI
Time Frame: 12 and 24 months
Modic changes will be assessed by MRI
12 and 24 months
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
3 , 6, 12, and 24 months
Zung self-rating depression scale score
Time Frame: 3, 6, 12, & 24 months
Patients will complete a questionaire to assess depression.
3, 6, 12, & 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zimmer Biomet

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Joel Batts, Zimmer Biomet Spine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 14, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 14, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CME2013-01S

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Degenerative Disc Disease

Clinical Trials on TM-Ardis Interbody

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings