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

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: Completed
• Conditions: Degenerative Disc Disease
• Intervention / Treatment: Device: TM-Ardis Interbody

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: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
Improvement in ODI score	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

Outcome Measure	Measure Description	Time Frame
Safety - Adverse Events	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	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		24 months
Modic changes - MRI	Modic changes will be assessed by MRI	12 and 24 months
Numerical Rating Scale (NRS) for back and leg	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	Patients will complete a questionaire to assess depression.	3, 6, 12, & 24 months

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Joel Batts, Zimmer Biomet Spine

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): September 14, 2018
• Study Completion (Actual): September 14, 2018

Study Registration Dates

• First Submitted: March 16, 2015
• First Submitted That Met QC Criteria: April 23, 2015
• First Posted (Estimate): April 29, 2015

Study Record Updates

• Last Update Posted (Actual): March 15, 2019
• Last Update Submitted That Met QC Criteria: March 14, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: CME2013-01S

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided