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

NCT02429908 | Completed Phase 4

• 1 other identifier: CME2013-01S
• Study Type: interventional
• Target: 80
• Locations: 6 countries
• Sites: 10

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.

Conditions

Degenerative Disc Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Safety - Adverse Events

  24 months

• Fusion rate - X-ray

  3, 6, 12 and 24 month

• Patient Outcomes - Mean EQ-5D

  24 months

• Modic changes - MRI

  12 and 24 months

• Numerical Rating Scale (NRS) for back and leg

  3 , 6, 12, and 24 months

Study Arms (1)

Post market study of TM-Ardis Interbody

OTHER

TM-Ardis TLIF MIS or Open single or multi level implant for lumbar fusion

Device: TM-Ardis Interbody

Interventions

TM-Ardis Interbody DEVICE

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).

Also known as: Interbody Cage

Post market study of TM-Ardis Interbody

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (10)

OLV Ziekenhuis Department Neurosurgery

Aalst, Belgium

Location

Vernon Jubile Hospital

Vernon, British Columbia, Canada

Location

McGill University

Montreal, Canada

Location

Sunnybrook Regional Hospital

Toronto, Canada

Location

C.H.U. RENNES - Pontchaillou

Rennes, France

Location

Klinikum Dortmund gGmbH

Dortmund, Germany

Location

Asklepios Kliniken GmbH - Auguststrasse

Schwedt, Germany

Location

St. Josef Hospital Troisdorf

Troisdorf, Germany

Location

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

Madrid, Spain

Location

Sahlgrenska University Hospital Department of Orthopedics, Spine Divison

Gothenburg, Sweden

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Joel Batts

  Zimmer Biomet Spine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2015
• First Posted: April 29, 2015
• Study Start: March 1, 2014
• Primary Completion: September 14, 2018
• Study Completion: September 14, 2018
• Last Updated: March 15, 2019

Record last verified: 2019-03

Locations

FR (1); BE (1); DE (3); ES (1); SE (1); CA (3)