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

Phase 4

Completed

• Conditions: Degenerative Disc Disease
• Interventions: Device: TM-Ardis Interbody

• Registration Number: NCT02429908
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-03
• Study First Submitted: 2015-03-16
• Study First Submitted QC: 2015-04-23
• Study First Posted: 2015-04-29
• Primary Completion: 2018-09-14
• Study Completion: 2018-09-14
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-14
• Last Update Posted: 2019-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Post market study of TM-Ardis Interbody	TM-Ardis Interbody	TM-Ardis TLIF MIS or Open single or multi level implant for lumbar fusion

Primary Outcome Measures

Name	Time	Method
Improvement in ODI score	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

Name	Time	Method
Safety - Adverse Events	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
Fusion rate - X-ray	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°.
Modic changes - MRI	12 and 24 months	Modic changes will be assessed by MRI
Numerical Rating Scale (NRS) for back and leg	3 , 6, 12, and 24 months	Patients will grade back and leg pain with a numeric scale 0 - 10
Zung self-rating depression scale score	3, 6, 12, & 24 months	Patients will complete a questionaire to assess depression.
Patient Outcomes - Mean EQ-5D	24 months

Trial Locations

Locations (10)

OLV Ziekenhuis Department Neurosurgery; 🇧🇪 Aalst, Belgium

Vernon Jubile Hospital; 🇨🇦 Vernon, British Columbia, Canada

Klinikum Dortmund gGmbH; 🇩🇪 Dortmund, Germany

McGill University; 🇨🇦 Montreal, Canada

Asklepios Kliniken GmbH - Auguststrasse; 🇩🇪 Schwedt/Oder, Germany

St. Josef Hospital Troisdorf; 🇩🇪 Troisdorf, Germany

C.H.U. RENNES - Pontchaillou; 🇫🇷 Rennes, France

Sunnybrook Regional Hospital; 🇨🇦 Toronto, Canada

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

Sahlgrenska University Hospital Department of Orthopedics, Spine Divison; 🇸🇪 Gothenburg, Sweden