Back to resultsPost-Market Surveillance Study of the TM Ardis Interbody Fusion System
Primary Purpose
Degenerative Disc Disease
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
TM-Ardis Interbody
Sponsored by
About this trial
This is an interventional treatment trial for Degenerative Disc Disease
Eligibility 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.
Sites / Locations
- OLV Ziekenhuis Department Neurosurgery
- Vernon Jubile Hospital
- McGill University
- Sunnybrook Regional Hospital
- C.H.U. RENNES - Pontchaillou
- Klinikum Dortmund gGmbH
- Asklepios Kliniken GmbH - Auguststrasse
- St. Josef Hospital Troisdorf
- Fundación Jiménez Díaz - Servicio de Cirugía Ortopédica y Traumatología -Avda. Reyes Católicos,
- Sahlgrenska University Hospital Department of Orthopedics, Spine Divison
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Post market study of TM-Ardis Interbody
Arm Description
TM-Ardis TLIF MIS or Open single or multi level implant for lumbar fusion
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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°.
Patient Outcomes - Mean EQ-5D
Modic changes - MRI
Modic changes will be assessed by MRI
Numerical Rating Scale (NRS) for back and leg
Patients will grade back and leg pain with a numeric scale 0 - 10
Zung self-rating depression scale score
Patients will complete a questionaire to assess depression.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02429908
Brief Title
Post-Market Surveillance Study of the TM Ardis Interbody Fusion System
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 Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
September 14, 2018 (Actual)
Study Completion Date
September 14, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Post market study of TM-Ardis Interbody
Arm Type
Other
Arm Description
TM-Ardis TLIF MIS or Open single or multi level implant for lumbar fusion
Intervention Type
Device
Intervention Name(s)
TM-Ardis Interbody
Other Intervention Name(s)
Interbody Cage
Intervention Description
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).
Primary Outcome Measure Information:
Title
Improvement in ODI score
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Safety - Adverse Events
Description
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
Time Frame
24 months
Title
Fusion rate - X-ray
Description
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°.
Time Frame
3, 6, 12 and 24 month
Title
Patient Outcomes - Mean EQ-5D
Time Frame
24 months
Title
Modic changes - MRI
Description
Modic changes will be assessed by MRI
Time Frame
12 and 24 months
Title
Numerical Rating Scale (NRS) for back and leg
Description
Patients will grade back and leg pain with a numeric scale 0 - 10
Time Frame
3 , 6, 12, and 24 months
Title
Zung self-rating depression scale score
Description
Patients will complete a questionaire to assess depression.
Time Frame
3, 6, 12, & 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Batts
Organizational Affiliation
Zimmer Biomet Spine
Official's Role
Study Director
Facility Information:
Facility Name
OLV Ziekenhuis Department Neurosurgery
City
Aalst
Country
Belgium
Facility Name
Vernon Jubile Hospital
City
Vernon
State/Province
British Columbia
Country
Canada
Facility Name
McGill University
City
Montreal
Country
Canada
Facility Name
Sunnybrook Regional Hospital
City
Toronto
Country
Canada
Facility Name
C.H.U. RENNES - Pontchaillou
City
Rennes
Country
France
Facility Name
Klinikum Dortmund gGmbH
City
Dortmund
Country
Germany
Facility Name
Asklepios Kliniken GmbH - Auguststrasse
City
Schwedt/Oder
Country
Germany
Facility Name
St. Josef Hospital Troisdorf
City
Troisdorf
Country
Germany
Facility Name
Fundación Jiménez Díaz - Servicio de Cirugía Ortopédica y Traumatología -Avda. Reyes Católicos,
City
Madrid
Country
Spain
Facility Name
Sahlgrenska University Hospital Department of Orthopedics, Spine Divison
City
Gothenburg
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Post-Market Surveillance Study of the TM Ardis Interbody Fusion System
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