Degenerative Disc DiseasePhase 4NCT02429908
Post-Market Surveillance Study of the TM Ardis Interbody Fusion System
A Phase 4 study testing TM-Ardis Interbody in people with Degenerative Disc Disease, run by Zimmer Biomet at 10 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- TM-Ardis Interbody
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 10 sitesin 6 countries
- Study dates
- Mar 2014to 14 Sep 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
10 sites in 6 countries.
10 sites in 6 countries
Canada3 sites
McGill University
Montreal
Sunnybrook Regional Hospital
Toronto
Vernon Jubile Hospital
Vernon, British Columbia
Germany3 sites
Klinikum Dortmund gGmbH
Dortmund
Asklepios Kliniken GmbH - Auguststrasse
Schwedt
St. Josef Hospital Troisdorf
Troisdorf
Spain1 site
Fundación Jiménez Díaz - Servicio de Cirugía Ortopédica y Traumatología -Avda. Reyes Católicos,
Madrid
Sweden1 site
Sahlgrenska University Hospital Department of Orthopedics, Spine Divison
Gothenburg
About this study
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
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.
Read the 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.
- Conditions
- Degenerative Disc Disease
- Being tested
- TM-Ardis Interbody
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TM-Ardis InterbodyDevice
Also called Interbody Cage
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).
| Study group | Role | What they receive |
|---|---|---|
| Post market study of TM-Ardis Interbody | Other | TM-Ardis TLIF MIS or Open single or multi level implant for lumbar fusion Receives: Device: TM-Ardis Interbody |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (6)
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
Measured: 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°.
Measured: 3, 6, 12 and 24 month
Patient Outcomes - Mean EQ-5D
Measured: 24 months
Modic changes - MRI
Modic changes will be assessed by MRI
Measured: 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
Measured: 3 , 6, 12, and 24 months
Zung self-rating depression scale score
Patients will complete a questionaire to assess depression.
Measured: 3, 6, 12, & 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startMar 2014
- Primary completion14 Sep 2018
- Study completion14 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joel Batts, Study director, Zimmer Biomet Spine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02429908
- Sponsor's protocol ID
- CME2013-01S
- Status last verified
- Mar 2019
- First submitted
- 16 Mar 2015
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02429908
- Acronym / sponsor ID
- CME2013-01S
- Conditions
- Degenerative Disc Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- 14 Sep 2018 (actual)
- Study completion
- 14 Sep 2018 (actual)
- First posted
- 29 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post market study of TM-Ardis Interbody | Other | Device: TM-Ardis InterbodyTM-Ardis TLIF MIS or Open single or multi level implant for lumbar fusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TM-Ardis InterbodyAlso: Interbody CageThe 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). | Device | Post market study of TM-Ardis Interbody |
Primary outcome
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.
6 secondary outcomes
Safety - Adverse Events
Time frame: 24 months
Fusion rate - X-ray
Time frame: 3, 6, 12 and 24 month
Patient Outcomes - Mean EQ-5D
Time frame: 24 months
Modic changes - MRI
Time frame: 12 and 24 months
Numerical Rating Scale (NRS) for back and leg
Time frame: 3 , 6, 12, and 24 months
Zung self-rating depression scale score
Time frame: 3, 6, 12, & 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel Batts study director
Zimmer Biomet Spine
10 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TM-Ardis Interbody in people with Degenerative Disc Disease, run by Zimmer Biomet at 10 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Canada, Germany, Belgium, France, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in ODI score (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2019.