Degenerative Disc DiseaseNCT02170558
Enhanced Metal Reduction Techniques for Definitive CT Scanning to Assess Spinal Fusion With TM-Ardis
An observational study of Degenerative Disc Disease, run by Zimmer Biomet at 1 site in United States.
Trial summary
To determine if the subject metal reduction software helps to better visualize bone interphase and fusion reliability. Assess whether the appropriate procedural modification facilitates clearer images when implanted with a trabecular metal spinal implant Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- TM- Ardis implant and Metal Reduction CT software
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Dec 2015
- Phase
- Observational
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who are having a spinal fusion procedure with TM-Ardis and meet the requirements below are eligible for this study.
Who may be able to join
- A signed informed consent.
- Male or non-pregnant female scheduled for Trabecular Metal (TM - Ardis) implant, single level lumbar.
- Participant must be at least 18 years of age.
Who cannot join
- Patient is pregnant Patient is unable to comprehend the requirements of the study.
- Patient is unable to undergo scanning (due to body habitus, inability to comply with positioning requirements, etc.).
Trial locations and contacts
1 site in 1 country.
United States1 site
St Alphonsus Regional Medical Center
Boise, Idaho, 83706
About this study
Official title: Evaluating Enhanced Metal Reduction Techniques for Definitive CT Scanning to Assess Spinal Fusion With Trabecular Metal Implants (TM-Ardis)
To determine if the subject metal reduction software helps to better visualize bone interphase and fusion reliability. Assess whether the appropriate procedural modification facilitates clearer images when implanted with a trabecular metal spinal implant
Read the detailed description
To determine if the subject metal reduction software helps to better visualize bone interphase and fusion reliability, and assess whether the appropriate procedural modification facilitates clearer images when implanted with a trabecular metal spinal implant.
- Conditions
- Degenerative Disc Disease
- Being tested
- TM- Ardis implant and Metal Reduction CT software
- Keywords
- Trabecular Metal, Metal reduction CT, TM- Ardis
- 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 implant and Metal Reduction CT softwareDevice
TM- Ardis implant and Metal Reduction CT software
| Study group | Role | What they receive |
|---|---|---|
| Patients implanted w/TM-Ardis | Patients who are receiving a TM-Ardis implant for degenerative disc disease will have a CT scan immediate post op (2 weeks) and again at 6 months to determine if fusion can be assessed with the study metal reduction software. Will utilize TM- Ardis implant and Metal Reduction CT software Receives: Device: TM- Ardis implant and Metal Reduction CT software |
What is being measured
The primary outcome is the main question the study is designed to answer.
CT scan to determine if the study software can reduce metal scatter on the scan.
Each CT scan will be evaluated to asses if you can visualize fusion, bone interface, and/or device migration with an experimental metal reduction software for CT scan
Measured: 6 month post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 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
- NCT02170558
- Sponsor's protocol ID
- CSU2013-05S
- Status last verified
- Jan 2019
- First submitted
- 18 Jun 2014
- Last updated
- 24 Jan 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 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Enhanced Metal Reduction Techniques for Definitive CT Scanning to Assess Spinal Fusion With Trabecular Metal Implants (TM-Ardis)
- ClinicalTrials.gov ID
- NCT02170558
- Acronym / sponsor ID
- CSU2013-05S
- Conditions
- Degenerative Disc Disease
- Keywords
- Trabecular Metal, Metal reduction CT, TM- Ardis
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 23 Jun 2014 (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.
To determine if the subject metal reduction software helps to better visualize bone interphase and fusion reliability. Assess whether the appropriate procedural modification facilitates clearer images when implanted with a trabecular metal spinal implant
Detailed description
To determine if the subject metal reduction software helps to better visualize bone interphase and fusion reliability, and assess whether the appropriate procedural modification facilitates clearer images when implanted with a trabecular metal spinal implant.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients implanted w/TM-Ardis | – | Device: TM- Ardis implant and Metal Reduction CT softwarePatients who are receiving a TM-Ardis implant for degenerative disc disease will have a CT scan immediate post op (2 weeks) and again at 6 months to determine if fusion can be assessed with the study metal reduction software. Will utilize TM- Ardis implant and Metal Reduction CT software |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who are having a spinal fusion procedure with TM-Ardis and meet the requirements below are eligible for this study.
Key inclusion criteria (3 listed)
- A signed informed consent.
- Male or non-pregnant female scheduled for Trabecular Metal (TM - Ardis) implant, single level lumbar.
- Participant must be at least 18 years of age.
Key exclusion criteria (2 listed)
- Patient is pregnant Patient is unable to comprehend the requirements of the study.
- Patient is unable to undergo scanning (due to body habitus, inability to comply with positioning requirements, etc.).
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 implant and Metal Reduction CT softwareTM- Ardis implant and Metal Reduction CT software | Device | Patients implanted w/TM-Ardis |
Primary outcome
CT scan to determine if the study software can reduce metal scatter on the scan.
Time frame: 6 month post operative
Each CT scan will be evaluated to asses if you can visualize fusion, bone interface, and/or device migration with an experimental metal reduction software for CT scan
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease, run by Zimmer Biomet at 1 site in United States.
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 3 inclusion and 2 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: withdrawn, as of the sponsor's last update on 24 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
CT scan to determine if the study software can reduce metal scatter on the scan. (time frame: 6 month post operative). 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 24 Jan 2019.