Subjects Received MAGNIFUSE in Posterolateral Lumbar SpineNCT02684045
Retrospective Chart Review to Assess Outcomes in Subjects That Received MAGNIFUSE® in the Posterolateral Lumbar Spine
An observational study of Subjects Received MAGNIFUSE in Posterolateral Lumbar Spine, run by Medtronic Spinal and Biologics at 2 sites in United States.
Trial summary
The purpose of this chart review is to assess outcomes in subjects that received MAGNIFUSE in the posterolateral lumbar spine at 1 or 2 continuous levels from L1-S1. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Subjects Received MAGNIFUSE in Posterolateral Lumbar Spine
- How many people
- 76 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2017to 15 Aug 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects who underwent a posterolateral surgical procedure with MAGNIFUSE in the lumbar spine.
Who may be able to join
- A subject's medical record must contain the following for the subject to be included:
- Posterolateral surgical procedure using MAGNlFUSE with local autograft and/or iliac crest bone graft at one or two continuous lumbar levels from L1-S1.
- Radiographs available for fusion assessment by clinician at 12 and/or 24 month post-surgery visits.
- Subject must be at least 18 years old at the time of index procedure.
Who cannot join
- The subject data will be excluded from this study if the medical record indicates:
- Additional surgical treatment adjacent to the initial lumbar levels treated per Inclusion Criterion 1.
- Infection at index level(s) at time of surgery.
- Extant tumor (evident at any level), spinal metastasis, or spinal tumor at the time of surgery.
- Pregnant at time of surgery.
- Surgery is due to trauma (e.g., motor vehicle accident or high impact fall).
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- Use of growth factors or growth peptide (BMP2, BMP7, or iFactor) in the index-level fusion surgery.
- Procedure is a revision surgery for previously failed fusion at the surgery index level(s).
- Subjects with body mass index > 40 at the time of surgery.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Virginia
Charlottesville, Virginia, 22908
Midwest Ortho. Center
Peoria, Illinois, 61614
About this study
Official title: A Retrospective Review of Charts to Assess Outcomes in Subjects That Received MAGNIFUSE® DBM in the Posterolateral Lumbar Spine
The purpose of this chart review is to assess outcomes in subjects that received MAGNIFUSE in the posterolateral lumbar spine at 1 or 2 continuous levels from L1-S1.
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion status at 12 or 24 months
Fusion status will be assessed using the Lenke posterior fusion criteria below:
- Grade I: Solid trabeculated transverse process and facet fusions bilaterally.
- Grade II: Thick fusion mass on one side, and difficult to visualize on the other side.
- Grade III: Suspected lucency or defect in the fusion mass.
- Grade IV: Definite resorption of graft with fatigue of instrumentation.
Measured: 12 or 24 months
Secondary outcomes (3)
Back pain and leg pain measured by visual analog scale (VAS)
Measured: 12 or 24 months
Pain and Disability status measured by Oswestry Disability Index (ODI)
Measured: 12 or 24 months
Quality of life measured by EQ-5D
Measured: 12 or 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study start1 Mar 2017
- Primary completion15 Aug 2017
- Study completion15 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjects Received MAGNIFUSE in Posterolateral Lumbar SpineStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Spinal and Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02684045
- Sponsor's protocol ID
- P15-03
- Status last verified
- Aug 2017
- First submitted
- 11 Feb 2016
- Last updated
- 21 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Review of Charts to Assess Outcomes in Subjects That Received MAGNIFUSE® DBM in the Posterolateral Lumbar Spine
- ClinicalTrials.gov ID
- NCT02684045
- Acronym / sponsor ID
- P15-03
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Medtronic Spinal and BiologicsIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 15 Aug 2017 (actual)
- Study completion
- 15 Aug 2017 (actual)
- First posted
- 17 Feb 2016 (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.
The purpose of this chart review is to assess outcomes in subjects that received MAGNIFUSE in the posterolateral lumbar spine at 1 or 2 continuous levels from L1-S1.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects who underwent a posterolateral surgical procedure with MAGNIFUSE in the lumbar spine.
Key inclusion criteria (4 listed)
- Posterolateral surgical procedure using MAGNlFUSE with local autograft and/or iliac crest bone graft at one or two continuous lumbar levels from L1-S1.
- Radiographs available for fusion assessment by clinician at 12 and/or 24 month post-surgery visits.
- Subject must be at least 18 years old at the time of index procedure.
Key exclusion criteria (9 listed)
- Additional surgical treatment adjacent to the initial lumbar levels treated per Inclusion Criterion 1.
- Infection at index level(s) at time of surgery.
- Extant tumor (evident at any level), spinal metastasis, or spinal tumor at the time of surgery.
- Pregnant at time of surgery.
- Surgery is due to trauma (e.g., motor vehicle accident or high impact fall).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fusion status at 12 or 24 months
Time frame: 12 or 24 months
Fusion status will be assessed using the Lenke posterior fusion criteria below: * Grade I: Solid trabeculated transverse process and facet fusions bilaterally. * Grade II: Thick fusion mass on one side, and difficult to visualize on the other side. * Grade III: Suspected lucency or defect in the fusion mass. * Grade IV: Definite resorption of graft with fatigue of instrumentation.
3 secondary outcomes
Back pain and leg pain measured by visual analog scale (VAS)
Time frame: 12 or 24 months
Pain and Disability status measured by Oswestry Disability Index (ODI)
Time frame: 12 or 24 months
Quality of life measured by EQ-5D
Time frame: 12 or 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 21 Aug 2017.
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subjects Received MAGNIFUSE in Posterolateral Lumbar Spine, run by Medtronic Spinal and Biologics at 2 sites 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 4 inclusion and 9 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 21 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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?
Fusion status at 12 or 24 months (time frame: 12 or 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 21 Aug 2017.