Spine FusionInductORNCT02280187
InductOs® in Real World Spine Surgery; A Retrospective, French, Multi-centric, Study
An observational study of Spine Fusion, run by Medtronic Spinal and Biologics at 10 sites in France.
Trial summary
It is a phase IV, national, multicenter, observational, retrospective study collecting data from patient medical files in French spinal centers. The aim of the study is to describe the real world use of InductOs in Spine fusion in France. Approximately 10 French centers will enroll 400 patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spine Fusion
- What is being tested?
- Spine Fusion
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 10 sitesFrance
- Study dates
- Oct 2014to Oct 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: The retrospective review of records will focus on patients who have undergone a spinal fusion surgery. Patient should be considered for enrollment if he/she has been treated with InductOs between January 1, 2011 and 31st December 2012.
Who may be able to join
- Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012
- Patient as medical records documenting Study Procedure with at least: Age, sex, medical history, primary diagnostic indication, level(s) treated, procedure(s) type, interbody device's information if used
- Patient has received the "information and non-objection letter" and reception is confirmed by registered courier
- Patient is ≥18 years old at the date of the Study Procedure
Who cannot join
- Patient declines participation
- Vulnerable patients, unable to understand the non-objection letter or unable to exercise free decision to refuse to participate to the study (at investigator's discretion)
- Patient died since study procedure*
- Participation in concurrent interventional trial during study participation (from Study Procedure to last study follow-up) which may confound study results
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
CHU de Bordeaux- Centre Universitaire Pellegrin
Bordeaux
Centre Orthopedique Santy
Lyon
Hopital De La Timone Adultes
Marseille
Hopital Prive Clairval
Marseille
CHU de Nantes
Nantes
Centre Hospitalier Universitaire Nice - Hôpital Pasteur
Nice, 06002
Nouvelle Clinique De L'Union
Saint-Jean
Clinique Du Parc à Saint -Priest en Jarez
Saint-Priest-en-Jarez
Hopital Civil
Strasbourg
Clinique Medipole Garonne
Toulouse
About this study
It is a phase IV, national, multicenter, observational, retrospective study collecting data from patient medical files in French spinal centers.
The aim of the study is to describe the real world use of InductOs in Spine fusion in France.
Approximately 10 French centers will enroll 400 patients. The retrospective review of records will focus on patients who have undergone a spinal fusion surgery. Patient should be considered for enrollment if he/she has been treated with InductOs between January 1, 2011 and 31st December 2012.
- Conditions
- Spine Fusion
- Being tested
- Spine Fusion
- Keywords
- InductOs, rhBMP-2, Retrospective, France, Fusion, real world use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spine FusionProcedure or surgery
All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center.
| Study group | Role | What they receive |
|---|---|---|
| Spine Fusion with InductOs | Patient had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012 Receives: Procedure: Spine Fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Diagnostic Indication for InductOs Use
The primary diagnostic indications, which patients were treated with InductOs during spine fusion surgery in France, are presented.
Measured: Baseline
Spine Levels Treated
The number of spine levels from the occiput to S1 is presented.
Measured: During surgery
Primary Surgical Approaches Used for Implantation of InductOs
The surgical approaches for implanting InductOs are classified as anterior lumbar interbody fusion (ALIF), posterior lumbar interbody fusion (PLIF), translateral lumbar interbody fusion (TLIF), lateral lumber interbody fusion (LLIF, including DLIF and XLIF), posterolateral fusion (PLF). The number of spine levels by surgical approaches is presented.
Measured: During surgery
The Interbody Device Brand/Generic Names Used With InductOs
The number of spine levels with InductOs is presented by interbody brand/generic names.
Measured: during surgery
Placement of the Matrix Wetted With InductOs
The placement of the matrix was classified as posterior lateral or interbody space (Inside the cage, between the cages or outside the cage) or any other placement specified. The number of spine levels is presented by placement of the matrix.
Measured: During surgery
Supplemental Fixation
The number of spine levels on which supplemental fixation was performed is presented by approaches of stabilization (anterior or posterior stabilization).
Measured: During surgery
Instrumentations Used for Stabilization
The number of spine levels using instrumentations for stabilization is presented by types of instrumentations.
Measured: during surgery
Secondary outcomes (6)
The Number of Adverse Events of Interest
An adverse event was considered an event of interest (AEI) if an adverse event was considered important to follow. These included reactions described in the EU product label, events monitored in the EU Risk Management Plan, events that were considered possible related to the treatment by the investigator, and events that had serious health consequences for patients (e.g. hospitalization).
Measured: 12 months
AEI Categorisation
The number of AEIs is presented by the categories predefined in the study protocol. The AEI MedDRA coded terms are presented in Section of serious adverse event.
Measured: 12 months
The Number of Subjects Having Secondary Spine Surgical Intervention
The number of subjects who had secondary spine surgical intervention at index level treated with InductOs and other level (either never treated or treated without InductOs) through 12 months is reported.
Measured: 12 months
The Number of Unplanned Secondary Spine Interventions in Subgroups
The number of unplanned secondary spine interventions is reported by subgroups (smoker, non-smoker, diabetics, and non-diabetics).
Measured: 12 months
Fusion Status at the Last Assessment Performed by 12 Months
According to the study protocol, fusion status was determined to be either success or no success based on the images. If fusion failed at 1 level, the fusion was considered to be failed for the patient. The fusion rate at the last assessment is reported.
Measured: 12 months
Fusion Rates in Subgroups
Fusion rates in subgroup (Smokers, non-smokers, Patients with and without diabetes) are reported.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spine FusionStudies 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
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Spinal and Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Norbert Passuti, Pr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02280187
- Sponsor's protocol ID
- 2.05.8005
- Acronym
- InductOR
- Status last verified
- Dec 2016
- First submitted
- 29 Oct 2014
- Last updated
- 6 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- InductOs® in Real World Spine Surgery; A Retrospective, French, Multi-centric, Study
- ClinicalTrials.gov ID
- NCT02280187
- Acronym / sponsor ID
- InductOR / 2.05.8005
- Conditions
- Spine Fusion
- Keywords
- InductOs, rhBMP-2, Retrospective, France, Fusion, real world use
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Medtronic Spinal and BiologicsIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 31 Oct 2014 (estimated)
- Results
- Posted 6 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is a phase IV, national, multicenter, observational, retrospective study collecting data from patient medical files in French spinal centers.
The aim of the study is to describe the real world use of InductOs in Spine fusion in France.
Approximately 10 French centers will enroll 400 patients. The retrospective review of records will focus on patients who have undergone a spinal fusion surgery. Patient should be considered for enrollment if he/she has been treated with InductOs between January 1, 2011 and 31st December 2012.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spine Fusion with InductOs | – | Procedure: Spine FusionPatient had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The retrospective review of records will focus on patients who have undergone a spinal fusion surgery. Patient should be considered for enrollment if he/she has been treated with InductOs between January 1, 2011 and 31st December 2012.
Key inclusion criteria (4 listed)
- Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012
- Patient as medical records documenting Study Procedure with at least: Age, sex, medical history, primary diagnostic indication, level(s) treated, procedure(s) type, interbody device's information if used
- Patient has received the "information and non-objection letter" and reception is confirmed by registered courier
- Patient is ≥18 years old at the date of the Study Procedure
Key exclusion criteria (4 listed)
- Patient declines participation
- Vulnerable patients, unable to understand the non-objection letter or unable to exercise free decision to refuse to participate to the study (at investigator's discretion)
- Patient died since study procedure*
- Participation in concurrent interventional trial during study participation (from Study Procedure to last study follow-up) which may confound study results
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 |
|---|---|---|
| Spine FusionAll patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center. | Procedure or surgery | Spine Fusion with InductOs |
Primary outcome
The Primary Diagnostic Indication for InductOs Use
Time frame: Baseline
The primary diagnostic indications, which patients were treated with InductOs during spine fusion surgery in France, are presented.
Spine Levels Treated
Time frame: During surgery
The number of spine levels from the occiput to S1 is presented.
Primary Surgical Approaches Used for Implantation of InductOs
Time frame: During surgery
The surgical approaches for implanting InductOs are classified as anterior lumbar interbody fusion (ALIF), posterior lumbar interbody fusion (PLIF), translateral lumbar interbody fusion (TLIF), lateral lumber interbody fusion (LLIF, including DLIF and XLIF), posterolateral fusion (PLF). The number of spine levels by surgical approaches is presented.
The Interbody Device Brand/Generic Names Used With InductOs
Time frame: during surgery
The number of spine levels with InductOs is presented by interbody brand/generic names.
Placement of the Matrix Wetted With InductOs
Time frame: During surgery
The placement of the matrix was classified as posterior lateral or interbody space (Inside the cage, between the cages or outside the cage) or any other placement specified. The number of spine levels is presented by placement of the matrix.
Supplemental Fixation
Time frame: During surgery
The number of spine levels on which supplemental fixation was performed is presented by approaches of stabilization (anterior or posterior stabilization).
Instrumentations Used for Stabilization
Time frame: during surgery
The number of spine levels using instrumentations for stabilization is presented by types of instrumentations.
6 secondary outcomes
The Number of Adverse Events of Interest
Time frame: 12 months
AEI Categorisation
Time frame: 12 months
The Number of Subjects Having Secondary Spine Surgical Intervention
Time frame: 12 months
The Number of Unplanned Secondary Spine Interventions in Subgroups
Time frame: 12 months
Fusion Status at the Last Assessment Performed by 12 Months
Time frame: 12 months
Fusion Rates in Subgroups
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Norbert Passuti, Pr principal investigator
Nantes University Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spine Fusion, run by Medtronic Spinal and Biologics at 10 sites in France.
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 4 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 6 Feb 2017. 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 France. 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?
Yes. Results are posted in the registry (first posted 6 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Primary Diagnostic Indication for InductOs Use (time frame: Baseline). The study lists 7 primary outcomes in all. 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 6 Feb 2017.