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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spine Fusion with InductOs | Patient had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spine Fusion | Procedure | All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| Spine Levels Treated | The number of spine levels from the occiput to S1 is presented. | 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. | 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. | 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. | 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). | During surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Norbert Passuti, Pr | Nantes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux- Centre Universitaire Pellegrin | Bordeaux | France | ||||
| Centre Orthopedique Santy |
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| ID | Title | Description |
|---|---|---|
| FG000 | Spine Fusion With InductOs | Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012 Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Spine Fusion With InductOs | Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012 Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | percentage of participants | Baseline |
|
|
12 months
This is a retrospective study. During this study, all Adverse Events of Interest (AEIs) that occurred after the application of InductOs were collected. Please see secondary outcome 8 (the number of AEIs) for the definition of AEI. The table below contains all AEI, regardless of seriousness.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Spine Fusion With InductOs | Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012 Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Meningocele | Congenital, familial and genetic disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Department | Medtronic Spinal and Biologics | 1800-876-3133 | 6068 | msbkclinicalresearch@medtronic.com |
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| Instrumentations Used for Stabilization | The number of spine levels using instrumentations for stabilization is presented by types of instrumentations. | during surgery |
| 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. | 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. | 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). | 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. | 12 months |
| Fusion Rates in Subgroups | Fusion rates in subgroup (Smokers, non-smokers, Patients with and without diabetes) are reported. | 12 months |
| Lyon |
| France |
| Hopital De La Timone Adultes | Marseille | France |
| Hopital Prive Clairval | Marseille | France |
| CHU de Nantes | Nantes | France |
| Centre Hospitalier Universitaire Nice - Hôpital Pasteur | Nice | 06002 | France |
| Nouvelle Clinique De L'Union | Saint-Jean | France |
| Clinique Du Parc à Saint -Priest en Jarez | Saint-Priest-en-Jarez | France |
| Hopital Civil | Strasbourg | France |
| Clinique Medipole Garonne | Toulouse | France |
| years |
|
| Gender | Count of Participants | Participants |
|
| Smoking Status | Number | participants |
|
| Medical history with or without Diabetes | Number | participants |
|
|
| Primary | Spine Levels Treated | The number of spine levels from the occiput to S1 is presented. | Posted | Number | spine level | During surgery | Spine level | Spine level |
|
|
|
| Primary | 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. | Posted | Number | spine level | During surgery | Spine level | Spine level |
|
|
|
| Primary | The Interbody Device Brand/Generic Names Used With InductOs | The number of spine levels with InductOs is presented by interbody brand/generic names. | Posted | Number | spine level | during surgery | Spine level | Spine level |
|
|
|
| Primary | 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. | The total levels across all the rows are higher than total number of levels analyzed because multiple answers are possible. | Posted | Number | spine level | During surgery | Spine level | Spine level |
|
|
|
| Primary | Supplemental Fixation | The number of spine levels on which supplemental fixation was performed is presented by approaches of stabilization (anterior or posterior stabilization). | The total levels across all the rows are higher than total number of levels analyzed because some levels may be represented in more than one rows. | Posted | Number | spine level | During surgery | Spine level | Spine level |
|
|
|
| Primary | Instrumentations Used for Stabilization | The number of spine levels using instrumentations for stabilization is presented by types of instrumentations. | The total levels in the summary are higher than total amount of levels because multiple answers are possible. | Posted | Number | spine level | during surgery | Spine level | Spine level |
|
|
|
| Secondary | 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). | Posted | Number | events | 12 months |
|
|
|
| Secondary | 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. | Posted | Number | events | 12 months | adverse event | adverse event |
|
|
|
| Secondary | 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. | Posted | Number | participants | 12 months |
|
|
|
| Secondary | 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). | Posted | Number | participants | 12 months |
|
|
|
| Secondary | 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. | The subjects with the image that unable to determine fusion status and the assessment not done" were not taken into account. | Posted | Number | percentage of participants | 12 months |
|
|
|
| Secondary | Fusion Rates in Subgroups | Fusion rates in subgroup (Smokers, non-smokers, Patients with and without diabetes) are reported. | Posted | Number | percentage of participants | 12 months |
|
|
|
| 27 |
| 400 |
| 0 |
| 0 |
| Intestinal Obstruction | Gastrointestinal disorders |
|
| Device Breakage | General disorders |
|
| Device Deployment Issue | General disorders |
|
| Device Dislocation | General disorders |
|
| Implant Site Haematoma | General disorders |
|
| Bacterial Sepsis | Infections and infestations |
|
| Endocarditis Staphylococcal | Infections and infestations |
|
| Postoperative Wound Infection | Infections and infestations |
|
| Wound Infection Staphylococcal | Infections and infestations |
|
| Extradural Haematoma | Injury, poisoning and procedural complications |
|
| Post Procedural Haematoma | Injury, poisoning and procedural complications |
|
| Post Procedural Inflammation | Injury, poisoning and procedural complications |
|
| Postoperative Wound Complication | Injury, poisoning and procedural complications |
|
| Cervical Spinal Stenosis | Musculoskeletal and connective tissue disorders |
|
| Osteoporotic Fracture | Musculoskeletal and connective tissue disorders |
|
| Pseudarthrosis | Musculoskeletal and connective tissue disorders |
|
| Spinal Meningioma Benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Carotid Artery Stenosis | Nervous system disorders |
|
| Motor Dysfunction | Nervous system disorders |
|
| Neuralgia | Nervous system disorders |
|
| Radiculitis Lumbosacral | Nervous system disorders |
|
| Sciatica | Nervous system disorders |
|
| Spinal Cord Ischaemia | Nervous system disorders |
|
| Retrograde Ejaculation | Reproductive system and breast disorders |
|
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| Title | Measurements |
|---|
|
| C3-C4 |
|
| C4-C5 |
|
| C5-C6 |
|
| C6-C7 |
|
| C7-T1 |
|
| T1-T2 |
|
| T2-T3 |
|
| T3-T4 |
|
| T4-T5 |
|
| T5-T6 |
|
| T6-T7 |
|
| T7-T8 |
|
| T8-T9 |
|
| T9-T10 |
|
| T10-T11 |
|
| T11-T12 |
|
| T12-L1 |
|
| L1-L2 |
|
| L2-L3 |
|
| L3-L4 |
|
| L4-L5 |
|
| L5-S1 |
|
| Title | Measurements |
|---|
|
| LLIF |
|
| PLF |
|
| Other |
|
| Title | Measurements |
|---|
|
| Perimeter |
|
| Pyramesh |
|
| Roi |
|
| Roi-A |
|
| Roi-T |
|
| Sovereign |
|
| Synfix-Lr |
|
| Vlift |
|
| Other |
|
| No Cage Used |
|
| Not Available |
|
| Title | Measurements |
|---|---|
|
| Interbody (outside cage) |
|
| Other placement |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|
|
| Other |
|
| Title | Measurements |
|---|---|
|
| Allergic reactions or inflammation |
|
| Fluid collection at the site of implant |
|
| Device (implant) displacement |
|
| Male fertility problems |
|
| Neoplasms (benign, malignant,and unspecified) |
|
| Other Adverse Event of interest |
|
| Title | Measurements |
|---|---|
|
| unplanned secondary surgeries-nondiabetics (n=371) |
|
| Title | Measurements |
|---|
|
| Successful fusion rate in non-diabetics (n=252) |
|