Spine Fusion
Conditions
Keywords
InductOs, rhBMP-2, Retrospective, France, Fusion, real world use
Brief 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. 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.
Interventions
PROCEDURESpine Fusion
All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center.
Sponsors
Medtronic Spinal and Biologics
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012 2. 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 3. Patient has received the information and non-objection letter and reception is confirmed by registered courier 4. Patient is ≥18 years old at the date of the Study Procedure
Exclusion criteria
1. Patient declines participation 2. 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) 3. Patient died since study procedure\* 4. Participation in concurrent interventional trial during study participation (from Study Procedure to last study follow-up) which may confound study results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Instrumentations Used for Stabilization | during surgery | The number of spine levels using instrumentations for stabilization is presented by types of instrumentations. |
| The Primary Diagnostic Indication for InductOs Use | Baseline | The primary diagnostic indications, which patients were treated with InductOs during spine fusion surgery in France, are presented. |
| Spine Levels Treated | During surgery | The number of spine levels from the occiput to S1 is presented. |
| Primary Surgical Approaches Used for Implantation of InductOs | 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 | during surgery | The number of spine levels with InductOs is presented by interbody brand/generic names. |
| Placement of the Matrix Wetted With InductOs | 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 | During surgery | The number of spine levels on which supplemental fixation was performed is presented by approaches of stabilization (anterior or posterior stabilization). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AEI Categorisation | 12 months | 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. |
| The Number of Subjects Having Secondary Spine Surgical Intervention | 12 months | 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. |
| The Number of Unplanned Secondary Spine Interventions in Subgroups | 12 months | The number of unplanned secondary spine interventions is reported by subgroups (smoker, non-smoker, diabetics, and non-diabetics). |
| Fusion Status at the Last Assessment Performed by 12 Months | 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. |
| Fusion Rates in Subgroups | 12 months | Fusion rates in subgroup (Smokers, non-smokers, Patients with and without diabetes) are reported. |
| The Number of Adverse Events of Interest | 12 months | 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). |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 400 |
| Total | 400 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 218 |
Baseline characteristics
| Characteristic | Spine Fusion With InductOs |
|---|---|
| Age, Continuous | 54.5 years STANDARD_DEVIATION 14.8 |
| Gender Female | 237 Participants |
| Gender Male | 163 Participants |
| Medical history with or without Diabetes Diabetics | 29 participants |
| Medical history with or without Diabetes Non-diabetics | 371 participants |
| Smoking Status Current smoker | 110 participants |
| Smoking Status Not available | 23 participants |
| Smoking Status Not currently smoking | 267 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 27 / 400 |
Outcome results
Primary
Instrumentations Used for Stabilization
The number of spine levels using instrumentations for stabilization is presented by types of instrumentations.
Time frame: during surgery
Population: The total levels in the summary are higher than total amount of levels because multiple answers are possible.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spine Fusion With InductOs | Instrumentations Used for Stabilization | Screws | 454 spine level |
| Spine Fusion With InductOs | Instrumentations Used for Stabilization | Rods | 394 spine level |
| Spine Fusion With InductOs | Instrumentations Used for Stabilization | Plates | 105 spine level |
| Spine Fusion With InductOs | Instrumentations Used for Stabilization | Other | 77 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.
Time frame: During surgery
Population: The total levels across all the rows are higher than total number of levels analyzed because multiple answers are possible.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spine Fusion With InductOs | Placement of the Matrix Wetted With InductOs | Posterior lateral | 270 spine level |
| Spine Fusion With InductOs | Placement of the Matrix Wetted With InductOs | Interbody (inside the cage) | 335 spine level |
| Spine Fusion With InductOs | Placement of the Matrix Wetted With InductOs | Interbody (between the cage) | 60 spine level |
| Spine Fusion With InductOs | Placement of the Matrix Wetted With InductOs | Interbody (outside cage) | 22 spine level |
| Spine Fusion With InductOs | Placement of the Matrix Wetted With InductOs | Other placement | 20 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.
Time frame: During surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spine Fusion With InductOs | Primary Surgical Approaches Used for Implantation of InductOs | ALIF | 188 spine level |
| Spine Fusion With InductOs | Primary Surgical Approaches Used for Implantation of InductOs | PLIF | 111 spine level |
| Spine Fusion With InductOs | Primary Surgical Approaches Used for Implantation of InductOs | TLIF | 4 spine level |
| Spine Fusion With InductOs | Primary Surgical Approaches Used for Implantation of InductOs | LLIF | 106 spine level |
| Spine Fusion With InductOs | Primary Surgical Approaches Used for Implantation of InductOs | PLF | 221 spine level |
| Spine Fusion With InductOs | Primary Surgical Approaches Used for Implantation of InductOs | Other | 4 spine level |
Primary
Spine Levels Treated
The number of spine levels from the occiput to S1 is presented.
Time frame: During surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spine Fusion With InductOs | Spine Levels Treated | Occiput-C1 | 0 spine level |
| Spine Fusion With InductOs | Spine Levels Treated | C1-C2 | 1 spine level |
| Spine Fusion With InductOs | Spine Levels Treated | C2-C3 | 0 spine level |
| Spine Fusion With InductOs | Spine Levels Treated | C3-C4 | 0 spine level |
| Spine Fusion With InductOs | Spine Levels Treated | C4-C5 | 0 spine level |
| Spine Fusion With InductOs | Spine Levels Treated | C5-C6 | 0 spine level |
| Spine Fusion With InductOs | Spine Levels Treated | C6-C7 | 0 spine level |
| Spine Fusion With InductOs | Spine Levels Treated | C7-T1 | 0 spine level |
| Spine Fusion With InductOs | Spine Levels Treated | T1-T2 | 0 spine level |
| Spine Fusion With InductOs | Spine Levels Treated | T2-T3 | 2 spine level |
| Spine Fusion With InductOs | Spine Levels Treated | T3-T4 | 2 spine level |
| Spine Fusion With InductOs | Spine Levels Treated | T4-T5 | 3 spine level |
| Spine Fusion With InductOs | Spine Levels Treated | T5-T6 | 4 spine level |
| Spine Fusion With InductOs | Spine Levels Treated | T6-T7 | 5 spine level |
| Spine Fusion With InductOs | Spine Levels Treated | T7-T8 | 3 spine level |
| Spine Fusion With InductOs | Spine Levels Treated | T8-T9 | 4 spine level |
| Spine Fusion With InductOs | Spine Levels Treated | T9-T10 | 5 spine level |
| Spine Fusion With InductOs | Spine Levels Treated | T10-T11 | 8 spine level |
| Spine Fusion With InductOs | Spine Levels Treated | T11-T12 | 9 spine level |
| Spine Fusion With InductOs | Spine Levels Treated | T12-L1 | 15 spine level |
| Spine Fusion With InductOs | Spine Levels Treated | L1-L2 | 18 spine level |
| Spine Fusion With InductOs | Spine Levels Treated | L2-L3 | 46 spine level |
| Spine Fusion With InductOs | Spine Levels Treated | L3-L4 | 106 spine level |
| Spine Fusion With InductOs | Spine Levels Treated | L4-L5 | 214 spine level |
| Spine Fusion With InductOs | Spine Levels Treated | L5-S1 | 189 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).
Time frame: During surgery
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spine Fusion With InductOs | Supplemental Fixation | Anterior stabilization | 200 spine level |
| Spine Fusion With InductOs | Supplemental Fixation | Posterior stabilization | 399 spine level |
| Spine Fusion With InductOs | Supplemental Fixation | No stabilization | 99 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.
Time frame: during surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spine Fusion With InductOs | The Interbody Device Brand/Generic Names Used With InductOs | Capstone | 26 spine level |
| Spine Fusion With InductOs | The Interbody Device Brand/Generic Names Used With InductOs | Crescent | 3 spine level |
| Spine Fusion With InductOs | The Interbody Device Brand/Generic Names Used With InductOs | Juliet An | 2 spine level |
| Spine Fusion With InductOs | The Interbody Device Brand/Generic Names Used With InductOs | Perimeter | 91 spine level |
| Spine Fusion With InductOs | The Interbody Device Brand/Generic Names Used With InductOs | Pyramesh | 4 spine level |
| Spine Fusion With InductOs | The Interbody Device Brand/Generic Names Used With InductOs | Roi | 43 spine level |
| Spine Fusion With InductOs | The Interbody Device Brand/Generic Names Used With InductOs | Roi-A | 26 spine level |
| Spine Fusion With InductOs | The Interbody Device Brand/Generic Names Used With InductOs | Roi-T | 5 spine level |
| Spine Fusion With InductOs | The Interbody Device Brand/Generic Names Used With InductOs | Sovereign | 45 spine level |
| Spine Fusion With InductOs | The Interbody Device Brand/Generic Names Used With InductOs | Synfix-Lr | 9 spine level |
| Spine Fusion With InductOs | The Interbody Device Brand/Generic Names Used With InductOs | Vlift | 5 spine level |
| Spine Fusion With InductOs | The Interbody Device Brand/Generic Names Used With InductOs | Other | 96 spine level |
| Spine Fusion With InductOs | The Interbody Device Brand/Generic Names Used With InductOs | No Cage Used | 271 spine level |
| Spine Fusion With InductOs | The Interbody Device Brand/Generic Names Used With InductOs | Not Available | 8 spine level |
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.
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spine Fusion With InductOs | The Primary Diagnostic Indication for InductOs Use | Degenerative disc disease (DDD) | 32.3 percentage of participants |
| Spine Fusion With InductOs | The Primary Diagnostic Indication for InductOs Use | Disc herniation | 4.5 percentage of participants |
| Spine Fusion With InductOs | The Primary Diagnostic Indication for InductOs Use | Stenosis | 3.5 percentage of participants |
| Spine Fusion With InductOs | The Primary Diagnostic Indication for InductOs Use | Spondylolisthesis | 29.8 percentage of participants |
| Spine Fusion With InductOs | The Primary Diagnostic Indication for InductOs Use | Spondylosis (e.g. osteoarthritis) | 0.8 percentage of participants |
| Spine Fusion With InductOs | The Primary Diagnostic Indication for InductOs Use | Deformity (i.e. Scoliosis, kyphosis) | 14.8 percentage of participants |
| Spine Fusion With InductOs | The Primary Diagnostic Indication for InductOs Use | Pseudoarthrosis | 7.3 percentage of participants |
| Spine Fusion With InductOs | The Primary Diagnostic Indication for InductOs Use | Other | 5.0 percentage of participants |
| Spine Fusion With InductOs | The Primary Diagnostic Indication for InductOs Use | Trauma | 2.3 percentage of participants |
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.
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spine Fusion With InductOs | AEI Categorisation | Exuberant bone formation/heterotopic bone growth | 0 events |
| Spine Fusion With InductOs | AEI Categorisation | Excessive bone resorption | 1 events |
| Spine Fusion With InductOs | AEI Categorisation | Nerve compression or nerve root disorders | 3 events |
| Spine Fusion With InductOs | AEI Categorisation | Allergic reactions or inflammation | 1 events |
| Spine Fusion With InductOs | AEI Categorisation | Fluid collection at the site of implant | 5 events |
| Spine Fusion With InductOs | AEI Categorisation | Device (implant) displacement | 7 events |
| Spine Fusion With InductOs | AEI Categorisation | Male fertility problems | 1 events |
| Spine Fusion With InductOs | AEI Categorisation | Neoplasms (benign, malignant,and unspecified) | 1 events |
| Spine Fusion With InductOs | AEI Categorisation | Other Adverse Event of interest | 12 events |
Secondary
Fusion Rates in Subgroups
Fusion rates in subgroup (Smokers, non-smokers, Patients with and without diabetes) are reported.
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spine Fusion With InductOs | Fusion Rates in Subgroups | Successful fusion rate in smokers (n=77) | 72.7 percentage of participants |
| Spine Fusion With InductOs | Fusion Rates in Subgroups | Successful fusion rate in non-smokers (n=179) | 74.3 percentage of participants |
| Spine Fusion With InductOs | Fusion Rates in Subgroups | Successful fusion rate in diabetics (n=14) | 78.6 percentage of participants |
| Spine Fusion With InductOs | Fusion Rates in Subgroups | Successful fusion rate in non-diabetics (n=252) | 73.0 percentage of participants |
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.
Time frame: 12 months
Population: The subjects with the image that unable to determine fusion status and the assessment not done were not taken into account.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spine Fusion With InductOs | Fusion Status at the Last Assessment Performed by 12 Months | Fusion success | 73.3 percentage of participants |
| Spine Fusion With InductOs | Fusion Status at the Last Assessment Performed by 12 Months | Fusion failed | 26.7 percentage of participants |
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).
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Spine Fusion With InductOs | The Number of Adverse Events of Interest | 31 events |
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.
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spine Fusion With InductOs | The Number of Subjects Having Secondary Spine Surgical Intervention | subjects having planned secondary spine surgery | 3 participants |
| Spine Fusion With InductOs | The Number of Subjects Having Secondary Spine Surgical Intervention | subjects having unplanned secondary spine surgery | 9 participants |
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).
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spine Fusion With InductOs | The Number of Unplanned Secondary Spine Interventions in Subgroups | unplanned secondary surgeries in smokers (n=110) | 2 participants |
| Spine Fusion With InductOs | The Number of Unplanned Secondary Spine Interventions in Subgroups | unplanned secondary surgeries in nonsmokers(n=267) | 1 participants |
| Spine Fusion With InductOs | The Number of Unplanned Secondary Spine Interventions in Subgroups | unplanned secondary surgeries-diabetics (n=29) | 0 participants |
| Spine Fusion With InductOs | The Number of Unplanned Secondary Spine Interventions in Subgroups | unplanned secondary surgeries-nondiabetics (n=371) | 3 participants |