InductOs® in Real World Spine Surgery; A Retrospective, French, Multi-centric, Study

Study Overview
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Brief Summary
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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.

Official Title
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InductOs® in Real World Spine Surgery; A Retrospective, French, Multi-centric, Study

Conditions
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Spine Fusion

Intervention / Treatment
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* Procedure: Spine Fusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Spine Fusion with InductOs<br>Patient had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012 | Procedure: Spine Fusion<br>* All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 
| Instrumentations Used for Stabilization | The number of spine levels using instrumentations for stabilization is presented by types of instrumentations. | during surgery | 

Secondary Outcome Measures

| Outcome Measure | 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). | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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InductOs, rhBMP-2, Retrospective, France, Fusion, real world use