InductOs® in Real World Spine Surgery; A Retrospective, French, Multi-centric, Study (InductOR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02280187|
Recruitment Status : Completed
First Posted : October 31, 2014
Results First Posted : February 6, 2017
Last Update Posted : February 6, 2017
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.
|Condition or disease||Intervention/treatment|
|Spine Fusion||Procedure: Spine Fusion|
|Study Type :||Observational|
|Actual Enrollment :||400 participants|
|Official Title:||InductOs® in Real World Spine Surgery; A Retrospective, French, Multi-centric, Study|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
Spine Fusion with InductOs
Patient had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012
Procedure: Spine Fusion
All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center.
- 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.
- The Number of Adverse Events of Interest [ Time Frame: 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).
- AEI Categorisation [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 12 months ]Fusion rates in subgroup (Smokers, non-smokers, Patients with and without diabetes) are reported.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02280187
|CHU de Bordeaux- Centre Universitaire Pellegrin|
|Centre Orthopedique Santy|
|Hopital De La Timone Adultes|
|Hopital Prive Clairval|
|CHU de Nantes|
|Centre Hospitalier Universitaire Nice - Hôpital Pasteur|
|Nice, France, 06002|
|Nouvelle Clinique De L'Union|
|Clinique Du Parc à Saint -Priest en Jarez|
|Saint-Priest en Jarez, France|
|Clinique Medipole Garonne|
|Principal Investigator:||Norbert Passuti, Pr||CHU de Nantes|